louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04947748: Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous
Official title: Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Appendicitis
Acute Appendicitis With Rupture
Acute Appendicitis Without Peritonitis
Acute Appendicitis With Appendix Abscess
Appendicitis; Perforation
Appendicitis Perforated
Appendicitis Acute
Lead sponsor: North Estonia Medical Centre
Sponsor class: OTHER
Collaborators: name: Tartu University Hospital
First posted: 2021-07-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous is a prospective randomized controlled trial comparing 24 hour intravenous antibacterial therapy to 24 hour oral antibacterial therapy after surgery in complicated appendicitis.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed with acute appendicitis and are candidates for laparoscopic appendectomy.

Exclusion Criteria:

Patients with compromised immune system (HIV, diabetes), ongoing or completed radio-chemotherapy in past 5 years, prosthetic heart valve, vascular prosthesis, pregnancy.

Primary outcomes:
measure: Infectious complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tallin
country: Estonia
facility: North Estonia Medical Centre
Study officials:
affiliation: North Estonia Medical Centre
name: Edgar Lipping, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01604148: Retrospective Review a Comprehensive Case Database of HoLEP Procedure Performed by a Single Surgeon
Official title: Retrospective Review of a Comprehensive Case Database of HoLEP (Holmium Laser Enucleation of Prostate) Procedure Performed by a Single Surgeon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Keywords: Holmium Laser Enucleation of Prostate
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 300
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients underwent Holmium Laser Enucleation of the Prostate by a single surgeon

Brief summary: Persistent detrusor overactivity (DO) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. Storage symptoms are major complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate (HoLEP). To investigate the effect of DO in the patients with Benign Prostatic Obstruction (BPO), the investigators evaluated the changes in the storage symptoms following HoLEP in conjunction with the prescription of the anticholinergic drugs.

Detailed description: Eighty men with urodynamically proven BPO underwent HoLEP at our hospital. All patients were evaluated preoperatively with International Prostate Symptom Score (IPSS), International Continence Society male questionnaire short form (ICS-SF), 3-day frequency - volume charts (FVC), transrectal ultrasonography, and uroflowmetry with postvoid residual urine volume. The patients were divided into two groups; BPO without DO (Non-DO group) and BPO with DO (DO group). We assessed the patients postoperatively at 2 weeks, 1, 3 and 6 months after surgery.

Eligibility criteria: Inclusion Criteria:

* 50 yrs or greater
* International prostatic symptom score \>= 12
* Bladder outlet obstruction confirmed by pressure-flow study (BOOI \> 20)

Exclusion Criteria:

* Patients with urologic malignancies such as prostate cancer and bladder cancer
* Patients underwent urethral, prostate surgery
* Patients with urethral stricture or bladder diverticulum or bladder neck contracture

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kyu-Sung Lee, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04737148: Analysis and Accuracy of Mortality Prediction Scores
Official title: The Analysis and Accuracy of Mortality Prediction Scores in Burn Patients Admitted to the Intensive Care Burn Unit (ICBU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Morality
Lead sponsor: Ministry of Health, Kuwait
Sponsor class: OTHER_GOV
First posted: 2021-02-03
Enrollment: 211
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to the ICBU between January 2017 to December 2019

Brief summary: Patients admitted to the ICU in a tertiary burn centre in Kuwait were analysed using multiple mortality prediction scores. The accuracy of these scores were compared to each other to ascertain which prediction modality provides the most accurate prognosis.

Detailed description: The aim of this study is to determine the accuracy of three established scoring systems used for burn patients admitted to the intensive care unit and to determine the risk factors associated with poor outcomes.

A total of 211 patients with who were admitted to the ICBU in a tertiary care centre in Kuwait from January 2017 to December 2019 were analysed retrospectively. Data were collected using patient medical records. The FLAMES, BOBI and revised Baux scores were calculated, and the survivor and non-survivor scores of patients were analysed to determine the sensitivity, specificity and Area Under the Receiver Operating Characteristics (AUROC) of the different scoring modalities.

Eligibility criteria: Inclusion Criteria:

Pediatric burn patients with partial/full thickness burns\>10% TBSA Adult patients with partial/full thickness burns \>15% TBSA Patients with electric burns Patients iwth burns involving the voice Any patient with suspected inhalational injury Burn patients with significant comorbidities

Exclusion criteria:

Patients with incomplete data records

Primary outcomes:
measure: Area under curve of the 3 aforementioned mortality prediction scores
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kuwait City
country: Kuwait
facility: AlBabtain Centre for burns and plastic Surgery
Study officials:
References:
Clinical trial NCT01943448: Macular Hemorrhage in Myopic Eyes
Official title: Macular Hemorrhage in Myopic Eyes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Macula Lutea Hemorrhage
High Myopia
Keywords: Macula Lutea Hemorrhage
High Myopia
Optical Coherence Tomography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Myopia more than -6D
2. Macular hemorrhage inside arcade
3. Patients who are willing to visit our clinic and receive examination regularly for at least 1 year

Brief summary: Visual impairment in high myopic eyes is mainly due to the different types of myopic maculopathies, such as diffuse or patchy atrophy, lacquer cracks and choroidal neovascularization. Macular hemorrhage was one of those complications. Despite choroidal neovascularization, simple hemorrhage from rupture of Bruch's membrane and choroidal microcirculation is also the cause of hemorrhage. The prognosis of those eyes with simple hemorrhage is generally good. However, some patients had persistently poor vision after the absorption of the hemorrhage. In the literature, the visual prognosis in those patients was reported to be associated with the microstructure change under the optical coherent tomography (OCT) or the presentation of the autofluorescence. The investigators will collect the patients with high myopia and presenting with macular hemorrhage. High resolution OCT and autofluorescence imaging will be used to analyze the change of the microstructure of retina and its correlation with the visual prognosis.


Eligibility criteria: Inclusion Criteria:

* Myopia more than -6D
* Macular hemorrhage inside arcade
* Patients who are willing to visit our clinic and receive examination regularly for at least 1 year

Exclusion Criteria:

* Patients who cannot cooperate.
* Macular hemorrhage unrelated to myopia

Primary outcomes:
measure: visual acuity
timeFrame: 1 year
Secondary outcomes:
measure: Optical coherence tomography
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Ophthalmology, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Tzyy-Chang Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02277548: A Pilot Study at a Single-Institution of Pregabalin in the Management of Mucositis Pain in Patients Undergoing Chemoradiation Therapy to the Head and Neck.
Official title: A Pilot Study at a Single-Institution of Pregabalin in the Management of Mucositis Pain in Patients Undergoing Chemoradiation Therapy to the Head and Neck.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oropharyngeal Cancer
Squamous Cell Carcinoma to the Head and Neck
Keywords: chemotherapy
radiation therapy
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 20
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: To assess the efficacy of pregabalin in the management of mucositis pain in patients receiving radiotherapy to the head and neck. Eligible study subjects will be enrolled among those being treated for oropharyngeal cancer with definitive chemotherapy and radiation therapy (photons) to the head and neck in the Department of Radiation Oncology at the University of Pennsylvania.


Eligibility criteria: Inclusion Criteria:

* Patients being treated for oropharyngeal cancer with undergoing concurrent chemotherapy and radiation therapy (photons) for a histological diagnosis of squamous cell carcinoma to the head and neck at the University of Pennsylvania
* Age at least 18 years old
* Treatment entails significant risk for symptomatic mucositis likely to require opioid analgesia, as per the discretion of treating physician/NP
* Subjects are capable of giving informed consent

Exclusion Criteria:

* Patients anticipated to receive radiation therapy with Protons
* History of hypersensitivity to pregabalin or gabapentin
* History of seizure or currently taking anti-epileptic medication
* Creatinine clearance of less than 30 mL/min by Cockcroft-Gault estimate
* Has another painful condition requiring chronic use of opioid analgesic, gabapentin, or pregabalin
* History of serious mood disorder or attempted suicide as determined by patients history and physical and by using theDepression Screening
* Subjects with a score of greater than 10 or those answering #5 with scores greater than a "0" will be deemed ineligible to be enrolled on study
* History of angioedema
* New York Heart Association class III or IV heart failure
* Platelets of less than 150 mg/dL or history of thrombocytopenia
* The patient has any uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that would limit compliance or interfere with their ability to participate

Primary outcomes:
measure: Average/Cumulative Opioid Dose
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Erin McMenamin, MSN, CRNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02584348: Gastric Ultrasound in Paediatric Anaesthesia
Official title: Ultrasound Assessment of Gastric Contents : the Way to Best Induce Children for Emergency Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Keywords: ultrasound, antrum, pulmonary aspiration, emergency surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 146
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Anesthesia for emergency surgery is a situation at risk of pulmonary aspiration of gastric contents. It has been previously reported that bedside two-dimensional ultrasonography can be a useful tool for anesthesiologists to determine gastric contents and volume in adults and children.

In this prospective study, preoperative qualitative ultrasound assessment of gastric contents is performed for each children admitted for emergency surgery, in order to plane in case of empty stomach an intravenous or inhalation technique induction rather than an rapid sequence induction.


Eligibility criteria: Inclusion Criteria:

* Children aged from 0 to 18 years old
* Parental consent

Exclusion Criteria:

* Gastric tube contraindication
* Parental refusal

Primary outcomes:
measure: Number of adapted changes in induction technique according to ultrasound assessment of gastric contents
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Department of paediatric anaesthesia
Study officials:
affiliation: Department of paediatric anaesthesia, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
name: Dominique CHASSARD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01052948: The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events
Official title: The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Hyperprolactinemia
Keywords: dopamine agonists
cabergoline
Parkinson's disease
hyperprolactinemia
epidemiology
cardiac valvulopathy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-21
Enrollment: 86939
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General research practice databases or record linkage systems in Europe that provide access to original medical information. These are: The Health Information Network (THIN), Health Search Database (HSD)-THALES, the Integrated Primary Care Information (IPCI) and PHARMO-Record Linkage System (RLS) and meeting criteria for entry into any of the 4 cohorts between 1995 - 2007

Brief summary: To assess the association between cabergoline and other dopamine agonists (DAs), and symptomatic, diagnosed serious cardiopulmonary disorders, including:

1. Cardiac valve regurgitation
2. Diffuse Pleural/pulmonary thickening and pericardial and retroperitoneal fibrosis
3. Heart failure
4. Total, cardiac and respiratory mortality


Eligibility criteria: Inclusion Criteria:

* At least one year registered with the general practitioner (GP), one year of valid data from the GP, or the date of software conversion (if GP software systems had changed) and meeting criteria for any one of the 4 cohorts as defined.

Exclusion Criteria:

* rheumatic heart disease
* congenital heart disease: includes structural defects, congenital arrhythmias, and cardiomyopathies
* dilated cardiomyopathy (congestive cardiomyopathy
* pericardial, pleural, pulmonary or retroperitoneal fibrosis
* endocarditis or myocarditis
* carcinoid syndrome
* intravenous drug abuse
* fibrotic valvular heart disease
* pleural/pulmonary/pericardial/retroperitoneal fibroses
* use of fenfluramine or amiodarone within 3 years prior to date of diagnosis of fibrotic valvular heart disease

Primary outcomes:
measure: Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up
timeFrame: Up to 12 years
measure: Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up
timeFrame: Up to 12 years
measure: Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up
timeFrame: Up to 12 years
measure: Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up
timeFrame: Up to 12 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00703248: The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Human Immunodeficiency Virus (HIV)
complementary therapies
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2008-06-23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

Brief summary: Treatment options that increase immune function, such as Osteopathic Manipulation Treatment (OMT) lymphatic techniques, may provide improved short or long term performance of the immune system. However, the efficacy of OMT to boost immune function among people living with HIV has not yet been examined in a controlled study. Our experiment is designed to examine the short (45 minutes) term impact of OMT on the white blood cells counts of HIV positive men who are either antiretroviral therapy (ART) naïve or have not taken ART for at least 12 months prior to enrollment in the study.


Eligibility criteria: Inclusion Criteria:

* are either Antiretroviral Therapy (ART) naïve or not have taken ART for the past 12 months
* are between the ages of 18 to 65
* have a CD4+ T cell count between 200-700cells/mm3
* have viral loads less than 100,000 copies/mL
* do not have any medical condition that limits his ability to participate in this study as defined by his physician (e.g., cancer, blood clotting disorder etc.)
* are willing to provide informed consent
* are not using any drugs recreationally
* are not on prescribed systemic steroids
* are willing to recruit a friend/partner, aware of the their HIV serostatus, to be trained in OMT techniques and apply it to him daily.

Exclusion Criteria:

* history of malignancy excluding both squamous cell carcinoma and basal cell carcinoma of the skin and/or any malignancies fully treated and considered cured by the treating physician for at least 1 year
* aortic aneurism/disease
* vertebral artery disease
* carotid artery stenosis/disease
* abdominal hernias
* portal hypertension
* cirrhosis
* cervical disc disease currently exhibiting radicular symptomatology (i.e. numbness, burning, muscle weakness, etc)
* infectious mononucleosis in the past 12 weeks,
* pneumothorax
* bone disease
* Participants with a medical access port and/or a noncompliant ribcage will be excluded from the study.
* The potential causes for ribcage noncompliance include:

  * congestive obstructive pulmonary disorder (COPD)
  * spinal arthritis
  * costochondritis
  * congestive heart failure (CHF)
  * pulmonary edema
  * recent trauma to the ribcage
  * certain connective tissue disease such as Ankylosing Spondylitis
* There is a risk of abdominal aortic aneurysm (AAA) rupture in participants with AAA and these participants are excluded from the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
References:
Clinical trial NCT03459248: Metoclopramide-Ondansetron vs. Metoclopramide Therapy for Treatment of Nausea and Vomiting Post Laparoscopic Surgery
Official title: Metoclopramide-Ondansetron Dual Therapy vs Metoclopramide Monotherapy for Treatment of Nausea and Vomiting Post Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The incidence of postoperative nausea and vomiting (PONV) after general anesthesia is up to 30% when inhalational anesthetics are used with no prophylaxis. This makes PONV one of the most common complaints following surgery under general anesthesia, together with postoperative pain.

Detailed description: This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups:

Group 1: Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia.

Group 2: Patients will receive 10 mg metoclopramide before induction of general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patients aging 16 years and above
* Patients undergoing laparoscopic cholecystectomy under General Anesthesia at Makassed General Hospital

Exclusion Criteria:

* Patients with history of motion sickness
* Patients on previous treatment by anti-emetics for dizziness, vertigo or other causes of nausea and vomiting
* Patients with any type of allergy to metoclopramide or ondansetron
* Patients refusing to be part of the study (refusal to sign consent)
* Patients on previous treatment by opioids

Primary outcomes:
measure: postoperative nausea and vomiting
timeFrame: 36 hours postoperatively
Secondary outcomes:
measure: Surgeon satisfaction
timeFrame: 36 hours postoperatively
measure: Patient satisfaction
timeFrame: 36 hours postoperatively
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
affiliation: Makassed General Hospital
name: Zoher Naja, MD
role: PRINCIPAL_INVESTIGATOR
References: