louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00731185: Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety of Mometasone Furoate Nasal Spray (MFNS) in the Post Surgical Treatment of Nasal Polyposis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasal Polyps
Keywords: functional
endoscopic
sinus
surgery
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 162
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 was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps. Patients who met Screening eligibility underwent endoscopic sino-nasal surgery (FESS) on visit 2. Mometasone nasal spray or placebo was started about 2 weeks after surgery and continued for up to 24 weeks or until relapse.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Bilateral nasal polyps
* Fulfill criteria for polypectomy (be indicated for surgical - FESS - treatment)

Exclusion Criteria:

* Polypectomy within the last 6 months
* Unhealed nasal surgery/trauma
* \>5 previous polypectomies
* Female of childbearing age who is pregnant, lactating, or not using active contraceptive methods
* Nasal infection
* Pulmonary tuberculosis
* Cystic fibrosis, glaucoma, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, hematological, or neurological disease
* Immunocompromised
* Rhinitis medicamentosa (rebound congestion following misuse of nasal decongestants)
* Known hereditary mucociliary dysfunction
* Significant nasal structure abnormalities
* Asthmatic attack within the past 30 days
* Asthmatic patients requiring \>1000 mcg beclomethasone or equivalent
* Asthmatic patients not stable on corticosteroid therapy

Primary outcomes:
measure: Time to relapse in polyp score after surgery
timeFrame: Assessment for relapse was performed at every study visit (up to 24 weeks of treatment)
Secondary outcomes:
measure: Signs and symptom scores
timeFrame: All study visits (up to 24 weeks of treatment)
measure: Quality of life, peak nasal inspiratory flow, olfaction threshold
timeFrame: Measured starting 1 week after treatment up to 24 weeks of treatment
measure: Adverse events
timeFrame: Throughout the whole study after the Screening period.
Other outcomes:
Locations:
Study officials:
References:
citation: Stjarne P, Olsson P, Alenius M. Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):296-302. doi: 10.1001/archoto.2009.2.
Clinical trial NCT04740385: Role of Lung Ultrasound in Confirmation of Correct Double Lumen Endotracheal Tube Placement in Thoracic Surgeries
Official title: Role of Transthoracic Lung Ultrasound in Confirmation of Correct Double Lumen Endotracheal Tube
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnostic Accuracy
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lung cancer patients undergoing thoracic surgeries requiring double lumen intubation

Brief summary: to assess the efficacy of lung ultrasound versus conventional auscultation method and fiberoptic bronchoscopy in confirmation of double lumen tube position

Detailed description: Confirmation of double lumen tube position by auscultation followed fiberoptic bronchoscopy then lung ultrasound. After double lumen intubation all patient tube position will be confirmed using auscultation then fiberoptic bronchoscopy then lung ultrasound

Eligibility criteria: Inclusion Criteria:

* patients scheduled for surgeries under general anesthesia requiring double lumen endotracheal intubation
* ASA I-II

Exclusion Criteria:

* patient refusal
* patients not meeting the inclusion criteria

Primary outcomes:
measure: sensitivity and specificity of lung ultrasound in confirmation of correct double lumen position
timeFrame: 5 minutes
Secondary outcomes:
measure: procedural time
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of anesthesia and pain medicine. National Cancer Institute
Study officials:
affiliation: Lecturer
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01850485: Microcirculatory Perfusion in Patients With Coma After Out-of-hospital Cardiac Arrest
Official title: Microcirculatory Perfusion as Measured by Sublingual SDF Imaging and NIRS in Patients With Coma After Out-of-hospital Cardiac Arrest Treated With Mild Therapeutic Hypothermia (TH) or Not Treated With Mild-TH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: cardiac arrest
therapeutic hypothermia
microcirculation
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients after out of hospital cardiac arrest

Brief summary: The hypothesis is: In patients after an out of hospital cardiac arrest, treated with therapeutic hypothermia (33°C) will be found significantly more microcirculatory abnormalities, compared to the same group of patients treated with 36°C.

Detailed description: The purpose of this study is to investigate the (sublingual) microcirculation in patients after an out of hospital cardiac arrest (OHCA). The microcirculation is measured in this study by Sublingual Side Stream Darkfield (SDF) Imaging and Near InfraRed Spectroscopy (NIRS) at admission and after 12 and 24 hours.

Eligibility criteria: Inclusion Criteria:

* out-of-hospital cardiac arrest
* \> 18 years
* informed consent
* ROSC (return of spontaneous circulation) \< 4 hours

Exclusion Criteria:

* recent maxillofacial surgery
* participation in other clinical trials

Primary outcomes:
measure: Microvascular Flow Index (MFI)
timeFrame: baseline measurement
Secondary outcomes:
measure: RincStO2
timeFrame: baseline
measure: Fluid Balance After 24 Hours
timeFrame: 24 hours
measure: Inotropes and Vasopressor Dose
timeFrame: baseline
measure: Cardiac Index
timeFrame: 24 hours
measure: Lactate
timeFrame: 24 hours
measure: SvO2
timeFrame: 24 hours
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
Study officials:
affiliation: medical center leeuwarden
name: Matty Koopmans, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koopmans M, Kuiper MA, Endeman H, Veenstra G, Vellinga NA, de Vos R, Boerma EC. Microcirculatory perfusion and vascular reactivity are altered in post cardiac arrest patients, irrespective of target temperature management to 33 degrees C vs 36 degrees C. Resuscitation. 2015 Jan;86:14-8. doi: 10.1016/j.resuscitation.2014.09.025. Epub 2014 Oct 18.
Clinical trial NCT03375385: Dexmedetomidine Versus Propofol for Sedation in Stereotactic Brain Biopsy
Official title: Effect of Dexmedetomidine Versus Propofol on the Onset and Recovery of Sedation in Stereotactic Brain Biopsy A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Primarily Acting on the Respiratory System
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pre-operative anxiety leads to higher sympathetic stimulation. Propofol in the main drug used during interventional or imaging techniques that need sedation. Also, dexmedetomidine causes sedation, analgesia, sympatholytic properties, without respiratory depression.In stereotactic brain biopsy; patient discomfort due to drilling a hole through the skull and the advancement of the biopsy needle make the patient in need for good sedation and analgesia.


Eligibility criteria: Inclusion criteria:

Patients with:

* brain secondaries from the lung/breast/pancreas
* tuberculoma
* pyogenic abscess
* intra-axial supratentorial space occupying lesion with or without hydrocephalus \*an average duration of the procedure 1- 2hr 30 min
* an available caregiver for overnight observation
* patient relative proximity to the hospital Exclusion criteria

Patients with:

* morbid obesity (body mass index \>35 kg/m2)
* significant comorbidities (a known history of hepatic disease, renal dysfunction, hypertension, and chronic pain)
* history of drug or alcohol abuse
* an allergic reaction to one of the study medications
* anticipated difficult airway
* uncontrolled epilepsy
* poor neurological status
* neuropsychological unsuitability taking psychotropic drugs (benzodiazepines and barbiturates)
* patients with brain stem lesions (vital areas of brain)
* un-cooperative
* refusing adults
* patients with ventricular drain
* already inpatient
* Intubated patients and those who had a prior craniotomy .

Primary outcomes:
measure: the sedation characteristics
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01868685: Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients
Official title: An Exploratory, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of BYM338 on Muscle in Patients Requiring Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Mechanical Ventilation
Keywords: Muscle, anabolism, cachexia, respiratory failure, diaphragm
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in Group III failure to wean patients, as compared to placebo controls.


Eligibility criteria: Inclusion Criteria:

* Adults on mechanical ventilation for at least 7 days with a tracheostomy in place for \>24 hours.
* Expected to survive at least 14 days.
* Receiving adequate nutritional support, defined as at least 20 kcal/kg and 0.6 g/kg protein per day (unless lower protein intake required by clinical status).

Exclusion Criteria:

* Patients deemed to be terminal wean patients.
* Patients who have progressive neuromuscular degenerative disorders.
* Patients who are comatose.
* Evidence of unstable medical status.

Primary outcomes:
measure: Change in thigh muscle thickness
timeFrame: After 14 days
Secondary outcomes:
measure: Number of patients with adverse events as a measure of safety and tolerability
timeFrame: After 12 weeks
measure: Sparse sampling of BYM338 serum levels to assess pharmacokinetic profile in mechanically ventilated patients
timeFrame: After 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00150085: Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion
Official title: A Prospective, Randomized, Open-label, Twenty-six Week Study of the Efficacy and Safety of Converting Kidney and Liver Transplant Recipients With Tacrolimus-associated Abnormal Glucose Metabolism to Cyclosporine Micro-emulsion With C2 Monitoring
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients
Keywords: diabetes, glucose, tacrolimus, cyclosporine micro-emulsion, liver, kidney, renal
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.


Eligibility criteria: Inclusion Criteria:

* Recipients of first or second cadaveric or living donor kidney transplantation or first cadaveric or living donor liver transplantation
* Receiving tacrolimus as a primary immunosuppressant
* Currently on any diabetic agent or meets the American Diabetes Association definition of diabetes mellitus

Exclusion Criteria:

* History of treated diabetes mellitus prior to transplantation
* Less than 2 weeks post-transplantation for kidney and less than 8 weeks for liver
* Greater than 36 months post-transplantation
* Onset of diabetes is greater than 12 months prior to time of study entry
* Has unacceptable or unstable graft function

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Proportion of patients who no longer require a hypoglycemic agent, or who move from insulin to an oral agent, or who no longer meet the American Diabetes Association criteria, or a relative improvement in mean glycosylated hemoglobin at 12 and 26 weeks
Secondary outcomes:
measure: Safety assessed by death, graft loss, biopsy supported clinically manifested acute rejection, change in kidney function, change in liver function, serious adverse events and adverse events at 12 and 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT00820885: A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide
Official title: A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics and Safety of Elevated Doses
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 95
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of the study was to study the safety and tolerability of teduglutide following a once or possibly twice daily subcutaneous injection for eight consecutive days in healthy subjects. A secondary objective was to study the pharmacokinetics of teduglutide following a once or possibly twice daily injection for eight consecutive days in healthy subjects.

Detailed description: Healthy subjects are enrolled once they have been screened and it is determined they qualify. The subjects are randomized to either placebo or the dose of teduglutide as outlined by the protocol at a 1:3 ratio. They will be injected with investigational product for eight consecutive days, with measurements taken including safety.

Eligibility criteria: Inclusion Criteria:

* Men and women between 20 and 55 years of age
* BMI of 18-35 inclusive
* Able to understand and sign informed consent form
* Willing and able to be confined at the clinical research center 8.5 days
* Women who are post-menopausal, surgically sterilized, or agree to use effective form of birth control
* Women of child bearing potential with a negative pregnancy test at screening and check-in
* Medically healthy with normal clinical results and ECG/lab profiles at screening and check-in

Exclusion Criteria

* Donated 1 pint or more of blood/blood products within 56 days prior to study or received plasma within 7 days prior to study
* Pregnancy or become pregnant
* Participated in another investigational trial 30 days prior
* Physical examination/medical history indicates clinical condition or concurrent illness unsuitable for study
* History/presence of clincally significant disease of any body system
* History/evidence of congenital hon-hemolytic hyperbilirubinemia
* History/evidence of gall stone disease, stomach or intestinal surgery
* History/evidence of colorectal cancer
* History/evidence of GI disease, e.g., malabsorption, Crohn's Disease, etc.
* History/evidence of skin rashes or dermatitis
* Taking prescription or over the counter medication (with the exception of oral contraception) during the 7 days preceding confinement to the clinical unit

Primary outcomes:
measure: Each dose arm is safe
timeFrame: Within 1 week of each cohort completion
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Northwest Kinetics
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01515085: MRI-Guided Laser Induced Thermal Therapy
Official title: MRI-Guided Laser-Induced Thermal Therapy for Cytoreduction of Inoperable Grade III/IV GLiomas Prior to Chemotherapy and Radiation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malignant Glioma
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Rutgers Cancer Institute of New Jersey
First posted: 2012-01-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with brain tumors receiving MR-guided laser ablation

Brief summary: Does MR-guided laser interstitial thermal therapy (MRgLITT) prior to chemotherapy and/or radiation give patients a beneficial increase in overall survival? Laser induced thermal therapy (LITT) is a minimally invasive procedure for destroying tissue through generation of heat.

Detailed description: Laser induced thermal therapy (LITT) is a procedure for destroying tissue through generation of heat. When used in conjunction with fiberoptic applicators, it offers an excellent means of minimally invasive surgery. As opposed to other thermal techniques like radio-frequency (RF) ablation, or cryo-ablation, LITT may be significantly faster and may exhibit sharper boundary of the thermal ablation zone. More importantly, LITT is highly compatible with MR imaging and when coupled with MR thermal imaging (MRTI) guidance, precise monitoring of the thermal ablation zone in order to avoid eloquent or critical structures is possible.

In this study, we propose to evaluate MR-thermal image guided laser interstitial therapy for the treatment of inoperable brain tumors as upfront therapy prior to initiation of chemotherapy and radiation. MR-thermal imaging (MRTI) will be used to provide information on thermal dose delivered to the target and be used to control laser delivery to prevent damage to critical structures.

Eligibility criteria: Inclusion Criteria:

* Subjects that have/will undergo MRgLITT for inoperable brain tumor.
* Tumor size \< 3cm in transverse diameter for each planned applicator placement.
* Tumor size \< 4 cm in largest dimension.
* Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.
* Karnofsky Performance Scale score \> 70.
* ECOG performance status of 2 or better.
* Biopsy proven histologic diagnosis of malignant glioma.

Exclusion Criteria:

* Patients with co-existing medical conditions with life expectancy \< 1 year.
* Patients having received pre-ablation chemotherapy and/or radiation to lesion.

Primary outcomes:
measure: Progression free survival
timeFrame: three years
Secondary outcomes:
measure: Overall survival
timeFrame: three years
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Shabbar F Danish, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03656185: Elbow Arthroscopy Data Analysis
Official title: Retrospective Chart Analysis of Elbow Arthroscopy for the Treatment of Osteoarthritis, Radiocapitellar Plica, Lateral Epicondylitis or Osteochondritis Dissecans
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis Elbow Left
Osteoarthritis Elbow Right
Lateral Epicondylitis, Left Elbow
Lateral Epicondylitis, Right Elbow
Plica Syndromes
Osteochondritis Dissecans
Lead sponsor: The Orthopaedic Research & Innovation Foundation
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients of the principal investigator receiving elbow arthroscopy for any indication at St. Elizabeth Healthcare between January 1, 2010 and October 31, 2017 will be evaluated and included in the data analysis. We anticipate approximately 150 patients to be included in the analysis.

Brief summary: The purpose of this study is to evaluate preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 13 years old or greater at the time of arthroscopic osteocapsular release were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.


Eligibility criteria: Inclusion Criteria:

1. English speaking
2. \>13 years of age
3. Patients treated with elbow arthroscopy for elbow arthritis, radiocapitellar plica, osteochondritis dissecans or lateral epicondylitis.

Exclusion Criteria:

1. Non-English speaking
2. \<13 years of age

Primary outcomes:
measure: Patient Outcomes
timeFrame: preoperative to up to 8 years postoperative
measure: Patient Satisfaction: one question assessment
timeFrame: 2 years to 8 years postoperative
measure: Patient Outcomes
timeFrame: preoperative to up to 8 years postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Edgewood
country: United States
facility: The Orthopaedic Research & Innovation Foundation
state: Kentucky
Study officials:
References: