louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00477217: Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee
Official title: A Randomized, Double-blind, Placebo-controlled, Proof of Concept Study of Zoledronic Acid in Spontaneous Osteonecrosis of the Knee (SONK)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Osteonecrosis
Keywords: Osteonecrosis
zoledronic acid
knee
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of zoledronic acid in patients presenting with spontaneous osteonecrosis of the knee.


Eligibility criteria: Inclusion Criteria:

* Adults 40-85 years of age
* Diagnosis of painful osteonecrosis of the knee within the last month.

Exclusion Criteria:

* Intravenous (iv) bisphosphonates within the last 2 years.
* Abnormal thyroid, kidney or liver function.
* Abnormal blood calcium or alkaline phosphatase levels.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Changes from baseline after 3 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI.
timeFrame: 3 months
Secondary outcomes:
measure: Changes from baseline after 6 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI.
timeFrame: 6 months
measure: Safety as assessed by adverse events.
Other outcomes:
Locations:
city: Gordon
country: Australia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis .
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01366417: Topical Antimicrobial Effectiveness Testing
Official title: Test for Preinjection Skin Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antimicrobial Effectiveness
Lead sponsor: CareFusion
Sponsor class: INDUSTRY
First posted: 2011-06-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator.


Eligibility criteria: Inclusion Criteria:

* in good general health
* have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders.

Exclusion Criteria:

- topical or systemic antimicrobial exposure within 14 days prior to the Screen Visit

Primary outcomes:
measure: Antimicrobial Efficacy
timeFrame: 30 seconds after treatment
measure: Antimicrobial Efficacy
timeFrame: 10 minutes after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sterling
country: United States
facility: Microbiotest
state: Virginia
Study officials:
affiliation: Microbiotest
name: Muhammad H Bashir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05747417: Prismatic Correction for Improving Near Visual Acuity in Patients With Maculopathy
Official title: Prismatic Correction for Improving Near Visual Acuity in Patients With Maculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Al-Shifa Trust Eye Hospital
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: patients with maculopathy reported in low vision clinic are tested for prismatic glasses for near vision. The pre and post visual acuity was recorded.

Detailed description: Diagnosed patient of maculopathy who was visited in low vision clinic are divided in two groups , one is control group (prescribed simple near vision glasses) and other is interventional group(prescribed prismatic glasses). Both groups were follow up after one month to check the improvement in near visual acuity

Eligibility criteria: Inclusion Criteria:

1. Diagnosed patients of maculopathy refer to low vision clinic
2. Patients with both genders
3. VA from LogMAR 1.0 to LogMAR 0.3

Exclusion Criteria:

1. Maculopathy patients with other ocular disease
2. VA worsen the LogMAR 1.0
3. Patients with mental illness and other physical lmitations

Primary outcomes:
measure: Prismatic Correction for Improving Near Visual Acuity in Patients with Maculopathy
timeFrame: 7 -8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Al Shifa Trust Eye Hospital Rawalpindi
state: Punjab
Study officials:
References:
Clinical trial NCT03753217: Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Intravenous Anesthesia
Official title: Assessment of the Depth of Anesthesia During Intravenous Anesthesia: Comparison of the Bispectral Index Monitor and the qCON Monitor.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Keywords: Anesthesia Monitoring
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Quantium Medical Company has an ElectroEncephalograph-based (EEG-based) algorithm with two outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide information about the depth of the hypnotic state, similar to that provided by the BIS™.


Eligibility criteria: Inclusion Criteria:

* Patients above 18 years,
* Patients affiliated to a national insurance scheme or benefiting from such a program,
* Patients having given their written consent,
* Patients that must benefit from a general anesthesia by intravenous drugs (propofol and remifentanil),
* For the patients taken care in ambulatory surgery, having a telephone and agreeing to communicate their phone number.

Exclusion Criteria:

* Pregnant or breast-feeding Women,
* Patients having a limit of use of the Bispectral Index (BIS) or qCON monitors,
* Patients having a contraindication to Propofol and/or to Remifentanil.

Primary outcomes:
measure: qCON monitoring during maintenance of anesthesia
timeFrame: Up to 10 hours
measure: BIS monitoring during maintenance of anesthesia
timeFrame: Up to 10 hours
Secondary outcomes:
measure: qCON monitoring during induction of anesthesia
timeFrame: One day
measure: BIS monitoring during induction of anesthesia
timeFrame: One day
measure: qCON monitoring during recovery of anesthesia
timeFrame: One day
measure: BIS monitoring during recovery of anesthesia
timeFrame: One day
measure: Burst Suppression ratio retrieved by qCON monitoring
timeFrame: One day
measure: Burst Suppression ratio retrieved by BIS monitoring
timeFrame: One day
measure: qNOX monitoring during anesthesia
timeFrame: One day
measure: Periods of loss of signal of qCON
timeFrame: One day
measure: Periods of loss of signal of BIS
timeFrame: One day
measure: Intraoperative memorising
timeFrame: One day
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06246617: Valuate the Clinical Performance and Safety of da Vinci SP Surgical System
Official title: A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Thoracic Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: da Vinci SP Surgical System
Thoracic Surgery
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Intuitive Surgical
First posted: 2024-02-07
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects who have received or plan to receive pulmonary lobectomy/segmentectomy, mediastinal tumor resection (including thymectomy), radical resection of esophagus cancer or other surgeries with the SP single-port robot
Primary purpose: TREATMENT

Brief summary: This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robot-assisted thoracic surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.

Detailed description: Subjects who have received or plan to receive pulmonary lobectomy/segmentectomy, mediastinal tumor resection (including thymectomy), radical resection of esophagus cancer or other surgeries with the SP single-port robot.

Eligibility criteria: Inclusion Criteria:

* 1. Subjects who have received or plan to receive pulmonary lobectomy/segmentectomy, mediastinal tumor resection (including thymectomy), radical resection of esophagus cancer or other surgeries with the SP single-port robot; 2. Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).

Exclusion Criteria:

* 1. Patients with missing data on the primary endpoint in retrospective cases; 2. Subjects having any contraindications of single-port robot surgery; 3. The intraoperative anatomy determined that minimally invasive surgery was not suitable; 4. Patients who are considered inappropriate to participate in this study by investigator.

Primary outcomes:
measure: Intraoperative conversion rate
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT00652717: Study To Assess The Efficacy Of A Cholesterol Lowering Drug On Top Of Statins In Patients After Myocardial Infarction (MI)(0653A-150)
Official title: A Multicenter, Open Study To Evaluate The Efficacy Of Ezetimibe 10 Mg Added On Statin Therapy, In Reducing LDL Cholesterol To Target Levels In Patients After Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disorder
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-04-04
Enrollment: 280
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: Collecting local data, safety and experience trial.


Eligibility criteria: Inclusion Criteria:

* Patients; Post Acute Coronary Syndrome

Exclusion Criteria:

-

Primary outcomes:
measure: LDL levels
timeFrame: 42 Days
Secondary outcomes:
measure: Safety measures
timeFrame: 42 days
measure: Total cholesterol levels.
timeFrame: 42 Days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00816517: Use of Botulinum Toxin to Treat Psoriasis
Official title: Pilot Study on the Safety and Efficacy of Botulinum Toxin Injections in the Treatment of Psoriasis Vulgaris.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis Vulgaris
Keywords: Psoriasis
Botulinum toxin
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2009-01-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Psoriasis vulgaris is a chronic disease in which psoriatic plaques may appear on the knees, elbows, scalp and trunk. Evidence suggests the role of neurogenic inflammation in the pathogenesis of psoriasis. Botulinum toxin has been shown to have an effect on inhibiting neurogenic inflammation.

Recently, it was reported that patients who suffered from dystonia and had concomitant psoriasis, when treated with botulinum toxin for dystonia noted a dramatic improvement of their psoriatic lesions.

This pilot study will determine the safety and efficacy of botulinum toxin in the management of psoriasis vulgaris.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects. Psoriasis vulgaris diagnosis made by a board certified dermatologist involving at least one area that has been intolerant or recalcitrant to at least two forms of recognized topical or systemic treatments in the past. In addition, the subject should have at least a score of 2 for keratoderma and erythema. Signed informed consent. Willing to adhere to protocol.

Exclusion Criteria:

* Immunosuppressed patients, pregnant, secondary skin infections, phototherapy within 4 weeks of the botulinum toxin injection, exposure to any topical or systemic retinoid treatment with the last 12 months, volunteers taking chloroquine and hydroxychloroquine, volunteers on warfarin.

Primary outcomes:
measure: psoriasis scoring scale
timeFrame: baseline and 3months
Secondary outcomes:
measure: 3mm skin biopsy.
timeFrame: baseline and at 3 months.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Univerisity of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Maria K Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00052117: Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens
Official title: A Phase 2, Randomized, Double-Blind, Dose-Ranging Study Of Capravirine (AG1549) In Combination With Kaletra (Trademark) and At Least 2 Nucleoside Reverse Transcriptase Inhibitors in Hiv-Infected Subjects Who Have Failed Antiretroviral Regimens Containing Protease Inhibitors, Nonnucleoside Reverse Transcriptase Inhibitors, and Nucleoside Reverse Transcriptase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-01-23
Enrollment: 300
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 is a 48 week study for HIV-infected patients who have failed several regimens including PI's, NNRTs and NRTIs. Patients will be randomly selected to be in 1 of 4 groups. Three of the 4 groups will contain capravirine in different doses combined with Kaletra and nucleosides and one of the groups will be a combination of Kaletra and nucleosides without the capravirine.


Eligibility criteria: Inclusion Criteria:

* HIV-infected male or female at least 18 years of age
* HIV RNA level \>1000 copies/mL at screening
* Subject has failed regimens that included at least 1 protease inhibitor but not more than 3 protease inhibitors, at least 1 nonnucleoside reverse transcriptase inhibitor, and least 2 nucleoside reverse transcriptase inhibitors
* Adequate renal function
* Adequate hematological function
* Adequate liver function

Exclusion Criteria:

* Women who are pregnant or lactating
* No previous experience with Kaletra

Primary outcomes:
measure: To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs
Secondary outcomes:
measure: the relationship of HIV baseline resistance (genotype and phenotype) to virologic outcome
measure: the population pharmacokinetics of capravirine and lopinavir/ritonavir (Kaletra) using mixed-effects modeling
measure: the pharmacokinetic drug-drug interactions between capravirine and Kaletra and selected concomitant medications
measure: changes in subject-reported health status and HIV symptoms using the Medical Outcomes Study - HIV Health Survey (MOS-HIV) and the Symptoms Distress Module (National Institute of Allergy and Infectious Diseases Adult AIDS Clinical Trials Group)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03125317: Evaluating the Efficacy of Valsalva's Maneuver and Music Therapy on Peripheral Venous Cannulation
Official title: Evaluating the Efficacy of Valsalva's Maneuver and Music Therapy on Peripheral Venous Cannulation Pain and Anxiety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cannulation,Pain
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that underwent surgery

Brief summary: Evaluating the efficacy of Valsalva's maneuver and music therapy on peripheral venous cannulation pain and anxiety

Detailed description: One hundred and fifty patients undergoing surgery were randomized to apply Valsalva's maneuver (the valsalva group) and music therapy(the music group) and a placebo (the control group) during peripheral venous cannulation (PVC). The patients' pain, anxiety, and satisfaction scores will be measured.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery

Exclusion Criteria:

* Patients with a history of anxiety disorders or hearing problem and preoperative pain.

Primary outcomes:
measure: Visual analog scale
timeFrame: one month
Secondary outcomes:
measure: satisfaction scale
timeFrame: one month
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Assistant professor
name: Hakan Tapar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06289517: PET Imaging of 68Ga-Her2-affibody in Tumors with High Her2 Expression
Official title: A Study to Evaluate 68Ga-Her2-affibody PET/CT Imaging of Her2 Expression in Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Keywords: 68Ga-Her2-affibody
PET/CT
Neoplasms
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2, aiming to provide a new imaging method for the determination of HER2 status in breast cancer At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.

Detailed description: This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2 in whole body cancer lesions, aiming to provide a new imaging method for the determination of HER2 status in breast cancer and supplement more overall information that is difficult to obtain by traditional core needle biopsy. At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.

Eligibility criteria: Inclusion Criteria:

- patients with confirmed or suspected cancer; Signed written informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer
timeFrame: 1 year
Secondary outcomes:
measure: The dosimetry of 68Ga-Her2-affibody
timeFrame: 1 year
measure: Quantitative evaluation of 68Ga-Her2-affibody
timeFrame: 1 year
measure: Correlation with pathological expression
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06692517: Benchmarks in Elective Laparoscopic Cholecystectomy
Official title: Benchmarks in Elective Laparoscopic Cholecystectomy - a National Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gall Stone
Gallbladder Inflammation
Gall Bladder Pain
Gallstone
Gall Stones (& [Calculus - Gall Bladder])
Keywords: Laparoscopic cholecystectomy
Benchmarking
Surgical Outcomes
Reference values
Quality Improvement
Risk factors of surgical complications
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 60000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with gall stone disease and, or previous gallbladder inflammation.

Brief summary: The aim of this observational cohort study is to define peri- and postoperative reference values for elective laparoscopic cholecystectomy, using the achievable benchmarks of care methodology (ABC™). Another aim is to develop adjusted reference values for groups with a risk factor of severe postoperative complications. The over-arching aim is to inspire quality improvement initiatives.

Detailed description: The data source is the Swedish patient registry GallRiks, a prospective quality registry for gallbladder surgery and endoscopic retrograde cholangio-pancreatography (ERCP). The time frame will be 2015-2023. Register variables related to surgical quality will be analyzed, such as postoperative complications, perioperative adverse events, surgical duration and length of stay. The study will analyze data for the time of surgery and up to 30 days afterwards. Since the data is not yet available to the researchers the number of enrolled study participants can not be specified with certitude; therefore an anticipated number is given.

Eligibility criteria: Inclusion Criteria:

* adults ≥ 18 years of age
* laparoscopic primary cholecystectomy

Exclusion Criteria:

* patients with current acute cholecystitis, pancreatitis or cholangitis
* cholecystectomy due to malignancy
* other organ surgery performed at the same occasion
* previous upper gastrointestinal surgery
* single port access
* robotic surgery
* no data concerning surgical intervention

Primary outcomes:
measure: Benchmark values of elective laparoscopic cholecystectomy
timeFrame: Day of surgery
measure: Postoperative benchmark values of elective laparoscopic cholecystectomy
timeFrame: 0-30 days after surgery
Secondary outcomes:
measure: Adjusted benchmarks for severe complications
timeFrame: 0-30 days after surgery
Other outcomes:
Locations:
Study officials:
References: