louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01139385: Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery
Official title: Comparative Study Between Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery: a Prospective Randomized Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholelithiasis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 218
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with gallstone undergoing cholecystectomy in day surgery setting

Brief summary: The aim of this study was to compare between the safety and efficacy of the harmonic shears and the commonly used clip technique in achieving safe closure and division of the cystic duct in the laparoscopic cholecystectomy in day surgery setting


Eligibility criteria: Inclusion Criteria:

* Symptomatic Cholelithiasis
* Age under 65 yr old
* BMI under 35
* ASA I or II

Exclusion Criteria:

* Acute cholecystitis
* Suspect of common bile duct stones

Primary outcomes:
measure: effectiveness closure of the cystic duct
timeFrame: at 1 months
Secondary outcomes:
measure: postoperative complication
timeFrame: 1 month
measure: efficacy and safety of the use of harmonic scalpel performing cholecystectomy
timeFrame: 24 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Oneday - Day Surgery Unit - Azienda Ospedaliera Sant'Andrea - University Sapienza of Rome
Study officials:
References:
Clinical trial NCT02646085: Multiparametric Imaging in Multiple Myeloma
Official title: Multiparametric Imaging in Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography imaging with intravenously injected C11 Methionine to detect viable lesions.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Multiple Myeloma with symptomatic bone or soft tissue disease
* Eastern Cooperative Oncology Group status 0 to 2
* Life expectance \>= 12 weeks
* Ability to understand and willingness to sign informed consent
* Tissue sampling with genotype data planned within 3 months of C11 positron emission tomography (PET) imaging

Exclusion Criteria:

* Pregnant or breast feeding
* Claustrophobic reactions and unable to lie still on a bed inside the PET scanner for 60 minutes
* Research related radiation exposure exceeding 50 millisieverts

Primary outcomes:
measure: Quantitative measure of C11 Methionine uptake
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00724685: Interest of Continuous Ropivacaine Administration Through an Elastomeric Pump (Pain Buster) for the Surgery of Latissimus Dorsi and Serratus Micro Anastomotic Flaps
Official title: Interest of Continuous Ropivacaine Administration Through an Elastomeric Pump (Pain Buster ) for the Surgery of Latissimus Dorsi and Serratus Micro Anastomotic Flaps
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Post Operative Analgesia
Keywords: Ropivacaine
elastomeric pump
patient controlled analgesia
morphine consumption
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Continuous bupivacaine administration through an elastomeric pump (Pain Buster) has been found effective for post operative analgesia in a large range of surgery. Ropivacaine is a less toxic drug, never tested in the surgery of latissimus dorsi and serratus micro anastomotic flaps (from the investigators knowledge). The aim of the study is to evaluate the usefulness of this drug and device for post operative analgesia, associated with patient controlled analgesia with morphine. For this purpose a controlled randomized double blind trial against placebo (saline) is performed, enrolling 40 (20x2) patients during 3 years, in order to measure total morphine consumption during the first 48 post operative hours and to evaluate analgesia and sides effects of morphine in each group.


Eligibility criteria: Inclusion Criteria:

* operated for latissimus dorsi and serratus micro anastomotic flaps.
* 18 to 75 years old
* ASA I-II
* hospitalized in Nantes CHU Burns ICU
* giving their written informed consent
* with healthcare protection

Exclusion Criteria:

* declining the study
* with known sides effects with morphine and local anesthetics
* with known allergy or other reaction with used drugs
* with disease incompatible with anaesthetic procedure
* under law protection
* taking antiepileptic or antidepressant drugs
* pregnant (not any gender criteria)

Primary outcomes:
measure: Total morphine consumption
timeFrame: H 48
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU
Study officials:
References:
Clinical trial NCT01057485: Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation
Official title: Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation
Ablation
Lead sponsor: Eastbourne General Hospital
Sponsor class: OTHER
First posted: 2010-01-27
Enrollment: 50
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: The purpose of the study is to assess combining AF ablation, with AV node ablation and pacemaker implantation for patients suffering with 'irregular heartbeats' or atrial fibrillation. The study will last 13 months.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic drug refractory atrial fibrillation.
* Patients who have had pacemaker implantation and AV node ablation with ongoing symptoms.
* Patients will already be refractory to at least 2 rate or rhythm control drugs.
* Patients must be over 18 years old.
* Patients give informed consent form prior to participating in this study.

Exclusion Criteria:

* Patient is suffering with unstable angina in last 1 week.
* Patient has had a myocardial infarction within last 2 months.
* Patient is expecting or has had major cardiac surgery within last 2 months.
* Patient is participating in a conflicting study.
* Patient is unable to perform exercise testing.
* Patient is mentally incapacitated and cannot consent or comply with follow-up.
* Patient has NYHA class III/ IV heart failure.
* Patient has LVEF \<35% not secondary to tachycardia.
* Pregnancy.
* Patient suffers with other cardiac rhythm disorders.
* Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).

Primary outcomes:
measure: To measure the two treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.To measure the two treatment effects on 6-minute hall walk distance.Echocardiographic parameters
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
state: East Sussex
Study officials:
References:
Clinical trial NCT00530985: Preserving Function Among Disability Applicants
Official title: Preserving Function Among Disability Applicants: A Motivational Enhancement Approach to Benefits Counseling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Disability
Keywords: disability
substance abuse
vocational rehabilitation
case management
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2007-09-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the hypothesis that veterans counseled around managing their benefits will work more and have a better quality of life than those receiving non-specific counseling.

Detailed description: The aim is to develop and test the efficacy of Benefits Counseling to improve quality of life among veterans who apply for VA benefits. Benefits Counseling involves providing claimants information about rehabilitation and work-related activities, benefits determination and management, and available substance abuse treatment . Benefits Counseling is designed to increase motivation to be active and promote engagement in substance abuse treatment. After enrolling 15 participants in an open-label pilot phase, 300 veterans who are not receiving benefits and are applying to VBA for disability benefits will be randomly assigned to Benefits Counseling or the control condition, VA Orientation, and both groups will be followed for one year.

The primary outcome measures will be observer-rated and self-rated quality of life. Secondary outcome measures will include substance use and treatment utilization.

Eligibility criteria: Inclusion Criteria:

1. Applying for VA service connection and not currently receiving VBA benefits.
2. Veterans who have been rated 0% service-connected but do not receive financial benefits are eligible to participate.
3. Able to provide valid consent
4. Age 18-65
5. Expresses willingness to discuss benefits with a counselor
6. Anticipates difficulty working

Exclusion Criteria:

1. Already receiving VA payments
2. Already receiving SSI or SSDI
3. Has a conservator

Primary outcomes:
measure: Days engaged in work and work-related activities
timeFrame: 6 months
Secondary outcomes:
measure: substance use (as measured by days having used illicit drugs, alcohol to intoxication in the preceding days)
timeFrame: 6 months
measure: treatment utilization (days in last 30 having participated in rehabilitation and work-related activities, number of days having participated in non-inpatient substance abuse treatment, number of days on any inpatient unit)
timeFrame: 6 months
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Health Care System (West Haven)
state: Connecticut
Study officials:
affiliation: VA Connecticut Health Care System (West Haven)
name: Marc I. Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06902285: Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
Official title: Use of Magnesium-L-Threonate to Improve Subjective Sleep Quality After Total Joint Arthroplasties: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sleep
Knee Osteoarthritis
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study team is conducting a study to see if Magnesium-L-Threonate (MgT) can help improve how well participants sleep and reduce pain after total joint replacement surgery


Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary total knee or hip arthroplasty at the University of Miami Hospital
* Patients \> 18 years of age
* Subjects must be capable of providing informed consent
* English or Spanish-speaking

Exclusion Criteria:

* Previous total joint arthroplasty at the surgical site
* History of sleeping disorders, including narcolepsy, sleep apnea, insomnia, parasomnias, and restless leg syndrome.
* History of Complex Regional Pain Syndrome in ipsilateral extremity
* History of demyelinating disorder or neurologic deficit in the affected extremity
* History of psychiatric disorders that could impact sleep, such as untreated depression, bipolar disorder, or schizophrenia.
* Participants taking medications known to cause significant sedation or insomnia.
* Pregnant or breastfeeding
* Being treated for a diagnosis other than primary osteoarthritis (e.g. pelvic/femur fracture)
* Patients with known substance use disorder within 6 months of surgery
* Liver Failure, via clinical diagnosis or international normalized ratio greater than 1.5 or Prothrombin time greater than 40
* Chronic Kidney Disease or glomerular filtration rate less than 30 mL/min

Primary outcomes:
measure: Change in Epsworth Sleepiness Score
timeFrame: 2 weeks, 4 weeks, 6 weeks
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 weeks, 4 weeks, 6 weeks
Secondary outcomes:
measure: Change in Morphine Milligram Equivalent Prescribed
timeFrame: 2 weeks, 4 weeks, 6 weeks
measure: Patient-reported outcome measured by Knee Injury and Osteoarthritis Outcome Score
timeFrame: 6 weeks
measure: Medication Compliance measured in number of days study medication taken
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Victor H Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03743285: A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus (T1D)
Official title: An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-11-16
Enrollment: 10
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: DEVICE_FEASIBILITY

Brief summary: The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system and to test whether the AID System functions as designed. The study will last about 3 months with up to 6 days of inpatient time.


Eligibility criteria: * Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months
* Have a body mass index of 18.5 to 37 kilogram per meter squared
* Have a hemoglobin A1c level ≥6.0% and ≤9.0%

Exclusion Criteria:

* Have known allergies or history of hypersensitivity to insulin lispro
* Have had an episode of severe hypoglycemia within the past 6 months
* Have had more than 1 episode of diabetic ketoacidosis in the past 6 months

Primary outcomes:
measure: Number of Adverse Events (AEs)
timeFrame: In-Patient Period (6 Days)
measure: Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL
timeFrame: In-Patient Period (6 Days)
Secondary outcomes:
Other outcomes:
Locations:
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Christiansen M, Bartee A, Lalonde A, Jones RE, Katz M, Wolpert H, Brazg R. Performance of an Automated Insulin Delivery System: Results of Early Phase Feasibility Studies. Diabetes Technol Ther. 2021 Mar;23(3):187-194. doi: 10.1089/dia.2020.0318. Epub 2020 Oct 5.
Clinical trial NCT01938885: Hepatic Pseudoaneurysms After Trauma
Official title: Hepatic Pseudoaneurysms After Conservatively Managed Liver Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudoaneurysm
Abdominal Trauma
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 238
Sex: ALL
Minimum age (years): 3
Maximum age (years): 77
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients conservatively managed and radiologically followed-up after liver injury, admitted Trauma Centre at the University hospital of Copenhagen, Rigshospitalet from January 2000 to December 2010.

Brief summary: Hepatic pseudoaneurysm (HPA) is a rare complication after liver trauma, yet it is potentially fatal, as it can lead to sudden severe haemorrhage. The risk of developing posttraumatic hepatic pseudoaneurysm is one of the reasons why some trauma centres do follow-up CT of patients with liver injuries to take the therapeutic consequence. The aim of this study was to investigate the occurrence of HPA post liver trauma.


Eligibility criteria: Inclusion Criteria:

* conservatively managed liver trauma patients with follow-up CT or US

Exclusion Criteria:

* patients who underwent laparotomy because of other intra-abdominal injuries

Primary outcomes:
measure: Incidence and nature of hepatic pseudoaneurysm after hepatic trauma
timeFrame: 2000-2010
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lene Osterballe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05997485: A Study to Learn About the Patients With COVID-19 Prescribed Paxlovid in Morocco
Official title: A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics Among COVID-19 Patients Receiving Treatment With Nirmatrelvir/Ritonavir (PAXLOVIDTM) in Morocco.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID-19 Drug Treatment
Keywords: Treatment
Covid Patient
Paxlovid
Morocco
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-08-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants treated with Paxlovid in single center in Morocco.

Brief summary: The purpose of this study is to collect information on the:

* general information of a group of people such as their age, sex, and other facts.
* clinical information of the patients such as any other illness before having COVID 19.

In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.

This study will be conducted in Morocco. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment. The inpatients will be admitted in the hospital for other reasons than COVID-19.

This study will have about 150 patients. The study will involve collection of patient information from medical records. The information collected can be either from papers or from computers.

The study will include patient information of those who:

* are confirmed to have COVID-19 infection during the study period from 01 June 2022 to 30 June 2023.
* are 18 years of age or older.
* are prescribed Nirmatrelvir and ritonavir. This study will help to inform decision-making on use of Paxlovid at the national level.


Eligibility criteria: Inclusion Criteria:

* Confirmed COVID-19 infection during the study period from 01 June 2022 to 30 June 2023
* Nirmatrelvir, ritonavir written prescription

Exclusion Criteria:

* There are no exclusion criteria for this study.

Primary outcomes:
measure: Demographical Characteristics of Participants
timeFrame: Approximately 01 June 2022 through 30 June 2023
measure: Clinical Characteristics of Participants
timeFrame: Approximately 01 June 2022 through 30 June 2023
measure: Number of Participants with Pre-existing Comorbidities
timeFrame: Approximately 01 June 2022 through 30 June 2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02753985: Adherence to Aromatase Inhibitors: The Role of Partners
Official title: Adherence to Aromatase Inhibitors: The Role of Partners
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Survivors
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 40
Sex: FEMALE
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: Women and partners of women with stage I-III breast cancer

Brief summary: This is a qualitative study which explores the role that partners play in breast cancer survivors adherence to aromatase inhibitors and management of their side effects. Both patients and their partners will be interviewed (separately) in order to capture multiple perspectives. The target number of subjects is 64 (32 patients and 32 partners). The primary method of data collection will be face-to-face semi-structured interviews. These interviews will be audio-recorded.


Eligibility criteria: Inclusion Criteria:

* Women and partners of women with stage I-III breast cancer who

  1. have completed primary cancer treatments (surgery, chemotherapy, radiotherapy)
  2. have experienced AI side effects
  3. live with a romantic partner.

     Exclusion Criteria:

Primary outcomes:
measure: Number of Surveys Completed
timeFrame: 2 years
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: Jun Mao, MD
role: PRINCIPAL_INVESTIGATOR
References: