louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02823015: Acute Pain Trajectories and Persistent Pain After Breast Cancer Surgery
Official title: Acute Pain Trajectories as a Predictive Factor for Persistent Pain After Breast Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult females, scheduled for breast cancer surgery

Brief summary: Persistent pain after breast cancer surgery (PPBCS) is a significant clinical problem, affecting between 25 and 50% of patients. Several factors are associated with the development of PPBCS, including acute postoperative pain. The analysis of pain trajectories through mixed model modeling is an alternative to static pain measures, improving precision and providing information on the time course of pain resolution. Our aim was to investigate if the characteristics of pain trajectories during the first postoperative week are correlated with the persistence of pain 3 months after breast cancer surgery.


Eligibility criteria: Inclusion Criteria:

* Scheduled for breast cancer surgery
* General anesthesia

Exclusion Criteria:

* Previous breast surgery
* Reconstructive surgery scheduled during follow-up
* Day-surgery patients
* Inability to understand the questionnaires

Primary outcomes:
measure: Presence of pain 3 months after surgery, assessed with the Brief Pain Inventory questionnaire. Yes/No
timeFrame: 3 months
Secondary outcomes:
measure: Acute pain trajectories (7 days) after surgery
timeFrame: One postoperative week
Other outcomes:
Locations:
city: Woluwé-St-Lambert
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Arnaud Steyaert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00873015: Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
Official title: Safety and Pharmacokinetic Evaluation of Sodium Nitrite Injection for the Prevention of Post-Subarachnoid Hemorrhage Induced Vasospasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Subarachnoid Hemorrhage
Keywords: Cerebral aneurysm
Subarachnoid hemorrhage
Nitrite
Lead sponsor: Hope Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2009-04-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.

Detailed description: Intravenous sodium nitrite has been shown to prevent and to reverse cerebral vasospasm in a primate model of subarachnoid hemorrhage (SAH). This was a Phase IIA dose escalation study of sodium nitrite to determine its safety in patients with aneurysmal SAH and to establish its pharmacokinetics during a 14 day infusion.

Sodium nitrite was delivered intravenously for 14 days in 18 patients with SAH from a ruptured cerebral aneurysm using a dose escalation scheme in three cohorts of 6 patients each (3 nitrite, 3 saline), with a maximum dose of 64 nmol/min/kg. Sodium nitrite blood levels were frequently sampled and measured using mass spectroscopy and blood methemoglobin levels were continuously monitored using a pulse oximeter.

Eligibility criteria: Inclusion Criteria:

* Ruptured cerebral aneurysm

Exclusion Criteria:

* Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy

Primary outcomes:
measure: Mean Plasma Nitrite Concentration (Micromol/L)
timeFrame: multiple time points up to the end of day 14
Secondary outcomes:
measure: Safety of a 14 Day Infusion of Sodium Nitrite
timeFrame: 14 days
measure: Efficacy of 14 Day Infusion of Sodium Nitrite
timeFrame: 14 days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System Medical Center
state: Virginia
Study officials:
affiliation: University of Virginia
name: Edward Oldfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oldfield EH, Loomba JJ, Monteith SJ, Crowley RW, Medel R, Gress DR, Kassell NF, Dumont AS, Sherman C. Safety and pharmacokinetics of sodium nitrite in patients with subarachnoid hemorrhage: a phase IIa study. J Neurosurg. 2013 Sep;119(3):634-41. doi: 10.3171/2013.3.JNS13266. Epub 2013 May 24.
Clinical trial NCT04558515: Automated Microscopy Evaluation Study
Official title: Clinical Evaluation of Automated Microscope Solutions for Malaria Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 190
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptoms suggestive of malaria seeking clinical care in health facilities

Brief summary: Since the introduction of Giemsa stain in 1904 until today, malaria microscopy has been the standard of practice for malaria diagnosis. However, microscopic detection of malaria parasites is labour-intensive, time-consuming and expertise-demanding. Moreover, the slide interpretation is highly dependent on the staining technique and the technician's expertise.

To address these, multiple organisations have developed next generation microscopes to move towards a next generation microscope that can improve slide preparation, interpretation or data collection, or a combination of these features.

In this study, a prospective evaluation of miLab™ and other next generation automated microscope solutions as well as a malaria rapid diagnostic test (RDT) reader app will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria clinical cases at POC.


Eligibility criteria: Inclusion Criteria:

* Aged 5 years or older
* Malaria status (positive or negative) established by microscopy at the health facility, where the patient is presenting
* Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17)
* Willing to provide finger prick blood sample at enrollment

Exclusion Criteria:

* Having received antimalarial treatment during the preceding four-week period
* Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines

Primary outcomes:
measure: Clinical performance assessment
timeFrame: up to 6 months
measure: Concordance
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Institute of Endemic Diseases, Medical Campus
Study officials:
References:
Clinical trial NCT00993915: Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications
Official title: Non Interventional (NI) Open Label Prospective Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Artery Disease
Keywords: Coronary Artery Disease
Hyperlipidemia
Atorvastatin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 687
Sex: ALL
Minimum age (years): 18
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: Coronary atery disease, prevention of high risk cardiovascular complications with statins.

Brief summary: In which CHD patients with high risk of CV complications are different doses of LIPRIMAR used? For this purpose, data on hyperlipidemia will be elicited over and above the basic nosographic and demographic data, concomitant diseases and cardiovascular risk factor.


Eligibility criteria: Inclusion Criteria:

* Patients, who eligible to sign informed consent;
* Patients with indications to lipid lowing therapy, according to local product document.
* Patients with CHD and high risk of CV complications (Diabetes Mellitus II, Myocardial Infarction, Heart Failure, Arterial Hypertension, ets) will be included into study;
* Patients with LDL levels: \> 3,5 mmol/l

Exclusion Criteria:

* Individual intolerance of atorvastatin, in accordance to local product document.

Primary outcomes:
measure: Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit
timeFrame: Month 1
measure: Change From Baseline in Lipid Parameters
timeFrame: Month 6
measure: Percent Change From Baseline in Lipid Parameters
timeFrame: Month 6
Other outcomes:
measure: Change From Baseline in Lipid Parameters at 1 Month
timeFrame: Month 1
measure: Percent Change From Baseline in Lipid Parameters at 1 Month
timeFrame: Month 1
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00910715: Duration of Antibiotic Treatment of Erythema Migrans
Official title: Duration of Antibiotic Treatment of Erythema Migrans. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema Chronicum Migrans
Keywords: erythema migrans
Lyme borreliosis
doxycycline treatment
outcome
subjective symptoms
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2009-06-01
Enrollment: 306
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.


Eligibility criteria: Inclusion Criteria:

* solitary erythema migrans in patients \> 15 years

Exclusion Criteria:

* a history of Lyme borreliosis in the past
* pregnancy or lactation
* immunocompromised status
* serious adverse event to doxycycline
* taking antibiotic with antiborrelial activity within 10 days
* multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis

Primary outcomes:
measure: Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.
timeFrame: 6 months after treatment
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana, Department of Infectious Diseases
Study officials:
affiliation: UMC Ljubljana
name: Franc Strle, MD
role: STUDY_CHAIR
References:
citation: Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y.
citation: Stupica D, Lusa L, Ruzic-Sabljic E, Cerar T, Strle F. Treatment of erythema migrans with doxycycline for 10 days versus 15 days. Clin Infect Dis. 2012 Aug;55(3):343-50. doi: 10.1093/cid/cis402. Epub 2012 Apr 20.
Clinical trial NCT03595215: Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
Official title: Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: TENS
Lead sponsor: Theranova, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
First posted: 2018-07-23
Enrollment: 18
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.


Eligibility criteria: Inclusion Criteria:

1. Females
2. 55-100 years old
3. Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding "training" diary)
4. Have self-reported bladder symptoms of more than 3 months
5. Are ambulatory and able to use the toilet independently
6. Have been off antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment OR on a stable dose for the prior 3 months
7. Patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe)
8. Able to provide informed consent
9. Capable and willing to follow all study-related procedures

Exclusion Criteria:

1. Have primary complaint of stress urinary incontinence
2. Have a pacemaker or implantable defibrillator
3. Had botox injections in the bladder or pelvic floor muscles in the past 12 months
4. Have a current urinary tract or vaginal infection
5. Have an active implantable SNS device (InterStim \& Bion)
6. Have been diagnosed with peripheral neuropathy or nerve damage
7. Currently pregnant
8. Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination

Primary outcomes:
measure: Change in Urge Incontinence Episodes
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in Micturitions Per Day
timeFrame: Baseline and 8 weeks
measure: Change in Health-related Quality of Life (HRQL)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
References:
Clinical trial NCT01559285: Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters
Official title: Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epidural Anesthesia
Ropivacaine Concentration
Hemodynamics
Keywords: epidural, local, ropivacaine
epidural administration
stroke volume variability
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2012-03-21
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: BASIC_SCIENCE

Brief summary: In this trial, the investigators intend to examine whether the concentration of local anesthetics during epidural analgesia could be modulating factor for change of hemodynamics in patients undergoing major upper abdominal surgery.

Detailed description: One hundred and twenty patients scheduled for major abdominal surgery under TEA combined general anesthesia were randomized in a double-blinded method to receive one of three different concentration study solutions in 8 ml of volume after the induction of anesthesia: 0.75% ropivacaine (60 mg), 0.375% ropivacaine (30 mg), or 0.2% ropivacane (16 mg).

In each group, the patients were divided into two subgroups at the age of 60 to perform age based analysis. The acquired hemodynamic data after administration of epidural loading dose were compared and analyzed between young and elderly groups in each group.

Eligibility criteria: Inclusion Criteria: all of the followings needed.

* ASA I or II patients
* 18 to 65 years old
* undergoing major upper abdominal surgery
* planned combined thoracic epidural analgesia and general anesthesia

Exclusion Criteria:

* any contraindication to epidural analgesia
* allergy to local anesthetics of the amide type
* communication difficulties that would prevent reliable assessment
* known significant cardiac or respiratory disease
* pregnant
* patients who were not in cardiac sinus rhythm

Primary outcomes:
measure: hemodynamic changes depends on the concentration of ropivacaine
timeFrame: during 1hour after administration of epidural drug dosing
Secondary outcomes:
measure: Age based hemodynamic changes depends on the concentration of ropivacaine
timeFrame: during 1hour after administration of epidural drug dosing
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Dept. of Anesthesia, Pusan National University, School of Medicine
name: Hyeon Jeong Lee, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong JM, Lee HJ, Oh YJ, Cho AR, Kim HJ, Lee DW, Do WS, Kwon JY, Kim H. Observations on significant hemodynamic changes caused by a high concentration of epidurally administered ropivacaine: correlation and prediction study of stroke volume variation and central venous pressure in thoracic epidural anesthesia. BMC Anesthesiol. 2017 Nov 16;17(1):153. doi: 10.1186/s12871-017-0444-x.
Clinical trial NCT01537185: Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
Official title: A Phase 1 Randomized, Double-Blind, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (SPWCV+Alum) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumococcal Vaccines
Lead sponsor: PATH
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults.


Eligibility criteria: Inclusion Criteria, Healthy adults:

* If female, not breastfeeding, not pregnant, not planning pregnancy during study period), and willing to consistently use an adequate method of contraception and have repeated pregnancy tests.
* In good health with normal laboratory results
* Willing to comply with study restrictions, study schedule, and can be reliably contacted

Exclusion Criteria:

* Currently consumes alcohol in excess of 2 drinks per day for men or 1 drink per day for women.
* current use or likely requirement for medications with potential for liver injury or effect immune system
* History of event or condition such as anaphylaxis, severe allergic reactions, serious reactions to any vaccines, or other events that might increase risk of reaction to an investigational disease
* History of diabetes, cancer, autoimmune or immunosuppressive disease or chronic such as HIV, Hepatitis B or C

Primary outcomes:
measure: Unsolicited Adverse Event Reports
timeFrame: within 1 week (0-7 days) following each vaccinations
Secondary outcomes:
measure: Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG
timeFrame: 28, 56 and 84 days following initial vaccination
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Comprehensive Clinical Development
state: Washington
Study officials:
affiliation: Comprehensive Clinical Development
name: Royce Morrison, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keech CA, Morrison R, Anderson P, Tate A, Flores J, Goldblatt D, Briles D, Hural J, Malley R, Alderson MR. A Phase 1 Randomized, Placebo-controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of Inactivated Streptococcus pneumoniae Whole-cell Vaccine in Adults. Pediatr Infect Dis J. 2020 Apr;39(4):345-351. doi: 10.1097/INF.0000000000002567.
citation: Campo JJ, Le TQ, Pablo JV, Hung C, Teng AA, Tettelin H, Tate A, Hanage WP, Alderson MR, Liang X, Malley R, Lipsitch M, Croucher NJ. Panproteome-wide analysis of antibody responses to whole cell pneumococcal vaccination. Elife. 2018 Dec 28;7:e37015. doi: 10.7554/eLife.37015.
Clinical trial NCT02673385: Study of the Impact of Administering t the Scale of Brazelton on the Mother's Confidence in Her Newborn Born Premature at the Approach of Returning Home
Official title: Study of the Impact of Administering t the Scale of Brazelton on the Mother's Confidence in Her Newborn Born Premature at the Approach of Returning Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 240
Sex: MALE
Minimum age (years): 0
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mother-child dyads whose infants were born before 36 S.A.

Brief summary: In France, the last national perinatal survey show that 6.6% of live births are premature. For these infants, transfer in Neonatology sector may result in mother-child separation can last several weeks or months. This hospital can complicate the implementation of the attachment process that allows parents to recognize their children as their own, to gain confidence in their abilities to deal with them and establish a relationship with him.

A study of mothers of premature shows the interest of the Brazelton scale to help them identify the skills their child and adjust their own behavior.


Eligibility criteria: Inclusion Criteria:

* Mother: over the age of 18, affiliated to a health social security.
* Newborn: born to a term of less than 36 S.A., hospitalized in neonatology, said leaving in three days.

Exclusion Criteria:

Mother :

* Legally protected
* Inability to understanding and monitoring of the protocol's terms (not master the French language, intellectual impairment, psychotic disorder ...)
* Who have had a premature child born.

New born :

* Opposition of one of the holders of parental authority to the award of the Brazelton Scale
* Having withdrawal syndromes or malformation syndromes requiring oxygen therapy, gastrostomy or nasogastric tube
* Twins and more.

Primary outcomes:
measure: Score GC (Global Confidence) of the MAPS scale (Mother Assessment Baby Scale)
timeFrame: 2 hours
Secondary outcomes:
measure: Scale "EVA Anxiety"
timeFrame: 1 hour
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges Hospital
Study officials:
References: