louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01707212: Prenatal Education About Infant Immunization Pain Management
Official title: A Prenatal Education Module for Parents to Improve the Use of Pain-management Strategies for Immunization in Two-month Old Infants: a Randomized Controlled Trial of Knowledge Translation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immunization
Keywords: parent education
pain management
immunization
infant
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, New York
First posted: 2012-10-16
Enrollment: 197
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are numerous pain management strategies available for the management of infant immunization pain. The majority of infants, however do not benefit from these interventions, which causes them to suffer pain unnecessarily. This study will assess the impact of educating parents about pain management strategies on their knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.

Detailed description: There is ample literature outlining effective pain management strategies for immunization including psychological, physical and pharmacological interventions; however their use in clinical practice has been limited. Teaching parents about these strategies in an enriching setting such as prenatal education classes has the potential to increase utilization of these strategies, and empower parents to take on a more active role in the management of their infant's pain during routine immunization. Educating parents about pain-management for infant immunization has not been previously investigated in this setting. The aim of this cluster-randomized controlled trial is to evaluate the effectiveness of an immunization pain-management education module added to the prenatal education program at Mount Sinai Hospital on parental knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.

Eligibility criteria: Inclusion Criteria:

* mothers attending weekend prenatal classes
* delivery of a healthy newborn \> 35 weeks gestational age
* available for followup for infant's 2-month immunization

Exclusion Criteria:

* mothers who do not plan to immunize their infants
* infant with major birth defect or hospitalized at time of immunization
* mothers who need to attend the prenatal class at a separate time when education not offered

Primary outcomes:
measure: Utilization of pain management strategies during infant immunization
timeFrame: within 2 months of immunization
Secondary outcomes:
measure: Attempted use of pain management strategies during infant immunization
timeFrame: within 2 months of immunization
measure: Knowledge
timeFrame: within 2 months of immunization
Other outcomes:
measure: Infant pain during immunization
timeFrame: within 2 months of immunization
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT00811512: Fundus Changes in the Microphthalmy Eyes
Official title: Fundus Changes in the Microphthalmy Eyes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Diseases, Hereditary
Keywords: retina
fold
fovea
Lead sponsor: Hospital de Olhos Sadalla Amin Ghanem
Sponsor class: OTHER
First posted: 2008-12-19
Enrollment: 3
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study is the description of three cases of microphthalmy with changes to fund of the eye, all documented with optical coherence tomography and clinical characteristics.

Brief summary: The goal is to describe the fundamental aspects of fundoscopic eye in patients with microphthalmia

Detailed description: Microphthalmos is a developmental ocular disorder defined as a small eyeball. The condition can be associated with abnormalities of anterior and posterior segments. The most common anterior characteristics include corneal opacities, angle-closure and a shallow anterior chamber and cataract. The main findings of posterior segment are uveal effusion, retinal folds, abnormalities of macular capillary vascularization, absence of foveal depression and peripheral retinoschisis. We performed on 3 patients with microphthalmos and their OCT features of posterior segment.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of microphthalmia

Exclusion Criteria:

* Eyes larger than 18mm

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Olhos Sadalla Amin Ghanem
name: Fernando J Novelli, Bsc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03009812: Transverse vs Longitudinal Incision in Myomectomy
Official title: Transverse Versus Longitudinal Uterine Incision in Abdominal Myomectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myoma;Uterus
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Aim of the study is to compare between transverse and longitudinal uterine incision in abdominal myomectomy regarding intraoperative blood loss.


Eligibility criteria: Inclusion Criteria:

1. Inclusion criteria for myomectomy as; abnormal uterine, pressure related symptoms, infertility and recurrent pregnancy loss in patients between 18 and 45 years old
2. Single myoma.
3. Women with BMI between 18.5-29.9 kg/m2.

Exclusion Criteria:

1. Pregnancy.
2. Patients with bleeding tendency
3. Previous laparotomies.
4. Patients with concomitant pelvic pathologies, such as ovarian cysts.

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Elguindy A, Hemeda H, Shawky ME, Elsenity M, Elsayed MA, Fahim A, Afifi K, Nawara M. Blood loss from transverse versus longitudinal uterine incision in abdominal myomectomy: a randomized controlled trial. BMC Womens Health. 2020 Dec 28;20(1):259. doi: 10.1186/s12905-020-01113-3.
Clinical trial NCT06232512: Multimodal Haptic Feedback for Plantar Sensory Substitution
Official title: Multimodal Haptic Feedback for Plantar Sensory Substitution
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoesthesia
Keywords: Plantar Sensation
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Querrey Simpson Institute for Bioelectronics
name: Northwestern University
First posted: 2024-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study will explore the use of a haptic device for sensory substitution in individuals with a movement disorder that has caused loss of plantar sensation. The haptic device consists of two components. The first element is a flexible insole with embedded pressure-sensing elements that transmit the spatial patterns of applied foot pressure over time. The second element is a haptic receiver with embedded actuators that vibrate or heat up in proportion to the transmitted pressure patterns, thus substituting the patient's lost plantar sensation.

Detailed description: OBJECTIVES:

1. Identify a systematic, methodical approach to determine whether different users of our haptic device can perceive and use vibrational and thermal feedback in order to correct their posture in real-time.
2. Evaluate whether a haptic device can be used to guide users to maintain a prescribed pattern of pressure on their feet during standing and walking.
3. Investigate whether a haptic device can improve outcomes on motor evaluation tasks.

Eligibility criteria: Inclusion Criteria:

* Able to ambulate 10 meters with or without assistance
* Able and willing to give written consent and comply with study procedures

Exclusion Criteria:

* Unable to give written consent or comply with study procedures
* Unable to perceive unsafe levels of heat in relevant areas
* Has a motor complete spinal cord injury
* Have transfemoral (above knee) amputation
* Any condition that would prevent the safe completion of study activities, as determined by the Principal Investigator

Primary outcomes:
measure: Pressure data from the insoles
timeFrame: During the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00221312: Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss
Official title: Alendronate to Prevent Perimenopausal Transition Bone Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perimenopausal Bone Loss
Keywords: Perimenopausal bone loss
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 48
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Perimenopausal women

Brief summary: This is a study to determine if Fosamax (alendronate), a medication approved by the Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in postmenopausal women, is effective in decreasing the rate of bone loss which often begins to increase in the three to five years preceding the menopause (perimenopausal transition).

During the three to five years prior to the menopause, the rate of bone loss increases. One way that physicians treat this is with oral contraceptive medication. However, the incidence of complications from oral contraceptives after the age of 40 increases. Therefore, a non-hormonal means of preventing bone loss should be useful. Fosamax (alendronate) is in a class of compounds called bisphosphonates. This study is being done to determine whether Fosamax can be used to prevent the increased rate of bone loss during the perimenopausal transition.


Eligibility criteria: Inclusion Criteria:

* Women ages 40-54 with symptomology of perimenopause including hot flashes, irregular periods and vaginal dryness.

Exclusion Criteria:

* Women should not be on hormone replacements, oral contraceptives, or bone mineral enhancing medications (bisphosphonates, selective estrogen receptor modulators \[SERM's\], parathyroid hormone \[PTH\], calcitriol, fluorides)
* They should not have any abnormalities of the esophagus which delay esophageal emptying
* They should not have hypocalcemia or severe kidney disease
* Their bone mineral density (T-score) should not be greater than 2 standard deviations.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Robert B. Jaffe, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02483312: A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)
Official title: Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: Recurrent
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Ozmosis Research Inc.
First posted: 2015-06-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 1 study (the first stage in testing a new treatment to see how safe and tolerable the treatment is) which will include patients with acute myeloid leukemia (AML) that has either returned or has a more than a 70% chance of coming back and cannot have a bone marrow transplant.

This study will see whether modifying a patient's AML cells to produce IL-12 and giving it back to the patient is safe and useful in patients with AML that cannot have bone marrow transplants.


Eligibility criteria: Inclusion Criteria:

* Patient with AML and \>=18 years of age.
* Agrees to participate in the study and signs the informed consent
* Viable cells are available for successful modification
* First or higher complete remission and have high risk features of relapse.
* Patients who have received prior treatment and are not in remission must have stable white blood cell count and are not receiving any chemotherapy or desiring further intensive treatment.
* Less than 10% blast cells in the bone marrow following induction or re-induction therapy and not desiring further intensive treatment.
* Acceptable creatinine, Aspartate transaminase (AST), Alkaline phosphatase (ALP), bilirubin lab results.
* Agree to use contraception
* Not pregnant
* Able to comply with study procedures

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status \>2
* Known persistent infection
* Known central nervous system (CNS) disease
* Greater than 10% blasts in the bone marrow or circulating blast cells
* Life expectancy \< 2 months
* Receiving any chemotherapy, corticosteroids, Cox2 inhibitors or any non-drug therapies with the intent of altering the immune response or kill leukemic cells within one week prior to infusion of IL-12, except azacytidine.
* Patients who are HIV positive.

Primary outcomes:
measure: Number of side effects by type and severity
timeFrame: 2 years
Secondary outcomes:
measure: Levels of IL-12
timeFrame: Day 28 to 2 years
measure: Levels of acute myeloid leukemia (AML)
timeFrame: Day 28 to 2 years
measure: Length of time patient is alive
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Centre Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Hassan Sibai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05187312: Registry for Advanced Endoscopy
Official title: Research Registry for Endoscopic Treatment and Diagnostics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cholangiocarcinoma
Pancreatic Cancer
Sclerosing Cholangitis
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2022-01-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for endoscopic procedures at Karolinska University Hospital

Brief summary: Observational registry including endoscopic diagnostic and therapeutic interventions in the gastrointestinal tract


Eligibility criteria: Inclusion Criteria:

* Clinical indication for endoscopic intervention/procedure

Exclusion Criteria:

* No informed consent
* Age \<18 years

Primary outcomes:
measure: Adverse events
timeFrame: 30-days and 60-days post-procedure
measure: Diagnostic yield
timeFrame: 1-year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Region Stockholm
name: Erik von Seth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04430712: Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume
Official title: Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume in Patients With Non-Small Cell Lung Cancer: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
Immune Checkpoint Inhibitor
Atherosclerosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2020-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer from a single tertiary care center in the United States.

Brief summary: In this study, investigators plan to test whether Immune Checkpoint Inhibitor (ICI) treatment leads to an accelerated progression of atherosclerosis in patients with lung cancer. Atherosclerosis is an immune-mediated inflammatory disease and these same checkpoints being targeted for cancer are critical negative regulators of atherosclerosis in animal and cellular models. Aortic plaque progression will be compared between cases (on ICI) and controls from pre-ICI to post-ICI among patients with non-small cell lung cancer. Groups will be matched for age, cancer type and stage and cardiovascular risk factors. Traditional markers of cardiovascular (CVD) risk and cancer-specific factors (ICI mono- and combination therapy, number of cycles, occurrence of immune-related adverse events, chest radiation, steroid use) will be associated with the change in aortic plaque volume.


Eligibility criteria: Inclusion Criteria:

Cases:

* Subjects with non-small cell lung cancer treated with Immune Checkpoint Inhibitors.
* Available contrast enhanced CT scans of the chest both immediately pre-ICI (\< 1 month) and latest follow-up.

Controls:

* Subjects with non-small cell lung cancer, age, cancer stage and cardiovascular risk factor matched to cases.
* Available contrast enhanced CT scan of the chest at two time-points at a similar interval between scans as the cases.

Exclusion Criteria:

none

Primary outcomes:
measure: Change in aortic plaque volume
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00480012: The Effects of TMS on Memory-consolidation in Human Primary Visual Cortex
Official title: The Effects of Transcranial Magnetic Stimulation of the Brain on Memory-consolidation in Human Primary Visual Cortex
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Keywords: healthy subjects
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-05-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Rapid Transcranial Magnetic Stimulation will be used in order to examine whether the human primary visual cortex is essential to visual memory consolidation.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Right handed

Exclusion Criteria:

* Active/past neurological/psychiatric disorder
* Personal/first-degree history of seizures
* Cardio-vascular disorder or disease including hypertension chronic use of medication
* Metal/electronic device implant
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Revital Amiaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02471612: Comparative Analysis of APACHE II and P-POSSUM
Official title: Comparative Analysis of APACHE II and P-POSSUM Scoring Systems in Predicting Postoperative Mortality in Patients Undergoing Emergency Laparotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: External Causes of Morbidity and Mortality
Lead sponsor: Tata Main Hospital
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 159
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 will be included in the study. All patients will be scored with APACHE II and P-POSSUM scoring systems on the day of surgery.The patients will be followed up till discharge, death or 30 days postoperatively.

Brief summary: To compare APACHE II and P-POSSUM scoring system in emergency laparotomy.

Detailed description: To compare APACHE II and P-POSSUM scoring system in predicting postoperative mortality in patients undergoing emergency laparotomy.

Eligibility criteria: Inclusion Criteria:

* All patients above 18 years of age undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 will be included in the study.

Exclusion Criteria:

* Patients willingly seeking referral to a different hospital

Primary outcomes:
measure: Area Under the Receiver Operating Curve (ROC) as a Measure of the Accuracy of the APACHE II and P-POSSUM Scoring Systems to Predict Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Length of Stay (LOS)
timeFrame: 30 days
measure: Need for Postoperative Ventilator Support
timeFrame: 30 days
measure: Need for Post Operative Inotropic Support
timeFrame: 30 days
measure: Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)
timeFrame: 30 days
measure: Number of Participants With Acute Kidney Injury (AKI)
timeFrame: 30 days
measure: Patients Needing Re-exploration
timeFrame: 30 days
Other outcomes:
Locations:
city: Jamshedpur
country: India
facility: Tata Main Hospital
state: Jharkhand
Study officials:
affiliation: Tata Main Hospital, Jamshedpur, India
name: Ankur Dembla, DA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nag DS, Dembla A, Mahanty PR, Kant S, Chatterjee A, Samaddar DP, Chugh P. Comparative analysis of APACHE-II and P-POSSUM scoring systems in predicting postoperative mortality in patients undergoing emergency laparotomy. World J Clin Cases. 2019 Aug 26;7(16):2227-2237. doi: 10.12998/wjcc.v7.i16.2227.