louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01537198: Surveillance of Synagis in Korean Pediatric Patients
Official title: Post-Marketing Surveillance of Synagis in Korean Pediatric Patients Under the "New Drug Re-Examination"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus Infection
Keywords: Postmarketing Drug Surveillance
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-02-23
Enrollment: 618
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General hospital

Brief summary: Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, gestational age, birth weight and underlying diseases and complications especially in regard to respiratory disease and cardiovascular disease. At routine visits for Synagis administration, which will occur according to usual medical practice, information on Synagis prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days after the last administration of Synagis.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients at high risk of RSV disease, who need the prevention of serious lower respiratory tract disease caused by RSV, and meet any of the following criteria:

  * Preterm newborn infants or infants born at 35 weeks of gestation or less, and less than 6 months of age at the onset of RSV season (RSV season defined as Oct. 1 to the following Mar. 31).
  * Newborn infants, infants, or children under 2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within the last 6 months preceding RSV season (RSV season defined as Oct. 1 to the following Mar. 31).
  * Newborn infants, infants, or children under 2 years of age with hemodynamically significant congenital heart disease (CHD).
* Obtained authorization form to use personal and/or health data from legal representative prior to the entry into the study.

Exclusion Criteria:

* Contraindications according to the approved label.

Primary outcomes:
measure: Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)
timeFrame: From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: SoRa Lee, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04259398: Anesthesia and Cancer Study: Colon Cancer
Official title: The Influence of Type of Anesthesia on Mortality and Cancer Recurrence After Colon Cancer Surgery: Multi-center Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer of Colon
Anesthesia
Keywords: anesthesia
propofol
cancer
inhalational anesthetics
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korean Society of Anesthesiologists
name: Seoul National University Bundang Hospital
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Seoul St. Mary's Hospital
name: Seoul National University Boramae Hospital
First posted: 2020-02-06
Enrollment: 797
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigates the influence of type of anesthesia on survival and recurrence rate in patients receiving colon cancer surgery. The participants will be allocated to either the TIVA group and the inhalation group.

Detailed description: The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, total intravenous anesthesia (TIVA) is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, there is no randomized controlled study to determine this difference in colon cancer patients.

Eligibility criteria: Inclusion Criteria:

* adults undergoing surgery to remove colon cancer

Exclusion Criteria:

* pregnancy
* colon cancer with invasion to perineum
* palliative surgery
* history of diagnosis or surgery for other cancer
* emergent surgery
* ASA PS classification 4 and 5
* refusion to participate in the study
* allergy to anesthetics

Primary outcomes:
measure: five year survival
timeFrame: five years survival
Secondary outcomes:
measure: five year recurrence free survival
timeFrame: five years after surgery
measure: 1 year recurrence free survival
timeFrame: 1 year after surgery
measure: 3 year recurrence free survival
timeFrame: 3 years after surgery
measure: 1 year survival
timeFrame: 1 year after surgery
measure: 3 year survival
timeFrame: 3 years after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03770598: Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
Official title: Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Psychosocial Care
Wellness
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-Distressed patients will be randomized to receive intervention or standard of care.

Distressed patients will be randomized to receive intervention or standard of care
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers are trying to see if proactive identification and team based individualized care of cancer patients having emotional difficulties can improve quality of life relative to treatment as usual. Also, to see if proactive approaches to maintain wellness can prevent grief among breast cancer patients, experiencing no emotional difficulties relative to treatment as usual.

Detailed description: Consented subjects will be randomized into two separate groups. Groups will be distressed and non-distressed subjects. Each group will be randomized into either intervention education training or standard of care. Both groups will be asked to fill out questionnaires during the duration of the study. Subjects will be remain in the study for up to one year.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of breast cancer within last three years
* Able to communicate in English or with the help of an interpreter.
* Access to a device with internet connection

Exclusion Criteria:

* Breast cancer patients who are considered for hospice or expected survival of less than six months.
* Presence of active suicidal ideations.
* Presence of active psychosis.
* Presence of dementia

Primary outcomes:
measure: Change in Wellness
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Improvement in depression compared to baseline
timeFrame: one year
measure: Improvement in anxiety compared to baseline
timeFrame: One Year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Shehzad K Niazi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02829398: Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage
Official title: Hemodynamic and Biochemical Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemia
Keywords: cerebral ischemia
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The risk of delayed cerebral ischemia (DCI) after subarachnoid hemorrhage (SAH) is associated with large cerebral artery vasospasm, but vasospasm is not a strong predictor for DCI. Assessment of cerebral autoregulation with transcranial Doppler (TCD) may improve the prediction of DCI. The aim of this prospective study was to assess the value of TCD-derived variables to be used alone or in combination for prediction of DCI


Eligibility criteria: Inclusion Criteria:

Group 1 : • Patients who presented a ruptured aneurysm by aneurysmal subarachnoid hemorrhage (SAH) older than 72 hours. Diagnosis of SAH was confirmed by computed tomography, magnetic resonance imaging (MRI) or lumbar puncture as recommended

* symptomatic aneurysm treated with endovascular,
* Absence of achieving a lumbar puncture,
* Patients affiliated to a social security scheme,
* Patients who have given their free and informed consent and signed the consent or consent of the family.

Group 2 :

healthy volunteers with cerebrospinal fluid sample

Exclusion Criteria:

* Patients with no readable acoustic temporal bone window
* Patients with previous disease that might impair cerebral autoregulation (e.g., carotid stenosis, history of stroke or head injury).

Primary outcomes:
measure: delayed cerebral ischemia
timeFrame: inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: LARRUE Vincent, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calviere L, Nasr N, Arnaud C, Czosnyka M, Viguier A, Tissot B, Sol JC, Larrue V. Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Cerebral Blood Flow Velocities and Cerebral Autoregulation Assessment. Neurocrit Care. 2015 Oct;23(2):253-8. doi: 10.1007/s12028-015-0125-x.
Clinical trial NCT00592098: 2PX (Topical Strontium Chloride Hexahydrate) in Patients With Post-Amputation Stump Pain.
Official title: A Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Efficacy of 2PX (Topical Strontium Chloride Hexahydrate) in Patients With Persistent, Moderate-to-Severe Lower Limb Post-Amputation Stump Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amputation Stumps
Pain
Keywords: Lower limb amputation at least 6 months prior to inclusion
Presenting with moderate-to-severe pain intensity
Outpatients, aged 18 years and above
Lead sponsor: SantoSolve AS
Sponsor class: INDUSTRY
First posted: 2008-01-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the analgesic effect of topical strontium chloride in stump pain, and to prospectively determine other efficacy and safety measures of topical strontium chloride in stump pain.


Eligibility criteria: Inclusion Criteria:

* Lower limb amputation at least 6 months prior to inclusion
* Presenting with moderate-to-severe pain intensity (above 50 on 100 mm VAS) at screening, to be confirmed prior to randomisation as: Mean (over the 14 days run-in period) stump API rating above 50 on a 100 mm VAS
* Outpatients, aged 18 years and above
* Written informed consent

Exclusion Criteria:

* Subjects who have received treatment with any potent opioid in the 4 weeks prior to study entry (i.e. an opioid assumed to cause abstinence symptoms upon abrupt cessation)
* Subjects taking any analgesic medication (except for rescue medication as defined in this protocol)
* Subjects with expressed dissatisfaction with their prosthesis comfort
* Pregnant or breast-feeding women
* Any malignant disease
* Subjects who have received an investigational drug or used an investigational device in the 30 days prior to study entry.
* Subjects unable to comply with the study assessments
* Subjects with documented or suspected alcohol or drug abuse

Primary outcomes:
measure: Average Pain Intensity (API): will be measured each evening in response to the question: 'What was your average pain intensity over the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable).
timeFrame: 24 hours
Secondary outcomes:
measure: • Worst Pain Intensity (WPI)
timeFrame: 24 hours
measure: • Pain relief
timeFrame: Weekly
measure: • Sleep disturbance
timeFrame: 24 hours
measure: • Use of rescue medication
timeFrame: Daily
measure: • Patient Global Impression of Change (PGIC)
timeFrame: Weekly
measure: • Prosthesis bothersomeness
timeFrame: Weekly
measure: • Quality of life assessment
timeFrame: Q 14 days
measure: Local skin irritability
timeFrame: Q 14 days
measure: Adverse events
timeFrame: Q 14 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Smerud Investigator site 1
Study officials:
affiliation: Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway
name: Knut T Smerud, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT04641598: Menstrual Phase Endometrial Scratch in IUI Cycles
Official title: The Effect of Menstrual Phase Endometrial Scratch on Intrauterine Insemination Cycle Outcomes and Participant Acceptability
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fertility Disorders
Fertility Issues
Keywords: infertility
insemination
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to endometrial scratch or "sham" procedure (speculum insertion but no endometrial scratch)
Primary purpose: TREATMENT

Brief summary: Patients undergoing treatment with intrauterine insemination (IUI) will be randomized to receive an endometrial scratch or sham procedure during the menstrual phase of the treatment cycle.

Detailed description: Infertility is a common issue faced by many couples throughout the United States. There are multiple fertility treatment options, including in vitro fertilization (IVF) and intrauterine insemination (IUI). Additionally, methods such as endometrial scratch (a modified endometrial biopsy) have been postulated to increase success rate. This prospective, randomized control trial will assess whether performing an endometrial scratch improves cycle outcomes and decreases time to pregnancy following IUI. Each patient will be randomly assigned to receive either an endometrial scratch or undergo a "sham" procedure (speculum insertion but no scratch) during the menstrual phase of the IUI cycle.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing intrauterine insemination procedures between the ages of 18 and 37 who have undergone a complete fertility work up (tubal, uterine, hormonal and sperm assessments) and do not have a current tubal or uterine factor infertility or severe male factor (expected to have \< 10 million total motile sperm on IUI sample) unless using donor sperm.

Exclusion Criteria:

* age \< 18 or \> 37, expectation (prior to randomization) of \< 10 million total motile sperm on IUI sample, tubal factor, uterine factor, incomplete fertility work up.

Primary outcomes:
measure: Pregnancy rate
timeFrame: Within one month from study randomization.
Secondary outcomes:
measure: Time to conception
timeFrame: To be assessed within 6 months of randomization.
measure: Participants perceived acceptability
timeFrame: The survey assessing this outcome is completed by the participant on the day of the study procedure.
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic Reproductive Medicine and Fertility
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Emily E Hoeker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wadhwa L, Pritam A, Gupta T, Gupta S, Arora S, Chandoke R. Effect of endometrial biopsy on intrauterine insemination outcome in controlled ovarian stimulation cycle. J Hum Reprod Sci. 2015 Jul-Sep;8(3):151-8. doi: 10.4103/0974-1208.165144.
Clinical trial NCT04949698: Risk Factors and the Effect of Plasma Exchange on Prognosis of Pregnancy-related Thrombotic Microangiopathies
Official title: "Risk Factors for Pregnancy-related Thrombotic Microangiopathies Retrospective Study of the Effect of Plasma Exchange on Prognosis of Pregnancy-related Thrombotic Microangiopathies"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy-related Thrombotic Microangiopathies
Keywords: pregnancy
thrombotic microangiopathies
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients admitted to the Department of critical care medicine, the Third Hospital of Peking University from 2015 to 2019

Brief summary: Early identification of the risk factors of pregnancy-related thrombotic microangiopathies can help us reduce the complications of such patients and increase the survival rate of patients. In addition, it is still controversial whether patients with pregnancy-related thrombotic microvessels should receive plasma therapy.

Detailed description: "Objective: To evaluate the risk factors of pregnancy-related thrombotic microangiopathies and the effect of plasma exchange on the prognosis (recovery status of renal function, recovery status of platelets, survival or death within 28 days).

Design: A retrospective analysis of pregnant patients admitted to the ICU from 2015 to 2019. According to the outcome indicator of the occurrence of pregnancy-related thrombotic microangiopathies, they were divided into thrombotic microangiopathies group and non-thrombotic microangiopathies group. Patients in the pregnancy-related thrombotic microangiopathy group were divided into plasma exchange combined non-plasma exchange group according to whether they received plasma exchange. Collect the clinical data of the patients, and analyze the data using SPSS 1 7.0 statistical software package. The measurement data were compared by paired t test and one-way analysis of variance; the count data were compared by χ2 test. Compare the differences of the indicators between the two groups and analyze the risk factors of pregnancy-related thrombotic microangiopathies. Then compare whether there is a difference in the prognosis between the plasma exchange group and the non-plasma exchange group."

Eligibility criteria: Inclusion Criteria:

* Pregnant patients admitted to the Department of critical care medicine, the Third Hospital of Peking University from 2015 to 2019

Exclusion Criteria:

* NO

Primary outcomes:
measure: TMA happen
timeFrame: 28th day after ICU admission
Secondary outcomes:
measure: renal function
timeFrame: 28th day after ICU admission
measure: platelet level
timeFrame: 28th day after ICU admission
measure: survival rate
timeFrame: 28th day after ICU admission
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Min Yi, chief physician
role: STUDY_DIRECTOR
References:
Clinical trial NCT02662998: Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Older Cancer Patients Within a Comprehensive Geriatric Assessment - BIS
Official title: Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Older Cancer Patients Within a Comprehensive Geriatric Assessment - BIS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Older Cancer Patients
Lead sponsor: General Hospital Groeninge
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 45
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This trial will recruit older patients with a minimum age of 70 years old who have been diagnosed with a solid tumour or hematologic malignancy, who are eligible for an oncogeriatric evaluation.

Brief summary: The aim of this study is to validate uHear™, an iOS-based tool, as a screening tool to detect significant hearing impairment as part of a comprehensive geriatric assessment in patients aged 70 years and older. The pass or fail screening cut-off is defined as having two or more consecutive hearing grades starting from the moderate-severe threshold zone ranging from 0.5 - 2.0 kHz.


Eligibility criteria: Inclusion Criteria:

* Patients should have reached the age of 70 or more at enrolment
* Histologically confirmed diagnosis of solid cancer or hematologic malignancy. All stages of cancer are eligible
* Patients should be fluent in Dutch or French
* Patients must receive their primary oncology care in the participating hospital
* Patients should be cognitively capable of performing the audiology assessment
* Patients should be scheduled to receive a CGA
* Patients should have signed informed consent

Exclusion Criteria:

* Patients who do not match the above inclusion criteria
* Patients presenting with clinically diagnosed Meniere's disease, retrocochlear hearing loss, autoimmune inner ear disease, fluctuating hearing loss or a history of sudden sensory neural hearing loss
* Patients who already have a hearing aid or a previously diagnosed hearing loss

Primary outcomes:
measure: Validation of uHear™ with its new scoring method as a screening tool to detect hearing loss in older cancer patients
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: General Hospital Groeninge, Cancer Center
Study officials:
References:
citation: Lycke M, Debruyne PR, Lefebvre T, Martens E, Ketelaars L, Pottel H, Van Eygen K, Derijcke S, Werbrouck P, Vergauwe P, Stellamans K, Clarysse P, Dhooge I, Schofield P, Boterberg T. The use of uHear to screen for hearing loss in older patients with cancer as part of a comprehensive geriatric assessment. Acta Clin Belg. 2018 Apr;73(2):132-138. doi: 10.1080/17843286.2017.1392070. Epub 2017 Oct 24.