louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01963468: Maximizing Language Development in Children With Hearing Loss
Official title: Pre-Implantation Communication Treatment for Children With Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing Loss
Cochlear Implant
Deaf
Hearing Impairment
Hard of Hearing
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2013-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of early intervention on language skills for children with hearing loss.


Eligibility criteria: Inclusion Criteria:

* 6 to 18 months of age
* bilateral, moderate to profound congenital hearing loss

Exclusion Criteria:

* auditory neuropathy
* no known additional disabilities (e.g., cerebral palsy, Down syndrome)
* both parents have a severe to profound hearing loss

Primary outcomes:
measure: MacArthur Communicative Development Inventories
timeFrame: one month
Secondary outcomes:
measure: Preschool Language Scale
timeFrame: 6 months
Other outcomes:
measure: Communication and Symbolic Behavior Scales
timeFrame: 6 months
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Megan Y Roberts, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03160768: Feasibility of Isolating P16 Expression
Official title: Feasibility of Isolating P16 Expression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Cancer
Keywords: p16
T cell isolation
physiologic age
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: Sapere Bio
First posted: 2017-05-19
Enrollment: 85
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: Participants will be childhood cancer survivors enrolled in the long-term follow-up study at St. Jude Children's Research Hospital.

Brief summary: Expression of the cell cycle regulator p16INK4a increases with age and toxic stressors. In mice, both radiation and chemotherapy are known to increase p16. Due to its influence on age-related regenerative capacity, p16 is an excellent candidate biomarker of physiologic reserve that may identify patients able to withstand the stressor of chemotherapy (low p16) from those unlikely to tolerate chemotherapy (high p16). That is, expression of p16 may predict physiologic, rather than chronologic, age. Such findings could have implications for care of cancer survivors and treatment decision-making in cancer patients.

STUDY OBJECTIVE: This is an observational pilot study to determine the feasibility of isolating p16INK4a in CD3+ T lymphocytes in adults treated with chemotherapy for cancer during childhood.

Detailed description: At St. Jude Children's Research Hospital, survivors who meet the eligibility criteria will be identified from SJLIFE protocol participants. After signing consent, the subject will have a blood specimen collected at the same time as the blood draw for the SJLIFE protocol. These samples will have T cell isolation performed then placed on ice and stored until batch shipment for investigation of p16 expression.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the SJLIFE study at St. Jude children's Research Hospital.
* Survivor of childhood cancer.
* Is 18 years of age and older.
* No evidence of cancer recurrence.
* Received prior chemotherapy (prior radiotherapy is allowed).

Exclusion Criteria:

* Inability or refusal to give consent.

Primary outcomes:
measure: Number of samples with successful isolation of expression of p16INK4a in CD3+ T lymphocytes
timeFrame: Within 3 months of enrollment of the last participant
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Kirsten K. Ness, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04433468: Study on the Protective Effect of RIPC in Patients Undergoing Cardiac Surgery.
Official title: Study on the Protective Effect of RIPC in Patients Undergoing Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 60
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: SUPPORTIVE_CARE

Brief summary: To observe the effect of RIPC on the function of vital organs after cardiac surgery, and to explore its possible mechanism.


Eligibility criteria: Inclusion Criteria:

* patients with aortic valve, mitral valve, tricuspid valve, ascending aortic disease and coronary atherosclerosis who were admitted to hospital for elective valve repair, replacement, artificial vascular replacement or coronary artery bypass grafting.
* age 18-80 years old.
* No restriction on gender.
* ASA grade II\~III.
* NYHAII\~III level.
* the patient or his family member has signed the informed consent form for the clinical trial

Exclusion Criteria:

* those who are disabled in the selected test.
* less than 5 years of education.
* The preoperative left ventricular ejection fraction ((LVEF)) was less than 40%.
* Myocardial infarction occurred in nearly one month.
* malignant tumor, hematological disease, severe liver and kidney dysfunction, recent severe infection, etc.
* History of nervous system, immune system and mental illness.
* recent operation history of heart, brain, lung, liver, kidney and other important organs

Primary outcomes:
measure: The incidence of acute renal injury after operation
timeFrame: within 7 days after operation
measure: The incidence of postoperative delirium
timeFrame: within 7 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
References:
Clinical trial NCT00580268: Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
Official title: Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Psychiatric Morbidity
Neonatal Outcome
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: psychiatrists, referring obstetricians, community-based health centers, triage, and women who have previously given written permission to be contacted about research studies within the MGH Perinatal and Reproductive Psychiatry Program

Brief summary: The purpose of this study is to examine risk factors for relapse of bipolar disorder during pregnancy and the postpartum period. The main goal of this study is to find the risks that may make it more likely for a woman with bipolar disorder to experience a depressive, manic, or hypomanic episode during her pregnancy and the postpartum period.


Eligibility criteria: Inclusion Criteria:

1. medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for bipolar disorder of any type (1 or 2) who are currently pregnant within 14 weeks gestation dated by last menstrual period;
2. euthymic at the time of conception;
3. able to give informed consent and comply with study procedures;
4. have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45

Exclusion Criteria:

1. active suicidality or homicidality;
2. active substance use disorder with 6 months prior to enrollment, or
3. positive urine drug screen at enrollment.

Primary outcomes:
measure: psychiatric morbidity
timeFrame: 15 months
Secondary outcomes:
measure: obstetrical outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts Geral Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Adele C Viguera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05242068: Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children
Official title: Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children: Preliminary Results.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization
Pain
Complication
Keywords: pain
children
vein imaging device
intravenous complications
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 139
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was a prospective randomized controlled clinical study of children treated in a pediatric surgical ward who required PIC. The aim of the research was to evaluate whether the Veinlite would prevent catheter-related complications
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the use of Veinlite LED+ (TransLite, Sugar Land, Tex) to assist with PIC placement. The Veinlite uses LED (light-emitting diode) lights to enhance the visualization of veins by using orange and red color that are absorbed in venous blood.

The investigators' hypothesis for this study was that the vein imaging would reduce the complications related to catheter and the pain that the participants would feel.

Detailed description: Peripheral Intravenous Catheterization (PIC) introduces multiple risks and potential morbidities. Patients with PIC-associated complications have longer length of stay, higher clinical and economic burden, and greater risk of death than patients without. The most serious complications due to intravenous (IV) catheters are infiltration and extravasation.

The primary endpoint was to evaluate whether Veinlite LED+ would prevent catheter-related complications.

The secondary endpoint were;

1. to evaluate the efficacy of the vein imaging device on pediatric pain during intravenous catheterization
2. to evaluate the efficacy of the vein imaging device on catheter dwell time.

Eligibility criteria: Inclusion Criteria:

* Children aged between 5 and 18
* Children with DIVA (Difficult intravenous access score) score 4 or more
* That the child and the parent speak Turkish

Exclusion Criteria:

* needing urgent treatment
* a critical health condition
* That the child or the parent has a communication problem

Primary outcomes:
measure: Reducing number of complications related with peripheral intravenous catheter
timeFrame: Duration of catheter dwell time (up to 168 hours)
Secondary outcomes:
measure: Pain scores during peripheral intravenous catheterization
timeFrame: Immediately after IV placement
measure: Catheter dwell time
timeFrame: Up to 168 hours (1 week)
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
References:
Clinical trial NCT04771468: "Hemodynamic Changes During Endovascular Revascularization for Acute Stroke. An Observational Study".
Official title: "Hemodynamic Changes During Endovascular Revascularization for Acute Stroke. An Observational Study".
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
Collaborators: name: Ospedale Policlinico San Martino
First posted: 2021-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted for acute ischemic stroke

Brief summary: Neurocardiology is an emerging specialty that addresses the interaction between the brain and the heart, i.e. the effects of cardiac injury on the brain, and the effects of brain injury on the heart. Accumulating clinical and experimental evidence suggests a causal relationship between brain damage and heart dysfunction.


Eligibility criteria: Inclusion criteria

1. Adult patients aged ≥ 18 years.
2. Acute supratentorial or carotid stroke. Exclusion criteria

1. Invasive arterial signal unsuitable to obtain hemodynamic data. 2. Emergency neurosurgery needed before intra-arterial treatment. 3. Once enrolled, the patient can be excluded from the study because of one of the following intraoperative conditions:

1. Intraoperative technical limitations limiting or impeding the arterial re-opening
2. Persistent low quality of the arterial signal. After positioning the patient and zeroing the arterial signal, the arterial waveform is checked for quality by means of a square-wave test and optimized in the case of the occurrence of under or over-damping.

Primary outcomes:
measure: Cardiac output measurement
timeFrame: Up to 6 hours after clot removal
measure: Arterial elastance measurement
timeFrame: Up to 6 hours after clot removal
measure: Arterial blood pressure measurement
timeFrame: Up to 6 hours after clot removal
measure: Heart rate variability measurement
timeFrame: Up to 6 hours after clot removal
Secondary outcomes:
measure: Transthoracic echocardiography
timeFrame: at the admission
measure: Transthoracic Echocardiography
timeFrame: up to 3 weeks after clot removal
measure: Transthoracic Echocardiography
timeFrame: up to 3 weeks after clot removal
measure: Transthoracic Echocardiography
timeFrame: up to 3 weeks after clot removal
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milano
Study officials:
References:
Clinical trial NCT04629768: Purastat Prevention Delayed Bleeding Duodenum
Official title: A Study to Evaluate the Effectiveness of Purastat® in the Prevention of Delayed Bleeding After EMR of Non-ampullary Duodenal Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lesion; Duodenum
Keywords: Purastat
EMR duodenum
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: 3-D Matrix Europe SAS
First posted: 2020-11-16
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: PuraStat is a viscous solution of synthetic peptides that provides a physical barrier to facilitate hemostasis. It is indicated for haemostasis in a variety of surgical indications. In this study the efficacy of PuraStat in reducing delayed bleeding following duodenal endoscopic mucosal resection (EMR) will be assessed. PuraStat will be applied to the EMR defect after the resection. The presence of active bleeding or high risk stigma of bleeding will be observed on an esophagogastroduodenoscopy (EGD) performed 1 day after the duodenal EMR. Furthermore the presence of clinical signs of delayed bleeding, other adverse events and the feasibility of PuraStat application will be assessed.


Eligibility criteria: Inclusion Criteria:

* Duodenal non-ampullary mucosal lesion ≥ 10 mm
* ≥ 18y of age
* Informed consent obtained

Exclusion Criteria:

* Ampulloma
* Submucosal lesion
* Lesion \< 10 mm
* \>1 lesion resected
* Active use of anticoagulant or antithrombotic medication other than aspirin
* Known clotting disorder
* Inability to give informed consent
* \< 18y of age

Primary outcomes:
measure: The presence of active bleeding or high risk stigma of bleeding
timeFrame: 1 day after EMR
Secondary outcomes:
measure: The presence of clinical signs of delayed bleeding
timeFrame: 'During hospital stay, assessed up to 10 days' and '30 days after EMR'
measure: The presence of other adverse events
timeFrame: 'During hospital stay, assessed up to 10 days' and '30 days after EMR'
measure: The feasibility of PuraStat application: Amount
timeFrame: During EMR procedure
measure: The feasibility of PuraStat application: Ease
timeFrame: During EMR procedure
measure: The feasibility of Purastat application: Coverage
timeFrame: During EGD procedure
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: UZ Leuven
name: Ingrid Demedts
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00981968: Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects
Official title: An Investigator- And Subjects- Blind Phase 1 Study To Investigate Pharmacokinetics, Safety And Tolerability Of Sitaxentan In Japanese Healthy Subjects Following Single And Multiple Doses And Western Healthy Subjects Following Single Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate safety, tolerability and pharmacokinetics of sitaxentan following single and multiple oral administrations of sitaxentan sodium in Japanese healthy subjects.


Eligibility criteria: Inclusion Criteria:

Healthy male and/or female subjects between the age of 18 and 55 years, inclusive.

Body Mass Index of 17.5 to 33.5 kg/m2, and a total body weight \>45 kg. Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.

Exclusion Criteria:

Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.

Primary outcomes:
measure: Adverse events (spontaneous and solicited)
timeFrame: Day 0 to Day 9 of Period 3 for cohort 1, Day 0 to Day 3 of Period 2 for cohort 2
measure: ECGs, Vital signs, Safety laboratory test
timeFrame: Screening visit to Day 9 of Period 3 for cohort 1 and Day 3 of Period 2 for cohort 2
measure: Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F
timeFrame: Day 1 of Periods 1 and 2
measure: Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss
timeFrame: Days 1 and 7 of Periods 1 and 3
Secondary outcomes:
measure: No secondary outcome
timeFrame: No secondary outcome
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05427968: Comparison of Hypotension During Spinal Anaesthesia for C-section
Official title: To Tilt or Not to Tilt?: Comparison of Severity of Hypotension Between Supine and Left Tilt Position During Spinal Anesthesia for Elective C-section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Cesarean Section
Aortocaval Compression
Keywords: Hypotension
Cesarean Section
Aortocaval Compression
Left titl
Lead sponsor: Rawalpindi Medical College
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 38
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants after fulfilling the inclusion exclusion criteria were randomized by lottery method into two groups; supine group (Group 1) and left tilt group. (Group 2).

Brief summary: Maternal hypotension during C section has been reported due to aortocaval compression (ACC) by full term uterus in supine position. This study aimed at reporting the effect of left tilt on maternal hemodynamics.

Detailed description: C-section is usually done in either general anesthesia or regional (epidural or spinal) anesthesia. The choice lies with the mother. In spinal anesthesia the anaesthetic agent is injected into the subarachnoid space. Hypotension in supine position that is associated with full term gravid uterus has been explained by compression of inferior venacava (IVF) and aorta. This aortocaval compression (ACC) can also cause hypotension during C- section after spinal block.

The aim of our study was to study the effect of left tilt on systolic (SBP) and diastolic blood pressure (DBP), heart rate and the frequency of phenylephrine used to maintain the blood pressure in normal range.

Eligibility criteria: Inclusion Criteria:

* Participants ≥ 18 years, undergoing Elective Caesarean Section for term singleton pregnancy, ASA I/II, were included after their consent for the participation of the study.

Exclusion Criteria:

* Participants with co-morbidities (Hypertension, diabetes mellitus, cardiovascular or cerebrovascular disease and a history of coagulation disorders), any contraindication to spinal anesthesia, with multiple pregnancy, pre-eclampsia, obesity (body mass index \> 30 kg.m2), intrauterine growth were excluded from the study.

Primary outcomes:
measure: Group 1 - Supine Group
timeFrame: December 2021 to February 2022
measure: Group 2 - Left tilt Group
timeFrame: December 2021 to February 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Rawalpindi Medical University
state: Punjab
Study officials:
References:
Clinical trial NCT03912168: Question Prompt List for Orthopaedic Conditions
Official title: Does Giving a Question Prompt List to Patients With Orthopaedic Conditions Improve Their Perceived Involvement in Care? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendon Injuries
Fracture
Arthritis
Sprains
Strains
Tumor
Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to investigate whether providing patients with a question prompt list (QPL) prior to their orthopaedic surgery clinic appointment improves their perceived involvement in care (PICs) score compared to being given 3 questions from the AskShareKnow model


Eligibility criteria: Inclusion Criteria:

* common orthopaedic condition new patient

Exclusion Criteria:

-

Primary outcomes:
measure: Perceived involvement in care scale
timeFrame: Immediately after the clinical encounter, same day as clinical encounter
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Stanford University
name: Robin N Kamal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mariano DJ, Liu A, Eppler SL, Gardner MJ, Hu S, Safran M, Chou L, Amanatullah DF, Kamal RN. Does a Question Prompt List Improve Perceived Involvement in Care in Orthopaedic Surgery Compared with the AskShareKnow Questions? A Pragmatic Randomized Controlled Trial. Clin Orthop Relat Res. 2021 Feb 1;479(2):225-232. doi: 10.1097/CORR.0000000000001582.