louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01165099: Acupuncture for Pain Relief During Induced Labour in Nulliparae
Official title: Acupuncture for Pain Relief During Induced Labour in Nulliparae: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: acupuncture
induced labour
labour outcome
nulliparae
pain-relief
epidural during labour
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2010-07-19
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was primarily designed to assess the role of acupuncture in reducing the need for epidural analgesia for pain relief during induced labour. The other outcomes of labour were to be observed in addition.

Detailed description: The study was limited to women in their first pregnancy having labour induced for prolonged pregnancy or mild hypertension. The study involved randomised groups managed with manual acupuncture, electro acupuncture, sham acupuncture and a no-treatment control group.

Eligibility criteria: Inclusion Criteria:

* nulliparae
* having labour induced for prolonged pregnancy or mild hypertension
* no previous experience of acupuncture
* give written informed consent

Exclusion Criteria:

* all who do not meet the inclusion criteria

Primary outcomes:
measure: the rate of intrapartum epidural analgesia
timeFrame: within 72 hours of trial entry
Secondary outcomes:
measure: the outcome of labour
timeFrame: within 72 hours of trial entry
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: University of Oxford
name: I Z MacKenzie, FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee H, Ernst E. Acupuncture for labor pain management: A systematic review. Am J Obstet Gynecol. 2004 Nov;191(5):1573-9. doi: 10.1016/j.ajog.2004.05.027.
citation: Mackenzie IZ, Xu J, Cusick C, Midwinter-Morten H, Meacher H, Mollison J, Brock M. Acupuncture for pain relief during induced labour in nulliparae: a randomised controlled study. BJOG. 2011 Mar;118(4):440-7. doi: 10.1111/j.1471-0528.2010.02825.x. Epub 2011 Jan 18.
Clinical trial NCT02411799: Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTMd
Official title: Prospective Multi-Center Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTM
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spondylolisthesis
Spinal Stenosis
Proximal Joint Kyphosis (PJK)
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are candidates for hybrid thoracolumbar fixation with the Implanet Jazz System during arthrodesis surgery.

Brief summary: Establish a data repository of patients who have undergone thoracic and/or lumbar instrumented arthrodesis procedure supplemented by the Implanet Jazz System.

Detailed description: The purpose of this study is to create a data repository of patients who have undergone spinal arthrodesis procedures supplemented with the Implanet Jazz System. This device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from T1 to L5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid bony fusion.

Patients who are candidates for hybrid thoracolumbar fixation with the Implanet Jazz System during arthrodesis surgery will be asked to participate in this protocol. Clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36 48, and 60 months post surgery in the database. Data collected will include demographic and surgical information, physiological data, neurological assessments and patient reported outcomes. This comprehensive database will allow for gathering of relevant information for potential future research use.

Eligibility criteria: Inclusion Criteria:

* Patients who are candidates for spinal arthrodesis surgery (thoracic and/or lumbar) supplemented by the Implanet Jazz System are eligible to participate in this study.

Exclusion Criteria:

* Patients under the age of 18 are excluded because the investigators do not routinely perform spinal arthrodesis surgery on these patients.

Primary outcomes:
measure: Number of patients who have undergone thoracic and/or lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Assistant Professor
name: H. Francis Farhadi, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Viswanathan VK, Kukreja S, Minnema AJ, Farhadi HF. Prospective assessment of the safety and early outcomes of sublaminar band placement for the prevention of proximal junctional kyphosis. J Neurosurg Spine. 2018 May;28(5):520-531. doi: 10.3171/2017.8.SPINE17672. Epub 2018 Feb 9.
Clinical trial NCT05917899: Limited English Proficiency Virtual Family-Centered Rounds
Official title: Virtual Family-Centered Rounds for Caregivers With Limited English Proficiency: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Disorder
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will be a pilot test of using telehealth with an interpreter as an additional option for parents with limited English proficiency to join family-centered rounds in the neonatal intensive care unit.


Eligibility criteria: We will enroll family units. Family units consist of the hospitalized infant and their eligible parents/guardians.

Inclusion Criteria - INFANT:

* Infants aged less than 365 days who are admitted to the neonatal intensive care unit
* Have at least one eligible parent or guardian (see below for parent eligibility criteria)

Exclusion Criteria - INFANT:

* Have restrictions placed by child protective services, including visitation restrictions or restricted access to patient information
* Infants with a previous neonatal intensive care unit admission (and enrollment) during the trial period
* Infants already enrolled in a different trial that includes a virtual family-centered rounds intervention

Inclusion Criteria - PARENT:

* Aged 18 years or older
* Preferred language that is other than English
* Have at least one infant enrolled in the trial

Exclusion Criteria - PARENT:

* Under age 18 years

Primary outcomes:
measure: Family-Centered Rounds Parent Attendance
timeFrame: From date of randomization until the date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Secondary outcomes:
measure: Patient length of stay
timeFrame: From date of admission to the neonatal intensive care unit until the date of disposition from the unit for any cause (assessed up to 396 days)
measure: Breastmilk feeding at discharge
timeFrame: Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
measure: Medical errors and adverse events
timeFrame: Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
measure: Patient Experience
timeFrame: Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
measure: Patient Activation
timeFrame: Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
measure: Parent Quality of Life
timeFrame: Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
References:
Clinical trial NCT03220399: Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2
Official title: Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2017-07-18
Enrollment: 0
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

Detailed description: pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

Eligibility criteria: Inclusion Criteria:

* Men 19years of age or older at screening test.
* BMI of \>18.5kg/㎡ and \<27.0kg/㎡ subject, weight more than 50kg.
* Subject has signed and dated informed consent.

Exclusion Criteria:

* Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
* History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
* Current alcohol abuse.

Primary outcomes:
measure: Pharmacokinetic interaction
timeFrame: 0h - 48hrs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05438199: Prototyping a Device for Automating Stool and Urine Output Tracking
Official title: Prototyping a Device for Automating Stool and Urine Output Tracking
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Waste Output
Keywords: urine output
stool output
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to test an electronic apparatus for measuring stool and urine output in an accurate and easy way. Participants will have one in-person or virtual visit with the study team prior to starting the study events. Participants that enroll in this study will have the freedom to choose when to begin and stop using the toilet apparatus when it is available for human testing. This apparatus will be located in a private bathroom in either the CIEMAS building or MSRB III Building.


Eligibility criteria: Inclusion Criteria:

* people who are able to use the private bathroom at no risk to themselves in the CIEMAS building (B508) or the bathroom located in room 4002, 4th floor of MSRB3.
* students or employees at Duke University since card access is required for our MSRB3 bathroom.
* people who spend most of their time in these buildings so we can assure the use of the toilet.
* If the recruitment number is slow, enrollment will include people from the closest buildings.

Exclusion Criteria:

* People who use wheelchairs or other mobility devices won't be able to enroll, since at this moment the bathroom is not compliant with the requirements on The Americans with Disabilities Act (ADA) of 1990.

Primary outcomes:
measure: Percent of urine output correctly identified as measured by toilet seat apparatus .
timeFrame: Up to 3 months
measure: Percent of stool output correctly identified as measured by toilet seat apparatus .
timeFrame: Up to 3 months
Secondary outcomes:
measure: Percent of urine weight correctly identified by toilet seat apparatus
timeFrame: Up to 3 months
measure: Percent of stool weight correctly identified by toilet seat apparatus
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University - MGM
name: Lawrence David
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05852899: Evaluation of Preoperative Risk Factors in Children
Official title: Evaluation of Preoperative Risk Factors in Prediction of ICU Admission in Children, An Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Morbidity
Preterm Birth
Difficult or Failed Intubation
Keywords: ASA-PS
surgical risk
risk assessment
preoperative
prediction of icu admission
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under the age of 18 who will have an operation in the pediatric surgery operating room at Cerrahpasa Medical Faculty

Brief summary: 1. The investigators aimed to make a more advanced risk assessment in predicting preoperative intensive care unit admission in pediatric patients.
2. The investigators aimed to better define the pediatric patient population and identify preoperative risk factors in detail in order to reduce perioperative complications.

Detailed description: The aim of this study was to evaluate preoperative risk factors and determine their efficacy in predicting ICU admission after emergency or elective surgery in pediatric patients of all age groups. To achieve this aim, data such as gender, age, height, weight, history of prematurity, post-conceptional week, ASA PS score, accompanying systemic diseases, history of previous anesthesia, history of emergency or elective surgery, tumor surgery, chemotherapy and radiotherapy, surgical risk classification, difficult airway will be collected.

Eligibility criteria: Inclusion Criteria:

* Children under the age of 18 who will have an operation in the pediatric surgery operating room.

Exclusion Criteria:

* Children who are scheduled for surgery in pediatric surgery room but are hospitalized in the intensive care unit.(Children admitted directly from the intensive care units to the operating rooms)

Primary outcomes:
measure: ASA-PS
timeFrame: Preoperative visit period ( 20 minutes)
measure: Postoperative PICU admission
timeFrame: postoperative follow-up ( in 72 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Tuğba Yeşilyurt Doğu
state: Istanbul, Fatih
Study officials:
affiliation: Istanbul University- Cerrahpaşa (IUC)
name: Tugba Yesilyurt Dogu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University- Cerrahpaşa (IUC)
name: Pinar Kendigelen, MD
role: STUDY_DIRECTOR
affiliation: Istanbul University- Cerrahpaşa (IUC)
name: Ayse Cigdem Tutuncu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04677699: Combined Antibody Screening for Celiac and Diabetes Evaluation
Official title: Combined Antibody Screening for Celiac and Diabetes Evaluation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Type 1 Diabetes
Celiac Disease
Keywords: Type 1 Diabetes
Celiac Disease
Diabetes
Celiac
Gluten
Autoantibodies
Lead sponsor: Pacific Northwest Research Institute
Sponsor class: OTHER
Collaborators: name: University of Exeter
First posted: 2020-12-21
Enrollment: 64410
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns and school aged children in the state of Washington.

Brief summary: The CASCADE Study (Combined Antibody Screening for Celiac and Diabetes Evaluation) is an observational study whose primary goal is to show that population-based screening for advanced prediction of type 1 diabetes (T1D) and celiac disease (CD) is feasible to prevent diabetic ketoacidosis (DKA), improve celiac disease diagnosis, and ultimately gain public health acceptance to facilitate future prevention. It has two arms, a Birth Cohort and a Kids (cross sectional) Cohort.


Eligibility criteria: Inclusion Criteria:

* Child must be between 0 to 8 months in age or between 4 to 7 years in age. Child must be born in the state of Washington.

Exclusion Criteria:

-

Primary outcomes:
measure: Diagnosis of Type 1 Diabetes
timeFrame: 5 years
measure: Diagnosis of Celiac Disease
timeFrame: 5 years
Secondary outcomes:
measure: Severity of disease at diagnosis
timeFrame: 5 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Pacific Northwest Research Institute
state: Washington
Study officials:
affiliation: Pacific Northwest Research Institute
name: William Hagopian, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01033799: Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
Official title: Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Diseases
Healthy Subjects
Respiratory Tract Infections
Sore Throat
Sinusitis
Otitis
Bronchitis
Pneumonia
Influenza
Gastroenteritis
Keywords: Probiotic - Lactobacillus casei DN114-001
dairy product - infections - shiftworkers
Common infectious diseases,
occuring in healthy subjects,
including upper respiratory tract infections (defined as rhinopharyngitis, sore throat, sinusitis and otitis),
lower respiratory tract infections (defined as bronchitis,
pneumopathy and flu and flu-like syndromes), and
gastrointestinal tract infection defined as gastroenteritis.
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2009-12-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This single-center, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria), and on immune functions in healthy shift workers. Volunteers received either 200g/day of tested product (N=500) or control product (N=500) for 3-months, followed by a 1-month follow-up.


Eligibility criteria: Inclusion criteria: male and female aged 18-65 years; working in 2- or 3-shift work patterns (including night work); same job position for at least 4.5 months; a 19 to 30 kg/m2 body mass index; no symptoms of CIDs during the 2 weeks before product consumption; agreeing to a written informed consent.

Exclusion criteria: part time work (\<90%); allergy/hypersensitivity to components of the study product; severe respiratory allergy; a situation which, in the investigator's opinion, could interfere with optimal participation or constitute a special risk for the volunteer; a history of chronic metabolic/gastro-intestinal disease (except appendectomy); surgery/intervention requiring general anesthesia in the last 4 weeks; administration of systemic/topical treatments likely to interfere with the evaluation parameters in the last 4 weeks; chronic disease requiring antibiotics/antiseptics/anti-inflammatory medications; special medicated diet; chronic/iatrogenic immunodeficiency; cardiac/renal/respiratory insufficiency; severe evolutive/chronic pathology; pregnancy, breast feeding or lacking effective contraception in females; susceptibility not to comply with dietary recommendation during the study period.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Harrisson Clinical Research Clinical Unit
Study officials:
References:
Clinical trial NCT05188599: Isokinetic Parameters and the Amputee Mobility Predictor Scale
Official title: Are There Any Relationship Between Isokinetic Parameters and the Amputee Mobility Predictor Scale?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation, Traumatic
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 43 patients with lower limb amputations

Brief summary: There is very limited research examining isokinetic parameters and activity level in patients with amputation.. Therefore, the aims of this study were to illustrate isokinetic measurements including strength and proprioception and to analyze the correlation between those isokinetic parameters and activity level and to predict amputee mobility score. It is hypothesized that muscle strength and proprioception were associated with activity level and could be used to estimate amputee mobility scale score in patients with amputation.

Detailed description: Isokinetic measurements are used in the rehabilitation of amputee patients and to evaluate the effectiveness of rehabilitation. The parameters that are frequently looked at in these measurements are isokinetic muscle strength and proprioception. There is very limited research examining isokinetic parameters and activity level in patients with amputation.. Therefore, the aims of this study were to illustrate isokinetic measurements including strength and proprioception and to analyze the correlation between those isokinetic parameters and activity level and to predict amputee mobility score. We hypothesized that muscle strength and proprioception were associated with activity level and could be used to estimate amputee mobility scale score in patients with amputation

Eligibility criteria: Inclusion Criteria:

* Aged 18-65 years
* Time after amputation ≥ 6 months
* Unilateral or bilateral amputation above the ankle level

Exclusion Criteria:

* Upper extremity amputation
* The presence of musculoskeletal or neurological disease that could cause functional impairment other than amputation
* The presence of neurological deficit

Primary outcomes:
measure: Isokinetic muscle strength
timeFrame: Through study completion, an average of 1 month
measure: Isokinetic proprioception
timeFrame: Through study completion, an average of 1 month
measure: Amputee mobility predictor
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
References: