louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00941213: Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis
Official title: Comparison of the Quantity of Bleeding and the Duration of Operation in Thoracoscopic Ventral Spondylodesis During Preparation With Monopolar Electrosurgery Compared to Ultrasound Scissors.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fractures of Vertebral Bodies
Keywords: fractures of vertebral bodies Th10-L2
(AO A1 with kyphosis, A2.3, B or C-type)
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery (Europe) GmbH
First posted: 2009-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was undertaken to investigate the effect of using ultrasound scissors in the preparation for Thoracoscopic Ventral Spondylodesis. Quantity of bleeding and the duration of operation in Thoracoscopic Ventral Spondylodesis are compared to the preparation with monopolar electrosurgery.

Detailed description: One group of patients will be operated on using ultrasound scissors in the preparation during Thoracoscopic Ventral Spondylodesis. The other group will be operated on using Monopolar Electrosurgery.

The study is designed as a randomized trial. That means that all patients who have given their consent to participate in the study will be allocated to either ultrasound scissors or Monopolar Electrosurgery by chance.

A total of 40 patients will be included in this study. The study ends with finishing of the first day after the operation, there is no longer follow up.

Eligibility criteria: Inclusion Criteria:

* informed consent
* fracture of vertebral bodies Th10-L2 with indication for operative treatment

Exclusion Criteria:

* missing informed consent
* mission indication for operative treatment
* revision of the trailing edge
* clotting inhibition therapy
* ASA III/IV
* pregnancy
* malfunction of liver Child C

Primary outcomes:
measure: duration of the operation
timeFrame: end of the scin suture at the end of operation
Secondary outcomes:
measure: loss of blood during operation and at first day after the operation
timeFrame: 24 hours after end of operation
measure: length of stay at the hospital
timeFrame: day of discharge from hospitalization
measure: trauma of internal organs during operation
timeFrame: end of the scin suure at the end of operation
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne, Department of Orthopaedics/Trauma surgery
state: NRW
city: Cologne
country: Germany
facility: Kliniken der Stadt Köln gGmbH Merheim
state: NRW
Study officials:
affiliation: University of Cologne, Department of Orthopaedics/Trauma surgery
name: Peer Eysel, Professor
role: STUDY_DIRECTOR
affiliation: University of Cologne, Department of Orthopaedics/Trauma surgery
name: Gereon Schiffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05246813: Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP)
Official title: Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP): a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis
Osteoarthritis, Hip
Hip Fractures
Clonal Hematopoiesis of Indeterminate Potential
Aging
Lead sponsor: Imelda Hospital, Bonheiden
Sponsor class: OTHER
Collaborators: name: Université Catholique de Louvain
First posted: 2022-02-18
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing hip arthroplasty for hip osteoarthritis or osteoporotic hip fractures.

Brief summary: Bone marrow samples will be collected from patients undergoing hip arthroplasty surgery. Blood and bone marrow samples will be used for metabolic profiling and analysis of relevant CHIP mutations. Combined single-cell transcriptomics and mutation-specific single-cell genotyping (biotin-PCR using mutation-targeted primers followed by sequencing) will subsequently be performed. The gene expression profile of wildtype and mutant hematopoietic stem cells will be compared, performing both broad gene set enrichment analysis and targeted analysis of metabolic pathways.


Eligibility criteria: Inclusion Criteria:

* Age 65 years and older

Exclusion Criteria:

* known haematological condition (myelodysplasia, leukemia, cancer)
* inability to provide written informed consent

Primary outcomes:
measure: Gene Set Enrichment Analysis (GSEA) Normalized Enrichment Score (NES)
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
state: België
Study officials:
affiliation: de Duve Institute
name: Nick Van Gastel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05046613: Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
Official title: A Prospective, Registry-based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Migraine
Keywords: Migraine, Migraine Headache, Pregnant, Pregnancy, Infant
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: PPD, Part of Thermo Fisher Scientific
First posted: 2021-09-16
Enrollment: 780
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include pregnant women of any age within the US with migraine who were treated with rimegepant as part of routine care at any time during pregnancy or just prior to pregnancy (up to 3 days prior to conception), as well as pregnant women with migraine not exposed to rimegepant before or during pregnancy.

Brief summary: The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.


Eligibility criteria: Inclusion Criteria:

* Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception)
* Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy

Exclusion Criteria:

• Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy

Primary outcomes:
measure: Major congenital malformation (birth defect)
timeFrame: Annually beginning April 2022
Secondary outcomes:
measure: Minor congenital malformation
timeFrame: Annually beginning April 2022
measure: Gestational hypertension
timeFrame: Annually beginning April 2022
measure: Pre-eclampsia
timeFrame: Annually beginning April 2022
measure: Eclampsia
timeFrame: Annually beginning April 2022
measure: Gestational diabetes
timeFrame: Annually beginning April 2022
measure: Spontaneous abortion
timeFrame: Annually beginning April 2022
measure: Stillbirth
timeFrame: Annually beginning April 2022
measure: Elective termination
timeFrame: Annually beginning April 2022
measure: Preterm birth
timeFrame: Annually beginning April 2022
measure: Small for gestational age
timeFrame: Annually beginning April 2022
measure: Postnatal growth deficiency
timeFrame: Annually beginning April 2022
measure: Infant developmental delay
timeFrame: Annually beginning April 2022
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01392313: Measurement of Renal Function With Iohexol in Subjects Ingesting Carnitine
Official title: Measurement of Glomerular Filtration Rate (GFR) Using Iohexol in Healthy Subjects Taking Creatinine Supplements
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Carnitine Ingestion
Keywords: carnitine, kidney
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators will measure renal function in subjects ingesting carnitine to determine if the product alters renal function.


Eligibility criteria: Inclusion Criteria:

* carnitine ingestion

Exclusion Criteria:

* renal disease

Primary outcomes:
measure: Iohexol clearance
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Joel Neugarten, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06389513: Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants
Official title: Phase IV Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Epidemic Meningitis
Keywords: Vaccine
ACYW135
CRM197
Safety
3 months of age
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age.


Eligibility criteria: Inclusion Criteria:

* Infants 3 months of age who had not received any epidemic encephalitis vaccine at the time of screening
* The legal guardian or delegate has given informed consent, has voluntarily signed an informed consent form, and is able to comply with the requirements of the clinical study protocol

Exclusion Criteria:

First dose exclusion criteria

* Fever before vaccination, axillary temperature \>37.0°C
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
* History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders
* Acute infections or active chronic diseases, severe infectious or allergic skin diseases
* Known allergy to a component of the vaccine, especially to diphtheria toxoid, or to previous administration of the product
* Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate

Subsequent dose exclusion criteria

* Severe allergic reactions after a previous dose of vaccine
* Those with serious adverse reactions causally related to the previous dose of vaccination
* Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate

Primary outcomes:
measure: Incidence of localized adverse reactions in subjects
timeFrame: Within 7 days after each dose of vaccination
measure: Incidence of systemic adverse reactions in subjects
timeFrame: Within 7 days after each dose of vaccination
Secondary outcomes:
measure: Incidence of adverse reactions in subjects
timeFrame: Within 30 days after each dose of vaccination
measure: Incidence of adverse events in subjects
timeFrame: Within 30 days after each dose of vaccination
measure: Incidence of severe adverse events
timeFrame: Through study completion, an average of 10 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Luhe District Center for Disease Control and Prevention Center for Disease Control and Prevention
Study officials:
References:
Clinical trial NCT06821113: Vale+Tú Salud: Corner-Based Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19
Official title: Vale+ Tu Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID 19
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COVID-19
Keywords: Latino Day Laborers
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-02-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the cultural, socioeconomic, inter/personal and work-related factors that influence COVID 19 mitigation practices including social distancing, hand-washing and Personal protective equipment (PPE) use, to adapt, implement, and test Vale+Tú Salud in a cluster randomized trial to assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention and to promote Vale+Tú Salud just-in-time results and increase its capacity to rapidly disseminate findings among groups that serve LDL and other Latino immigrants.


Eligibility criteria: Inclusion Criteria:

* Self-identify as Hispanic or Latino
* Be present at the corner for the purposes of looking for work

Exclusion Criteria:

* Have not been previously hired to work at a corner
* Symptoms of COVID-19 in the previous 48 hours

Primary outcomes:
measure: Change in COVID-19 vaccination status as assessed by a survey
timeFrame: Baseline, 4 weeks post intervention
measure: Change in hand washing frequency as assessed by a survey
timeFrame: Baseline, 4 weeks post intervention
measure: Percentage of participants who report contacting the gold card agency
timeFrame: Baseline, 4 weeks post intervention
measure: Percentage of participants who report contacting the agency for assistance to get food
timeFrame: Baseline, 4 weeks post intervention
measure: Percentage of participants who report contacting the agency for assistance for health acre resources
timeFrame: Baseline, 4 weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Maria E Fernandez-Esquer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04734613: Tai Chi for Behavioral Modification Among Individuals With Metabolic Syndrome
Official title: Tai Chi Applied Behavioral Modification Program for Individuals With Metabolic Syndrome: Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Chungnam National University
Sponsor class: OTHER
Collaborators: name: National Research Foundation, Singapore
First posted: 2021-02-02
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized trial to assign the participants either to intervention group 1 (Tai Chi exercise) or to intervention group 2 (self management)
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is the randomized trial to explore the effect of behavioral modification program (Tai Chi vs. self management) on adults with metabolic syndrome. The outcome variables include health behavior, metabolic syndrome indicators, quality of life.

Detailed description: 1. venue: the individuals with diagnosis of metabolic syndrome are recruiting from university hospital outpatient clinic or primary clinic.
2. inclusion criteria: diagnosed of metabolic syndrome, agree to participate either programs, no history of participating regular exercise program past 6 months.
3. intervention: The behavioral modification program consisting of Tai Chi exercise (twice a week for 12 weeks) and self-management program (6 sessions every two weeks) is provided to the participants who randomly assigned to either group. Short form Yang style Tai Chi (16 movements) were led by trained Tai Chi practitioners, and self-management program were provided by nurse educators.

Eligibility criteria: Inclusion Criteria:

* diagnosis of metabolic syndrome
* adults who agree to participate either behavioral modification programs for 12 weeks
* be able to understand the questionnaire and follow the exercise or education program

Exclusion Criteria:

* who attend regular exercise program past 6 months

Primary outcomes:
measure: Change in Cardiac health behavior scale
timeFrame: change from baseline health behavior score at 3 months
measure: Change in blood pressure
timeFrame: change from baseline blood pressure at 3 months
measure: change in lipid profile
timeFrame: change from baseline lipid profile at 3 months
measure: Change in blood glucose
timeFrame: change from baseline blood glucose at 3 months
measure: Change in abdominal obesity
timeFrame: change from baseline waist circumference at 3 months
Secondary outcomes:
measure: Change in quality of life
timeFrame: change from baseline QOL score at 3 months
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
affiliation: Chungnam National University
name: Rhayun Song
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05415813: Effects of IC With and Without MET on Upper Trapezius Trigger Points
Official title: Effects of Ischemic Compression With and Without Muscle Energy Technique on Pain, Range of Motion and Functional Disability in Patients With Trigger Points in Upper Trapezius; A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Trapezius Trigger Points
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of the study is to check the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. In previous studies, Muscle Energy Technique and Ischemic Compression are compared with different conventional and combined therapy approaches, including most of the techniques used to treat Trigger Points in the upper trapezius. No study has evaluated the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. The outcome measures are a Numeric pain rating scale, universal goniometer and neck disability index questionnaire.


Eligibility criteria: Inclusion Criteria:

* Both gender Aged 18 to 50 years (40)
* Participants with active myofascial trigger points in the upper trapezius diagnosed by a senior physiotherapist on the basis of Travel and Simon criteria will be randomly allocated into two clinical groups.
* Taut band having palpable nodule within upper trapezius muscle
* Pain produced in a specific pattern which is radiating in character when firm pressure is applied on trigger points

Exclusion Criteria:

* Trauma (whiplash injury)
* Injury to Cervical Spine
* Cervical Spine surgery
* Cervical Myelopathy and Radiculopathy
* Osteoporosis of the cervical spine
* Cervical myeloma
* Complex regional pain syndrome
* Patients with the H/O any Neurological, Rheumatology and other serious medical illnesses.

Primary outcomes:
measure: Change from Baseline in pain on Numeric Pain Rating Scale at week 4
timeFrame: Baseline and week 4
measure: Change from Baseline in Goniometer readings at week 4
timeFrame: Baseline and week 4
measure: Change from baseline in Neck disability index questionnaire scores at week 4
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Pain on Numeric Pain Rating Scale at week 2
timeFrame: week 2
measure: Goniometer readings at week 2
timeFrame: week 2
measure: Neck disability index questionnaire scores at week 2
timeFrame: week 2
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: University of Sialkot
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Syeda Khadija Kazmi, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01261013: Intrastromal Corneal Ring Segment Implantation in 219 Keratoconic Eyes at Different Stages
Official title: Intrastromal Corneal Ring Segment Implantation in 219 Keratoconic Eyes at Different Stages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Keywords: Keratoconus
intrastromal corneal ring segment
To evaluate the visual and refractive outcomes of intrastromal corneal ring segment in keratoconic eyes at different stages
Lead sponsor: Fernandez-Vega Ophthalmological Institute
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 219
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with keratoconus (stage I; stage II and stage III,according to the Amsler-Krumeich keratoconus classification) in whom KeraRing ICRS were implanted at the Fernández-Vega Ophthalmological Institute, Oviedo, Spain.

Brief summary: The purpose of this study is to properly analyse the visual and refractive outcomes of implantation of KeraRing intrastromal corneal ring segment (ICRS) at the different stages of keratoconus.


Eligibility criteria: Inclusion Criteria:

* Patients who had keratoconus
* Contact lens intolerance and clear cornea.
* The maximum keratometric reading was less than 60.00 diopters (D)
* The minimum corneal thickness more than 300 μm.

Exclusion Criteria:

* Acute or grade IV keratoconus.
* Previous corneal or intraocular surgery.
* Cataract, history of glaucoma or retinal detachment, macular degeneration or retinopathy, neuro-ophthalmic diseases, and history of ocular inflammation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: