louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02514993: The Unstable Thoracic Cage Injury
Official title: The Unstable Thoracic Cage Injury: The Concomitant Sternal Fracture Indicates a Severe Thoracic Spine Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Spine Fracture
Concomitant Sternal Fracture
Keywords: Sternal fracture
Thoracic spine fracture
Thoracic cage injury
Lead sponsor: BG Unfallklinik Murnau
Sponsor class: OTHER
First posted: 2015-08-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering a thoracic spine fracture and a concomitant sternal fracture

Brief summary: * Analysis of patient data and computed tomography scan of polytraumatized patients thoracic spine fractures
* A concomitant sternal fracture was identified an indicator for an unstable thoracic spine fracture

Detailed description: Previous studies stated, that sternal fractures can be regarded as an indicator for thoracic spine fractures and described the combined injury pattern of thoracic spine fracture and sternal fracture as "upper thoracic cage injury". But literature research is lacking data that in patients with a thoracic cage injury a highly unstable thoracic spine fracture can be expected.

In a large cohort of 130 patients with a thoracic spine fracture and concomitant sternal fracture the investigators analyzed the injury pattern and evaluated associated injuries, trauma mechanism, and clinical outcome.

The investigators could prove that in patients with a thoracic cage injury the concomitant sternal fracture may be regarded as an indicator for an unstable thoracic spine fracture, which requires surgical stabilization. Furthermore the analysis revealed that even a highly rotationally unstable type C fracture has to be expected, if sternal and thoracic spine fractures are located in the same segment.

Eligibility criteria: Inclusion Criteria:

* Sternal fracture and concomitant thoracic spine fracture
* Injury Severity Scale ≥ 16
* Age under 50 years
* Presence of a whole body computed-tomography (CT-scan) performed at admission of the patient to the hospital

Exclusion Criteria:

* Missing consent
* Incomplete patient data

Primary outcomes:
measure: Survival
timeFrame: 1 year after trauma
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Trauma Center Murnau
name: Mario Morgenstern, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04701593: Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery
Official title: Using Intraoperative Triamcinolone Acetonide Irrigation to Reduce Post-Operative Pain From Scleral Buckle Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinal Detachment
Keywords: Scleral Buckle
Triamcinolone Acetonide
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 14
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain following scleral buckle surgery. The investigators aim to control pain following scleral buckle surgery with sub-tenon's irrigation with triamcinolone acetonide at the time of surgery. Using a randomized prospective clinical study, the investigators test if this technique will reduce the pain, nausea/vomiting, and analgesic use caused by scleral buckle surgery.

METHODS: Forty-eight patients undergoing scleral buckle surgery will be randomized into two groups. The experimental group receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation. The control group does not receive any triamcinolone irrigation. Pain scores are measured 1 day post-operatively via 11-pt numerical rating scale as the primary outcome. The nausea/vomiting score is measured 1 day post-operatively via standard 6-pt scale. Patients track pain medication use via pill count. Values will be measured again at 1-2-week and 6 months post-op.


Eligibility criteria: Inclusion Criteria:

* Patient must have rhegmatogenous retinal detachment and be scheduled to undergo scleral buckle surgery for correction

Exclusion Criteria:

* Advanced Glaucoma
* History of corticosteroid responsive elevation in IOP
* Allergy to Triamcinolone Acetonide or other corticosteroids
* Pre-existing chronic pain disorders
* Herpes zoster
* Prior corneal allograft
* Allergy to local anesthetic or penicillin
* Patients unable to consent on own behalf
* Patients unable to communicate pain and nausea levels
* Pregnancy
* Incarceration

Primary outcomes:
measure: Post Operative Pain Day 1
timeFrame: 1 Day Post-Op
Secondary outcomes:
measure: Post Operative Pain Week 1
timeFrame: 1 Week Post-Op
measure: Pain Medication Use (Tylenol in mg)
timeFrame: Cumulative amount used was assessed at one week after operation
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Vistar Eye Centers
state: Virginia
Study officials:
affiliation: Virginia Tech, Vistar Eye Center
name: Vishak J John, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02724293: Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy
Official title: Analgesic Efficacy and Safety of Peri-operative Pregabalin Following Radical Cystectomy, a Prospective,Randomized, Double-blinded, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain Following Radical Cystectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study compares analgesic efficacy, and safety of three different doses of peri-operative pregabaline to placebo following radical cystectomy.


Eligibility criteria: Inclusion Criteria:

* Sixty patients between the ages of 18 and 60 years.
* American Society of Anesthesiologists (ASA) I-II physical status.
* undergoing radical cystectomy under general anesthesia.

Exclusion Criteria:

* Patients with a history of drug or alcohol abuse.
* patients with chronic pain or daily intake of analgesics.
* uncontrolled diabetes mellitus.
* uncontrolled hypertension.
* atherosclerotic heart disease.
* seizures.
* impaired kidney or liver functions,
* patients with body mass index ≥35 kg/m2, and whom
* patients that could not control a patient controlled analgesia (PCA) device.

Primary outcomes:
measure: visual analogue scale (VAS) score
timeFrame: 24 hours postoperatively
measure: postoperative opioid consumption
timeFrame: 24 hours postoperatively
measure: time to first request of opioid analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Safety assessed by incidence of side effects
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00197093: In-Patient Study In Schizophrenic Patients
Official title: A Placebo Controlled, Double-Blind, Randomised Study Investigating the Safety, Tolerability and Pharmacokinetics of Ascending Multiple Oral Doses of SB-773812 in Male and Female Schizophrenic Patients for up to 28 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Schizophrenia
safety
tolerability
pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a placebo-controlled study to assess the safety and tolerability of a novel antipsychotic medication, (773812) when given to schizophrenic patients for twenty-eight days. Assessments include blood sampling to determine drug concentrations, psychiatric assessments while under treatment, and movement assessments to evaluate potential side effects.


Eligibility criteria: Inclusion Criteria:

* Must have schizophrenia that has been stable for at least three months.
* Willing to discontinue current anti-psychotic medications (under supervision) prior to the study.
* Willing to live at the study center for a total of 38 days and then return for three follow-up visits.

Exclusion Criteria:

* Taking medications for conditions other than schizophrenia.
* History of alcohol or drug abuse within six months of the study, and their alcohol consumption must meet moderate guidelines.

Primary outcomes:
measure: Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing.
Secondary outcomes:
measure: Assessment of (1) changes in testing scores on a range of psychiatric assessments (PANSS, BPRS. CGI) (2) psychometric performance and (3)body weight/ girth measurement /glucose and lipd measurement, each as a function of duration of dosing.
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04033393: Dual-task Performance in Young-onset PD
Official title: Decrement of the Dual-task Performance in Individuals With Young-onset Parkinson's Disease and the Training Effects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Onset Parkinson Disease
Early Stage Parkinson Disease
Keywords: Executive function
Dual-task performance
Dual-task training
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effects of Game based dual-task training with treadmill on executive function and dual-task performance in individuals with early-onset PD and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as PD and Hoehn and Yahr stage between 1\~3
* Age between 20 to 80
* Able to walk 10 m independently without an assistive device
* A score of greater than or equal to 24 on the mini-mental state examination (MMSE)
* In stable medical condition allowing participation in the testing protocol and intervention

Exclusion Criteria:

* Any comorbidity or disability other than PD that would preclude gait training
* Any uncontrolled health condition for which exercise was contraindicated
* Any neurological or orthopedic disease that might interfere with the study
* Server freezing of gait, FOG questionnaire \> 15

Primary outcomes:
measure: Dual-task walking performance
timeFrame: Change from baseline at 8 weeks
Secondary outcomes:
measure: Single walking performance
timeFrame: Change from baseline at 8 weeks
measure: Timed up and go test
timeFrame: Change from baseline at 8 weeks
measure: Parkinson's Disease Questionnaire 39
timeFrame: Change from baseline at 8 weeks
measure: Frontal lobe battery test-Chinese version
timeFrame: Change from baseline at 8 weeks
measure: Trail-making test
timeFrame: Change from baseline at 8 weeks
measure: Stroop color and word test-Chinese version
timeFrame: Change from baseline at 8 weeks
measure: Verbal fluency test-Chinese version
timeFrame: Change from baseline at 8 weeks
measure: Digit span test
timeFrame: Change from baseline at 8 weeks
measure: Dual-task costs
timeFrame: Change from baseline at 8 weeks
measure: Functional near-infrared spectroscopy
timeFrame: Change from baseline at 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05983393: Erector Spina Plane Block for Multilevel Major Spinal Surgery
Official title: Effect of Ultrasound-guided Bilateral Erector Spina Plan Block for Postoperative Analgesia in Patients Undergoing Multilevel Posterior Spinal Instrumentation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Post Operative Pain
Keywords: Pain
postoperative analgesia
Erector spinae plane block
posterior spinal instrumentation
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block in patients undergoing posterior spinal instrumentation

Detailed description: Postoperative patient-controlled analgesia in the ESP group and control group will be compared with 24-hour morphine consumption and NRS scores at different time points. In addition, the need for rescue analgesics and patient satisfaction will be evaluated.

Eligibility criteria: Inclusion Criteria:

* ASA I-III patients
* Agreed to participate in the study

Exclusion Criteria:

* Patients with infection at the injection site
* Coagulopathy Allergy to amide-type local anesthetics
* History of peripheral neuropathy
* Hepatic and/or renal failure
* Refusing the procedure
* Patients with heart disease
* Patients who have previously undergone surgery from the same area

Primary outcomes:
measure: opioid consumption
timeFrame: up to 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Kahramanmaras Sutcu Imam University Hospital
Study officials:
affiliation: Kahramanmaras Sutcu Imam Universty
name: Gökce Gişi
role: PRINCIPAL_INVESTIGATOR
affiliation: Kahramanmaras Sutcu Imam Universty
name: Gözen Öksüz
role: STUDY_DIRECTOR
References:
Clinical trial NCT02680093: Birth Rate in Conservative Monitoring of Pregnancy Beyond the Date of Birth.
Official title: Birth Rate in Conservative Monitoring of Pregnancy Beyond the Date of Birth.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy, Prolonged
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-02-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant Women beyond the date of birth in conservative monitoring and prenatal follow-up.

Brief summary: Pregnant Women beyond the date of birth. will be followed while coming to routine monitoring. physiological parameter of cervical length will be measured as the differential predictor to determine their due date. the cervical length will be measured as part of routine gynecologic examination to women who come for routine over due date follow up.

additional medical data will be collected from the patient medical record.- demographic data, and all the routine prenatal medical care the women will receive up to the delivery.and delivery outcomes.

Detailed description: The clinical part of the study: the first visit of pregnancy monitoring is carried out at 40 full weeks. First visit to make sure the gestational age to receive full medical anamnesis , perform physical examination and vaginal and NST and BPP. Also, assess the clinical weight and when the need arises assessment of weight sonography. monitoring fetal movements . The women are ordered to return for routine check ups every 3 days. from - 41 full weeks the women should come every two days and 42 weeks should be referred for induction. In practice, the women offered induction at 41 weeks + 3 or 4 days.

Eligibility criteria: Inclusion Criteria:

1. Age 18-50 .
2. Individual fetus
3. The dating of gestational age based on first- trimester ultrasonography or by last menstrual
4. Gestational age between 39 weeks and 0 days to 41 weeks and 6 days .
5. The pregnant women is not in pain ( VAS \<3 ) while signing on consent to participate.
6. Normal fetal monitoring measures and Sonar
7. Expectant mother is in active labor
8. Consent to participate

Exclusion Criteria:

1. Multi-pass Pregnancy
2. Without accurate dating of gestational age based on first- trimester ultrasonography or by last menstrual
3. Indicators for abnormal fetal monitoring and / or Sonar
4. Active labor
5. pain ( VAS \> = 3 )
6. Expectant mother does not agree to participate or delivery if consent was given earlier

Primary outcomes:
measure: Time interval between measurement of cervical length and delivery
timeFrame: 2 weeks.
Secondary outcomes:
measure: Delivery with in 48 hours
timeFrame: 48 hours
measure: Delivery with in 7 days
timeFrame: 7 days
measure: Necessity of labor induction duo to post date
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: yariv yogev, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05374993: An Early Feasibility Evaluation of a Novel 3rdMolarTooth Bud Ablation Procedure
Official title: An Early Feasibility Evaluation of a Novel 3rdMolarTooth Bud Ablation Procedure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Molar, Third
Lead sponsor: TriAgenics Inc
Sponsor class: INDUSTRY
First posted: 2022-05-16
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm prospective study
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This single-arm prospective study will enroll a minimum of 7 and a maximum 10 subjects between the ages of 7 and 13 years of age with radiographic evidence of mandibular 3rd molar tooth bud development without enamel formation. Each subject will undergo a 3TBA procedure for each qualifying mandibular 3rd molar tooth buds. Each subject will receive treatment for qualifying mandibular tooth buds during the same session. Subjects will be followed for a minimum of 12 weeks post treatment.


Eligibility criteria: Inclusion Criteria:

1. Subject is between 7 and 13 years of age
2. Subject has radiographic evidence of at least one mandibular 3rd molar tooth bud

Exclusion Criteria:

1. Subject use of articaine is contraindicated (known hypersensitive to products containing sulfites).
2. Subject has any condition which, in the opinion of the Investigator, would prevent adequate performance of the procedure or affect the health and/or safety of the subject.-

Primary outcomes:
measure: Tooth Structure Development Assessment
timeFrame: 12 weeks
measure: Bony Crypt Growth Assessment
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01946893: Mindfulness Meditation for Cognition and Mood
Official title: Mindfulness Meditation for Cognition and Mood: A Pilot Study Evaluating Feasibility and Collecting Preliminary Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: meditation
education
stress, psychological
aged
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this pilot study is to collect feasibility and acceptability of an internet mindfulness meditation intervention for older adults and to collect preliminary data on mood and cognition changes from before to after the intervention. Up to 32 older adults will be randomized to receive a mindfulness meditation intervention or a time and attention control, both delivered over the internet (16 completers). Participants will have a one-hour session weekly for six weeks with daily home practice between sessions. Participants will complete the sessions online with a study iPad. Their home practice will also be installed on the study iPad as well as an objective adherence monitoring program that the investigators developed to track actual home practice between sessions. The feasibility and acceptability measures are enrollment rate, completion rate, and participant satisfaction. Self-report mood questionnaires and cognitive tasks will be measured before and after the intervention period and data used to conduct power analyses and sample size estimation for a larger clinical trial.


Eligibility criteria: Inclusion Criteria:

* Age 65 - 90 years old
* Baseline Perceived Stress Scale1 score ≥ 9
* Stable on medications six weeks prior to and during study
* Willing to learn and use study technology
* Can hear and understand instructions
* Willing to accept randomization scheme and agrees to follow the study protocol

Exclusion Criteria:

* Cognitive impairment limiting ability to give consent or follow the protocol (≤26 on the mTICS)2
* Significant acute medical illness that would decrease likelihood of study completion (self-report).
* Significant, untreated depression, as assessed by CESD-5 \>16 during screening.
* Current daily meditation practice (≥5 min/day daily for at least 30 days in the last 6 months. Past practice not exclusionary but will be recorded)

Primary outcomes:
measure: Recruitment
timeFrame: Week 8
measure: Participant satisfaction
timeFrame: Week 8
Secondary outcomes:
measure: Mood
timeFrame: Week 0, Week 8
measure: Cognition
timeFrame: Week 0, Week 8
Other outcomes:
measure: Perceived Stress Scale
timeFrame: Week 0, Week 8
measure: Pittsburgh Sleep Quality Index
timeFrame: Week 0, Week 8
measure: Mindfulness-Five-factor Mindfulness Scale
timeFrame: Week 0, Week 8
measure: Positive and Negative Affect Scale
timeFrame: Week 0, Week 8
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Helane Wahbeh
role: PRINCIPAL_INVESTIGATOR
References: