louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03649399: Sonographic Detection of Prophylactic Pancreatic Stents
Official title: Sonographic Detection of Pancreatic Stents Placed for Prophylaxis of Post-ERCP Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatitis
Stent Dislodgement
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Retention of pancreatic stents for prophylaxis of post-ERCP pancreatitis (PEP) is assessed by abdominal x-ray according to international Guidelines. The current study aimed to analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.

Detailed description: Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Several pharmacologic and procedure-related measurements have been established for post-ERCP pancreatitis (PEP) prophylaxis one being the placement of pancreatic duct stents in patients with high risk for PEP. The beneficial role of pancreatic stenting in the prophylaxis of PEP was demonstrated in large meta-analyses. The used stents have a high potential of self dislodgment, retained stents have to be removed endoscopically after 5-10 days. For evaluation of spontaneous stent passage abdominal x-ray ist used and accordingly retained stents removed. The current study aimed to analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.

Eligibility criteria: Inclusion Criteria:

* patient after pancreatic stent placement for prophylaxis of post-ERCP pancreatitis
* age 18-79
* signed informed consent

Exclusion Criteria:

* any disease that rules out study participation
* patient not legally competent to sign informed consent
* chronic pancreatis as indication for pancreatic stenting

Primary outcomes:
measure: Positive predictive value of the sonographic detection of pancreatic stents
timeFrame: 5-10 days after stent placement
Secondary outcomes:
measure: Negative predictive value of the sonographic detection of pancreatic stents
timeFrame: 5-10 days after stent placement
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinikum der J.W. Goethe-Universität
Study officials:
affiliation: Goethe University
name: Mireen Friedrich-Rust, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michael FA, Gerber L, Weiler N, Hunyady PM, Abedin N, de la Vera AL, Stoffers P, Filmann N, Zeuzem S, Bojunga J, Friedrich-Rust M, Dultz G. Transabdominal ultrasonography to reduce the burden of X-ray imaging in prophylactic pancreatic stent localization after ERCP-A prospective trial. United European Gastroenterol J. 2021 May;9(4):469-477. doi: 10.1002/ueg2.12063. Epub 2021 Apr 22.
Clinical trial NCT06917599: Low-Level Laser Therapy vs. Saline for Wound Healing After Primary Molar Extraction.
Official title: Effect Of Low-Level Laser Therapy Versus Saline On Wound Healing Of Primary Molars Extraction: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wound-healing
Keywords: laser
therapy
low-level
wound healing
molar
extraction
oral
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of low level laser therapy versus the saline on wound healing after extraction of primary Molars


Eligibility criteria: Inclusion Criteria:

* ● Children aged from 4 to 6 years.

  * Children of both genders.
  * Medically fit ASA I.
  * Children with badly decayed primary molars beyond repair and indicated for extraction.
  * Parents acceptance to participate in the study.
  * Cooperative children.
  * Antibiotics and painkillers have been stopped at least 12 hours prior to the procedure.(Özer et al., 2024)
  * Teeth with at least two-thirds of the root.

Exclusion Criteria:

* ● Uncooperative children.

  * Lack of informed consent by the child patient's parent to be approved ethically.
  * Unable to attend follow-up visits to avoid attrition bias by decreasing the number of drop off cases.
  * Medical history includes conditions such as prolonged bleeding, platelet disorders, hypersensitivity, allergic reactions to pain relievers, contraindications to laser therapy, and acute pain.
  * Teeth with root lengths less than two-third of the normal root length or those who experienced extensive iatrogenic trauma during tooth extraction.

Primary outcomes:
measure: Presence of granulation tissue
timeFrame: Follow-up day of, 3 days and 7 days after extraction
Secondary outcomes:
measure: Assessment of tissue color
timeFrame: Follow-up day of, 3 days, and 7 days after extraction
measure: Rate of bleeding on palpation
timeFrame: Follow-up day of, 3 days, and 7 days after extraction
measure: Presence of suppuration
timeFrame: Follow-up day of, 3 days, and 7 days after extraction
measure: Assessment of gingival margin status
timeFrame: Follow-up day of, 3 days, and 7 days after extraction
measure: Size of wound
timeFrame: Follow-up day of, 3 days, and 7 days after extraction
measure: Rate of post operative pain
timeFrame: Follow-up day of, 3 days, and 7 days after extraction
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02526342: Impact of Negative Pressure Wound Therapy on Free Muscle Flaps
Official title: Impact of Negative Pressure Wound Therapy on Free Muscle Flaps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Negative-Pressure Wound Therapy
Edema
Free Flap
Microcirculation
Macrocirculation
Lead sponsor: Klinik Bogenhausen
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to prove the utility and safety of the negative pressure wound therapy (NPWT) in the postoperative management of free flaps.

The quantitative assessment of the entirety of clinical main relevant parameters like edema formation, microcirculation, macrocirculation and wound healing should create a better and comprehensive understanding of the NPWT effects in this field.

Detailed description: This study evaluates the impact of negative pressure wound therapy on free muscle flaps. Flaps were treated with NPWT or with a conventional dressing (control) for five days following tissue transfer. Edema formation is measured by a 3D scan (Artec SpiderTM) during the operation, five and fourteen days after surgery. The macrocirculation- and microcirculation parameters of the flaps are assessed using an implanted Doppler probe (Cook-Swartz®) as well as combined flowmetry and remission spectroscopy (O2C®). These measurements are conducted daily at the day of the operation as well as the first five days following the operation. Following dressing removal at the fifth postoperative day, skin graft take is assessed.

Eligibility criteria: Inclusion Criteria:

* Patients requiring free muscle flap reconstruction at the lower extremity covered with a split thickness skin graft
* existing cognitive faculty
* consent

Exclusion Criteria:

* non-compliance
* non-consent

Primary outcomes:
measure: Change of Flap Edema in the early postoperative period measured by a 3D Scan - Artec SpiderTM, Artec Group, Palo Alto, California, USA
timeFrame: Measurements were conducted at the day of the operation, five and fourteen days following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Technische Universität München
Study officials:
affiliation: Bogenhausen Academic Hospital, Technische Universität München, Munich, Germany
name: Ulf Dornseifer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01028742: Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity
Official title: Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Hypopituitarism
Keywords: Traumatic brain injury
Hypopituitarism
Incidence
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Aalborg University Hospital
name: Aarhus University Hospital
First posted: 2009-12-09
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalised with a traumatic brain injury at any danish hospital between 01.01.2008 - 31.12.2008

Brief summary: The purpose of the study is to estimate the incidence of posttraumatic hypopituitarism, and to identify predisposing factors in order to establish a rational responsible socioeconomic screening program.


Eligibility criteria: Inclusion Criteria:

* International Classification of Diseases (ICD) 10 code S06.0-06.9
* Age 18 - 65 years at time of traumatic brain injury
* Duration of hospitalization \> 24 hours.

Exclusion Criteria:

* Known pituitary disease
* Clinically significant liver or renal disease
* Breast-feeding
* Pregnancy
* Alcohol or drug abuse

Primary outcomes:
measure: Hypopituitarism
timeFrame: 5 years
Secondary outcomes:
measure: Quality of life
timeFrame: 5 years
measure: Fatigue
timeFrame: 5 years
measure: Hypopituitary specific symptoms
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Dept of Endocrinology, Rigshospitalet
name: Ulla Feldt-Rasmussen, MD
role: STUDY_CHAIR
References:
citation: Klose M, Stochholm K, Janukonyte J, Christensen LL, Cohen AS, Wagner A, Laurberg P, Christiansen JS, Andersen M, Feldt-Rasmussen U. Patient reported outcome in posttraumatic pituitary deficiency: results from The Danish National Study on posttraumatic hypopituitarism. Eur J Endocrinol. 2015 Jun;172(6):753-62. doi: 10.1530/EJE-14-1069. Epub 2015 Mar 12.
Clinical trial NCT03819842: Evaluating the Need for the Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation
Official title: Evaluating the Need for Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Nuclear Sclerosis
Cortical Cataract
Posterior Subcapsular Cataract
Astigmatism
Keywords: cataract surgery
cataract
toric IOL
Lead sponsor: Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine clinically significant difference in results obtained from cataract surgery using IA. One eye will receive aphakic measurements only and the fellow eye will receive aphakic and then pseudophakic measurements when implanting a toric IOL.

Detailed description: To determine if there is a clinically significant difference in the results obtained for the toric IOL implantation when using IA to measure the aphakic eye only and when using IA to measure the aphakic eye and then the pseudophakic eye, with toric IOL implantation.

Eligibility criteria: Inclusion Criteria:

* willing and able to understand and sign an informed consent
* willing and able to attend all study visits
* presenting for uncomplicated bilateral cataract surgery and have an interest in a toric iol
* have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error)
* have visually significant cataracts
* have regular corneal astigmatism of 1.0D to 5.0D in both eyes with a difference between eyes of 1.0D or less
* have potential post operative acuity of 20/25 or better

Exclusion Criteria:

* corneal pathology
* amblyopia
* prior corneal refractive surgery or other refractive surgery
* previous anterior or posterior chamber surgery that the investigator feels may compromise visual outcomes
* Diabetic retinopathy if the investigator feels this will compromise visual outcomes
* macular degeneration
* history of retinal detachment
* irregular astigmatism or keratoconus
* strabismus
* if in the surgeon's opinion the subject is not an appropriate candidate for iol implantation
* subjects who have an acute or chronic disease or illness that would confound the results of this investigation

Primary outcomes:
measure: Clinically significant difference in results obtained for tori iol implantation when using IA
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Poughkeepsie
country: United States
facility: Alterman Modi and Wolter Ophthalmic Physicians and Surgeons
state: New York
Study officials:
References:
Clinical trial NCT02934542: Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder
Official title: Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Laparoscopic Surgeries
Keywords: Laparoscope holder
Colon resection
Right hemicolectomy
Left hemicolectomy
Sigmoid resection
Anti-reflux
Hiatal hernia
Lead sponsor: M.S.T. Medical Surgery Technology LTD.
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the AutoLap system compared with the standard operation.


Eligibility criteria: Inclusion Criteria:

1. Aged ≥ 18 years
2. Able to provide a written informed consent

Exclusion Criteria:

1. Pregnancy
2. Obesity (BMI \>35 Kg/m2)
3. Contra-indications for performing laparoscopy

Primary outcomes:
measure: Success rate in performing an operation with at least one OR person less
timeFrame: During surgery
Secondary outcomes:
measure: Duration of the operation
timeFrame: During surgery
measure: Number of times the laparoscope is removed for cleaning
timeFrame: During surgery
measure: Usability evaluation
timeFrame: Up to two days post surgery
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
Study officials:
affiliation: Meander Medisch Centrum
name: Ivo A. M. J. Broeders, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01855542: The Aim of This Investigation is to Compare the Influence of 0.9% Saline and Plasmalyte Solution on Acid-base Balance and Electrolytes in Healthy Patients Undergoing Major Spine Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Surgery
Keywords: metabolic acidosis, plasmalyte solution, 0.9% normal saline
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance and metabolic acidosis in critically ill patients. The aim of this investigation is to compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and electrolytes in healthy patients undergoing major spine surgeries.


Eligibility criteria: Inclusion Criteria:

1.50 patients (aged 20-65) undergoing cervical or lumbar spine surgery who were diagnosed spinal stenosis involving more than tow spinal levels.

Exclusion Criteria:

1. ASA class III or IV
2. pregnancy
3. breast feeding
4. lack of mental weakness(including disabled)
5. using diuretics
6. respiratory insufficiency
7. metabolic acidosis or alkalosis
8. coagulation disorder
9. over hydtration
10. renal failure or serum creatinine \> 1.4mg/dl
11. anemia (Hemoglobin 9.0\<mg/dl)
12. hypernatremia (Na \> 145mEq/L)
13. Hyperkalemia (K\>5.5mEq/L)
14. psychological medication or any drugs that influences renal clearance

Primary outcomes:
measure: base-excess
timeFrame: Change from baseline in base-excess at postoperative 12 h
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Song JW, Shim JK, Kim NY, Jang J, Kwak YL. The effect of 0.9% saline versus plasmalyte on coagulation in patients undergoing lumbar spinal surgery; a randomized controlled trial. Int J Surg. 2015 Aug;20:128-34. doi: 10.1016/j.ijsu.2015.06.065. Epub 2015 Jun 27.
Clinical trial NCT01743742: First-day High Dose Vitamin C, E in Severe Birth Asphyxia
Official title: The First-day High Dose Vitamin E and Vitamin C in Hypoxic Ischemic Encephalopathy (Following Birth Asphyxia) in Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Birth Asphyxia
Keywords: Oral vitamin C and Oral vitamin E
Lead sponsor: Sir Takhtasinhji General Hospital
Sponsor class: OTHER_GOV
First posted: 2012-12-06
Enrollment: 95
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To study the role of first-day high dose oral vitamin C and first-day single high dose oral vitamin E in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and adverse neurodevelopmental sequelae.

Detailed description: Design: A prospective, randomized controlled trial over 5 months. Patients: Newborns admitted within 6 hours after birth with gestation \>32 weeks, Apgar score of \<6 at 5 minutes, features suggestive of neonatal encephalopathy.

Intervention: After randomization, Group A newborns received oral vitamin C 250 mg once a day within a 24-hour interval along with a single dose of vitamin E 200 IU. Group B newborns received no intervention.

Outcome measures: Severity and progression of birth asphyxia, duration of hospitalization and mechanical ventilation, mortality, and neurodevelopmental outcome.

Eligibility criteria: Inclusion Criteria

1. Apgar score of \<6 at 5 minutes
2. Clinical features suggestive of neonatal encephalopathy (coma, seizures or hypotonia)

Exclusion Criteria

1. Newborn hospitalized in neonatal intensive care unit (NICU) after 6 hours of birth
2. Gestational age \<32 weeks.
3. Lethal congenital anomaly

Primary outcomes:
measure: To assess the role of first day high-dose vitamin E and vitamin C in reduction of adverse neurodevelopmental sequel in newborns with birth asphyxia.
timeFrame: 6 months
Secondary outcomes:
measure: Mortality and morbidity in newborns with birth asphyxia administered vitamin E and vitamin C.
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 DAYS.
Other outcomes:
measure: Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic ischemic encephalopathy.
timeFrame: at 12 hours
measure: Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic-ischemic encephalopathy.
timeFrame: 15 days
Locations:
city: Bhavnagar
country: India
facility: NICU, Sir T Hospital, Bhavnagar
state: Gujarat
Study officials:
affiliation: Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India
name: Jayendra R Gohil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Darlow BA, Buss H, McGill F, Fletcher L, Graham P, Winterbourn CC. Vitamin C supplementation in very preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2005 Mar;90(2):F117-22. doi: 10.1136/adc.2004.056440.
Clinical trial NCT04472442: Intermittent Hypoxia Paired with High Intensity Training in Brain Injury
Official title: Intermittent Hypoxia Paired with High Intensity Training in Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Rehabilitation Hospital of Indiana
First posted: 2020-07-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2-arm, randomized, crossover trial
Primary purpose: TREATMENT

Brief summary: The central hypotheses are that HIT combined with AIH results in: 1) greater locomotor gains as compared to HIT alone; 2) improvements in gait quality and motor coordination during walking, and 3) changes in measures of community participation and integration.

Detailed description: The central hypotheses are that HIT combined with AIH results in: 1) greater locomotor gains as compared to HIT alone; 2) improvements in gait quality and motor coordination during walking, and 3) changes in measures of community participation and integration. To test these hypotheses, the proposed crossover, assessor-blinded, randomized clinical trial (RCT) is designed to test the effects of safety, feasibility, and preliminary efficacy of HIT+AIH. In this phase I-II trial, patients \>6 months post-BI with mobility deficits will be allocated to 5 weeks (15 sessions) of HIT+AIH or HIT alone. Blinded assessments will be performed prior to and following training paradigms to address 3 specific aims.

Eligibility criteria: Inclusion Criteria:

* \> 6 months post brain injury
* 18-85 years old
* ability to walk without physical assistance
* Self selected walking speed of 0.01-1.0 m/s

Exclusion Criteria:

* \<18 years old
* \>85 years old
* self selected walking speed of \> 1.0 m/s
* \< 3 months from botulinum toxin injection above the knee brace
* Currently receiving physical therapy

Primary outcomes:
measure: Change in gait speed
timeFrame: Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks
measure: Change in Endurance
timeFrame: Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks
Secondary outcomes:
measure: Metabolic capacity
timeFrame: Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Rehabilitation Hospital of Indiana
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Thomas Hornby, PT,PhD
role: PRINCIPAL_INVESTIGATOR
References: