louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02941575: Patient Satisfaction and Peri-Implant Tissue Success of Hybrid Ceramic Versus E-Max Superstructures
Official title: Esthetic Patient Satisfaction and Peri-Implant Tissue Success of Crystal Ultra Hybrid Ceramic Compared to E-Max Superstructures in Esthetic Zone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prosthesis Survival
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients receiving implants in the esthetic zone, would the use of new Nano hybrid ceramic crown material (Crystal Ultra) improve esthetic patient satisfaction and peri-implant tissue success when compared with Lithium Disilicate crown (E-max)?

Detailed description: The patient will be treated in visits designated as follows:

Visit 1: Preoperative records, face-to-face adherence reminder session, signing consents, clinical, radiographic examination and primary impression for diagnostic cast construction.

Visit 2: (first stage surgery): implant placement surgical procedure and postoperative radiograph.

Visit 3: After 3months (second stage surgery): re-opening of surgical site, placement of healing abutments and temporary crowns.

Visit 4: After 2 weeks, removing of temporary restorations and taking of final impressions Visit 5: placement of different ceramic crown superstructures and recording different outcome values.

Eligibility criteria: Inclusion Criteria:

1. Age above 18 years with at least one tooth missing in the esthetic area.
2. Available bone for implant placement:

   A. Labial and Palatal Plate of bone not less than 2mm. B. Mesio- distal dimension not less than 6.5mm. C. Bone length not less than 9mm.
3. Patient with good oral hygiene.
4. Class 1 occlusion.
5. Lack of excessive parafunctional activity leading to implant failure.
6. Tooth extracted not less than 6 month.

Exclusion Criteria:

1. Young patients in whom the jaws are still growing. (Less than 18 years).
2. Jaw pathology.
3. Smokers.
4. Uncontrolled Diabetic or particularly insulin-dependent.
5. Radiotherapy to the neck or face.
6. Multiple loss of teeth which may be indicated for more complicated procedure.

Primary outcomes:
measure: Esthetic Patient satisfaction
timeFrame: 1 year
Secondary outcomes:
measure: Peri-implant tissue success (A-Marginal Bone Loss, B-Relative attachment level, C-Peri-Implant Probing depth, D-Sulcus bleeding)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Jylian El Guindy, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03427775: Multimodal Analgesia After Shoulder Arthroscopy
Official title: Assessment of Patient Outcomes After Shoulder Surgery After Implementation of a Multimodal Perioperative Management Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Arthroscopy
Shoulder Joint
Keywords: multimodal analgesia
quality of recovery
quality of pain management
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for shoulder arthroscopy

Brief summary: This proposal aims to measure the quality of recovery and quality of pain management after shoulder surgery before and after implementation of a multimodal pain protocol.

Detailed description: Pain management after shoulder surgery remains to be a major challenge. Reliance on a single agent (most commonly opioids) results in increased incidence of side effects. Multimodal pain management refers to the use of multiple drugs that target different components of pain pathway.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Age 18-80
* Speaks and understands the English language
* Have a phone number
* Scheduled for shoulder arthroscopy

Exclusion Criteria:

* Inability to read or speak English
* Individuals outside of age range
* Pregnant women
* Persons under the jurisdiction of the Department of Corrections

Primary outcomes:
measure: QOR-9
timeFrame: 24 hours
Secondary outcomes:
measure: quality of pain management
timeFrame: 24 and 48 hours
measure: amount of opioids
timeFrame: 24, 48 and 72 hours after surgery
measure: QOR-9
timeFrame: at 48 hours and 72 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Elkassabany NM, Wang A, Ochroch J, Mattera M, Liu J, Kuntz A. Improved Quality of Recovery from Ambulatory Shoulder Surgery After Implementation of a Multimodal Perioperative Pain Management Protocol. Pain Med. 2019 May 1;20(5):1012-1019. doi: 10.1093/pm/pny152.
Clinical trial NCT06396975: Comparison of Short-term Outcomes of Robotic and Laparoscopic Surgery in Patients With Different Body Mass Index for Mid and Low Rectal Cancer
Official title: Comparison of Short-term Outcomes of Robotic and Laparoscopic Surgery in Patients With Different Body Mass Index for Mid and Low Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 1413
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The clinical records of patients who had laparoscopic or robotic proctectomy at Northern Jiangsu People's Hospital between December 2019 and August 2023 were analyzed in order to conduct research utilizing a retrospective research technique.

Brief summary: Numerous comparison studies on the outcomes of robotic and laparoscopic surgery in the treatment of rectal cancer have been undertaken and reported. But there aren't many studies that compare the safety and effectiveness of the two surgery procedures used to treat people with mid and low rectal cancer who have different body mass indexes (BMIs). This study was done to organize the clinical data we had at our hospital so we could compare the perioperative effectiveness of two minimally invasive approaches for people with different BMIs.


Eligibility criteria: Inclusion Criteria:

The inclusion decision was made based on the following criteria: the results of the preoperative evaluation revealed the existence of adenocarcinoma in the middle to lower rectum (less than 10 centimeters distant from the anal edge); received a drastic operation that might have been laparoscopic or robotic and was based on the principle of TME; distant metastases that are non-conformist or heteroclinic, and there are no additional malignant tumors present at the same time as the operation.

Exclusion Criteria:

a high tumor location that was more than 10 centimeters away from the anal margin; surgery was unsuccessful in completing anal preservation due to invasion of the external anal sphincter; cancerous obstruction or perforation; severe cardiopulmonary dysfunction classified as stage IV according to the ASA score; and poor preoperative anal function; any resection that is performed in combination, rather than being a R0 resection.

Primary outcomes:
measure: Oncological outcomes
timeFrame: 2019-2023
measure: the frequency of complications
timeFrame: 2019-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT03889470: Nitroglycerin as Spasmolytic Regimen for RAS Prevention in Radial Center
Official title: A Randomized Comparison of Nitroglycerin Versus Placebo as Spasmolytic Regimen to Prevent Moderate to Severe Radial Artery Spasm in Radial Center
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Radial Artery Injury
Keywords: transradial catheterisation
radial artery spasm
Lead sponsor: Hermina Heart Center Kemayoran
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: NTG vs Placebo
Primary purpose: PREVENTION

Brief summary: The investigators will investigate whether administration of Nitroglycerin (NTG) as spasmolytic regimen reduces the incidence of moderate to severe radial artery spasm (RAS) in patients undergoing transradial catheterization in radial center.

Detailed description: Patients will be randomized to receive either 200 microgram NTG or placebo (saline) at the beginning of the procedure soon after radial sheath placement. The operators will be blinded to both assignment. The primary outcome is the incidence of moderate to severe RAS evaluated by the operators during the radial procedure.

Both NTG and placebo will be administered using an identical syringe to keep the operators blinded to the treatment allocation. Radial angiogram is mandatory to measure the diameter of both radial and ulnar arteries. Doppler ultrasound of the radial artery will be examined at the day after the procedure.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing transradial catheterisation using proximal radial artery puncture technique

Exclusion Criteria:

* Blood pressure \<100 mmHg
* Refuse to participate

Primary outcomes:
measure: The incidence of Moderate to severe radial artery spasm
timeFrame: During the index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Hermina Heart Center
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT05623670: Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation
Official title: Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation for Minimally Invasive Cardiac Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-interventional VJI Thrombi After CPB
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing minimally invasive cardiac surgery requiring full cardiopulmonary bypass at our centre during the observation period.

Brief summary: The primary objective of the study is to prospectively analyse the occurrence of post-interventional internal vena jugularis (VJI) thrombi after minimally invasive cardiac surgery using a VJI cannula to perform cardiopulmonary bypass (CPB). The study follows the question whether the performance of a jugular cannulation for the operation under CPB regularly causes wall thromboses despite continuous anticoagulation and a short length of stay of a few hours. The thromboses to be assessed for the study will be obtained by bedside (Doppler) sonography by experienced intensive care physicians in the cardiac surgery intensive care unit. A prospective analysis of all minimal invasive procedures performed with regard to thrombi in the VJI.


Eligibility criteria: Inclusion Criteria:

- Minimally invasive cardiac surgery carried out using complete cardiopulmonary bypass.

Exclusion Criteria:

* Postoperative support by veno-venous or veno-arterial extracorporeal membrane oxygenation.
* Complications of neck cannula placement or removal.
* Pre-existing occlusion of the vena jugularis interna
* Pre-existing thrombosis of the vena jugularis interna
* Pre-existing prothrombotic coagulation disorder
* Existing catheterisation of the vena jugularis interna within 14 days
* Pre-existing anatomical anomaly of the vena jugularis interna

Primary outcomes:
measure: Incidence of post-interventional internal jugular vein thrombi
timeFrame: Detection of thrombi within 24 hours post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
References:
Clinical trial NCT01020370: Exploratory Study to Investigate the Reparative and Regenerative Potential of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Patients Participating in the CARE MS I and MS II Studies
Official title: An Exploratory Study to Investigate the Reparative and Regenerative Potential of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis: A Multi-Parametric Non-Conventional MRI Sub-Study in Patient Participating in the CARE MS I and CARE MS II Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Patients with RRMS who are participating in the CARE MS I and CARE MS II
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2009-11-25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with RRMS who are participating in the CARE MS I and CARE MS II studies and are receiving either alemtuzumab or interferon beta-1a SC

Brief summary: The primary goal of this study will be to explore the reparative and regenerative potential of alemtuzumab in RRMS patients who are participating in the CARE MS I and CARE MS II studies using conventional and non-conventional MRI sequences.


Eligibility criteria: Inclusion Criteria:

* Participating in either the CARE MS I or CARE MS II studies

Exclusion Criteria:

* Not a participant in the CARE MS I or CARE MS II studies

Primary outcomes:
measure: Explore the reparative and regenerative potential of alemtuzumab in RRMS patients who are participating in the CARE MS I and CARE MS II studies
Secondary outcomes:
measure: Compare the effect of alemtuzumab to interferon beta-1a SC on non-conventional MRI outcomes
Other outcomes:
Locations:
Study officials:
affiliation: Wayne State University
name: Omar Khan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02881970: Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
Official title: Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neonatal Hypoxic-ischaemic Encephalopathy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss.

Currently, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions.

Cord blood stem cells are a promising treatment for the near future.

The primary objective of this study is to test the safety and feasibility of a curative treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy.

The secondary objectives are to test the efficacy of this curative treatment with cell with neurogenic potential on the prevention of neurologic sequelae, as well as to test the optimum timing of cell preparation administration


Eligibility criteria: Inclusion Criteria:

Term ≥ 36 weeks of gestation

* and (2) :
* a blood pH \< 7 with base deficit \> 12 mmol/l (at birth or within 60 minutes of age)
* or a blood pH between 7,01 and 7,15, with additionnal criteria:
* a history of acute perinatal event (e.g : abnormal fetal cardiac rate, cord prolapse, uterine rupture, maternal hemorrhage)
* and a 5 minutes Apgar score ≤ 5, or a continued need for resuscitation, including endotracheal or mask ventilation at 5 min after birth.
* signs of encephalopathy within 12 hours of age (Sarnat and Sarnat classification, score ≥ 2)
* ± abnormal electroencephalogram or aEEG within 12 hours of age
* therapeutic hypothermia.
* no maternal infection with VIH, HTLV 1 or 2, Hepatitis B or C virus.
* maternal negative serology for syphilis
* written parental consent

Exclusion Criteria:

* presence of known chromosomal anomaly.
* presence of major congenital anomalies. severe intrauterine growth restriction (weight \<1800g)
* infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.

Primary outcomes:
measure: Adverse clinical or paraclinical event rates due to stem cell preparation
timeFrame: 2years
Secondary outcomes:
measure: - Preliminary efficacy as measured by neurodevelopmental function
timeFrame: 2years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: AP HM
name: CATHERINE GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT05961670: Application of Lung Near-Infrared Spectroscopy (NIRS) in Preterm Infants
Official title: Application of Lung Near-Infrared Spectroscopy (NIRS) During Invasive and Non-Invasive Ventilation and Pre- and Post-Surfactant Administration in Preterm Infants
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Respiratory Distress Syndrome, Newborn
Lead sponsor: Keck School of Medicine of USC
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2023-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inborn premature infants

Brief summary: Premature infants are more likely to develop hypoxemia after birth often requiring invasive and Non-Invasive Mechanical ventilation and surfactant therapy to improve alveolar gas exchange and oxygen transport. Near-infrared spectroscopy (NIRS) has been used to detect pulmonary regional oxygen saturation (rpSO 2 ) as well as cerebral regional oxygen saturation (rcSO2 ) and evaluate the oxygenation state of the lung and brain. This is a prospective observational study to evaluate utility of rpSO2 and compare it with rcSO2 in preterm infants born between 23-32 weeks of gestation receiving noninvasive ventilation and surfactant treatment. Enrolled patients will be continuously studied with placement of NIRS monitor using cerebral sensor (INVOS™) for 6 hrs and 15 min before and after surfactant administration. Pulmonary regional oxygen saturation (rpSO2) with a sampling interval of 6 s will be followed for 6hrs.


Eligibility criteria: Inclusion Criteria:

Infants born between 23-32 weeks of gestation admitted to the Neonatal Intensive Care Unit with respiratory distress receiving non-invasive ventilation and requiring Surfactant Replacement Therapy.

Exclusion Criteria:

Neonates with no need for respiratory support/Surfactant. Neonates with congenital malformations.

Primary outcomes:
measure: rpSO2 before and after surfactant therapy
timeFrame: 6 hours
Secondary outcomes:
measure: variations on rpSO2 and rcSO2 during changes in ventilation modes
timeFrame: 6 hours
measure: correlation between rpSO2L and SpO2/FiO2 ratio, a/APO2, and O.I
timeFrame: 6 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles General Medical Center
state: California
Study officials:
References:
Clinical trial NCT02088970: Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study. (CXL)
Official title: Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bacterial Keratitis
Fungal Keratitis
Keywords: Infectious keratitis
Corneal cross linking
Topical antibiotics
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The corneal collagen cross linking is currently used in the treatment of keratoconus but this procedure has also a sterilizing non-specific effect on bacteria and fungus. So the corneal cross linking in association with the antibiotic treatment could result in a reduction of the duration of epithelial complete healing of the cornea.


Eligibility criteria: Inclusion Criteria:

* Infectious bacterial or fungal keratitis with : size \> 2mm or within the central corneal area ( 3mm of the visual axis ) or with a reaction in anterior chamber.
* Being major responsible.
* Agreement in writing to participate in the study.
* Being affiliated to a national insurance scheme.

Exclusion Criteria:

* Present an infectious keratitis without all the previous criteria.
* Herpes or acanthamoeba keratitis
* preperforated or perforated cornea.

General criteria:

* Pregnant woman.
* Minors(miners).
* Adults under guardianship.
* Patient can not be followed during 3 necessary months.
* French speaking patient.
* Unaffiliated patient in a national insurance scheme.
* HIV infected patients

Primary outcomes:
measure: Duration of corneal complete epithelial healing in days.
timeFrame: 3 months
Secondary outcomes:
measure: Size of the corneal scar
timeFrame: 3months
measure: Corneal thinning
timeFrame: 3 months
measure: Gain of visual acuity
timeFrame: 3 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Orignac
Study officials:
References:
citation: Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.