louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06776640: Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration
Official title: Efficacy of Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration in Patients With Vitamin D Deficiency
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Implant Site Reaction
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be conducted on patients with vitamin D deficiency or insufficiency who visit the Restorative and Surgical Dentistry Department at the Dental Care Center of Nantes University Hospital for implant surgery.

Brief summary: The number of patients treated in Implantology at Nantes University Hospital is 400 per year. This pilot study aims to demonstrate the efficacy of a 6-month oral cholecalciferol supplementation on osseointegration in patients requiring dental implants and presenting with vitamin D deficiency, compared to French patients who have not undergone vitamin D screening

Detailed description: This study will be conducted on patients with vitamin D deficiency or insufficiency who visit the Restorative and Surgical Dentistry Department at the Dental Care Center of Nantes University Hospital for implant surgery. The investigator will present the study to them and record their verbal non-opposition. Clinical data from before the surgery (approximately 3 months prior), during the surgery, and postoperative visits up to 3 months afterward will be included in the OSIVID study.

Eligibility criteria: Inclusion Criteria:

* Male or female patient ≥ 18 years old, candidate for dental implant placement.
* with vitamin D deficiency or insufficiency: 25(OH)D \< 25 ng/L.
* affiliated with a social security scheme.

Exclusion Criteria:

* with a local contraindication for implant placement.
* under guardianship, curatorship, or legal protection
* Pregnant or breastfeeding women

Primary outcomes:
measure: The stability of the implan
timeFrame: 3 months (surgery and 3 months after)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: Anne-Gaelle Chaux, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00214240: The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease
Official title: The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 28
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: This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more effective in reducing the CMV viral load over time, as compared to standard treatment with IV ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®. Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until the CMV infection is no longer detectable, whichever is longer duration.


Eligibility criteria: Inclusion Criteria:

* Renal or renal/pancreas transplant patients who are diagnosed with symptomatic CMV infection
* receiving no more than 48 hrs of therapy prior to study enrollment

Exclusion Criteria:

* serum creatinine \<2.2 at the time of enrollment
* no prior use of CMV IgG

Primary outcomes:
measure: CMV viral load
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: John Pirsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04886440: Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis
Official title: Predictive Value of the Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lithiasis
Keywords: sialendoscopy
submandibular gland
classification
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with submandibular sialolithiasis

Brief summary: Salivary disorders are common reason for ENT specialist consultation. Sialolithiasis are the most frequent salivary obstruction disease and are characterized by the development of calcified structures in the salivary gland, especially in the submandibular gland.

The management of salivary obstruction has changed over the past 30 years. Sialendoscopy is considered as a minimally invasive procedure that allows endoscopic visualization of the salivary ductal system and is increasingly used in both diagnosis and treatment. Moreover, many studies have shown the effectiveness of this procedure.

Classification of lithiasis has been set up in 2008 to standardize the nomenclature and was used for patient care since 2009. The main objective of this study is to evaluate the relevance of the lithiasis's classification to predict the efficacy of sialendoscopy in treatment of sialolithiases.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Patient treated in CHR Metz-Thionville between 2013 and 2020
* With a pathological impairment (suspected or confirmed) of a salivary gland
* With sialendoscopy indication for diagnosis and/or treatment

Exclusion Criteria:

* Opposed to use data
* Without sialendoscopy indication
* Without lithiasis salivary gland disorder
* With parotid gland lithiasis

Primary outcomes:
measure: Recurrence of symptom
timeFrame: Month 6
Secondary outcomes:
measure: Number of clinical signs
timeFrame: Day 1
measure: Number of intraoperative complications
timeFrame: Day 1
measure: Number of post-operative complications
timeFrame: Day 1
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville
state: Moselle
Study officials:
References:
Clinical trial NCT06759740: An Exploratory Study of 68Ga-DOTA-SEMA in Preoperative Precise Imaging of Patients with Glucagon-Like Peptide-1 Receptor (GLP1R) Positive Insulinomas
Official title: An Exploratory Study of 68Ga-DOTA-SEMA in Preoperative Precise Imaging of Patients with Glucagon-Like Peptide-1 Receptor (GLP1R) Positive Insulinomas
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypoglycaemia
Lead sponsor: The Affiliated Hospital Of Southwest Medical University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Traditional imaging techniques for insulinomas have a low detection rate. This study aims to evaluate the safety, internal radiation dosimetry, and targeted imaging capability of the novel GLP1R imaging agent, 68Ga-DOTA-SEMA, in patients with GLP1R-positive insulinomas.


Eligibility criteria: Inclusion Criteria:

1. Patients who are capable of understanding and voluntarily signing an approved informed consent form (ICF).
2. Age ≥ 18 years.
3. Normal renal function (serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min, and estimated glomerular filtration rate (eGFR) \> 80 mL/min/1.73 m²).
4. Recurrent hypoglycemia with biochemically confirmed endogenous hyperinsulinemic hypoglycemia (at least 3 episodes of biochemically confirmed endogenous hyperinsulinemic hypoglycemia within the past 3 months, each with detailed blood glucose monitoring records and symptom descriptions confirming endogenous hyperinsulinemia as the cause).
5. Negative for sulfonylurea drugs and insulin autoantibodies.
6. ECOG performance status ≤ 2, able to tolerate the examination.
7. All other toxicities must be ≤ NCI-CTCAE v5.0 Grade 0 or 1.

Exclusion Criteria:

1. History of allergy or hypersensitivity to the components or excipients of the investigational drug.
2. Claustrophobia or inability to tolerate imaging procedures for other reasons.
3. Clinically significant active infection as determined by the investigator.
4. History or current presence of uncontrolled primary or metastatic brain tumors.
5. Serious and/or uncontrolled and/or unstable conditions that may affect the study as judged by the investigator, including but not limited to:

   1. Poorly controlled diabetes.
   2. Congestive heart failure.
   3. Myocardial infarction within the past 12 months.
   4. Uncontrolled and unstable hypertension.
   5. Chronic kidney disease or liver disease.
   6. Severe pulmonary diseases.
6. Poor compliance and inability to complete study procedures as expected.
7. Any other conditions that the investigator considers unsuitable for participation in the clinical study.

Primary outcomes:
measure: Radiation dose to major organs and tumors
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
Study officials:
References:
Clinical trial NCT00387140: A Study to Evaluate the Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain (MK-2295-005)
Official title: A Randomized Double-blind, Placebo-and Active Comparator-Controlled 2-Part Study to Evaluate the Efficacy of MK2295 in Patients With Postoperative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Tooth Extraction
Keywords: Dental Pain, Postoperative
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-10-12
Enrollment: 89
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate the safety and tolerability of the drug and to evaluate its efficacy compared to placebo and to ibuprofen in the treatment of postoperative dental pain in male patients.


Eligibility criteria: Inclusion Criteria:

* Patients in generally good health who are scheduled to have two or more third molars removed, at least one of which is partially or completely embedded in bone and is a mandibular impaction

Exclusion Criteria:

* Patient has a temperature of 37.5C or greater prior to dosing
* Patient has participated in another clinical study within the last 4 weeks

Primary outcomes:
measure: Peak analgesic response, safety, and tolerability
timeFrame: Over 24 Hours
Secondary outcomes:
measure: Onset of analgesia, duration of analgesia
timeFrame: Over 24 Hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02277340: Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol
Official title: Endoscopic Treatment of Pilonidal Sinus May Decrease the Recurrence After Crystallized Phenol Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pilonidal Sinus
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study presents 23 sacrococcygeal pilonidal disease cases treated with endoscopic cleaning and fulguration of pilonidal sinus inner surfaca followed by application of crystallized phenol into the sinus.

Detailed description: Endoscopic treatment and crytallized phenol application are two sovereign treatments described for pilonidal disease. The curative rate may be as low as 65 % and the recurrence rate is at least 10 % after crystallized phenol alone application for pilonidal disease. The experience with endoscopic treatment of pilonidal sinus is only limited but at least 4 % recurrence rate was reported.

In this study a preliminary group of 23 patients were treated with combination of these two modalities between February to May 2014 and at the end of 6-9 months follow up, there was no recurrence after excellent cosmetic results. Patients were all operated and mild sedation and local anesthesia. There was no serious complication but only some skin irritation was noticed secondary to phenol burn. Some patients felt mild pain and the pain was self limited in most cases where only a few needed oral pain killers. Some patients were observed to have mild drainage from the sinus but only two of them needed further application of phenol crystals.

Eligibility criteria: Inclusion Criteria:

* Patients with pilonidal disease with no acute abscess

Exclusion Criteria:

* Patients with aacute pilonidal disease abscess

Primary outcomes:
measure: Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application
timeFrame: six months
Secondary outcomes:
measure: Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application
timeFrame: six months
measure: Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Surgery, Ankara University Medical School
name: İbrahim E Gecim, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06802640: Transcutaneous Spinal Cord Electrical Stimulation Combined With Kunming Locomotor Training for the Treatment of Spinal Cord Injury
Official title: Transcutaneous Spinal Cord Electrical Stimulation Combined With Kunming Locomotor Training for the Treatment of Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Kunming Tongren Hospital
Sponsor class: INDUSTRY
First posted: 2025-01-31
Enrollment: 18
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spinal cord injury (SCI) is a common and severe traumatic central nervous system injury in clinical practice. Currently, the treatment of SCI remains a worldwide challenge.International studies have confirmed that TSCS is an effective non-invasive technique to activate the body's movement-related circuits. This method utilizes a unique stimulation waveform that is transmitted through electrodes placed on the skin of the spine and spreads through the dorsal roots (DRs) to activate the spinal cord neural circuits.The main objective of this study is to have patients with chronic incomplete (AIS B/C/D) spinal cord injuries wear "transcutaneous spinal cord electrical stimulator " and undergo "Kunming locomotor training" for 6 months, observe the synergistic effects of the two, and evaluate whether this treatment method can improve patients' motor functions.


Eligibility criteria: Inclusion Criteria:

* 1. Chronic (≧6 months) paraplegics (T1-T10) with incomplete(AIS B/C/D) spinal cord injury Incomplete aged 16-50 years;
* 2.Subjects must be able to read, understand, and complete the Visual Analogue Scale;
* 3.Subjects voluntarily sign the informed consent form approved by the ethics committee.

Exclusion Criteria:

* 1. Obvious renal, cardiovascular, hepatic, and mental diseases;
* 2.Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
* 3. Limb contracture deformity;
* 4. Modified Ashworth \> Grade 2;
* 5. Unhealed fractures;
* 6. The subject is currently participating in other studies;
* 7. The researcher's opinion is that the subject does not comply with the research protocol and/or is not suitable to participate in this study.

Primary outcomes:
measure: Change from Baseline Kunming Locomotor Scale (KLS) at 6 months
timeFrame: Day 0, Month 6
measure: Change from Baseline 10 Meter Walk Test (10mWT) at 6 months
timeFrame: Day 0, Month 6
Secondary outcomes:
measure: Change from Baseline Spinal cord injury functional ambulation profile (SCI-FAP) at 6 months
timeFrame: Day 0, Month 6
measure: Change from Lower extremity motor score(LEMS) at 6 months
timeFrame: Day 0, Month 6
Other outcomes:
measure: Change from Walking Index for Spinal Cord Injury (WISCI) at 6 months
timeFrame: Day 0, Month 6
Locations:
Study officials:
References:
Clinical trial NCT01151267: Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia
Official title: Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Surgery
Keywords: Isocapnic hyperpnoea (IH)
Anesthesia
Accelerate elimination of inhalation agents
Recovery from anesthesia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-06-28
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rate of elimination of inhalation agent is directly proportional to the degree of alveolar ventilation. Using Isocapnic Hyperpnoea (IH) device, it is possible to maintain constant end-tidal CO2 with increased minute ventilation. This is achieved by passively adding a flow of CO2 to the inspirate in proportion to increases in ventilation above the baseline. In animal and human studies IH shortens the time of awakening from isoflurane and sevoflurane anesthesia when manual positive pressure ventilation is applied. IH device could be used for spontaneous hyperpnoea as well. The investigators want to compare recovery times from sevoflurane anesthesia in patients with application of hypercapnic spontaneous hyperpnoea (HSH) versus the standard anesthesia protocol (controls). 44 patients ill be randomized to either HSH facilitated recovery, or conventional recovery (controls).The time intervals from the end of anesthesia (turning off the vaporizer) until recovery milestones will be recorded.


Eligibility criteria: Inclusion Criteria:

* elective gynecological surgery
* age 18-80
* ASA I-III
* informed consent

Exclusion Criteria:

* ASA IV-V,
* contra-indications to sevoflurane anesthesia or other anesthetics included in the protocol
* history of cardiac or respiratory disease
* intracranial pathology
* alcohol or drug abuse
* psychiatric illness and/or medications

Primary outcomes:
measure: Time from the end of anesthesia to the readiness for post-anesthesia care unit (PACU) discharge.
timeFrame: End of anesthesia (turning off the vaporizer) until readiness for PACU discharge, approximately 30 minutes to 2 hours
Secondary outcomes:
measure: Comparison of pain and sedation scores
timeFrame: End of anesthesia (turning off the vaporizer) to PACU discharge, approximately 30 minutes to 2 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
Study officials:
affiliation: Toronto General Hospital
name: Rita Katznelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01364467: The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Official title: The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Rhinitis
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 14-day, randomized, placebo-controlled, parallel group, masked clinical trial of oral guaifenesin for the therapy of Chronic Rhinitis (CRS) in 36 children between the ages of 7 and 18 years. The study investigates the effectiveness of guaifenesin in the relief of nasal symptoms in children with CRS using the sinonasal 5 survey (SN-5) in comparison to nasal airway volume, and biophysical properties of nasal secretion. The investigators hypothesize that Guaifenesin use over a period of 14 days improves subjective nasal complaints in pediatric patients with chronic rhinitis and nasal congestion, as measured by the SN-5 survey compared to use of placebo. There will be an observed improvement in nasal volume and cross-sectional area following use of guaifenesin, and nasal secretions will have more favorable mucociliary and sneeze clearability compared to use of placebo.


Eligibility criteria: Inclusion Criteria:

* Children between the ages of 7 and 18 years, diagnosed with Chronic Rhinitis and nasal stuffiness for at least 3 month duration.

Exclusion Criteria:

* Children with immunodeficiency, cystic fibrosis, acute or subacute symptoms, signs of bacterial infection, and/or those who are unable to cooperate with testing will be excluded. Children with documented use of the study medication in the month before evaluation and during period of symptoms will also be excluded.

Primary outcomes:
measure: Change in Subjective Nasal Scoring
timeFrame: Baseline to 10 Minutes
Secondary outcomes:
measure: Nasal Volume
timeFrame: 15 Minutes
measure: Nasal Secretion Collection
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Children's Hospital of Richmond, Children's Pavilion & Nelson Clinic
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Kelley Dodson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: