louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06811337: Marginal Bone Changes Around Dental Implant Placed With Open vs. Closed Sinus Elevation
Official title: A 36 - Month Randomized Controlled Trial Comparing the Marginal Bone Changes Surrounding Dental Implants Placed With Open Versus Closed Sinus Elevation and Allogenic Bone Grafting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Marginal Bone Levels
Open Sinus Elevation
Closed Sinus Elevation
Keywords: Dental Implants
Bone Loss
Maxillary Sinus Floor Augmentation.
Bone-Implant Interface
Bone Resorption,
Lead sponsor: Misr International University
Sponsor class: OTHER
Collaborators: name: Suez Canal University
First posted: 2025-02-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: In cases with atrophic posterior maxilla, sinus elevation techniques are essential for a successful implant placement. The optimal strategy for treating pneumatized maxillary sinus in terms of dental implant insertion and surrounding bone stability has been a scientific conundrum for many years. The objective of this study was to evaluate and contrast the long-term marginal bone alterations around dental implants that were positioned utilizing transcrestal (closed) versus lateral (open) sinus elevation procedures.

Material and methods:

Fifty six dental implants were inserted for patients with inadequate residual bone height due to maxillary sinus pneumatization after receiving approval from Suez Canal University's ethics council. Depending on the method, these patients were randomly assigned to one of two groups: the test group, which received the closed sinus elevation, or the control group, which received the open sinus elevation.Allogenic bone grafting was used to treat the elevated sinuses in both groups.The mesial and distal marginal bone loss for these dental implants was evaluated over a 12-month period following surgery using a standardized digital periapical radiography and the Cliniview Software to measure radiographic bone alterations.


Eligibility criteria: Inclusion Criteria:

* Patients who have at least one missing posterior maxillary tooth with sound adjacent teeth.
* Adults above the age of 18.
* Bone height from 4mm to 7mm under the maxillary sinus assessed in CBCT.
* Good oral hygiene.
* Patient accepts to sign an informed consent.

Exclusion Criteria:

* Smokers (more than 10 cigarettes per day).
* Medically compromised patients.
* Patients with active infection related at the site of implant/bone graft placement.
* Patients with untreated active periodontal diseases.
* Patients with parafunctional habits.
* Acute or chronic sinusitis.

Primary outcomes:
measure: Mesial and Distal marginal bone loss
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ismalia
country: Egypt
facility: Suez Canal University
state: Ismailia
Study officials:
References:
Clinical trial NCT00718237: Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)
Official title: A Phase III Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of V260 in Healthy Infants in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotavirus
Gastroenteritis
Keywords: Gastroenteritis
Rotavirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 762
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age

Exclusion Criteria:

* History Of Known Prior Rotavirus Gastroenteritis
* Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period

Primary outcomes:
measure: Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
timeFrame: At least 14 days following the 3rd vaccination
Secondary outcomes:
measure: Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
timeFrame: At least 14 days following the 3rd vaccination
measure: Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
timeFrame: At least 14 days following the 3rd vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Iwata S, Nakata S, Ukae S, Koizumi Y, Morita Y, Kuroki H, Tanaka Y, Shizuya T, Schodel F, Brown ML, Lawrence J. Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial. Hum Vaccin Immunother. 2013 Aug;9(8):1626-33. doi: 10.4161/hv.24846. Epub 2013 May 31.
Clinical trial NCT05519137: Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia
Official title: Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 14
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will randomly be assigned to initially receive the active or control lighting intervention
Primary purpose: TREATMENT

Brief summary: To test the effect of a tailored lighting intervention controlled by the Readings At Desk (RAD) controller on sleep and mood in Alzheimer's disease participants.

Detailed description: Each participant will be enrolled for 22 weeks. Participants will be randomly assigned to receive either the active or control lighting condition. Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition. Assessments will be performed before and at the end of each lighting intervention.

Eligibility criteria: Inclusion criteria:

* Diagnosis of Alzheimer's disease with a Mini Mental Score Examination (MMSE) between 0 and 19
* a score \>5 on the PSQI.

Exclusion criteria:

- use of sleep medication

Primary outcomes:
measure: Sleep disturbance using the Pittsburgh Sleep Quality Index
timeFrame: up to 22 weeks
Secondary outcomes:
measure: Depression screening utilizing the Cornell Scale for Depression in Dementia (CSDD)
timeFrame: up to 22 weeks
measure: Sleep efficiency measured by actigraphy
timeFrame: up to 22 weeks
Other outcomes:
Locations:
city: Menands
country: United States
facility: Light and Health Research Center
state: New York
Study officials:
affiliation: Mount Sinai Icahn School of Medicine
name: Mariana Figueiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00484237: A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis
Official title: A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-08
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

Detailed description: This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

Eligibility criteria: Inclusion Criteria:

* Presence of \>6 swollen joints and \>6 tender joints
* Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD)
* Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit

Exclusion Criteria:

* Previous treatment with etanercept, antibody to TNFα, or other TNFα inhibitors
* Received investigational drugs within 6 months of the baseline visit
* Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit

Primary outcomes:
measure: The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12).
Secondary outcomes:
measure: ACR 20, 50, and 70; Number of swollen joints (68 joints); Number of painful joints on pressure or motion (71 joints); Physician global assessment; Patient global assessment; Duration of morning stiffness.
Other outcomes:
Locations:
city: Goshogawara
country: Japan
state: Aomori
city: Choseigun
country: Japan
state: Chiba
city: Yotsukaido
country: Japan
state: Chiba
city: Fukushima City
country: Japan
state: Fukushima
city: Higashihiroshima
country: Japan
state: Hiroshima
city: Katoh
country: Japan
state: Hyogo
city: Sagamihara
country: Japan
state: Kanagawa
city: Sendai-City
country: Japan
state: Miyagi
city: Sasebo
country: Japan
state: Nagasaki
city: Fukuoka
country: Japan
city: Kumamoto
country: Japan
city: Nagano
country: Japan
city: Oita
country: Japan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05173337: Nefopam as a Multimodal Analgesia for Thoracic Surgery
Official title: Nefopam as a Multimodal Analgesia for Video-assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Acute postoperative pain after video-assisted thoracoscopic surgery is very severe. Because pain after thoracic surgery prevents early recovery, and increases postoperative complications, its is important to prevent pain after video-assisted thoracoscopic surgery. In the present study, we will evaluate whether nefopam reduces pain after video-assisted thoracoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* patient scheduled for elective video-assisted thoracoscopic surgery
* American Society of Anesthesiologists physical grade I, II, III
* patient aged from 18 years old

Exclusion Criteria:

* history of allergy in nonsteroidal anti-inflammatory drugs, or nefopam
* renal insufficiency
* liver insufficiency
* myocardial infarction
* glaucoma
* pregnant and lactating women at the time of surgery
* patient who did not consent to the use of patient-controlled analgesia

Primary outcomes:
measure: Pain after 1 hour of surgery
timeFrame: 1 hour after surgery.
measure: Pain after 6 hour of surgery
timeFrame: 6 hours hours after surgery.
measure: Pain after 12 hour of surgery
timeFrame: 12 hours after surgery.
measure: Pain after 24 hour of surgery
timeFrame: 24 hours after surgery.
Secondary outcomes:
measure: Patient-controlled analgesia use
timeFrame: 24 hours after surgery
measure: Rescue analgesics
timeFrame: 24 hours after surgery.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eunah Cho
Study officials:
References:
Clinical trial NCT02699437: Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia
Official title: Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: Preeclampsia
Antiphospholipid Antibodies
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Attendants of Tertiary Hospital Obstetric Outpateint Clinics and Emergency Department

Brief summary: The purpose of this study is to determine the prevalence of positive antiphospholipid antibodies among women with preeclampsia and to determine the effect of antiphospholipid antibodies on the severity of preeclampsia and the obstetric outcomes

Detailed description: For all women included in the study, blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant. The clinical details of all women will be collected by reviewing their hospital and prenatal records. The following clinical characteristics will be evaluated: maternal age, previous gestations, parity, past or family history of preeclampsia, gestational age at the onset of preeclampsia, gestational age at delivery and birth weight. The following pregnancy and delivery complications will be assessed: placental insufficiency, intrauterine growth restriction, fetal loss (stillbirth) and early neonatal death.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with preeclampsia.

Exclusion Criteria:

* Women with systemic autoimmune disease.
* Women with active thromboembolic disorders.
* Women with history of previous thromboembolic disorders.

Primary outcomes:
measure: Rate of positive antiphospholipid antibodies
timeFrame: 20 weeks to 42 weeks gestational age
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Obstetrics and Gynecology Department in Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Hanaa M El-Shafiey
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Alaa El-Din M El-Gohary, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: El-Said M Abd El-Hady, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT06774937: Clinical and Laboratory Profile of Myasthenia Gravis in Children At Sohag University Hospitals
Official title: Clinical and Laboratory Profile of Myasthenia Gravis in Children At Sohag University Hospitals
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myasthenia Gravis in Children
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients:

Patients diagnosed with myasthenia gravis at the pediatric out patient clinic by clinical charactristics ,nerve study and laboratory data will be elligable for the study.

Brief summary: This study includes clinical and laboratory studies of patients with Myathenia gravis at Sohag Neurology outpatient clinic of pediatric department

Detailed description: All patients in this study were subjected to the followings:

(A) Clinical history focusing on: Sociodemographic data: age, gender , residence,and degree of consanguinity. Full neurodevelopmental history: neurological evaluation Family history. Mode of delivery

(B) Thorough clinical examination: General examination including general look, vital signs and anthropometric measurements.

Scale system include gross motor function and muscle power(Quantitative Myasthenia Gravis Scale) \[36\] detailed neurological examination including motor ,sensory and reflexes. (C) Investigations:

1. Electrophysiological testing:

   EMG : is especially useful in diagnosis of seronegative MG and congenital myasthenic syndromes.

   NCS: including repetitive nerve stimulation test (r NST)
2. laboratory studies: Serology. Detection of antibodies to the AChR supports the diagnosis of JMG. In young children where AChR antibodies are negative this can lead to difficulty in differentiating from CMS.

   Thyroid function tests :
3. Imaging:

   CT chest: Although thymoma in children is rare, the thymus must be imaged once JMG has been diagnosed.
4. molecular studies (when possible).

Eligibility criteria: Inclusion Criteria:

* All patients from 1 month to 16 years confirmed diagnosis of myasthenia gravis by neurological and laboratory data.

Care giver accept to participate in the study.

Exclusion Criteria:

* Failure to obtain informed consent. Other neurological and neuromuscular disorders. Age above 16 years.

Primary outcomes:
measure: Clinical and laboratory profile of patients with myasthenia gravis at Sohag Neurology Outpatient clinic of pediatric department
timeFrame: Follow up for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
city: Sohag
country: Egypt
facility: Sohag university
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References:
Clinical trial NCT05889637: Gastric Ultrasound Assessment for Preoperative Prandial State of Patients Taking Glucagon-Like Peptide-1 Receptor Agonists
Official title: Gastric Ultrasound Assessment for Preoperative Prandial State of Patients Taking Glucagon-Like Peptide-1(GLP-1) Receptor Agonists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Aspiration
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 132
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: subjects presenting for elective surgery who are on Glucagon-Like peptide-1 agonist subcutaneous injection, once weekly will be included

Brief summary: The purpose of this study is to determine the type of gastric content and quantify the volume of liquid gastric contents using ultrasonography in patients on GLP-1 agonists that have presented for elective surgery and to determine if risk factors are associated with a higher gastric volume in patients on GLP-1 receptor agonists.


Eligibility criteria: Inclusion Criteria:

* Patients taking GLP-1receptor agonists (N=62)
* Patients not taking GLP-1 receptor agonists (N=62)

Exclusion Criteria:

* Previous gastric resection or bypass
* Gastric band in situ
* Previous fundoplication
* Large hiatal hernia
* Pregnant patients
* Recent trauma
* Inability to turn to the right lateral decubitus position

Primary outcomes:
measure: Number of subjects that are at risk for aspiration
timeFrame: end of ultrasound
measure: Number of subjects that are at low risk for aspiration
timeFrame: end of ultrasound
Secondary outcomes:
measure: Age
timeFrame: end of ultrasound
measure: Number of participants that are male as indicated in the medical records
timeFrame: end of ultrasound
measure: Number of participants that are female as indicated in the medical records
timeFrame: end of ultrasound
measure: Body mass Index (BMI)
timeFrame: end of ultrasound
measure: Physical status as assessed by the American Society of Anesthesiologists (ASA) physical status classification system
timeFrame: end of ultrasound
measure: Number of participants with diabetes
timeFrame: end of ultrasound
measure: Number of participants with reported nothing by mouth (NPO) status
timeFrame: end of ultrasound
measure: Pain severity as assessed by the numeric scale
timeFrame: end of ultrasound
measure: Number of participants with Gastroesophageal reflux disease (GERD)
timeFrame: end of ultrasound
measure: Number of participants that have use opioids preoperatively
timeFrame: end of ultrasound
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: Sudipta Sen, MD,FASA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04468737: Effect of Inadequate Bowel Preparation on Urgent Colonoscopy in Patients With PPB.
Official title: Effect of Inadequate Bowel Preparation on Urgent Colonoscopy in Patients With Post-polypectomy Bleeding (PPB): A Descriptive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-polypectomy Bleeding
Bowel Preparation
Urgent Colonoscopy
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing urgent colonoscopy

Brief summary: The purpose of this study was to explore the effect of abbreviated bowel preparation on repeated colonoscopy in patients with PPB.


Eligibility criteria: Inclusion Criteria:

patients with bleeding after polypectomy patients treated with colonoscopy within 24 hours after bleeding patients who did not receive adequate bowel preparation (oral laxatives).

Exclusion Criteria:

patients whose main outcome indicators were not clearly described patients whose baseline characteristics were missing.

Primary outcomes:
measure: Diagnostic rate
timeFrame: 1 Day of colonoscopy
Secondary outcomes:
measure: Ileocaecal intubation rate
timeFrame: 1 Day of colonoscopy
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo first hospital
state: Zhejiang
Study officials:
References: