louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04569929: 3D-printed Implant Overdentures
Official title: Clinical Evaluation of Implant Overdentures Fabricated Using 3D -Printing Technology Versus Conventional Fabrication Technique: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Mouth
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 14
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial (RCT) was designed. Fourteen completely edentulous participants were randomly allocated into two equal groups. All participants received two implants in the inter-foraminal area with ball attachments. Participants in the control group were rehabilitated with conventionally manufactured Polymethyl Methacrylate (PMMA) maxillary complete denture and mandibular implant overdentures while participants in intervention group received digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent maxillary complete denture and mandibular implant overdentures. Follow-up appointments were scheduled at 3,6, and 12 months where data of Oral Health Impact Profile 19(OHIPEDENT19) was used to assess the OHRQoL (oral health related quality of life). In addition, denture retention was measured using digital force gauge device. Data were collected and statistically analyzed.


Eligibility criteria: Inclusion Criteria:

* completely edentulous
* ranging in age from 50 to 65 years
* Angle's class I skeletal relationship, normal facial symmetry.
* Adequate quantity of bone (class IV -VI ) and quality (classes 1 - 3 ) in the mandibular inter-foraminal area to accommodate standard implants of at least 11 mm length and 3.7 mm diameter
* appropriate inter-arch space of at least 15 mm (class I ) to accept all types of tested dentures

Exclusion Criteria:Metabolic disorders affecting osseointegration such as hepatic disorders

* osteoporosis and diabetes mellitus.
* Temporomandibular disorders, anticoagulant therapy or bleeding disorders
* sharp mandibular residual ridge or flabby tissues
* neuromuscular disorders, and class II and III Angle's classification skeletal relationship
* Smokers and patients on chemotherapy or radiotherapy or suffering from psychiatric conditions

Primary outcomes:
measure: . OHRQoL (oral health related quality of life)
timeFrame: 12 months
Secondary outcomes:
measure: Overdentures' retention
timeFrame: 12 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Msa Uni
Study officials:
affiliation: MSA
name: Dina Elawady, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05309629: Safety and Efficacy Study of First-line Treatment With QL1706 Plus Chemotherapy in Extensive-Stage Small Cell Lung Cancer
Official title: An Open-label Phase 2 Study of QL1706 Plus Carboplatin and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Extensive-stage Small-cell Lung Cancer
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, phase 2 clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetic (PK) profile, and immunogenicity of QL1706 plus carboplatin and etoposide as first-line therapy in patients with extensive-stage small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

1. Subjects participate voluntarily and sign informed consent.
2. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system)
3. No prior systemic treatment for ES-SCLC
4. Eastern Cooperative Oncology Group performance status of 0 or 1
5. Measurable disease, as defined by RECIST v1.1
6. Adequate hematologic and end organ function

Exclusion Criteria:

1. Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
2. Active, known or suspected autoimmune disease
3. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, radiation pneumonia requiring steroid treatment or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
4. Positive test result for human immunodeficiency virus (HIV)
5. Active hepatitis B or hepatitis C
6. Significant cardiovascular disease

Primary outcomes:
measure: Number of Participants Who Experienced At Least One Adverse Event (AE)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Up to approximately 2 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 2 years
measure: Duration of Progression-Free Survival (PFS)
timeFrame: Up to approximately 2 years
measure: Duration of Overall Survival (OS)
timeFrame: Up to approximately 2 years and a half
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT01180829: Pilot Study of Text Message Brief Interventions for Problem Drinkers
Official title: Pilot Study of Text Message Brief Interventions for Problem Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Health Canada
First posted: 2010-08-12
Enrollment: 91
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will provide a pilot test of two different text message interventions for problem drinkers. Participants will be recruited using a general population telephone survey. Participants in a control group (who will not receive text messages) will be compared to participants who receive one of two different types of text message packages (12 text messages sent once per week in each) - a series of personalized feedback text messages or a series of consciousness raising test messages (i.e., messages that keep the thought of cutting down on their drinking in the participants' mind). Participants in the three different conditions will be followed-up in three months time to assess changes in drinking. It is predicted that participants who receive either of the text message packages will report reduced drinking as compared to those participants in the control condition who do not receive any text messages.


Eligibility criteria: Inclusion Criteria:

* Resident of Ontario
* 19 years of age or over
* Have consumed alcohol in the one month prior to the telephone survey.
* A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
* Are willing to participate in follow-up at three months

Exclusion Criteria:

•None

Primary outcomes:
measure: Number of drinks in a typical week
timeFrame: Three months
Secondary outcomes:
measure: Frequency of consumption
timeFrame: Three months
measure: usual number of drinks per occasion
timeFrame: Three months
measure: Frequency of consuming 5 or more drinks on one occasion
timeFrame: three months
measure: highest number of drinks on one occasion
timeFrame: 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: John Cunningham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00155129: The Role of CGRPand Nociceptin in Migraine
Official title: The Role of Calcitonin Gene-Related Peptide(CGRP)and Nociceptin in the Pathogenesis of Migraine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine
Headache
Keywords: migraine
CGRP
nociceptin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The release of the neuropeptide calcitonin gene-related peptide (CGRP) is thought to play a causative role in migraine. Nociceptin immunoreactivity and ORL-1 mRNA have been detected in human trigeminal ganglia where it was co-localized with CGRP. It may play a role in migraine pathogenesis. We are collecting the blood samples of migraineurs for analysis of these neuropeptides.

Detailed description: The release of the neuropeptide calcitonin gene-related peptide (CGRP) is thought to play a causative role in migraine. Nociceptin immunoreactivity and ORL-1 mRNA have been detected in human trigeminal ganglia where it was co-localized with CGRP. It may play a role in migraine pathogenesis. We are collecting the blood samples of migraineurs for analysis of these neuropeptides.

Eligibility criteria: Inclusion Criteria: patients with headache -

Exclusion Criteria: fever, congenital anomaly, CNS organic lesions

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Pediatrics
Study officials:
affiliation: Department of Pediatric, NTUH
name: Pi-Chuan Fan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05689229: Aerosolized Versus Intravenous Colistin-based Antimicrobial Regimens in Hospitalized COVID-19 Patients With Bacterial Coinfection: A Randomized Controlled Trial
Official title: Aerosolized Versus Intravenous Colistin-based Antimicrobial Regimens in Hospitalized COVID-19 Patients With Bacterial Coinfection: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Bacterial Infection in COVID-19 Patients
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Secondary bacterial pathogen infection has been demonstrated to aggravate COVID-19 clinical outcomes. Bacterial infections acquired during a hospital stay are likely resistant to several antimicrobial medicines, making COVID-19 patient management difficult. As a result, it is believed that aerosolized colistin might be a viable choice for treating secondary bacterial infections caused by gram-negative resistant strains in individuals who also have COVID-19 infection.


Eligibility criteria: Inclusion Criteria:

* Covid-19 patients with secondary gram-negative bacterial infections

Exclusion Criteria:

* Patients with resistant bacterial strains to polymyxins
* patients less than 18 years

Primary outcomes:
measure: Microbial eradication
timeFrame: 10 days
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Nephrotoxicity
timeFrame: 10 days
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: University Hospital
state: Beni-Suef
Study officials:
References:
Clinical trial NCT01807429: Is Analgesic Effect of Low Dose Ketamine-midazolam the Same as Morphine
Official title: Comparing Low Dose IV Ketamine-midazolam Versus IV Morphine Regarding ED Pain Control in Patients Sustaining Closed Limb Fracture(s)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Closed Multiple Fractures of Upper and Lower Limbs
Keywords: Ketamine,
Midazolam,
Morphine,
visual analogue score
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the investigators assessed the effects of low-dose IV ketamine-midazolam versus morphine on pain control in trauma patients with closed limb fracture(s); and also compared the incidence of adverse events (mainly cardio pulmonary ) between two groups.

Detailed description: this prospective, single blind, noninferiority trial randomized consecutive ED patients aged 18 to 60 years to two groups: receiving either 300-500 mcg ketamine plus 0.03 mg midazolam, or 0.05 to 0.1 mg morphine. Visual analogue score and adverse events were carefully verified during an interval of 30 minutes.

Two hundreds, thirty six patients were selected, among whom were 207 males (87.3%), and 29 females (12.2%). The average age was 29±2, with extremes of 60 years and 18 years.the patients were divided into two groups: G1: 116 patients receiving ketamine-midazolam and G2: 120 patients receiving morphine alone.

Eligibility criteria: Inclusion Criteria:

1. Between 18 and 60 years
2. Patients with closed limb fracture(s)
3. VAS score of at least 6

Exclusion Criteria:

1. Acute pulmonary infection
2. Previous coronary artery diseases,ACS,congestive heart failure,
3. suspected aortic dissection
4. History of uncontrolled hypertention or blood pressure \> 140/90mmHg
5. Brain injury with focal neurological deficit or loss of consciousness
6. Central nervous system mass lesion,hydrocephalus, or other states with increased intracranial pressure
7. Glaucoma and acute globe injury
8. History of porphyria
9. Previous hyperthyroidism or thyroid hormone replacement
10. Pregnancy or laction
11. Major psychiatric disorder
12. Previous allergic reaction to the agents administered in the study
13. Patient declined to provide written informed conse

Primary outcomes:
measure: VAPS
timeFrame: 30 minutes
Secondary outcomes:
measure: HR,RR,SPO2,BP
timeFrame: 30 minutes
Other outcomes:
measure: adverse drug effects
timeFrame: 30 minutes
Locations:
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Omid Ahmadi, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04148729: USG Guided ESP Block in Spinal Surgery
Official title: Effect of USG Guided ESP Block in Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: erector spinae plane block
postoperative analgesia
spinal surgery
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: American Society of Anaesthesiologist physical status I-II, aged between 18-65, 40 patients which underwent lumbar spinal surgery will recruited to this study. These subjects will Ultrasound (USG) guided erector spinae block will perform at T10 level (bilaterally) to the all patient under general anaesthesia. 15 ml bupivacaine %0.5 and 5 ml lidocaine %2 will use for USG guided ESP block. 0.1 microgram/kg morphine will apply intravenously and diclofenac Na 75 mg intramuscularly will apply at last 30 minutes of surgery postoperative analgesia to all patients. Postoperative pain assessment will perform with visual analog scale (VAS)

Detailed description: American Society of Anaesthesiologist physical status I-II, aged between 18-65, 40 patients which underwent lumbar spinal surgery will recruited to this study. The patients were randomly allocated into two groups (1:1), via a computer-generated randomization list. Ultrasound (USG) guided erector spinae block will perform at T10 level (bilaterally) to the 20 patients under general anaesthesia in Group E and same volume saline will apply to the ESP block region at T10 level for control group (Group C). Total intravenous anaesthesia (propofol+remifentanil) will perform to the all patients. 15 ml bupivacaine %0.5 and 5 ml lidocaine %2 will use for USG guided ESP block. 0.1 microgram/kg morphine intravenously and diclofenac Na 75 mg intramuscularly will apply for postoperative analgesia to the all patients at last 30 minutes of surgery. Postoperative pain assessment will perform with visual analog scale (VAS). VAS, morphine consumption and complications will record. The rescue analgesic 0.4 mg/kg mepheridine will administer intravenously whenever the patient requested to the analgesic. Diclofenac sodium 75 mg will repeat to the all patients at the 12th of postoperative period, intramuscularly.

Eligibility criteria: Inclusion Criteria:

* accepting to participate the study
* ASA I-II patients
* The patients underwent spinal surgery

Exclusion Criteria:

* Non Volunteers
* ASA III and over
* Renal and hepatic failure
* Emergency surgical procedures

Primary outcomes:
measure: 11-point numerical rating scale score (NRS score)
timeFrame: up the postoperative 24th hours.
Secondary outcomes:
measure: Postoperative analgesic requirement
timeFrame: up the postoperative 24th hours.
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çukurova University
state: In The USA Or Canada, Please Select...
Study officials:
References:
Clinical trial NCT03338829: Incentives and Glucose Adherence in Diabetes
Official title: Incentive Models on Testing Adherence for Women With Diabetes During Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes in Pregnancy
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 130
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Diabetes in pregnancy carries significant pregnancy specific risks and requires frequent glucose monitoring to reduce these risks. This project compares the effect of two incentive schemes on adherence rates of glucose testing in pregnancy.

Detailed description: Diabetes in pregnancy is associated with increased risks of maternal and fetal complications and can be challenging to manage due to increasing insulin requirements with advancing gestational age. Based on standard of care guidelines, patients with diabetes check their blood glucose at least 4 times per day. Optimal management requires frequent glucose self-monitoring and active management of abnormal blood sugars and medications by clinicians. Poorly controlled diabetes has both significant maternal and neonatal consequences: Improving test adherence could benefit both the pregnant woman and her fetus. In this study, we propose to test the effect of two incentive schemes on rates of glucose monitoring on pregnant women with diabetes requiring medication.

Pregnant women with diabetes requiring medication are invited to participate if they meet specific inclusion criteria (\<28 weeks) and followed in our outpatient clinic. Participants are randomized into one of three groups:

1. control group - receive compensation at time of enrollment,
2. positive incentive group - receive compensation per test completed
3. loss aversion group - receive between a range of compensation depending on their overall level of adherence.

Primary outcome of the study is frequency of prescribed glucose testing in pregnancy

Eligibility criteria: Inclusion Criteria:

* pregnant women with insulin dependent diabetes prior to 28 weeks gestation.

Exclusion Criteria:

* incarcerated, not English speaking

Primary outcomes:
measure: Frequency of glucose monitoring
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Janet Andrews, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00226629: Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC
Official title: Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the cost effectiveness, quality of life and outcomes of the endovascular stent graft repair with the open surgical repair of abdominal aortic aneurysms.

Detailed description: Abdominal Aortic Aneurysms have been traditionally repaired using the standard open surgical technique. The use of Endovascular stent grafts(EVAR) to treat aortic aneurysms has been ongoing for approximately 8-10 years. Use of EVAR to treat aortic aneurysms in high risk has been reported to be beneficial. However, the costs of this therapy are quite significant and therefore in order to best understand the cost effectiveness of this type of aneurysm treatment, an extensive prospective comparative evaluation is required. This study will compare outcomes and cost-effectiveness for patients receiving EVAR, with high surgical risk, and OSR, with low surgical risk, and OSR, where there is high surgical risk and not suitable for EVAR based on anatomical complexity. Demographic, medical, health care resource utilization, cost, and quality of life information is collected from participating patients over a period of a year following repair.

Eligibility criteria: Inclusion Criteria:

* infrarenal abdominal aortic aneurysm,
* \> 5.5 cm diameter
* scheduled for elective surgical repair

Exclusion Criteria:

* previous repair of AAA

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: LHSC, UWO
name: Gaetano DeRose, MD, FACS, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00868244: Relationship of Facial Pattern With Bruxism
Official title: Relationship of Facial Pattern With Bruxism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bruxism
Keywords: facial patterns
bruxism
masticatory muscles
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
First posted: 2009-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: radiographs, photographs and dental plaster models of people who come to orthodontic treatment

Brief summary: The purpose of this study is to determine if the facial pattern is related to the degree of bruxism because the muscles of mastication are the factors of force to the wear of the teeth.


Eligibility criteria: Inclusion Criteria:

1. Both genders
2. Age 18 to 60 years
3. Case studies to understand orthodontic intraoral photographs of the upper and lower dental arches, and models of lateral skull radiography for orthodontic
4. Cases with any facial biotype development.

Exclusion Criteria:

1. Totally toothless people
2. Partially toothless the posterior (include both molars and premolars).
3. Dawn Syndrome,alzheimer , partial or bilateral facial palsy, autism, which manifest with bruxism
4. Some other syndrome which alters the pattern of facial development as Pierre Robin,crouzon

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: Carlos Martinez Torres
state: Guanajuato
Study officials:
References: