louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06281535: Early Versus Conventional Loading for Fully Guided Immediate Implant Placement
Official title: Early Versus Conventional Loading for Fully Guided Immediate Implant Placement in Molar Sites (A Randomized Controlled Clinical Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implant
Keywords: early loading
conventional loading
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2024-02-28
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate.

Detailed description: The conventional loading protocol presented involves healing period of 3 -6 months. A healing period without stress was recommended in the order to present better survival rate. This loading protocol was developed in the time when micro- and macro design of implant surface was machine produced. Early loading of dental implants within 2 months following placement on healed posterior mandible showed 100% survival rate for five years follow up, with uneventful crestal bone loss. The lack of difference between conventional loading 6 months following implant placement and early loading could be explained by the fact that even if the crowns were not put in direct occlusion, patients used them functionally when chewing. The most relevant factor which may explain the positive results obtained in this trial is the high insertion torque at implant placement.

Eligibility criteria: Inclusion Criteria:

* Patients age range from 20-60 years.
* Molar tooth to be extracted due to periodontal diseases, peri- apical diseases, Endo-perio diseases, or tooth fracture.
* Primary implant stability is above 30 Ncm.

Exclusion Criteria:

* History or presence of severe uncontrolled systemic disease.
* Heavy smokers (\>10 cigarettes per day) or alcohol/drug abusers.
* Poor oral hygiene.
* Acute periapical infection.

Primary outcomes:
measure: Implant stability
timeFrame: 2 and 3 months following implant placement
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor Faculty of Dentistry, Ain Shams University
name: Doaa Adel-Khattab, PhD
role: STUDY_CHAIR
affiliation: Lecturer of Faculty of Dentistry, Assiut University
name: Abdel Rahman Khalaf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05864235: Texting to Reduce Alcohol Misuse Pilot Trial
Official title: Texting to Reduce Alcohol Misuse Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Keywords: young adults
binge drinking
text message
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aims of this project are to determine the feasibility and acceptability of recruiting and retaining young adult binge drinkers online and using text messaging to provide weekly Goal Support (GS) or weekly GS + Coaching for Context-specific Peer Support (CCPS) on alcohol consumption. The secondary aims will determine effect sizes for GS and GS+CCPS groups relative to controls on alcohol consumption at 6- and 12-weeks to inform design of an adequately-powered trial.


Eligibility criteria: Inclusion Criteria:

* English reader
* Owns a mobile phone with SMS
* Hazardous alcohol consumption as measured by: "How many times in the past year have you had X or more drinks in a day?", where X is 5 for men and 4 for women, and a response of 1 or greater is considered at-risk
* At least in contemplative stage of change for reducing alcohol consumption

Exclusion Criteria:

* Currently enrolled or past enrollment in a 4-year college
* Pregnant or pregnancy plans in the next 3-months
* Current or planned treatment for alcohol or substance use disorder in next 3-months

Primary outcomes:
measure: The % of people screened to participants enrolled
timeFrame: 2 months
measure: The % of participants who complete both 6- and 12-week web-based assessments
timeFrame: 12 weeks
measure: The % of SMS queries with valid responses
timeFrame: 6 weeks
measure: The % of participants who at least agree that the SMS program helped them reduce their drinking
timeFrame: 12 weeks
Secondary outcomes:
measure: # Binge drinking days
timeFrame: 6-weeks
measure: Binge drinking days
timeFrame: 12-weeks
measure: Drinks per drinking day
timeFrame: 6-weeks
measure: Drinks per drinking day
timeFrame: 12-weeks
measure: # Alcohol negative consequences
timeFrame: 6-weeks
measure: Alcohol negative consequences
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Brian Suffoletto
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01891435: The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.
Official title: A Randomized Controlled Clinical Trial on the Antipyretic Efficacy of Oral Paracetamol, Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever to Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Reduction in Temperature
Keywords: antipyretics
oral paracetamol
intravenous paracetamol
intramuscular diclofenac
emergency department
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2013-07-03
Enrollment: 434
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial to check the antipyretic efficacy of oral and intravenous paracetamol and intramuscular diclofenac sodium in patients presenting with fever to emergency department.


Eligibility criteria: Inclusion Criteria:

* Adults between the age of 14-75 years with an oral temperature of more than 38.5 C

Exclusion Criteria:

* History of allergy to any of the drugs in the study
* Had taken antipyretics within 8 hours
* Renal, hepatic or haematological disorders
* bronchial asthma, peptic ulcer disease, vomiting
* Pregnant or lactating women

Primary outcomes:
measure: Reduction in temperature in every thirty minutes till 120 minutes after receiving antipyretics
timeFrame: Reduction in temperature is checked every 30 minutes for a maximum of 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad medical corporation
Study officials:
affiliation: Hamad Medical Corporation
name: osama H Mohammed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01654835: A Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Low Systolic Blood Pressure
Official title: A Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Low Systolic Blood Pressure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intraoperative Low Blood Pressure
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators thus propose to use an innovative randomized effectiveness trial design to test the theory that early automatic identification of a ¡ Low Systolic Blood Pressure¡± clinical condition and decision-support alerts will prompt earlier hemodynamic support and a consequently reduce the duration of such conditions. Specifically, the investigators will test the hypothesis that providing DSS alerts in regards to hypotension reduces the duration of hypotensive episodes. The core of the investigators study will be an existing electronic anesthesia record and smart-alarm decision-support system. All patients undergoing surgery at Hillcrest will be randomly assigned to routine care or to DSS support. In patients assigned to DSS support, a systolic blood pressure less than 80 mmHg will generate a warning within three minutes after detection. Clinicians will be free to act on the alert, ignore the alert, or to consider the provided information without acting on it. The randomization, complete anesthesia record, detailed record of hypotensive events, alerts provided, clinician responses, and SAP response, will be captured by the investigators electronic record-keeping system. The investigators primary outcome will be the duration of time the patient has a systolic blood pressure less than 80 mmHg. Secondary outcome will be duration of hospitalization. The investigators will assess the effect of the alert on the primary outcome of time to SBP returning to above 80 mmHg using survival analysis, with time to event censored (and considered a non-event) at either the end of surgery or end of monitoring if patient did not return to above 80 mmHg.


Eligibility criteria: Inclusion Criteria:

* Patients will be enrolled in the study if systolic blood pressure (SBP) is measured to be below 80 mmHg for at least 3 minutes, either with the arterial line or cuff (non-invasive blood pressure, NIBP).

Primary outcomes:
measure: duration of time having low blood pressure
timeFrame: day 1
Secondary outcomes:
measure: hypotension
timeFrame: day 1
measure: duration of hospitalization
timeFrame: up to day 3
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Hillcrest Hospital Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT05159635: Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA)
Official title: The Effectiveness of Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA) to Promote Community Participation in Young Stroke With Foot Drop Problem- The Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Foot Drop (Acquired)
Keywords: Wearable
Lead sponsor: Kowloon Hospital, Hong Kong
Sponsor class: OTHER
Collaborators: name: Kwong Wah Hospital
name: Chinese University of Hong Kong
First posted: 2021-12-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effectiveness of adopting a home-use Wearable Technical Aids (WTA) with the structured Active Living Program (ALP) to promote community participation in young stroke patients.

Detailed description: Two groups of patients would receive Wearable Technical Aids Training or Wearable Technical Aids Training and structured Active Living Program (ALP) for 8 sessions.

Eligibility criteria: Inclusion Criteria:

-diagnosed with foot drop with tibialis anterior muscle strength between 1 to 3- out of 5 in manual muscle testing for more than six months due to cerebrovascular accident (CVA)

Exclusion Criteria:

* pre-existing orthopedic conditions affecting ambulation
* subjects who are incompetent in giving written consent

Primary outcomes:
measure: Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA-SIP 30)
timeFrame: before intervention, 8 weeks (after intervention )
Secondary outcomes:
measure: Change score in 10 meters walk Test
timeFrame: before intervention,8 weeks (after intervention)
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Community Rehabilitation Service Support Centre
Study officials:
affiliation: Community Rehabilitation Service Supoort Centre
name: Marko Chan, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01316835: Effectiveness of Sitagliptin in Glycemic Control in Real World
Official title: A Retrospective, Observational Study to Assess the Effectiveness of Glycemic Control of Diabetes in Real World After Sitagliptin Usage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Keywords: retrospective,sitagliptin, glycemia control,real world
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-03-16
Enrollment: 1120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with ICD-9 diagnostic codes of T2DM plus any prescription record of the anti-glycemic drugs included in the hospital formulary during the study period will be extracted from the hospital outpatient electronic database. Sitagliptin users who stayed with Sitagliptin for at least 24 weeks will then further identified from this diabetes cohort for efficacy analysis.

Brief summary: This study will evaluate whether the addition of sitagliptin treatment provides additional decrease in HbA1C levels and increase in goal attainment in patients with inadequate glycemic control on their current oral anti-glycemic therapy in real world practice.

Detailed description: To explore the change of glycemic control (HbA1c or FPG) before and after 24 weeks of Sitagliptin treatment in Type 2 Diabetic patients who have started Sitagliptin as add on therapy during the index period and received Sitagliptin continuously\* for at least 24 weeks.

Eligibility criteria: Inclusion Criteria:

1. All subjects diagnosed of type 2 diabetes (ICD-9 code= 250.0; 250.1; 250.2; 250.3; 250.4; 250.5; 250.6) and have been followed up regularly in the study center who have started to receive Sitagliptin as an add-on treatment to their prior regimen during the index period
2. Subjects must be on a stable dose of all antidiabetic regimens, with stable dose defined as "at least 3 months with no therapy/dose change" prior to adding sitagliptin
3. Subjects in whose medical records a minimum core data set can be found.
4. Outpatient

Exclusion Criteria:

1. Subjects with type 1 DM
2. Subjects have been treated with insulin regularly
3. Subject with DM which results from other general diseases, e.g. surgery, pharmaceutical products, malnutrition, infections and other conditions
4. Subjects who participated in a clinical trial or other clinical study during the index period

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospita
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-Jung Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02046135: Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
Official title: Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Kidney Injury
Congenital Heart Disease
Keywords: Pediatric
Sodium bicarbonate
Acute kidney injury
Cardiac surgery
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 51
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will investigate the effect of sodium bicarbonate on the prevention of acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The investigators hypothesize that the occurrence of acute kidney injury will be less in children treated with sodium bicarbonate in the perioperative period when compared to placebo. The specific aims of this proposal are as follows:

1. To institute a prospective, randomized, double-blinded, placebo-controlled trial in pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.


Eligibility criteria: Inclusion Criteria:

1. Subjects age ≤18 years
2. Subjects scheduled for cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

1. Subjects with abnormal creatinine clearance (\<90 ml/min/1.7m2) as measured by the Schwartz formula
2. Subjects with known cystic kidney disease or posterior ureteral valves (subjects with solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be excluded if renal function is preserved)
3. Subjects with known metabolic disorder
4. Premature infants born \<30 weeks gestation and \<30 days old due to risk of intraventricular hemorrhage

Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the study.

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: 7 days
Secondary outcomes:
measure: Cumulative Fluid Balance
timeFrame: 6 days
measure: Hospital and Intensive Care Unit Length of Stay
timeFrame: 1 month
measure: Need for Dialysis
timeFrame: 1 month
measure: Length of Mechanical Ventilation
timeFrame: 1 month
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center of New York
state: New York
Study officials:
affiliation: Cohen Children's Medical Center of New York
name: James Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06364735: Entities and Variables Related to Catch-up Growth
Official title: Entities and Variables Related to Catch-up Growth in Pediatric Patients With Celiac Disease (CD) on a Gluten-free Diet (GFD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Celiac Disease in Children
Lead sponsor: ASST Fatebenefratelli Sacco
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Childhood celiac disease patients on a gluten-free diet

Brief summary: A retrospective monocentric observational no-profit study with the aim of evaluating the entity and potential variables influencing the catch-up growth of childhood gluten-free diet patients with celiac disease during a 10-year follow-up. The only extrapolation of the data collected in anonymized form from the medical records of patients who match the necessary study criteria will be planned in order to achieve this aim. A 900-patient sample size will be planned.


Eligibility criteria: Inclusion Criteria:

* celiac disease diagnosis established at the V. Buzzi Children\&amp;#39;s Hospital in Milan between January 2010 and December 2020, excluding the extremes, in accordance with the ESPGHAN 2012 or 2020 recommendations.

Exclusion Criteria:

* patients with unclear or non-specific duodenal histological alterations (e.g., atrophy with unavailable or negative specific antibodies for celiac disease);
* patients with additional chronic illnesses;
* absence of the data required for the study;
* patients with IgA deficiency, defined as IgA \&amp;lt;20 mg/dl in children \&amp;lt;3 years old or with levels that are below normal for their age.

Primary outcomes:
measure: Measure the catch-up growth degree.
timeFrame: 6 and 24 month
Secondary outcomes:
measure: Calculate the degree of catch-up growth
timeFrame: 6 and 24 month
Other outcomes:
measure: Exploratory objectives 1
timeFrame: 6 and 24 month
measure: Exploratory objectives 2
timeFrame: 6 and 24 month
Locations:
city: Milan
country: Italy
facility: ASST Fatebenefratelli Sacco
Study officials:
References:
Clinical trial NCT00460135: The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.
Official title: The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Body Composition
Resistance Training
Insulin Resistance
Keywords: Resistance
Training
Obesity
Children
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2007-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Impact of resistance training in prepubertal children with obesity focusing mostly in changes in body composition and markers of insulin resistance.

Hypothesis is that this will show positive changes in this randomized controlled trial.

Detailed description: 24 obese prepubertal obese children randomized to either resistance training program or usual care for 12 weeks. Baseline blood profiles and DEXA scans done before and after 12 weeks of training with the help of kinesiology graduates from Concordia University kinesiology department.

Eligibility criteria: Inclusion Criteria:

* Between 8-12y
* Prepubertal
* Not on medications with known impact on weight loss

Exclusion Criteria:

* Pubertal
* Uncontrolled thyroid condition
* Type 2 diabetes

Primary outcomes:
measure: Changes in body composition as per DEXA scans
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in insulin resistance as per HOMA score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: Montreal Children's Hospital of the MUHC
name: Laurent Legault, MD
role: PRINCIPAL_INVESTIGATOR
References: