louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06536933: Study of Metabolic Dysfunction-Associated Steatotic Liver Disease Among Sohag University Employees
Official title: Study of Metabolic Dysfunction-Associated Steatotic Liver Disease Among Sohag University Employees
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 100 Employees in Sohag University will be included in the study.

Brief summary: * Metabolic dysfunction-associated steatotic liver disease (MASLD) is the latest term for steatotic liver disease associated with metabolic syndrome. MASLD is a common cause of chronic liver disease and is the leading cause of liver-related morbidity and mortality.
* The high prevalence of this disease has been fueled by the rapid rise in levels of sedentary behavior, low levels of physical activity, excess calorie intake relative to expenditure in nutritionally imbalanced and unhealthy diets. In parallel, the prevalence of poor metabolic health in adults from many countries is high, even in normal weight individuals.
* MASLD has been estimated to affect 30% of the adult population worldwide, with its prevalence increasing from 22% to 37% from 1991 to 2019 . The increasing prevalence of MASLD parallels the increasing prevalence of obesity and obesity-related diseases.


Eligibility criteria: Inclusion Criteria:

* 100 Employees in Sohag University will be included in the study.

Exclusion Criteria:

Employees with drug induced liver disease. Employees with chronic liver disease. Employees with decompensated liver cirrhosis. Employees with excessive alcohol consumption.

Primary outcomes:
measure: waist circumference
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Chan WK, Chuah KH, Rajaram RB, Lim LL, Ratnasingam J, Vethakkan SR. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A State-of-the-Art Review. J Obes Metab Syndr. 2023 Sep 30;32(3):197-213. doi: 10.7570/jomes23052. Epub 2023 Sep 13.
citation: Inoue Y, Qin B, Poti J, Sokol R, Gordon-Larsen P. Epidemiology of Obesity in Adults: Latest Trends. Curr Obes Rep. 2018 Dec;7(4):276-288. doi: 10.1007/s13679-018-0317-8.
citation: Stefan N, Schick F, Haring HU. Causes, Characteristics, and Consequences of Metabolically Unhealthy Normal Weight in Humans. Cell Metab. 2017 Aug 1;26(2):292-300. doi: 10.1016/j.cmet.2017.07.008.
citation: Chan WK, Treeprasertsuk S, Imajo K, Nakajima A, Seki Y, Kasama K, Kakizaki S, Fan JG, Song MJ, Yoon SK, Dan YY, Lesmana L, Ho KY, Goh KL, Wong VW. Clinical features and treatment of nonalcoholic fatty liver disease across the Asia Pacific region-the GO ASIA initiative. Aliment Pharmacol Ther. 2018 Mar;47(6):816-825. doi: 10.1111/apt.14506. Epub 2018 Jan 14.
Clinical trial NCT01130233: Randomized Trial on Robotic Assisted Resection for Rectal Cancer
Official title: Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rectal Cancer
Adenocarcinoma
Keywords: rectal cancer
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2010-05-25
Enrollment: 98
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: Hypothesis: the bladder and sexual functions can be better preserved in patients with robotic assisted rectal surgery

This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer.

Detailed description: This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer

The primary objective of this study is to compare the bladder and sexual functions of patients who undergo laparoscopic and robotic assisted resection for rectal cancer through a randomized controlled trial.

The secondary outcome measures include

1. The operative outcome in terms of the complication rate, hospital stay and reoperation of the two groups;
2. The quality of life of the patients and the cost of the two groups
3. The quality of the resected specimens
4. The local recurrence rates at two years after the surgery

Eligibility criteria: Inclusion Criteria:

1. Histologically proven new case of rectal cancer with the lower border within 15 cm from anal verge
2. Age \>18 years
3. Informed consent obtained
4. American Society of Anesthesiologist class 1-3
5. No contraindication to laparoscopic surgery
6. Acceptable operating risk

Exclusion Criteria:

1. Locally advanced fixed tumor with the need for exenterative surgery
2. Severe cardiac or pulmonary comorbidity rendering pneumoperitoneum hazardous
3. Multiple previous operations with the anticipation of dense peritoneal adhesions
4. No informed consent

Primary outcomes:
measure: Bladder function
timeFrame: one year
Secondary outcomes:
measure: tumor status
timeFrame: One year
measure: Quality of life
timeFrame: one year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Wai Lun Law, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00417833: Multifocal Electrophysiologic Findings After Intravitreal Bevacizumab(Avastin)Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Diabetic Proliferative Retinopathy
Vascular Vein Oclussion
Choroidal Neovascularization
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2007-01-04
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Purpose: Determine the short-term safety of intravitreal bevacizumab by multifocal electroretinography (mf-ERG).

Methods: 120 eyes with choroidal neovascularization, proliferative diabetic retinopathy and retinal vein occlusion received intravitreal bevacizumab (2.5mg/0.1cc). All patients underwent best corrected visual acuity, fluorescein angiography, optical coherent tomography and mf-ERG before and 1 month after treatment.


Eligibility criteria: Inclusion Criteria:

* Proliferative diabetic retinopathy, vascular vein oclussion, choroidal neovascularization
* Multifocal electroretinogram before intravitreal bevacizumab and at 1,3, and 6 months after treatment
* Completely studies

Exclusion Criteria:

Complications

* Tractional Detachment
* Endophthalmitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Myrian L Hernández, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04306133: PENG Block Combined to Wound Infiltration for Hip Replacement
Official title: Pericapsular Nerve Group (PENG) Block Combined to Wound Infiltration vs. Wound Infiltration Alone for Postoperative Analgesia After Total Hip Replacement: a Prospective Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Analgesia
Hip Arthropathy
Acute Pain
Pain
Postoperative Complications
Keywords: regional anesthesia
hip surgery
PENG
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 60
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 study analyze the effect of Pericapsular Nerve Group (PENG) Block combined to wound infiltration for analgesia after elective hip replacement.

Half of participants will receive a PENG Block combined with wound infiltration, while the other half will receive wound infiltration alone.


Eligibility criteria: Inclusion Criteria:

* Elective hip replacement surgery
* ASA physical status score \< 4

Exclusion Criteria:

* Contraindications to regional anesthesia
* ASA physical status score ≥ 4
* Patient's refusal or inability to sing the informed consent
* Pre-operatively therapy with opioids
* Allergies to any drug provided by the study protocol

Primary outcomes:
measure: Maximum Pain Score
timeFrame: 24 hours
measure: Total opioids consumption
timeFrame: 48 hours
Secondary outcomes:
measure: Time to first opioid
timeFrame: 48 hours
measure: Range of hip motion
timeFrame: 24 hours
measure: Time to ambulation
timeFrame: 48 hours
measure: Quadriceps weakness
timeFrame: 48 hours
measure: Incidence of block complications
timeFrame: 48 hours
measure: Opioids side effects
timeFrame: 48 hours
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università Campus Biomedico
Study officials:
affiliation: University Hospital Campus Biomedico of Rome
name: Giuseppe Pascarella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
citation: Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
citation: Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
Clinical trial NCT00202033: Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes
Official title: Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: referred to
comprehensive
diabetes
education
program
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: International Diabetes Center at Park Nicollet
name: LifeScan
First posted: 2005-09-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if the frequency of blood glucose testing in patients with type 2 diabetes who are being treated with diet and exercise alone or diet and exercise plus oral agents will impact the HbA1c level.

Detailed description: To determine the impact of SMBG frequency on blood glucose control in patients receiving systematic diabetes management education through Type 2 Diabetes BASICS at International Diabetes Center.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Treatment with diet and exercise alone or with the addition of 1 or 2 oral agents
* Enrolled in Type 2 BASICS program
* A1c between 7.0 and 11%, inclusive
* Able to understand spoken English

Exclusion Criteria:

* Insulin therapy
* Unable/unwilling to perform SMBG
* Participating in another research study
* Currently performing SMBG \>3 times/week

Primary outcomes:
measure: HbA1c
timeFrame: 2 years
Secondary outcomes:
measure: blood glucose testing frequency
timeFrame: 2 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: Park Nicollet Institute/International Diabetes Center
name: Richard M Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05376033: Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers
Official title: Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontically Treated Teeth
Keywords: root canal treatment
healing rate
warm obturation technique
bioceramic sealer
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical use of a flowable premixed calcium-silicate bioceramic sealer used in association with warm carrier-based/single-cone technique will be compared with epoxy resin-based sealer with carrier-based technique.

Detailed description: Healthy consecutive patients (n= 109) requiring 141 root canal treatments were enrolled in this study and divided in 3 groups (Group 1: Ceraseal + single cone cold technique n=47. Group 2: Ceraseal + Carrier-based technique n=47. Group 3 AH Plus + Carrier based technique n=47).

Periapical X-rays were taken preoperatively, after root canal filling and after 6, 12 and 24 months. Two evaluators blindly assessed the Periapical Index (PAI) and sealer extrusion in the 3 groups (k =0.90). Healing rate and survival rate were also analysed.

Chi square tests was used to analyse significant differences among the groups. Multilevel analysis was performed to analyse the factors associated to healing status and survival status.

Eligibility criteria: Inclusion Criteria:

1. age 18-75 years
2. no use of antiresorptive or antiangiogenic drug
3. healthy status (ASA 1 or 2).
4. Needing one or more root canal treatment

Exclusion Criteria:

1. Teeth with less than 2 walls of structural integrity
2. Wide apexes (\>40 diameter)
3. ASA \> 3,
4. Any pathology that could compromise bone healing or the immune response,
5. pregnancy or breast feeding
6. heavy smoking (\>15 cigarettes/day), (Tverdal \& Bjartveit 2006)
7. exposure to radiation therapy focussed on the head and neck region and malignant disease directly involving the jaws.
8. Lacks of occlusal contacts

Primary outcomes:
measure: Healing rate
timeFrame: 24 months
Secondary outcomes:
measure: Survival rate
timeFrame: 24 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Dental School University of Bologna
state: Emilia-Romagna
Study officials:
References:
Clinical trial NCT06518733: Orthodontic Treatment Impact on Life Experience of Adolescents With Fixed Orthodontic Appliances
Official title: Orthodontic Treatment Impact on Day-to-Day Life Experience of Adolescents With Fixed Orthodontic Appliances: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthodontic Appliance Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 364
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian adolescent patients with age 13-18 with fixed orthodontic appliances

Brief summary: This cross-sectional study aimed to investigate the impact of different fixed orthodontic appliances on the day-to-day life experience of adolescent patients at any stage of their orthodontic treatment. A validated questionnaire was translated and used in the assessment, 364 patients (242 female and 122 male) were recruited, impact on the social and emotional well-being status of the participants was assessed as well as oral health, pain, and discomfort.

Detailed description: This cross-sectional study aimed to evaluate the impact of orthodontic treatment on the daily life experience of adolescents wearing fixed orthodontic appliances. We aimed to assess the impact of different fixed orthodontic appliances in a sample of 364 patients either having labial fixed orthodontic appliances only or combined with palatal anchorage appliances, combined with mini-screws, combined with both palatal anchorage appliances and mini-screws or having fixed retainers. The outcomes were the impact on the patient's social and emotional well-being status and the impact on the patient's oral health, pain, and discomfort. a questionnaire was distributed and the patient was asked to fill it in. The questionnaire is composed of 22 questions with a 3-point scale.

Eligibility criteria: Inclusion Criteria:

* Male and female patients
* Patients wearing fixed orthodontic appliances at any stage of treatment (labial fixed appliance only - labial fixed appliance combined with any palatal or lingual appliance - labial fixed appliance combined with mini-screws) or fixed retainers either in the upper arch only, lower arch only, or in both arches.
* Age: 13-18 years old

Exclusion Criteria:

* Patients who refused to participate in the study.
* Patients with cleft lip or palate.
* Illiterate patients.
* Patients who had a complicated medical history.
* Patients with severe skeletal discrepancy undergoing combined orthodontic and orthognathic surgical treatment.

Primary outcomes:
measure: Impact on the social and emotional well-being status of the patient.
timeFrame: during the intervention
Secondary outcomes:
measure: Impact on the oral health, pain, and discomfort of the respondent
timeFrame: during the intervention
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT00581633: Acute Salt Handling in Orthostatic Intolerance
Official title: Acute Renal Salt Handling in Orthostatic Intolerance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postural Tachycardia Syndrome
Orthostatic Tachycardia
Orthostatic Intolerance
Keywords: saline
sodium
kidney
tachycardia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will test the hypothesis that patients with chronic orthostatic intolerance or postural orthostatic tachycardia syndrome (OI or POTS) will be unable to conserve urinary sodium as compared to healthy control subjects.

Detailed description: Patients with chronic OI appear to be hypovolemic with abnormalities in hormones that regulate salt \& water handling. Increases in dietary salt have salutary effects on orthostatic tolerance in a physiological laboratory. The infusion of intravenous saline acutely decreased heart rate in this patient population. Preliminary data from Vanderbilt suggests abnormal salt handling in patients with chronic OI in a few patients. These data need to be confirmed and a better understanding of sodium handling in response to acute salt loads is required in these patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with orthostatic intolerance by Vanderbilt Autonomic Dysfunction Center (or healthy control subject)

Exclusion Criteria:

* Overt or acute cause for orthostatic tachycardia
* Hypertension (BP\>145/95 or need for anti-hypertensive medications)
* QRS duration \> 120 msec on EKG
* Pregnancy

Primary outcomes:
measure: Urinary Na excretion
timeFrame: 24h and then hourly post saline load
Secondary outcomes:
measure: Catecholamine levels
timeFrame: 1 day
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Satish R Raj, MD MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03969433: Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring
Official title: Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foetal Wellbeing
Lead sponsor: Bloom Technologies
Sponsor class: INDUSTRY
First posted: 2019-05-31
Enrollment: 231
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to support the development of a new generation of the Bloomlife sensor, enabling continuous monitoring of foetal wellbeing.

Data is collected in four Phases, with different experimental setups. Recordings with investigational and reference devices are performed on the subjects, at different gestational ages.

The collected data is used for developing algorithms for the extraction of parameters descriptive of foetal wellbeing.

Clinical information related to subjects' pregnancy and foetal health is also collected.


Eligibility criteria: Inclusion Criteria:

* Pregnant
* Gestational age of at least 20 weeks
* Singleton pregnancy
* Willingness to participate in the study

Exclusion Criteria:

* Multiple pregnancy
* Implanted pacemaker or any other implanted electrical device
* History of allergies to silicone-based adhesives

Primary outcomes:
measure: Accuracy and reliability in the detection of foetal heart rate
timeFrame: Throughout the subject's participation in the study, from inclusion until delivery
measure: Accuracy and reliability in the detection of foetal movements
timeFrame: Throughout the subject's participation in the study, from inclusion until delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Wilfried Gyselaers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: