louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03377140: The Effects of Hesperidin on Biochemical Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease
Official title: Evaluation of the Effects of Hesperidin Supplementation on Hepatic Enzymes, Inflammatory Factors, Lipid Profile, Blood Glucose, Insulin Sensitivity, and Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Alcoholic Steatohepatitis
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 50
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: To study the effects of Hesperidin supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to receive placebos or 2 capsules Hesperidin for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) between 25-40
* Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

* Diabetes
* Taking any kind of antibiotics two weeks before recruitment
* History of alcohol consumption
* pregnancy or lactation
* Professional athletes
* Other liver disease (viral/etc)
* Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
* A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
* Following program to lose weight in recent 3 mo
* A history of hypothyroidism or Cushing's syndrome

Primary outcomes:
measure: liver fibrosis
timeFrame: 12 weeks
Secondary outcomes:
measure: body mass index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
Study officials:
References:
Clinical trial NCT03189940: Lifestyle Modification Using an App in OSA
Official title: Effect of Lifestyle Modification Using Smartphone Application on Weight Reduction and Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Obesity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to investigate the effects of a mobile phone app linked to hospital electronic medical record (EMR) system on weight reduction and obstructive sleep apnea (OSA). Adults aged \> 20 years with witnessed snoring or sleep apnea from a sleep clinic of a tertiary center were prospectively enrolled, and the participats were randomized into app user and control groups. The mobile app was designed to collect daily lifestyle data by wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both physicians and app users. Further lifestyle modification was encouraged on the basis of the electronically collected data. In the control group, the lifestyle modification performed as the usual practice. All participants underwent Watch PAT and body mass index (BMI) measurement twice: on enrollment; and after 4-weeks follow up. Changes of BMI, and parameters of sleep related breathing were analyzed.


Eligibility criteria: Inclusion Criteria:

ᆞ patients must agree to participate in our clinical study ᆞ patients without severe cardiopulmonary disease ᆞ patients must be with BMI \> 23 Kg/m2

Exclusion Criteria:

ᆞ patients who did not agree ᆞ patients with severe cardiopulmonary disease ᆞpatients who are under treatment using a continuous positive airway pressure device or a mandibular advancement device ᆞ patients who were pregnant

Primary outcomes:
measure: changes in body weight
timeFrame: base line and after 4weeks of life style modiciation
Secondary outcomes:
measure: apnea hypopnea index (AHI)
timeFrame: base line and after 4weeks of life style modiciation
measure: respiratory distress index (RDI)
timeFrame: base line and after 4weeks of life style modiciation
measure: oxygen desaturation index (ODI)
timeFrame: base line and after 4weeks of life style modiciation
measure: sleep time proportion with snoring loudness > 45dB
timeFrame: base line and after 4weeks of life style modiciation
measure: lowest oxygen saturation
timeFrame: base line and after 4weeks of life style modiciation
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jeong-Whun Kim, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04543240: Bacterial Load for Integra™ in Operative Wounds
Official title: The Relationship Between Bacterial Load and the Clinical Outcomes for Integra™ in Operative Wounds
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wounds and Injuries
Keywords: Lower extremity
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Integra LifeSciences Corporation
First posted: 2020-09-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be anyone who is experiencing partial or full thickness wounds, pressure ulcers, venous and diabetic ulcers, burns, and traumatic wounds.

Brief summary: Proportion of postoperative complications (infections, dehiscence, graft slough) after initial application of Integra™

Detailed description: This is a study examining the use of Integra™ for the treatment of lower extremity wounds to better understand the relationship between bacteria contamination levels and post-operative complications. Wounds requiring operative application of Integra™ alone or Integra™ followed by a planned subsequent application of a STSG will be enrolled into this study.

The tolerance of Integra™ to bacterial bioburden at the time of application will be determined by observing their respective postoperative wound complications and correlating these findings with quantitative bacterial counts, qualitative culture results, and bacterial and wound protease levels at the time of Integra™ alone application or Integra™ followed by STSG application.

Patients will then be followed until complete healing has occurred or until 16 weeks, whichever comes first.

Eligibility criteria: Inclusion Criteria:

* Male or Female age 18-90.
* Full-thickness wounds below the knee.
* Patients who require, in the opinion of the Investigator, operative application of Integra™.
* Patients able and willing to comply with the study protocol.

Exclusion Criteria:

* Male or Female under 18 or over 90
* Patients that do not have Full-thickness wounds below the knee
* Patients who do not require, in the opinion of the Investigator, operative application of Integra™.
* Patients that are not able or willing to comply with the study protocol.

Primary outcomes:
measure: Determine a threshold in which Integra is tolerant to bacteria that yields positive results (healing). The investigators believe that this device is more tolerant to bacterial load then current perception.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: MedStar Georgetown University Hopsital
name: Christopher Attinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04935840: Evaluation of the Effect of FertyBiotic Pregnancy in the Metabolic Profile in Pregnant Women
Official title: Clinical Study to Evaluate the Effect of a Food Supplement With Probiotics on the Metabolic Profile of Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Fertypharm
Sponsor class: INDUSTRY
First posted: 2021-06-23
Enrollment: 84
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is determine the effect of a food supplement with probiotics on metabolic profile and weight gain in pregnant women.

Detailed description: After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will be randomized in a double-blind manner in a ratio 1:1 to receive the food supplementation associated with probiotics or placebo (folic acid) once daily.

Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Age: \> 35 years old
* BMI \> 25
* Women who have signed the informed consent to participate in the study.
* No intention to change their routine physical activity or usual dietary intakes throughout the study

Exclusion Criteria:

* \> 14 weeks' gestation
* Taking food supplements or probiotics
* History or current pathology that influence in the study
* With major fetal abnormalities
* Had used continuous antibiotic therapy for at least 3 months

Primary outcomes:
measure: Glucose homeostasis
timeFrame: 30-32 weeks gestation
Secondary outcomes:
measure: Insulin levels
timeFrame: 30-32 weeks gestation
measure: Insulin resistance
timeFrame: 30-32 weeks gestation
measure: Weight gain
timeFrame: 30-32 weeks gestation
measure: Lipid concentration
timeFrame: 30-32 weeks gestation
Other outcomes:
Locations:
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
Study officials:
References:
Clinical trial NCT06833840: Evaluation of the Expression and Prognostic Role of Tumor Stem Cell Marker SOX2 in Odontogenic Cysts and Tumors
Official title: Evaluation of the Prognostic Role of SOX2 as a Tumor Stem Cell Marker in Odontogenic Cysts and Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Odontogenic Cysts
Odontogenic Tumors
Keywords: Ameloblastoma
odontogenic keratocyst
dentigerous cyst
SOX2
immunohistochemistry
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.

Brief summary: The pathogenesis of odontogenic lesions remains unclear; however, a probable explanation may involve the existence of tumor stem cells (TSCs), which are thought to generate both benign and malignant tumors. The preservation of stem cells during early dental development is governed by many transcription factors, including sex-determining region Y (SRY)-box 2 (SOX-2). Numerous studies observed the increased expression of SOX2 in various benign and malignant tumors, as its impact on tumorigenesis varies according to tumor type. The purpose of this study is to assess the immunoexpression of the stem cell marker SOX2 in diverse types of odontogenic cysts and tumors in order to identify its prognostic significance and to show if it correlates to clinicopathologic parameters of those odontogenic lesions.

Detailed description: Forty-five surgical specimens were included in this study: 15 ameloblastomas (Ab), 15 odontogenic keratocysts (OKC), and 15 dentigerous cysts (DC). An immunohistochemical (IHC) study using the SOX2 Rabbit Polyclonal Antibody was done, and SOX2 expression was evaluated by two methods: computer-assisted digital image analysis to measure staining surface area percentage and a semi-quantitative method for subjectively scoring percentage and intensity of SOX2 staining. Positive specimens were considered when the nucleus had brown staining.

Eligibility criteria: Inclusion criteria:

1. Patients with benign odontogenic cysts and tumors which presented either in Maxilla or Mandible ( as indicated by incisional biopsies )

Exclusion criteria:

1. Patients with systemic diseases that absolutely contraindicate surgical procedures.
2. Malignant odontogenic tumors.

Primary outcomes:
measure: SOX2 staining score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry, Mansoura University
state: Dakahlia
Study officials:
References:
Clinical trial NCT04279340: Correlation Between Chronic Neck Pain and Shoulder Proprioception Among Patients With Cervical Radiculopathy
Official title: Correlation Between Chronic Neck Pain and Shoulder Proprioception Among Patient With Cervical Radiculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Radiculopathy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Out patient clinic at faculty of physical therapy

Brief summary: Is there correlation between cervical radiculopathy and shoulder proprioception or not?


Eligibility criteria: Inclusion Criteria:

* chronic neck pain with unilateral cervical radiculopathy.

Exclusion Criteria:

* has impingement syndrome ,history of instability and any systemic disease.

Primary outcomes:
measure: Shoulder Proprioception among cervical radiculopathy patients
timeFrame: 15 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
References:
Clinical trial NCT01619540: Valsalva Manœuvre in the Diagnosis of Left Ventricular Failure in Chronic Obstructive Pulmonary Disease Exacerbation
Official title: Study of the Valsalva Manœuvre in the Diagnosis of Left Ventricular Failure During Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Heart Failure
COPD Exacerbation
Keywords: COPD
Left Ventricular Failure
Valsalva Manoeuver
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2012-06-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Left ventricular failure (LVF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD).

This association is frequently underestimated with regard to the difficulty of clinical diagnosis .

The investigators expect that Valsalva Maneuver (VM) could be useful in this issue.


Eligibility criteria: Inclusion Criteria

* We included in this group, patients with a history (previous history) of COPD who consulted the emergency room for an exacerbation of COPD defined by a respiratory rate\> 25c/min and a pH \<7.35 and a PaCO2 \>6 KPa.
* This group is also divided into two groups according to clinical expert assessment and the BNP value: Group1 : BNP\> 400pg/ml, Group2 : BNP \<400PG / ml

Exclusion Criteria:

* We excluded from this study patients with Prominent cardiac arrest
* Rhythm disorders including severe tachycardia arrhythmia
* Auricular fibrillation
* Hemodynamic instability requiring the use of vasoactive drugs and a contre indications of non invasive ventilation such us consciousness disorders with a Glasgow score \<12/15,a swallowing disorder
* A significant bronchial obstruction ,the upper airway obstruction , in upper gastrointestinal bleeding in progress, an extreme obesity and Cirrhosis or cancer.
* We are also excluded patients who did not cooperate and those who refused the study.

Primary outcomes:
measure: left ventricular dysfunction
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: University Hospital of Monastir
state: Monstir
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University hospital
city: Monastir
country: Tunisia
facility: University hospital of Moastir
city: Monastir
country: Tunisia
facility: University hospital of Monastir
Study officials:
affiliation: Monastir University
name: Nouira Semir, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boubaker H, Grissa MH, Debbabi H, Beltaief K, Dridi Z, Najjar MF, Bouida W, Boukef R, Marghli S, Nouira S. Value of Plethysmographic Pulse Amplitude Ratio With Valsalva Maneuver in Identifying Left Ventricular Dysfunction During COPD Exacerbation. Respir Care. 2016 Apr;61(4):439-46. doi: 10.4187/respcare.04091. Epub 2015 Dec 8.
Clinical trial NCT00921440: Computed Tomography Coronary Angiography (CTCA) and Coronary Flow in Stenosis Analysis
Official title: CT Coronary Angiography: Coronary Flow Quantification Supplements Morphological Stenosis Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: coronary artery
stenosis
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Dept. of Radiology
First posted: 2009-06-16
Enrollment: 50
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: people with suspected or known coronary artery disease (CAD)

Brief summary: The investigators' rationale was to evaluate whether a 64-slice CT scanner allows accurate measurement of computed tomographic changes in coronary artery flow profiles and whether CT flow measurements are suitable for classifying the significance and hemodynamic relevance of a stenosis and thereby supplement as a functional parameter for morphological stenosis analysis.

Detailed description: A total of 50 patients prospectively underwent computed tomography coronary angiography (CTCA) in a multidetector CT scanner (Brilliance 64, Philips) ± 1 day before or after invasive coronary angiography (ICA). Immediately thereafter, 2 radiologists reviewed the imaging data to detect any vessel segments with morphology poorly evaluable by CTCA. A locally constant cyclical measurement was acquired in these coronary arteries in breath-hold technique during the passage of a 50ml bolus of contrast media. For analysis, time-density curves of the bolus passage were registered in the coronary artery and the aorta (internal reference), the up-slopes were determined and correlated with each other. The results were compared with the ICA findings.

Eligibility criteria: Inclusion Criteria:

* Clinically known or presumed CAD
* Age \> 50 years
* Hospitalization for invasive coronary angiography
* Sinus rhythm
* Written informed consent by the patient to participate in the study after comprehensive presentation of the facts

Exclusion Criteria:

* Age \<= 50 years
* Contraindications to contrast media administration (medical history of iodine allergy, nephropathy, latent or manifest hyperthyroidism)
* Arrhythmias
* Dyspnea at rest, acute unstable angina pectoris, acute myocardial infarction
* Pregnancy
* Implanted pacemaker
* Unwillingness of patient to consent to the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Radiology, University Hospital of Cologne
name: Barbara Krug, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02567240: Carbon Monoxide-Saturated Medium for Islet Isolation
Official title: A Novel Approach to Harvest Islets for Autologous Islet Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Pancreatitis
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to determine whether harvesting islets using carbon monoxide (CO)-saturated mediums can protect islet cell from death after autologous islet transplantation in patients with chronic pancreatitis.

Detailed description: Investigators plan to harvest human islets using carbon monoxide-saturated mediums. Survival and function of transplanted islets will be compared with islets harvested using regular mediums.

Eligibility criteria: Inclusion Criteria:

1. Chronic pancreatitis patient selected for total pancreatectomy and islet autotransplantation.
2. Age between 18-69.

Exclusion Criteria:

1. Had prior pancreatic surgeries.

Note: The study was initially designed only to enroll diabetes free patients. To increase enrollment, we extended the inclusion criteria by allowing patients who are pre-diabetic to participate the study. This revision was approved by the MUSC IRB on 11/10/2015.

Primary outcomes:
measure: Area under the curve during mixed meal tolerance test
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: GI Surgery, Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Hongjun Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: