louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05918315: Comparison Between Two Techniques Used in Treatment of Long Anterior Urethral Stricture
Official title: Dorsolateral Versus Dorsal Approach Urethroplasty for Managing Long Anterior Urethral Stricture.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urethral Stricture, Male
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 40
Sex: MALE
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate dorsolateral and dorsal approach urethroplasty in treatment of anterior urethral stricture by using buccal mucosal graft as regard voiding and sexual outcomes.

Detailed description: At the Department of Urology, Sohag university Hospital, both techniques of dorsolateral and dorsal approach urethroplasty in treatment of anterior urethral stricture by using buccal are used in repair of long stricture anterior urethra.Therefore, our data can be used as a source for the comparative analysis of these two Buccal mucosa graft urethroplasty techniques.This study aimed to compare these procedures to determine their advantages and disadvantages, as regard voiding ,sexual function and quality of life after the surgery.

Eligibility criteria: Inclusion Criteria:

* long anterior urethral stricture

Exclusion Criteria:

* children.
* Recurrent stricture

Primary outcomes:
measure: Voiding function
timeFrame: 2 months after catheter removal
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
state: Faculty Of Medicine
Study officials:
affiliation: Sohag University
name: Ahmed M Reyad, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06923215: Glucose Disposal Rate as a Metric for Detection of Metabolic Associated Fatty Liver
Official title: The Role of Estimated Glucose Disposal Rate as a Metric for Detection of Metabolic Associated Fatty Liver Disease and Its Severity in Patients With Metabolic Syndrome.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: MAFLD
Keywords: MAFLD
eGDR
Fibroscan
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults (18-65 years) with suspected/confirmed metabolic syndrome (IDF criteria) attending a metabolic clinic in Egypt over 12 months. Exclusions include other liver diseases, high alcohol intake, pregnancy, or advanced cirrhosis. All participants undergo:

Clinical/laboratory assessment: Anthropometrics, blood pressure, fasting glucose, HbA1c, lipid profile, liver enzymes, platelet count.

eGDR calculation: Formula incorporating waist circumference, hypertension status, and HbA1c.

FibroScan® evaluation: CAP for steatosis grading (S0-S3) and LSM for fibrosis staging (F0-F4).

Brief summary: A 12-month prospective observational cohort study assessing eGDR's utility in diagnosing MAFLD (via FibroScan® CAP ≥248 dB/m) and correlating it with steatosis/fibrosis severity. Secondary aims compare eGDR to FLI/FIB-4 scores and identify optimal diagnostic cut-offs

Detailed description: Primary Aim

Determine eGDR's diagnostic accuracy for MAFLD using FibroScan® (CAP ≥248 dB/m) as the gold standard.

Secondary Aims

Correlate eGDR with MAFLD severity (steatosis via CAP, fibrosis via liver stiffness measurement \[LSM\]).

Compare eGDR's performance to Fatty Liver Index (FLI) and FIB-4 in detecting MAFLD and predicting fibrosis.

Identify optimal eGDR cut-offs for MAFLD detection (\<6 mg/kg/min) and advanced fibrosis staging (\<4 mg/kg/min).

Evaluate eGDR's reclassification improvement (net reclassification index \>10%) over existing scores.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years.
* Suspected/confirmed MS per IDF criteria:
* Central obesity (waist circumference ≥94 cm \[men\]/≥80 cm \[women\]) plus ≥2 of: Triglycerides ≥150 mg/dL.

HDL \<40 mg/dL (men)/\<50 mg/dL (women). Blood pressure ≥130/85 mmHg or antihypertensive treatment. Fasting glucose ≥100 mg/dL or diabetes diagnosis.

Exclusion Criteria:

* Other liver diseases (viral/autoimmune hepatitis).

Alcohol intake \>20 g/day (men) or \>10 g/day (women).

Pregnancy, malignancy, advanced cirrhosis.

Medications affecting metabolism (e.g., steroids)

Primary outcomes:
measure: eGDR will demonstrate high accuracy for MAFLD detection
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01510015: Evaluation of the Effects of Treatment of Psycho-stimulant and Cannabis-dependent Users in Israel
Official title: Evaluation of the Effects of Psychological and Pharmacological Treatment of Psycho-stimulant and Cannabis-dependent Users in Kfar Izun in Israel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cannabis Dependence
Psychostimulant Dependence
Keywords: cannabis
psychostimulants
psychosis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of psychological and pharmacological treatment of regular users of cannabis and psychostimulants in a treatment center (Kfar Izun) in Israel. The participants will undergo psychological evaluation before and during treatment and follow up at 4 months. Ten participants will undergo brain imaging of the dopamine receptor D2 in order to evaluate the effects of treatment on dopamine turnover in the brain. A control group of psychiatric in-patients undergoing treatment for psychiatric illness with be recruited from Geha Hospital in Israel. It is predicted that successful treatment of regular users of cannabis will be resulted in improvement in anxiety, depression and psychotic symptoms as well as in upregulation of dopamine turnover in participants that will undergo brain imaging.

Detailed description: There is a significant number of cannabis and psychostimulant users that experience psychotic episodes and require psychiatric treatment. This study evaluates the effects of psychological and pharmacological treatment of regular users of cannabis and psychostimulants in a treatment center (Kfar Izun) in Israel. The participants will undergo psychological evaluation before and during treatment and follow up at 4 months. Ten participants will undergo brain imaging of the dopamine receptor D2 using \[I123\] IBZM in Single Photon Emitted Tomography (SPECT) before and after treatment in order to evaluate the effects of treatment on dopamine turnover in the brain. A control group of psychiatric in-patients undergoing treatment for psychiatric illness with be recruited from Geha Hospital in Israel.

Eligibility criteria: Inclusion Criteria:

* cannabis dependence with or without history of psychosis.

Exclusion Criteria:

* pregnant women
* under 18
* neurological damage
* HIV positive
* dependence on other drugs such as heroin
* cocaine or alcohol

Primary outcomes:
measure: Questionnaire ratings of anxiety, depression and psychotic symptoms
timeFrame: 4 months
Secondary outcomes:
measure: Dopamaine receptor D2 occupancy
timeFrame: At baseline and after 4 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sourasky Medical center
Study officials:
affiliation: Sourasky Medical Center
name: Michal Roll, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00167115: Metabolic Effects of Alcohol
Official title: Metabolic Effects of Alcohol in the Form of Wine in Persons With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Alcohol
Type 2 diabetes mellitus
Plama glucose
HDL cholesterol
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The hypotheses to be tested are 1) the use of alcohol in the form of wine with the evening meal will lower plasma glucose during the night and result in lower fasting plasma glucose the next morning; 2) the chronic use of alcohol in moderation in the form of wine will have beneficial effects on plasma lipids in type 2 diabetic subjects.

Detailed description: The use of alcohol in moderation has been associated with reduced mortality rates, reduced risk of cardiovascular disease and reduced risk for type 2 diabetes. However, the effects of alcohol in persons with type 2 diabetes have not yet been defined. Moreover, the possibility of alcohol induced hypoglycemia remains a safety concern. Finally, little is known about the effects of alcohol on plasma lipids in people with diabetes. To address these issues, two substudies are proposed. The first substudy will examine the acute effects of alcohol in the form of wine at supper on postprandial and nocturnal glucose levels. The second substudy will examine the effects of alcohol in the form of wine consumed regularly for one month on plasma lipids.

To test these hypotheses, 20 type 2 diabetics will be studied. In substudy 1, subjects will be admitted to the Clinical Research Center for a two day inpatient stay. Blood samples for plasma glucose and serum insulin will be obtained every two hours from 5:00 pm to 7:00 am. On one day, subjects will recieve 8 ounces of wine with dinner. On the other day, subjects will recieve 8 ounces of fruit juice with dinner. The primary endpoint of substudy 1 will be fasting plasma glucose. In substudy 2, subjects will be asked to consume 4-8 ounces of wine in the evening for one month and to abstain from wine and alcohol containing beverages for one month. Fasting blood samples will be obtained after the month of wine consumption and after the month of abstention from alcohol for measurement of fasting lipids. The primary endpoint of substudy 2 will be fasting HDL cholesterol.

Eligibility criteria: Inclusion Criteria:

Type 2 diabetes HbA1c 6.0-8.0% age \> 40 years

Exclusion Criteria:

History of alcoholism or alcohol abuse liver disease blood pressure \> 150/90

Primary outcomes:
measure: Fasing plasma glucose
measure: Fasting plasma HDL cholesterol
Secondary outcomes:
measure: Episodes of hypoglycemia
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: John Bantle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04041115: Effect of Non-alcoholic Beer in Cirrhosis
Official title: Effect of a Multifactorial Intervention (Non-alcoholic Beer, Diet and Exercise) on Endothelial Function, Nutritional Status and Quality of Life in Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Nutritional Status
Quality of Life
Keywords: cirrhosis
nutrition
sarcopenia
non-alcoholic beer
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 42
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: The implementation of nutritional strategies targeting several variables at once could benefit patients with cirrhosis. Non-alcoholic beer has different compounds derived from hops that exert antioxidant, anti-inflammatory and nutritional properties. The aim of this study is to evaluate the effect of diet + exercise and non-alcoholic beer on nutritional status, endothelial function and quality of life in patients with cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Liver Cirrhosis of any aetiology (liver biopsy or a combination of clinical and biochemical variables plus evidence of portal hypertension); without decompensation during the past month; serum creatinine \<1.5 mg%; able to attend the appointed visits and willing to participate in the study.

Exclusion Criteria:

* Severe concomitant cardiopulmonary diseases; decompensated type 2 Diabetes Mellitus, insulin use or proliferative diabetic retinopathy; orthopedic or osteomuscular limitations; any type of cancer; primary sclerosing cholangitis and inflammatory bowel disease.

Primary outcomes:
measure: Nutritional status
timeFrame: 8 weeks
measure: Endothelial function
timeFrame: 8 weeks
measure: Endothelial dysfunction
timeFrame: 8 weeks
measure: Quality of life questionnaire
timeFrame: 8 weeks
measure: Changes in the heterogeneity of gut Microbiota
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Ricardo U. Macías-Rodríguez, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05883215: Effects of Social Media Usage on Pain Catastrophizing and Disease Impact in Female Patients With Fibromyalgia Syndrome
Official title: Effects of Social Media Usage on Pain Catastrophizing and Disease Impact in Female Patients With Fibromyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Başakşehir Çam & Sakura City Hospital
name: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
First posted: 2023-05-31
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with fibromyalgia syndrome diagnosis who gave consent to participate.

Brief summary: The aim of this study is to investigate the effects of social media usage on pain catastrophizing and disease impact in female individuals diagnosed with fibromyalgia syndrome.

Detailed description: In this study, the total number of female patients obtained as a result of sample size calculations was 73, and the effect of social media use on pain catastrophizing and disease impact of patients diagnosed with fibromyalgia will be investigated. Social media use will be evaluated with the Social Media Use Integration Scale, disease impact with the Fibromyalgia Impact Questionnaire, anxiety levels with the Beck Anxiety Inventory, and pain catastrophizing level with the pain catastrophizing scale. At the same time, a form including demographic data of the patients will be filled. The results will be evaluated with the tests prescribed by the statistical expert, and correlation will be investigated.

Eligibility criteria: Inclusion Criteria:

* Giving consent.
* Being diagnosed with Fibromyalgia syndrome
* Being female

Exclusion Criteria:

* Not giving consent.
* Any disability or illness that may prevent filling out the form or communicating.

Primary outcomes:
measure: Correlation between social media use and pain catastrophizing
timeFrame: 1 day
measure: Correlation between social media use and disease impact
timeFrame: 1 day
measure: Correlation between social media use and anxiety
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04990115: Bacterial Reduction and Post Operative Endodontic-pain Using Different Kinematics
Official title: Bacterial Reduction and Post Operative Pain After Cleaning and Shaping of Root Canals With Single File Systems Used in Different Kinematics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Canal Infection
Keywords: Reciprocation
Kinematics
Bacterial reduction
post-operative pain
endodontic flare-ups
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial design is a prospective, parallel, randomized with an allocation ratio (1:1), double-blinded, single-center clinical trial
Primary purpose: TREATMENT

Brief summary: This study was conducted to compare the antibacterial effect and degree of postoperative pain of single rotary and reciprocating file systems during endodontic therapy

Detailed description: Introduction: Instrumentation kinematic is one of the many aspects of shaping files that underwent heavy development through the last decade. The impact of the type of motion used to drive shaping instruments was heavily studied but mostly in-vitro. More randomized clinical trials are needed to achieve a reliable body of data concerning the issue.

Aim: This study aimed to evaluate the effect of varying shaping files' kinematics on bacterial reduction, post-operative pain and the incidence of flare-ups. Methods: Necrotic, asymptomatic, single-rooted mandibular premolars with single canals were used in the study, where 46 patients were randomly allocated to two groups. In the first group, WaveOne Gold was used for mechanical preparation while One Shape was used in the second group. Samples were taken preoperatively (S1) and after chemomechanical preparation (S2). Bacterial reduction was evaluated and compared between both groups via culturing technique and quantitative analysis by real-time polymerase chain reaction (qPCR). Post-operative pain and the incidence of flare-ups were also evaluated using the visual analog scale (VAS) method.

Eligibility criteria: Inclusion Criteria:

* mandibular premolars
* single rooted
* single canalled
* necrotic pulps
* asymptomatic apical periodontitis

Exclusion Criteria:

* gross caries
* root/crown fracture
* sinus tract
* swelling
* intake of antibiotics within previous 3 months
* pain with percussion

Primary outcomes:
measure: bacterial reduction
timeFrame: up to 1 hour
measure: post operative pain
timeFrame: after the treatment visit by 24 hours
measure: post operative pain
timeFrame: after the treatment visit by 48 hours
measure: post operative pain
timeFrame: after the treatment visit by 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry. Ain Shams University
Study officials:
affiliation: professor
name: shehabeldin M Saber, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02491515: Effects of Denosumab Therapy for Japanese
Official title: Effects of Denosumab Therapy for Japanese Osteoporotic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Keywords: Osteoporosis
BMD
denosumab
previous therapy
Lead sponsor: Tomidahama Hospital
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 500
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Osteoporotic patients who admit to our hospital

Brief summary: In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of denosumab in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

The main objective of this study is to investigate effects of denosumab. The researchers also investigate the effects of Effects of previous osteoporotic therapy to denosumab treatment. In this study, the investigators analyse the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.

Detailed description: Registry criteria: Patients treated in the investigators hospital using denosumab. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (\< young adult mean 65%).

Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants

Eligibility criteria: Inclusion Criteria:

* Osteoporotic patients

Exclusion Criteria:

* cancer, hypercalcemia, etc (i.e. patients who could not use denosumab)

Primary outcomes:
measure: BMD increase by denosumab in Japanese
timeFrame: Up to 48 months
Secondary outcomes:
measure: The determinants related to BMD increase and fracture prevention for denosumab treatment
timeFrame: Up to 48 months
measure: Effects of previous therapy to denosumab
timeFrame: Up to 48 months
Other outcomes:
Locations:
city: Yokkaichi
country: Japan
facility: Tomidahama Hospital
state: Mie
Study officials:
affiliation: Tomidahama Hospital
name: Rui Niimi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04396015: Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
Official title: Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function 1, Social
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized, placebo control cross-over study, with an open label extension
Primary purpose: TREATMENT

Brief summary: The present study is being done in a scientifically rigorous manner, using readily available MCT oil (refined from coconut oil) versus a placebo oil to assess any cognitive and functional benefits for AD patients.

Detailed description: The proposed study, is a randomized placebo controlled cross-over study for 6 months, with an open label extension for another 6 months designed to test the benefits and safety of MCT oil in patients with established AD. It will be the first study on MCT oil ever done with this design, and for this duration in AD.

Eligibility criteria: Inclusion Criteria:

* Patients \>49years with a clinical diagnosis of AD
* Mini Mental Status Examination (MMSE) score 10-29/30
* on stable dose of medications for 3 months (AChEI, memantine and antidepressants allowed)
* able to speak English
* patient or designate able to sign informed consent
* stable chronic medical conditions (Heart disease, thyroid disease)
* reliable caregiver

Exclusion Criteria:

* age \<50 years
* medically unstable
* unable to swallow liquids
* diagnosis of diabetes mellitus
* residence in a nursing/long term care home
* allergy to coconut
* allergy to olive oil

Primary outcomes:
measure: cognition
timeFrame: 15months
measure: Cognition
timeFrame: 15 months
measure: cognition
timeFrame: 15 months
measure: Behavior
timeFrame: 15 months
measure: Function
timeFrame: 15 months
Secondary outcomes:
measure: maximum tolerated daily dose (ml) of MCT oil
timeFrame: 11 months
measure: maximum tolerated daily dose (ml) of placebo (olive) oil
timeFrame: 4 months
measure: Serum cholesterol mmol/l
timeFrame: 15 months
measure: Serum Triglyceride mmol/l
timeFrame: 15 months
measure: Serum Low density lipoprotein (LDL) mmol/l
timeFrame: 15 months
measure: Dual Energy Absorptiometry (DXA) Body fat
timeFrame: 15 months
measure: Incidence of treatment-emergent Adverse events
timeFrame: 15 months
Other outcomes:
Locations:
Study officials:
References: