louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06666894: Intermittent Fasting Versus Diet to Stop Hypertension on Metabolic Risk Profile in Nonalcoholic Fatty Liver Patients
Official title: Intermittent Fasting Versus Dietary Approach to Stop Hypertension on Metabolic Risk Profile in Nonalcoholic Fatty Liver Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting, Intermittent
Diet
Hypertension
Metabolic Syndrome
Non-Alcoholic Fatty Liver Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to compare between the effect of intermittent fasting and diatery approach to stop hypertension on metabolic risk profile in nonalcoholic fatty liver patients.

Detailed description: Non-alcoholic fatty liver is a liver disease linked to obesity, insulin resistance, type 2 diabetes, hypertension, hyperlipidemia, and metabolic syndrome. The subtype, non-alcoholic steatohepatitis, can lead to liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver transplantation. The prevalence of Non-alcoholic fatty liver disease is increasing at the same rate as obesity, with the global prevalence estimated at 25%. By 2020, the burden of Non-alcoholic fatty liver is expected to exceed that of communicable disease in most regions.

Eligibility criteria: Inclusion Criteria:

* Non-alcoholic fatty liver patients diagnosed by radiological ultrasound
* BMI \>30
* All patients are sedentary lifestyle with little or no exercise.
* High lipid profile (total cholesterol \> 200, LDL \> 130, TAGs \> 150) patients by laboratory investigation.
* High fasting insulin level \> 20mlU/mL \& high fasting Glucose level \>100, HbA1c \> 5.7 \& high HOMA- IR \> 2.5 patients by Laboratory investigation.
* High inflammatory markers (IL6) patients.
* Age ranged from 30 to 40 years old.

Exclusion Criteria:

* Alcoholic fatty liver patients.
* Cirrhosis patients.
* Diabetes patients.
* Cognitive impaired patients.
* History of epilepsy patients.
* Cardiac pacemaker patients.
* Anemic patients
* pregnancy

Primary outcomes:
measure: assessment of Non-alcoholic fatty liver using ultrasonography
timeFrame: at baseline at after two months
Secondary outcomes:
measure: assessment of change of lab profile using laboratory investigations
timeFrame: at baseline at after two months
measure: assessment of change of body mass index
timeFrame: at baseline at after two months
measure: assessment of macronutrients distribution
timeFrame: at baseline at after two months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: out-patient clinic, faculty of physical therapy, Cairo university
Study officials:
References:
Clinical trial NCT04888494: Hippocampal Stimulation in Chronic Low Back Pain
Official title: Enhancing Cortical-hippocampal Functional Connectivity as a Novel Means for Relieving Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Back Pain
Pain
Keywords: transcranial magnetic stimulation
resting state MRI
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-05-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will receive the 2 modalities of stimulation (hippocampal and sham-TMS). Each stimulation round is composed by 5 daily sessions of stimulation, participants will not know which round is active and which is sham. The order of the stimulation modalities will be different across subjects. Subjects will be randomly assigned to one of two possible modality order according to the entrance in the study.
Primary purpose: OTHER

Brief summary: In this study the investigators aim to examine the effects of Transcranial Magnetic Stimulation (TMS) on hippocampal network connectivity and pain levels in individuals with chronic low back pain.


Eligibility criteria: Inclusion Criteria:

* ≥ 6 months of back pain on a daily basis;
* male or female with no racial or ethnic restrictions;
* 18 to 75 years old;
* average back pain intensity \> 4/10 at study entry;
* must be able to read, understand, and sign consent form;
* generally healthy.

Exclusion Criteria:

* back pain with fever, chills, rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
* history of tumor in the back;
* back surgery within the past 6 months;
* Chronic neurologic conditions, e.g., Parkinson's
* involvement in litigation regarding back pain;
* other severe medical diseases;
* pregnancy;
* positive urinary screen for any recreational drugs,
* opioids use;
* use of anticoagulants (low dose ASA allowed);
* history of gastric ulcer; renal insufficiency or congestive heart failure,
* contraindication to MRI,
* contraindication to TMS; including history of seizure/epilepsy\*
* Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
* In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
* Diagnosis of major depression;
* Intra-axial implants (e.g. spinal cord stimulators or pumps)

Primary outcomes:
measure: Changes in Pain Scales
timeFrame: Pain is assessed at baseline, end of first intervention and end of the second intervention.
Secondary outcomes:
measure: Changes in Hippocampal Connectivity
timeFrame: approximately 6 weeks - Baseline and after the end of hippocampal stimulation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
References:
Clinical trial NCT03129594: Plasma Glucagon-like Peptide-1 Levels and Acute Myocardial Infarction
Official title: Prognostic Value of Plasma Glucagon-like Peptide-1 Levels in Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Angiography
Glucagon-like Peptide-1
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 709
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A single center study on PCI-treated myocardial infarction patients

Brief summary: GLP-1(9-36) amide and (9-37), which was previously thought to be the inactive metabolite of GLP-1, also exerts cardioprotective effects. Direct administration of GLP-1(9-36) during reperfusion reduced ischaemic damage in isolated hearts and increased cGMP release, vasodilatation and coronary flow in AMI mouse model, one may speculate that total GLP-1 level may associate with adverse cardiovascular events in AMI patients, the hypothesis is therefore tested in this study.


Eligibility criteria: Inclusion Criteria:

* consecutive patients of acute AMI come to our department,absent of cardiogenic shock, and survival for at least 24 h after PCI treatment.

Exclusion Criteria:

* patients with cancer, and patients who were taking a DPP4 inhibitor or a glucagon-like peptide-1 (GLP-1) analogue

Primary outcomes:
measure: all-cause mortality
timeFrame: The median follow-up was 29 months
measure: cardiovascular mortality
timeFrame: The median follow-up was 29 months
Secondary outcomes:
measure: non-cardiovascular mortality
timeFrame: The median follow-up was 29 months
measure: Myocardial infarction
timeFrame: The median follow-up was 29 months
measure: heart failure readmission
timeFrame: The median follow-up was 29 months
measure: Stroke
timeFrame: The median follow-up was 29 months
measure: repeated revascularization
timeFrame: The median follow-up was 29 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02978794: Implementation of Clinical Pathway to Improve Quality of Healthcare in Stroke Inpatients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: stroke, clinical pathway, medical care
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: stroke inpatient

Brief summary: With the extension of the average life expectancy, the incidence of cardiovascular diseases is also rising. Stroke in Taiwan has been the leading cause of morbidity and mortality, but also in countries around the world), stroke and the impact of socio-economic and health spending are large how to reduce the degree of disability after stroke is an important issue in medicine. For a long time, the resident will fill the clinical pathway form before the stroke inpatients were discharged. We also analyzed the data of clinical pathway every three months.

According to the current data of stroke clinical pathway included demographic data, length of hospitalization days, complications, functional independent measure, Brunnstrom motor recovery stage, mini-mental state examination, geriatric depression scale, blood pressure data, and post-stroke checklist for a retrospective analysis to provide more complete and more comprehensive information on follow-up care for stroke patients and effective use of medical resources, to improve the quality of future medical care and quality of life for stroke patients.


Eligibility criteria: Inclusion Criteria:

1. Ischemic and hemorrhagic stroke patients
2. MRI confirmed the diagnosis of stroke
3. Within three months of onset of unilateral limb hemiplegia in patients

Exclusion Criteria:

1. Initial tracheostomy impantation and hospital stay is less than 5 days
2. Combined with other neurological diseases, such as epilepsy, multiple neuropathy, Meniere's disease, vestibular neuritis, Parkinson's disease, dementia or cerebellar atrophy, etc.
3. Significant lesions of the lower limb joints, including joint contractures, lower limb fractures, joint replacement or long-term pain in patients with osteoarthritis
4. Unstable signs of life (if not through the tilt bed test) or severe cardiopulmonary disease
5. Those who can not cooperate with the study or who have not signed the inform consent

Primary outcomes:
measure: functional independent measurement
timeFrame: 1 year
measure: post-stroke checklist
timeFrame: 1 year
measure: Brunnstrom motor recovery stage
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06146894: The Effect of Different Obturation Techniques on Postobturation Pain in Single-Visit Root Canal Treatment
Official title: The Effect of Different Obturation Techniques on Postobturation Pain in Single-Visit Root Canal Treatment: A Prospective Clinical Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative Pain
Bioceramic sealer
Obturation
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this prospective clinical randomized study is to evaluate the effect of different obturation techniques on postobturation pain in single-visit root canal treatment in 18-60 years old patient who present no systemic disease (American Society of Anesthesiology class I or II) and require nonsurgical root canal treatment The main question it aims to answer which obturation technique used with bioceramic sealer cause less postobturation pain in single-visit root canal treatment in comparison to AH plus sealer used with lateral condensation or warm vertical compaction.

Participants will receive single visit root canal treatment using bioceramic sealer with different obturation techniques Group 1: Single cone technique Group 2: lateral condensation technique Group 3: Vertical compaction technique to see effect of different obturation technique on postobturation pain in single-visit root canal treatment.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-60 years who presented no systemic disease (American Society of Anesthesiology class I or II) and required nonsurgical root canal treatment.
* Diagnosis of asymptomatic irreversible pulpitis in a molar tooth with 3 independent root canals.

Exclusion Criteria:

* Presence of immature root apexes, root fracture, or periodontal disease
* Use of any analgesic, anti- inflammatory, or antibiotics before the treatment.

Primary outcomes:
measure: postobturation pain
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: kafrelsheikh University
state: Kafr El-Shaikh
Study officials:
affiliation: Kafrelsheikh University
name: Hisham Abada, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04688294: The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure
Official title: The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the bio-clinical effects of sacubitril/valsartan combination in treatment of patients with Congestive heart failure. Moreover, the investigators aim to evaluate side effects of this combination.

- The following parameters were determined at baseline and at end of the study at 6 months of the beginning.

1. New York Heart Association (NYHA) Class.
2. Frequency of hospitalization by acute exacerbation of CHF
3. NT-ProBNP
4. Left ventricular systolic function by Echocardiography

Moreover, the side effects of the drugs used during study was assessed by

1. Renal function (Serum creatinine) was performed every month till the end of the study.
2. Serum electrolytes (Potassium and Sodium) was performed every month till the end of the study.


Eligibility criteria: Inclusion Criteria:

1. Age 40 - 60 years
2. Patients with chronic congestive heart failure class ( II-IV) symptoms according to New York Heart Association (NYHA) classification
3. Left Ventricular Ejection Fraction of 40% or less.
4. NT-proBNP level of at least ≥400 pg per milliliter
5. ACE-inhibitor or ARB therapy with stable dose for prior 4 weeks, equivalent to enalapril ≥ 10 mg/day.

Exclusion Criteria:

1. Patients with symptomatic hypotension.
2. Pregnant and nursing women
3. Systolic blood pressure \< 100 mmHg at screening or \< 95 mmHg at randomization
4. Patients with glomerular filtration rate \<30 mL/min/1.73 m2
5. Patients with history of angioedema
6. Patients with unacceptable side effects with ACE-inhibitors or ARBs.

Primary outcomes:
measure: change in NTproBNP plasma concentration
timeFrame: at baseline
measure: change in NTproBNP plasma concentration
timeFrame: at 6 months
measure: severity of congestive heart failure.
timeFrame: at baseline
measure: severity of congestive heart failure.
timeFrame: at 6 months
Secondary outcomes:
measure: change in plasma potassium concentration
timeFrame: every month, up to 6 months
measure: change in serum sodium concentration
timeFrame: every month, up to 6 months
measure: change in serum creatinine
timeFrame: every month, up to 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Wadi El-Neel Hospital
Study officials:
References:
Clinical trial NCT00725894: Pediatric Locking Nail for the Treatment of Femoral Fractures in Children
Official title: A Prospective Multi-Center Clinical Outcomes Study To Assess The Safety and Effectiveness Of The Pediatric Locking Nail For Treatment Of Femoral Fractures In Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femur Fracture
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-07-31
Enrollment: 33
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric femoral fractures in patients 8-16 years of age where a nail is preferred

Brief summary: The purpose of this multi-center prospective clinical outcomes study is to determine validity and safety of the pediatric locking nail for femoral fracture management in children with open physes.


Eligibility criteria: Inclusion Criteria:

1. Subject, representative willing to sign informed consent.
2. Ability and willingness of the subject to follow postoperative care instructions until healing is complete
3. Subject age must be between 8-16 inclusive.
4. Subjects with a minimal canal diameter of 9mm or greater

And any of the following fracture types

1. Non-comminuted and comminuted mid-shaft fractures
2. Distal third fractures 4 cm above the distal physis
3. Fractures that are open or closed
4. Subtrochanteric fractures

Exclusion Criteria:

1. A subject has a bone or soft tissue infection.
2. Subject has a systemic infection.
3. Subject has a distal (supracondylar) fracture.
4. Subject with pathological bone (osteogenesis imperfecta and other conditions resulting in abnormal bone quality).
5. Subjects with mental or neurological condition who are unwilling or incapable of following postoperative care instructions.
6. Subject with conditions including blood supply limitation, and insufficient quantity or quality of bone.
7. Foreign body sensitivity, where material sensitivity is suspected, testing is to be completed prior to implantation of device if at all practical or the subject should be excluded.

Primary outcomes:
measure: limb alignment
timeFrame: 48 months
Secondary outcomes:
measure: length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications
timeFrame: 48 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Childrens Hospital
state: Arizona
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children/OH Pediatric Orthopedics Clinic
state: Florida
city: Charlotte
country: United States
facility: Orthopedic Clinical Research
state: North Carolina
Study officials:
affiliation: Zimmer Biomet
name: Russell Schenck, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02733094: Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum
Official title: Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pyoderma Gangrenosum
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2016-04-11
Enrollment: 8
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: The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17 therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration until week 16) for the treatment of pyoderma gangrenosum.


Eligibility criteria: * Key Inclusion Criteria:

  * Confirmed diagnosis of Pyoderma gangrenosum
  * Biopsy-proven, non-healing ulcer with primarily neutrophil infiltration, regardless of size and location
  * Characterization of target lesion (size, PGA, duration)
  * 18-75 years of age
  * Body weight ≥ 40 kg and ≤ 160 kg
  * Signed informed consent
* Key Exclusion Criteria:

  * Permanent severe diseases, especially those affecting the immune system
  * Pregnancy or breast feeding
  * History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
  * Myocardial infarction or cardiac arrhythmia which requires drug therapy
  * Evidence of severe renal dysfunction or significant hepatic disease
  * History of irritable bowel disease
  * History of lymphoproliferative disorders
  * Evidence for active infection including but not limited to active tuberculosis, HIV or hepatitis B/C that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
  * History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin

Primary outcomes:
measure: Change of the Physician's global assessment
timeFrame: Week 16
Secondary outcomes:
measure: Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²)
timeFrame: Week 2,3,8,16,28,40
measure: Assessment of patient's quality of life
timeFrame: Week 2, 4, 8, 16, 28, 40
measure: Measurement of serum C reactive protein (mg/dl)
timeFrame: Week 2, 4, 8, 16, 28, 40
measure: Measurement of leukocyte counts (x10.e3/µl)
timeFrame: Week 2, 4, 8, 16, 28, 40
measure: Measurement of blood sedimentation rate (mm/h)
timeFrame: Week 2, 4, 8, 16, 28, 40
measure: Immunohistochemical analysis of IL-17+ immune cells
timeFrame: Week 16
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technical University of Munich
Study officials:
affiliation: Technical University of Munich
name: Kilian Eyerich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: