cyrilzakka/clinical-trials huggingface dataset:
Integrin Alpha-v-Beta and [18F]-R01-MG-F2 PET/CT in Measuring Response in Patients With Pancreatic Cancer and Healthy Volunteers

This pilot clinical trial studies the use of integrin alpha-v-beta \[18F\]-R01-MG-F2 Positron Emission Tomography/Computed Tomography (PET/CT) and Positron Emission Tomography-Magnetic Resonance Imaging in (PET/MRI) in measuring response in patients with pancreatic cancer and healthy volunteers. Integrins, such as integrin alpha-v-beta-6 (avb6), are a family of membrane receptors that are overexpressed on the cell surface of pancreatic cancers. \[18F\]-R01-MG-F2 targets avb6, which may improve early detection of and better stratify treatment options for patients with pancreatic cancer.

PRIMARY OBJECTIVES:

I. Evaluate the biodistribution and safety of \[18F\]FP-R01-MG-F2 in healthy volunteers.

II. Evaluate the feasibility of \[18F\]FP-R01-MG-F2 PET/CT scanning in patients with pancreatic cancer.

OUTLINE:

Patients receive \[18F\]FP-R01-MG-F2 intravenously (IV) and undergo PET/CT or PET/MR scan immediately after and at 60 and 120 minutes. Patients will be followed up at 24-48 hours.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers:

1. Must be 18 years of age or older.
2. Must have no known medical problems and have had a full medical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the nuclear medicine physicians will conduct the medical exam prior to any study procedures.
3. Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.
4. Women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose.

Pancreatic cancer subjects:

1. Participant must be 18 years or older at the time of radiotracer administration
2. Provides written informed consent
3. Suspected or established diagnosis of pancreatic cancer based on any radiographic scan or pathology and who is scheduled for surgery OR Biopsy proven diagnosis of pancreatic cancer who is no longer a surgical candidate

Exclusion Criteria:

Healthy volunteers:

1. Participant is less than 18 year-old
2. Pregnant or breast feeding women.
3. Patients who are not likely to comply with the protocol requirements.

Pancreatic cancer subjects:

1. Participant is pregnant or breast-feeding
2. Participant is not able to comply with the study procedures
3. Participant has serious uncontrolled concurrent medical illness that would limit compliance with study requirements
4. Metallic implants (contraindicated for MRI)
5. History of renal insufficiency (only for MRI contrast administration)
The Impact of Telemedicine on Orthopaedic Trauma Patients With Closed Fractures

The purpose of this study is to determine whether telemedicine video calls for follow-up visits between patients and their orthopaedic trauma surgeons has an impact on patient satisfaction, quality of life, and treatment adherence. This study will also assess the feasibility of telemedicine as a medium for follow-up visits.

Patients who are over the age of 18 years with closed fractures treated at Vanderbilt University Medical Center by the Orthopaedic Trauma Department will be recruited into the study into one of two arms: a telemedicine arm in which the patient will have some of his or her visits conducted through video calls, and a control arm in which all of the visits for the patient will be in-person at the Vanderbilt University Orthopaedic Trauma Clinic. Comparisons between the two groups will be made through surveys administered to the patients half-way through the study and at the conclusion of the study, and comparisons will be made using standard statistical tests. The feasibility of telemedicine as a medium for follow-up visits in lieu of in-person visits will be assessed in this study.

Eligibility Criteria:
Inclusion Criteria:

* adults over 18 years old with closed fracture and having access to telemedicine technology (i.e. high speed Internet) at home

Exclusion Criteria:

* patients as part of vulnerable populations
The Effects of Ambulatory Treatment at the Dead Sea on Osteoarthritis of the Knees

This study will check the efficacy of balneological therapy of bathing in Dead Sea fountain waters over a 6 week period on a twice a week basis (overall 12 treatments) in patients suffering from osteoarthritis of the knees.

Since stay in the Dead Sea for a long period of time is an expensive matter, it is important to determine whether twice a week treatments can be as beneficiary as two straight weeks of treatments as was shown to be effective in previous studies.

Our study will follow the patients for a longer period of time (6 months) than was done in previous studies.

An additional advantage will be separating the therapeutical effect of our specific treatment from the therapeutical effect of being in a comfortable hotel away from the daily nuisances for 2 weeks which by itself has been shown to be pain relieving in patients suffering from rheumatic diseases.

Our study will take 50 patients suffering from Osteoarthritis of the knees and divide them in to 2 equal groups. One group will be treated twice a week with thermo-mineral baths at the temperature of 35-36 degrees Celsius for approximately 20 minutes. The other group will be treated twice a week with hot sweet water tub (without the water jets!) of the same temperature and for the same length of time.

Both groups will change nothing in their current medical treatment.

The patients will be examined at 5 points during this study: a few days before their first treatment, right after their last treatment (after 6 weeks), after one month, after 3 months and after 6 months.

All examination will be performed in the Soroka University Medical Center.

The clinical indexes and questionnaires which would be filled during this trial will be:

1. WOMAC index
2. Lequesne's index
3. Visual analogue scale by the patient
4. Visual analogue scale by the doctor
5. SF 36 and Health assessment questionnaire (HAQ)

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Osteoarthritis of the knees according to the conventional measurements of the American College of Rheumatology and who are treated in the Rheumatological clinics of the Soroka University Medical Center

Exclusion Criteria:

* Patients suffering from any other rheumatological disease other than osteoarthritis
* Patients that were previously treated with hydrotherapy or balneotherapy
* Patients suffering from balance disorders or loss of consciousness disorders such as epilepsy, arrhythmias etc.
Perioperative Aspirin Usage Survey

This is a survey of members of the American College of Surgeons (ACS), to describe and explore current patterns of their decisions about withholding or continuation for patients taking aspirin (ASA) in the perioperative period. Secondarily, the survey will also explore surgeons' knowledge about the risks and benefits attending this decision, and about national organizations' recommendations.

An announcement of the survey and invitation to participate will be posted in the "ACS Surgery News" newsletter published by the American College of Surgeons. Surgeons of all specialties will be invited to participate. No identifiers will be maintained with survey responses. In addition to the substantive questions below, typical demographic data will be obtained including participants' duration of practice, specialty, gender, state, etc.

The survey will include questions intended to characterize current practice surrounding the decision to continue or withhold aspirin in the perioperative period. Other questions will focus on surgeons' knowledge of national medical/surgical organizations that have published guidelines on the perioperative use of aspirin. Finally, other survey questions will characterize surgeons' knowledge of the platelet rebound effect.

Eligibility Criteria:
Inclusion Criteria:

* Members of the American College of Surgeons

Exclusion Criteria:

* None
Phospholipid and Sphingolipid Composition of High-density Lipoproteins (HDL) in Obese Non-diabetic Patients With Metabolic Syndrome

HDL in obese non-diabetic patients show major alterations in their function and thus their cardio-protective effects. These alterations could be explained by the quantitative and qualitative anomalies in the phospholipids and sphingolipids in the HDL. These molecules play a major role in HDL function and probably present early modifications in obesity, even before the onset of glycaemia deregulation.

The aim of this study is to show the presence of qualitative and quantitative modifications of phospholipids and sphingolipids in HDL from obese patients compared with HDL from non-obese controls.


Eligibility Criteria:
Inclusion Criteria:

* aged \> 18 years
* fasting glycaemia \< 1.10 g/l
* waist circumference \> 102 cm for men and 88 cm for women (criteria NCEP/ATP III)
* 2 criteria among the following 3 (NCEP/ATP III criteria for metabolic syndrome):
* triglyceridaemia ≥ 1.50 g/l
* HDL cholesterol \< 0.40 g/l for men and 0.50 g/l for women
* arterial blood pressure ≥ 130/85 mmHg or treatment for arterial hypertension
* patients who have provided written consent INCLUSION CRITERIA FOR HEALTHY SUBJECTS
* age \> 18 years
* fasting glycaemia \< 1.10 g/l
* waist circumference \< 102 cm for men and 88 cm for women
* triglyceridaemia \< 1.50 g/l
* HDL cholesterol ≥ 0.40 g/l for men and 0.50 g/l for women
* Healthy subjects who have provided written consent

Exclusion Criteria:

* Persons without national health insurance cover
* Diabetes
* Diseases that interfere with lipoprotein metabolism (dysthyroidism not controlled with the treatment, kidney or liver disease)
* Treatments that interfere with lipoprotein metabolism (lipid-lowering agents, oestrogens, corticoids, retinoids, antiretroviral agents)
* Pregnancy/breast feeding
Acceptability and Tolerance Study of a Low Calorie Peptide Based Paediatric Tube Feed Formula.

This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of a low calorie paediatric peptide based tube feed formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae;

The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).

Patients well established and stable on a standard or peptide enteral tube feed will be changed to a low calorie paediatric formula for a period of seven days. This group will act as their own controls. Each child will receive for a period of seven days the paediatric formula.

The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube. A baseline questionnaire will be completed by the dietitian to ensure eligibility of study, current stool patterns or symptoms and weight at the start of the study.

The parents will complete a week intake chart to monitor how much feed has been consumed each day and a tolerance diary to review gastrointestinal symptoms at the start and end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Exclusively tube fed
* Paediatrics aged 1 year above who require a low calorie feed
* Children with Neurological impairment (NI) who require long term tube feeding
* Patients established on a standard or peptide Enteral formula (no gastrointestinal intolerances on a current formula)
* Willingly given, written, informed consent from patient or parent/guardian.
* Willingly given, written assent (if appropriate).

Exclusion Criteria:

* Inability to comply with the study protocol, in the opinion of the investigator
* Known food allergies to any ingredients (see ingredients list)
* Patients with significant renal or hepatic impairment
* Participation in another interventional study within 2 weeks of this study.
Index of Microcirculatory Resistance After Immediate Versus Deferred Stenting in Patients With Acute Myocardial Infarction

This study will compare the microcirculatory resistance (IMR) of infarct-related artery (IRA) in patients who underwent immediate versus deferred stenting during percutaneous coronary intervention (PCI) for acute myocardial infarction.

Primary PCI with immediate stenting (IS) is the current standard of reperfusion strategy for STEMI. However, it is thought that IS may cause additional myocardial injury by increasing distal embolization of clot and atheromatous plaque debris. Only about 35% of patients without cardiogenic shock can achieve optimal myocardial tissue perfusion at the microvascular level, even after restoration of epicardial coronary artery patency. IS in highly pro-thrombotic and inflammatory milieu of IRA during primary PCI would increase distal embolization of clot and atheromatous plaque debris, and provoke the inflammation process, so deferred stenting after a cooling down period of IRA for several days, have a potential to mitigate or prevent microvascular obstruction (MVO). Among several methods to evaluate MVO after STEMI, IMR has been well known as an good indicator of MVO and strong predictor for short and long term clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. More than 30 minutes in duration of typical chest pain
2. Thrombolysis In Myocardial Infarction (TIMI) flow 0, 1 or 2 prior to the procedure

Exclusion Criteria:

1. Cardiogenic shock,
2. Previous history of myocardial infarction, or coronary artery bypass surgery
3. Rescue PCI after fibrinolysis
4. Life expectancy of less than 1 year
5. Acute occlusion of left main coronary artery
6. STEMI due to stent thrombosis
7. Major coronary dissection (type D\~F) following procedures achieving TIMI 3 flow
Internet-based Treatment for Insomnia

The study will test an internet-based treatment for insomnia.

This study will develop and evaluate the feasibility of a cost-effective, more accessible alternative treatment approach for insomnia. Traditional CBT, including the behavioral, cognitive, and educational aspects, will be operationalized and transformed for an Internet intervention system, so individuals can access a personalized treatment any time, at their own convenience. Phase 1 of this study will involve developing the web program. The investigators research team and collaborators has extensive experience developing such web interventions, as well as considerable experience with insomnia. Phase 2 will be a large randomized controlled trial testing the Internet intervention compared to passive patient education/sleep hygiene. Two hundred individuals with insomnia will be assessed pre and post the six week treatment program. It is hypothesized that the Internet intervention will promote improvements in sleep, mood, and cognitive functioning. If successful, the current project may result in improved implementation of a low-threshold treatment for a common disorder with devastating impact on both individual and socioeconomic outcomes

Eligibility Criteria:
Inclusion Criteria:

1. age 18 years or older
2. fulfillment of the DMS-IV criteria for insomnia
3. duration of at least 3 months
4. complaints of impaired daytime functioning

Exclusion Criteria:

1. presence of a major depressive disorder or other severe mental disorder as identified by in the telephone interview
2. working night shifts and unable to discontinue this work pattern
3. having a serious somatic condition preventing further participation.
Evaluate the Safety of Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Healthy Females

This study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years of age at enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female between, and including, 9 and 45 years of age at the time of the first vaccination
* Provide legal identification for for the sake of recruitment.
* Be able to understand and sign informed consent prior to enrollment (For subjects below the legal age of consent, informed consent must be signed by parent(s)/legal guardian(s) in addition).
* Subject must be not pregnant at the enrollment and agree to using adequate contraceptive precautions within 7 months.

Exclusion Criteria:

* History of cervical cancer
* History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
* History of allergic to vaccine, or to any ingredient of vaccine.
* History of epilepsy, seizures or convulsions, or family history of mental illness
* Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose.
* History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant
* Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
* Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
* Acute disease or chronic disease acute exacerbation 7 days prior to vaccination
* Administration of immunoglobulins and/or any blood products within 3 months, or administration of any live attenuated vaccine within 28 days, or administration of any subunit or inactivated vaccines within 14 days.
* Fever or axillary temperature\> 37.0 °C before vaccination
* During menstrual period, breastfeeding, pregnancy(pregnancy test positive), or planned pregnant within 7 month
* History of hypertension, physical examination systolic blood pressure\> 150mmHg and/or diastolic blood pressure\> 100mmHg
* Abnormal laboratory tests parameters
* Any clinical significant disease or findings during study screening that, in the opinion of the Investigator may interfere with the study
Evaluation of Bone Metabolism Biomarkers in Periodontal Diseases

This study evaluates the levels of biomarkers associated with bone metabolism in patients with different periodontal conditions.

Background: In this study, the levels of bone metabolism markers found in the saliva of individuals with different periodontal conditions were compared and the relationship of these markers with periodontal status was examined.

Method: A total of 60 individuals, 20 with periodontitis (P), 20 with gingivitis (G), and 20 with periodontal healthy (S), were included in the study. Periodontal clinical parameters (plaque index, gingival index, bleeding on probing, clinical attachment level and probing pocket depth) and saliva samples were obtained from the individuals. Bone metabolism biomarker (necrotizing factor (TNF)-α, osteoprotegerin (OPG), nuclear factor kappa-β receptor activator ligand (RANKL) and sclerostin) levels in saliva samples were evaluated by enzyme-linked immunosorbent assay (ELISA).

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old.
* not having any systemic disease that may affect periodontal status
* not smoking and alcohol use
* volunteer to participate in the study

Exclusion Criteria:

* periapical pathologies;
* resulting from orthodontics and occlusion extreme forces, including mechanical forces;
* chronic high-dose steroid therapy;
* radiation or immunosuppressive therapy;
* pregnancy;
* breastfeeding;
* allergy or sensitivity to any medication.
* Periodontal therapy or drug therapy for at least 6 months of study participants
Aerobic Capacity Muscle Strength and Health Related Quality of Life in Children With Chronic Liver Disease

Physical therapy program for children with chronic liver disease consist of gait training, strengthening ex for UL\&ll, stretching exercise to improve physical fitness and quality of life

Intervention study for one group of children diagnosed with chronic liver disease ages more than 6ys, study include assessment and intervention, assessment of 6MWt, grip strength by hand held dynamometer, quadriceps strength by Lafayette, al children subjected to laboratory investigation pre and post of study completion, anthropometric measure, quality of life and fatigue assessment then all children will perform physical therapy program of gait training muscle strengthening for 8 week

Eligibility Criteria:
Inclusion Criteria:

* Their age ranged from7 to14 years old.
* Residence in Cairo to be able to attend the rehabilitation program.
* Diagnosis of CLD as (Wilson disease, autoimmune hepatitis, chronic cholestasis , ....etc).
* All children were medically stabled
* All children had the same socioeconomic status

Exclusion Criteria:

* Complication that prevent children from performing maximal exercise test as fracture of both upper and lower limbs, cardiovascular instability and muscle disease in patient with glycogen storage disease(GSD) or abnormal creatine phosphokinase(CPK).
* Patients with cognitive and motor disorders as in case of hepatic encephalopathy and or ascites.
* Patients who underwent liver transplantation.
* Patient with end stage liver disease.
* History of variceal bleeding from one month ago or less.
* No other system disease (chest, cardiac and nervous system).
* Medical examination no hernia.
RADIOFREQUENCY TREATMENT OF CHRONIC PELVIC PAIN MANAGEMENT IN INTERSTITIAL CYSTITIS

Interstitial cystitis/painful bladder syndrome is a collection of symptoms that includes urinary urgency, urge incontinence, nocturia, and painful urination. Various treatment modalities are utilized in the management of the disease. Superior hypogastric plexus block, which is used in the treatment of chronic pelvic pain, is one of these treatment methods. Additionally, tibial nerve stimulation is used in the treatment of urinary symptoms. This study aims to compare the effectiveness of superior hypogastric plexus pulsed radiofrequency and adjunctive transcutaneous tibial nerve stimulation in the treatment of patients with interstitial cystitis


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years
* Diagnosed with interstitial cystitis and experiencing symptoms for at least 3 months

Exclusion Criteria:

* Pregnancy or breastfeeding
* Patients with renal, hepatic, cardiovascular, or psychiatric diseases
* Additional interventional treatments within the first 3 months after the procedure
* A history of previous surgery or trauma