cyrilzakka/clinical-trials huggingface dataset:
18FDG- PET/CT Contribution to the Assessment of Lesion Severity in Cystic Fibrosis (CF)

Cystic fibrosis (CF) is an autosomal recessive disorder caused by mutations in the CF trans-membrane conductance regulator (CFTR) protein. CF is the most common inherited disease of Caucasians, with a carrier frequency of 1 in 25-30 individuals. Even with the impressive advances achieved in the understanding of the molecular basis and physiopathology of CF, it remains a life-threatening disorder that causes severe lung damage and nutritional deficiencies. It is generally accepted that early therapy could delay the progression of lung disease. A number of non-invasive methods are available to monitor disease activity in CF patients; however none of the currently used tools are able to monitor real-time events. Recently high resolution computed tomography (HRCT) has been used to monitor changes in lung structure. However, HRCT does not allow differentiating between acute and chronic lesions. Positron emission tomography (PET) with 18fluoro-deoxy-glucose (FDG) has already been used in a variety of settings to visualize inflammation or infection. FDG-PET imaging appears to be a promising new tool to quantify inflammation as it can detect clinically relevant changes even when no changes or minimal ones are detected by morphologic imaging. PET/CT may consequently be used to evaluate the severity of lung inflammation/infection in CF patients, and therefore the aim of this study is to evaluate the use of PET/CT for the assessment of the severity of lung inflammation/ infection in CF patients.

Cystic fibrosis patients with active lung disease will undergo a high resolution PET-CT.PET/CT scans (GE ST Discovery PET/CT scanner) will be performed 60 to 90 minutes after injection of 5 MBq/kg of FDG. PET/CT will be repeated at the end of the treatment and compared with the results of the initial scan. PET and CT will be interpreted by a certified nuclear medicine physician and by a certified radiologist, respectively, blinded to clinical data, using the PET severity score (PSS), based on the number and the intensity of FDG uptake of lung foci. Intensity of uptake will be determined by calculating the mean value for the maximum standardized uptake values (MSUV) of all foci.

(SUV = Activity concentration in ROI (region of interest) divided by injected dose / patient body weight). SUV will be measured in normal lungs to receive the normal baseline control for the calculations. The correlation with clinical data (FEV1% predicted) and sputum bacteriology will then be performed. Inflammation status will also be followed by cytokine analysis.

Eligibility Criteria:
Inclusion Criteria:CF patients with active lesions in their lungs -

Exclusion Criteria:pregnancy,

-
Efficacy of Traditional Persian Medicine Preparation Versus Artificial Saliva for Radiation Induced Xerostomia

Head and neck cancers(HNC) is one of the most common cancers worldwide. Xerostomia is one of the most common side effect of radiation therapy among patients with HNC. Mouth dryness significantly impairs patients' quality of life (QOL).

HNC.Regarding to traditional use of A. digitata and M. sylvestris in addition to known their beneficial effects in recent studies, we decided to design a randomized, controlled clinical trial to try to evaluate efficacy of the these herbs in QOL of HNC patients with radiation induced xerostomia


Eligibility Criteria:
Inclusion Criteria:

* patients with head and neck cancer who had grade 1 and 2 xerostomia (based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0) and finished radiotherapy at least two months before the study(22).

Exclusion Criteria:

* history of connective tissue disorder (e.g., Sjogren) other medical causes of xerostomia (such as diabetes, bowel and renal diseases), using antidepressants drugs, recurrence of cancer, end stage cancer, pregnancy, lactation history of hypersensitivity or allergy to A. digitata and M. sylvestris
Food and Friends: Healthy Meals Delivered to You

The goal of this clinical trial is to learn if home delivered healthy meals (HDHM) with or without (intervention vs. control) social interaction can impact mental health and food security in adults aged 65 and older who live alone and have trouble accessing food.

The main questions it aims to answer are:

Does HDHM with or without social interaction change the quality of participant food intake? Does HDHM with or without social interaction change the loneliness that participants may experience? Does HDHM with or without social interaction change the depression that participants may experience?

Researchers will compare a group that receives HDHM only to a group that receives HDHM and social interaction to see if there is a difference between the two groups in their experienced loneliness and depression, and the quality of food that they eat.

Participants will receive 12 weeks' worth of HDHM delivered to their home. Half of the participants will receive weekly phone calls from volunteer student "companions) Participants will also be asked to complete questionnaires over the phone at three timepoints (baseline, 6 weeks, and 12 weeks) during the study. Some participants may also be asked to give their opinions on the program via a telephone conversation.

This study is a randomized control trial (RCT) to measure the impact of a combined social interaction and culturally tailored home delivered healthy meals (HDHM) intervention on participants' mental health and food insecurity compared to those in the control group receiving HDHM alone. In addition, the study aims to test the feasibility of including structured, consistent social interactions as part of HDHM.

This study will include a sample size of 60 participants. Participants in the study will be randomized to a HDHM only group (control), or HDHM with social interactions group (intervention). All participants will receive HDHM (a frozen meal product based on the Mediterranean Diet adapted for United States Southeastern taste preferences) for 12 weeks.

The study team will collect data from participants at baseline, 6 weeks, and 12 weeks via a telephone-administered survey.

A subgroup of 10 participants (5 from the intervention, 5 from the control group) will participate in informant interviews to assess feasibility.

Eligibility Criteria:
Inclusion Criteria:

* 65 and older
* Live alone
* Screen positive for food insecurity or have a medical professional concerned about their food security
* Diagnosed with at least 1 diet-related chronic illness
* Be a Medicaid/Medicare dual beneficiary
* Speak English
* Have a microwave

Exclusion Criteria:

* Diagnosis of dementia/Alzheimer's
* Presence of illness or allergies that would preclude consuming HDHM
Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies

For drivers with Parkinson's Disease (PD), autonomous in-vehicle technologies may help mitigate functional deficits, improve driving performance, decrease driving errors and enhance their ability to stay on the road. Using a pretest/posttest design the investigators will quantify the use of In-vehicle Information Systems (IVIS) and Advanced Driver Assistance Systems (ADAS) during driving to illustrate how IVIS and ADAS may affect driving, and provide recommendations to drivers with PD, the clinical community and industry.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects diagnosed by a neurologist/ movement disorder specialist with clinically probable PD by Movement Disorders Society (MDS) criteria 25
2. Has mild or moderate disease severity, based on the MDS-Unified Parkinson's Disease Rating Scale for motor symptoms (hereafter referred to as the UPDRS section 3) in the on state of medications (i.e., one hour of taking PD medications) and the Modified Hoehn and Yahr disease severity scale
3. Is representative of one of two PD groups based on age, i.e., participants with symptom onset between 35-64 years of age (younger onset), or participants with symptom onset between ages 65- 85 years (older onset)
4. Currently driving with a valid license
5. Meets the Florida state requirement for visual acuity of at least 20/50 in one eye, if one eye is blind or 20/200 or worse the other eye must be 20/40 or better (20/40 in at least one eye) and field of vision (130 degrees or more)
6. Lives independently in the community
7. Proficient in reading/speaking English
8. A Montreal Cognitive Assessment (MoCA) score of 20 or higher

Exclusion Criteria:

1. Concurrent neurological conditions (e.g., stroke, seizures; dementia)
2. Severe psychiatric (e.g., psychoses/ significant anxiety) or physical conditions (e.g., missing limbs) precluding full participation
3. Use of psychotropic medications having adverse effect on mental/physical functioning
4. Severe, unpredictable motor fluctuations
5. Severe sleep difficulties.
Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis

This is a single dose, open label study in adult male subjects with cystic fibrosis to investigate the pharmacokinetics, safety and tolerability of GLPG2737.


Eligibility Criteria:
Inclusion Criteria:

* Male subject ≥18 years of age on the day of signing the informed consent form (ICF).
* A confirmed clinical diagnosis of CF.
* Two mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene belonging to class I and/or class II and/or class III (documented in the subject's medical record or CF registry).
* Weight ≥40 kg.
* Exocrine pancreatic insufficiency (documented in the subject's medical record).
* Stable concomitant medication regimen for at least 2 weeks prior to study drug administration.
* Forced expiratory volume in one second (FEV1) ≥40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator).

Exclusion Criteria:

* History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
* Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 2 weeks prior to study drug administration.
* History of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of splenomegaly, esophageal varices).
* Use of CFTR modulator therapy (e.g., lumacaftor or ivacaftor) within 2 weeks prior to study drug administration.
Persistent Post Surgical Pain After Total Knee Arthroplasty

Patients undergone total knee replacement are randomized to receive a "fast track" regional anesthesia protocol or a "traditional" regional anesthesia continuous infusion by both a femoral and sciatic catheter to assess if this latter technique may reduce persistent postoperative pain six months after surgery

Patients undergone to primary total knee replacement with spinal anesthesia are randomized to receive a continuous adductor canal block infusion + an ipack block or a continuous femoral nerve block + a continuous sciatic nerve block just at the end of surgery. Both group will receive a multimodal analgesia with paracetamol, ketorolac, desametasone and morphine as a rescue.

Eligibility Criteria:
Inclusion Criteria:

* primary total knee replacement with a written informed consent

Exclusion Criteria:

* Allergy to local anesthetics or any drugs involve in the study
* Controindication to regional anesthesia
* chronic use of opioids
* BMI \> 35 kg m2
The Effect of Systemic Antibiotics on Post-surgical Complications and Patient-centered Outcomes in Patients Undergoing Implant Surgery With Guided Bone Regeneration and Simultaneous Sinus Floor Elevation

The primary aim of the trial is to evaluate the effect of systemic antibiotic administration compared to placebo in patients undergoing oral implant therapy with simultaneous lateral sinus floor elevation and guided bone regeneration (GBR) in regard to patient-centered outcomes.

The secondary aims of the trial is to evaluate the effect of systemic antibiotic administration on postsurgical complications, in patients undergoing oral implant therapy with simultaneous lateral approach sinus floor elevation and guided bone regeneration (GBR).


Eligibility Criteria:
Inclusion Criteria:

1. Medically healthy adult: ASA (American Society of Anesthesiologists) classification I-II, age ≥ 21 years old
2. Non-smoker, previous smoker (quit ≥ 5 years); light smoker with less than 10 cigarettes/ day
3. Not allergic to Amoxicillin/Penicillin antibiotics, NSAIDS (Nonsteroidal anti-inflammatory drugs) or corn-starch
4. Edentulous spaces in the posterior maxilla in one or 2 posterior quadrants with an alveolar bone defect requiring sinus floor elevation and allowing implant placement of up to 3 dental implants and simultaneous GBR (residual crest height 3-5 mm; per implant site (Felice et al. 2012; Park et al. 2019).
5. Absence of signs of pathology of the sinus membrane and acute sinusitis requiring ongoing management -

Exclusion Criteria:

1. Medically compromised subjects (ASA classification III-V)
2. General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)
3. Those taking Bisphosphonates/anti-angiogenic/RANKL (Receptor activator of nuclear factor kappa-Β Ligand) inhibitor medications or receiving local radio-therapy
4. Heavy smoker or previous heavy smoker (quit \< 5 years; ≥ 10 cigarettes/day)
5. Allergic to Amoxicillin or Penicillin antibiotics, NSAIDS and / or corn starch
6. Use of any form of antibiotics in the last 3 months or subjects requiring regular antibiotic prophylaxis prior to dental treatment
7. Pregnant or breast feeding. Self-declared intend to conceive (A pregnancy test will be performed for all female patients).
8. Need for 2 stage sinus augmentation
9. Acute or unmanaged symptomatic sinusitis
10. Type 1 implant placement (immediate implant placement following extraction)
11. Need for simultaneous soft tissue augmentation
12. Residual bone height of \> 5mm.
13. Subjects aged \< 21 years old
Investigation of the Efficacy of PNF and Schroth Treatment

our study was to compare the advantages of Schroth and PNF methods used in AIS treatment

there are studies showing that Schroth and PNF are effective on AIS seperately. While there are studies showing that Schroth is particularly effective on AIS, the number of studies on PNF is insufficient. However, no evidence was found comparing the efficacy of Schroth and PNF. Therefore, the aim of our study was to compare the advantages of Schroth and PNF methods used in AIS treatment

Eligibility Criteria:
Inclusion Criteria:

* Participants were between ages 10-18
* Volunteered for the study.
* Diagnosed with adolescent idiopathic scoliosis
* Cobb angle between 10-30 degrees
* 0-3 Risser sign
* Lenke curve type 1

Exclusion Criteria:

* non-idiopathic scoliosis
* previous spinal surgery
* who had exercise contraindications who had rheumatological disease who had mental handicap and who another neuromuscular problem
SDOCT-GMPE Software

The investigators prospectively evaluate the new glaucoma premium edition (GMPE) software for spectral domain optical coherence tomography (SDOCT) and if this software is superior to the conventional one that is currently used for SDOCT.

The new GMPE software can now identify the ocular structures without input from the operator thus reducing operator induced errors. It also measures the thickness of the entire optic nerve head so as to allow for another anatomic area of the eye to be measured for assessment of glaucoma. In addition, it permits collection of retinal nerve fiber layer thickness data in three concentric circles instead of just one in order to account for different sizes of optic nerves.

Subjects who are receiving routine SDOCT (CPT 92133) will be recruited from the Duke Eye Center and its associated satellite clinics. Following informed consent, subjects undergo additional imaging using the SDOCT-GMPE software at the Duke Eye Center and its associated satellite clinics. The imaging results may be used in clinical care for the subjects.

Eligibility Criteria:
Inclusion Criteria:

* capable and willing to provide consent
* history of clinically-diagnosed glaucoma
* at least 18 years of age

Exclusion Criteria:

* unable or unwilling to give consent
* under 18 years of age
Boosting Reward-based Attention Through VEstibular STimulation

The exploration of space is more effective when intrinsically rewarding elements are located in the visual scene. Thus, rewards could be exploited as a novel rehabilitation approach to various attentional disorders. The first part of the project aims to characterize these effects at the behavioural level. The interventional part consists then in the administration of Caloric Vestibular Stimulation (CVS), which by means of injection of a small quantity of water in the external ear activates the vestibular organs and subsequently vestibular-related brain areas. Among the observed brain activations, the possibility to reach cingulate areas appears particularly interesting because it foreshadows the possibility to further enhance attentional capture by rewards.

CVS will be delivered to patients with brain lesion of the right hemisphere, engaged in cancellation tasks requiring the processing of targets of different nature (e.g. monetary or neutral). The main prediction is that CVS administration would enhance spatial exploration in terms of center of gravity of the cancellation and improved accuracy as a function of the type of target processed (e.g. its value).


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years of age, less than 85
* right handed
* Benefit of social health security
* Normal or corrected-to-normal vision
* Brain lesion localised in the right hemisphere, confirmed by CT or MRI

Exclusion Criteria:

* Anamnesis of neurological of psychiatric illness
* Pregnancy or breastfeeding
* Administrative measures restricting legal rights
* Recent participation to other brain stimulation studies (\< 1 week)
* Perforation of the tympanic membrane
* Anamnesis of recurrent otitis media
Comparison of the Effectiveness of Two Glucocorticoid Regimens for Treatment of Graves' Orbitopathy

The goal of this interventional study is to compare the effectiveness of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. The main questions it aims to answer are:

1. Are the two glucocorticoid regimens similarly effective?
2. Do the two glucocorticoid regimens have similar safety profile? The patients involved are treated with one of the two glucocorticoid regimens. Their ocular status, therapeutic response and quality of life reassessed during the treatment, at its end, and 3 month later.

Systemic glucocorticoids are the mainstay of treatment for active moderate-to-severe Graves' orbitopathy. However, there are a number of different glucocorticoid regimens with different total dosage, schemes of administration and duration. The goal of this interventional study is to compare the effectiveness of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. The main questions it aims to answer are:

1. Are the two glucocorticoid regimens similarly effective?
2. Do the two glucocorticoid regimens have similar safety profile? The patients involved are treated with one of the two glucocorticoid regimens. The first group is treated with modified monthly regimen, including 3 pulses of 3 infusions of 500 mg methylprednisolone administered in three consecutive months, with application of 125 mg methylprednisolone intramuscularly once per week between the pulses. Total cumulative dose - 5.5. g., duration - 3 months. After completion of the venous infusions, a low dose peroral glucocorticoid therapy is prescribed for the next 3 months. The second group is treated with weekly glucocorticoid regimen: 6 infusions of 500 mg methylprednisolone during the first 6 weeks followed by 6 infusions of 250 mg methylprednisolone during the next 6 weeks. Total cumulative dose - 4.5 g., duration - 3 months. Patients' ocular status and therapeutic response are assessed at 1st, 3rd and 6th months; quality of life - at 3rd and 6th month.

Eligibility Criteria:
Inclusion Criteria:

* Active moderate-to-severe Graves' orbitopathy
* Without previous treatment with glucocorticoids or orbital radiotherapy
* Euthyroid state

Exclusion Criteria:

* Uncontrolled hyper- or hypothyroidism
* Previously treated Graves' orbitopathy
* Mild or sight-threatening form of Graves' orbitopathy
* Inactive moderate-to-severe Graves' orbitopathy
* Contraindications for glucocorticoid treatment
A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine

The purpose of this clinical research study is to assess the safety and effectiveness of switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.


Eligibility Criteria:
* Male and female subjects =/\> 16 years of age (or minimum age required in a given country) with history of HBeAg-positive chronic hepatitis B infection;
* Incomplete response to current lamivudine therapy;
* HBeAg-positive;
* Absence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV);
* Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease.
Effect of TCI188 Probiotic on Oral Health

To assess the efficacy of TCI188 (Pediococcus acidilactici) Probiotic on Oral Health


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years old
* Participants suffer from severe periodontal disease throughout the mouth with symptoms at third and fourth stages, do not have immediate indications for the extraction of multiple teeth or complex denture stimulation, and have not undergone periodontal planing within one year.

Exclusion Criteria:

* Participants have had periodontal or antimicrobial treatment within the past 6 months
* Participants are smokers, pregnant or with systemic diseases
* Participants had probiotic supplements or with history of adverse reactions to lactose or fermented dairy products
Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine

The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.

This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.

In "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" for 8 weeks.

In "Rosuvastatin/Ezetimibe +Telmisartan " treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.

In "Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Telmisartan/Amlodipine" for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

* Patient with known or suspected secondary hypertension
* Other exclusions applied