cyrilzakka/clinical-trials huggingface dataset:
An Imaging Agent (Fluorodopa F 18) With Positron Emission Tomography/Magnetic Resonance Imaging for Assessing Treatment Response in Patients With High-Grade Soft Tissue Sarcomas

This study evaluates the use of a new imaging agent called fluorodopa F 18 (18F-DOPA) with positron emission tomography/magnetic resonance imaging (PET/MRI) for assessing treatment response in patients undergoing standard of care radiation therapy and/or surgery for high-grade soft tissue sarcomas that are new or that have come back (recurrent). Though there have been improvements in treatment options for soft tissue sarcomas, there is currently a need for a non-invasive way to determine a patient's potential benefit from receiving one of these treatments. 18F-DOPA with PET/MRI allows a patient's tumor to be visualized and their response to a given treatment assessed.

PRIMARY OBJECTIVE:

I. Determine the correlation between 18F-DOPA PET/MRI quantitative metrics after neoadjuvant treatment (pre-surgery) with percent tumor necrosis.

SECONDARY OBJECTIVE:

I. Compare the changes in 18F-DOPA PET/MRI quantitative metrics between baseline (before radiotherapy \[RT\]) and after RT, but before surgery with percent tumor necrosis.

OUTLINE:

Patients receive 18F-DOPA intravenously (IV) and undergo PET/MRI over 60 minutes before standard of care radiotherapy and/or before standard of care surgery.

Eligibility Criteria:
Inclusion Criteria:

* PRE-ELIGIBILITY - INCLUSION CRITERIA:
* Age \>= 18 years
* Histological confirmation of newly diagnosed soft tissue sarcoma or recurrent soft tissue sarcoma \>= 1-year post-treatment
* Tumors \> 1 cm in diameter in largest dimension located midline within the torso or neck, retroperitoneal, or lower extremities
* Operable sarcoma, planning to receive surgery with or without neoadjuvant RT/chemotherapy at Mayo Clinic Florida. Systemic therapy is allowed during radiotherapy
* Provide informed written consent
* Willingness to participate in mandatory imaging studies at Mayo Clinic Florida

Exclusion Criteria:

* POST-ELIGIBILITY - EXCLUSION CRITERIA:
* 18F-DOPA PET uptake deemed as unacceptable for quantitative assessment
* Unable to undergo an 18F-DOPA PET/MRI scan due to standard MRI restrictions, such as for those with certain implanted devices, those who cannot fit inside the bore, or those with severe claustrophobia
* Any of the following:

  * Pregnant women
  * Nursing women
  * Men or women of childbearing potential who are unwilling to employ adequate contraception
Teenagers: Impact of Eccentric eXercise Training on Overweight and Obesity

Nowadays, eccentric exercise can be realized in a dynamic way with an ergocycle which permits eccentric (ECC) lower limbs contractions at a defined power output. With this type of ergometer, O2 consumption (VO2) in ECC is three fold lower than in concentric (CON) for the same power output. Consequently, ECC program could be used in chronic disorders with limited capacities, such as obesity.

The investigators hypothesis that an eccentric training program, as it will induce higher mechanical constraints, would improve body composition, especially by reducing fat mass. This effect could be explained by an increased rest energy expenditure and a better improvement in biological parameters (particularly lipid profile and insulin-resistance) after ECC training (versus CON training).

This study aims to compare the modification of fat mass after an ECC program versus a CON program at the same VO2.. The secondary goal is to assess the physiological mechanisms involved in the modification of body composition.

40 obese adolescents will be randomized into 2 groups: CON or EXC. The patients of ECC group will follow habituation sessions (2 weeks) to avoid the secondary muscular effects of high intensity eccentric exercise. The training program will last 12 weeks for the two groups. Before and after, each subjects will participate to the following measurements: total and segmental body composition (DXA), aerobic capacities (maximal incremental exercise test, VO2max), muscular lower limbs strength (isometric and isokinetic dynamometer), rest energy expenditure (indirect calorimetry), biological parameters (lipid profile, insulin-resistance), physical activity (actimetry), food intakes and quality of life (questionnaires).

Eligibility Criteria:
Inclusion Criteria:

* Adolescent (12 to 17 years old)
* BMI\>90th percentile
* Post puberty (Tanner 3 to 5)
* Inactive (\<10 METS/h/week)
* No other chronic disease (cardio pulmonary, osteo articulary or muscular diseases), no surgery during the last 3 months, no genetic obesity and no contraindication to physical activity

Exclusion Criteria:

-
Comparing Platelet-Rich Plasma (PRP) Centrifugation Methods on Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia

This research is a preliminary, randomized, double blind clinical trial, which will examine the differences in PRP preparation methods, a single-spin centrifugation of 3000 rpm in 15 minutes compared to a double-spin centrifugation of 1500 rpm in 6 minutes followed by 2500 rpm in 15 minutes, on the results of Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia.

Several examinations will be performed in every visit, including history taking, physical examination, trichoscopy and trichoscan. Laboratory evaluations (complete blood count) for the measurement of the thrombocyte for baseline and PRP will be performed for all assented subjects on the first visit. Each subject will be instructed to apply 5% topical minoxidil twice a day everyday as primary therapy during the study

Eligibility Criteria:
Inclusion Criteria:

* Met the criteria of androgenic alopecia (Hamilton Norwood grade III-IV)
* Men between ages 25-59 years old
* Have stopped taking topical anti-androgen or minoxidil for at least one month, or oral anti-androgen or minoxidil for at least three months

Exclusion Criteria:

* alopecia of any other type
* subject with a history of keloid or blood coagulation disorders underwent anticoagulant therapy
* subjects on Non-Steroidal Anti-Inflammatory Drugs (NSAID) medications in seven days prior to the study
* subjects who had hair treatment using growth factors, including PRP and microneedling within at least six months prior to the study.
Gliflozins on HF in Regurgitant Rheumatic Heart

The objective of this trial is to detect impact of Gliflozin on patients with heart failure due to reurgitant rheumatic valve disease

* Rheumatic heart disease is a chronic sequel of acute rheumatic fever caused by group A β hemolytic Streptococcal pharyngitis and possibly pyoderma, which mimics molecular heart structures so the immune response leads to carditis and valvular heart damage. Damage to valves cause mitral and/or aortic regurgitation, or in long-standing stenosis. Complications of rheumatic heart disease include heart failure, embolic stroke, endocarditis and atrial fibrillation .
* Heart failure (HF) is a progressive syndrome characterised by the inability of the heart to provide adequate blood supply to meet the metabolic demand of different tissues .
* The recent ESC/AHA/ACC guidelines of HF set medications as class 1 for the HF therapy as ACE-I/ ARNI/beta-blocker/MRA/ SGLT2 I as they reduced the risk of cardiovascular death and worsening HF in patients with HFrEF , Unless contraindicated or not tolerated.
* Empagliflozin is an orally available inhibitor sodium glucose co-transporter 2 receptor (SGLT-2), empagliflozin exerts its effect by preventing sodium and glucose reabsorption from proximal convoluted tubules. This leads to increased urinary sodium and glucose excretion, This is associated with a modest osmotic diuresis, blood pressure lowering effect, improvement in arterial stiffness , and decrease in heart rate.
* DAPA-HF trial shows: The primary outcome of cardiovascular death, HF hospitalization, for dapagliflozin vs. placebo, was 16.3% vs 21.2% (p \< 0.001).
* EMPA-REG OUTCOME trial shows: The primary outcome, cardiovascular death or HF hospitalization, for empagliflozin vs. placebo, was 19.4% vs. 24.7% ( p \< 0.001).

Eligibility Criteria:
Inclusion Criteria:

* All male or female patients having rheumatic heart disease with either mitral, aortic, tricuspid regurge as a single or combined valvular lesion
* Patients aged 18 years or older at time of inclusion in the study
* Patients with HF currently in NYHA class II-IV, or asymptomatic patients with proved mitral regurgitant lesion.
* Body Mass Index (BMI) \< 45 kg/m2

Exclusion Criteria:

* Advanced stage liver and kidney failure (glomerular filtration rate \< 20 mL/min/1.73 m2).
* Patient with implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac re-synchronization therapy (CRT) or implanted left ventricular assist device (LVAD)
* Diagnosis of cardiomyopathy induced by other etiologies rather than rheumatic heart disease eg, ischemia , dilated cardiomyopathy,.....etc within the 12 months prior to Visit 1
* Known allergy or hypersensitivity to SGLT-2 inhibitors
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* ongoing hematological diseases and malignancies
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (\>3 months and ≤12 months), or chronic (\>12 months) ITP

This study is designed to elucidate the effects of PF-06835375 on platelet counts in participants with moderate to severe primary ITP. Based on the experience with other B-cells depleting agents, it is expected that the platelet counts will increase following a standard treatment. Each participant in cohort 1 will receive 1 subcutaneous injection of dose 1 every month for 3 months during the 12-week treatment period. And each participant in cohorts 2 and 3 will receive 1 subcutaneous injection of dose 2 or 3 every month for 4 months during the 16-week treatment period. This should provide sufficient levels of exposure and depletion of CXCR5 positive cells to sustain the effects of PF-06835375 during the treatment period. Additional depletion of Tfh cells may provide sustained increase in platelet count following the last treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Primary ITP. Ongoing ITP (platelet counts \<50 x 109/L) \[No severe bleeding within 1 month or during screening\] AND Persistent ITP (3 to 12 months) or Chronic ITP \>12 months

Exclusion Criteria:

* Bleeding event according to the WHO grading scale ≥2 occurring ≤4 weeks prior to screen OR a current bleeding event that, in the opinion of the investigator, requires treatment with standard of care therapy OR require blood or blood products during screening
* Splenectomy within 3 months of randomization or planned during the study duration.
Comparisons of Urodynamic, Bladder Diary, Quality of Life Parameters Between OAB-wet and OAB-dry Female Patients

A small bladder capacity and more frequent urgency episodes were predictors of OAB-wet, and the above findings might indicate that OAB-wet and OAB-dry are a continuum of OAB. Older age, high maximum flow rate, high detrusor pressure at maximum flow rate and the presence of urodynamic stress incontinence were also independent predictors for OAB-wet, and the above might indicate that OAB-wet and OAB-dry have at least partly different underlying pathophysiologies.

Aims: To identify factors predicting the presence of OAB-wet and to further derive the underlying pathophysiology in OAB-wet vs. OAB-dry.

Methods: Between September 2007 and September 2013, the medical records of women with OAB who completed a 3-day bladder diary and underwent urodynamic studies in a tertiary referral center will be reviewed. OAB-wet will be diagnosed in patients who complained of at least one episode of urgency incontinence in the previous month; otherwise, OAB-dry is diagnosed. Multivariate logistic regression analysis will be used to predict the presence of OAB-wet.

Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of overactive bladder disease
2. Female patient of more than 20 year-old

Exclusion Criteria:

1. Dominant symptoms with stress urinary incontinence (SUI)
2. Regular urethral catheterization or intermittent self-catheterization
3. Urinary tract infection or chronic inflammation in the previous 2 weeks
4. Bladder calculus
5. A history of pelvic radiotherapy
6. A preexisting malignant pelvic tumor.
Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers

Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo laryngeal demolition surgery, total laryngectomy, who agree to phonatory prosthesis placement
* Patients who have undergone previous total laryngectomy surgery and intend to undergo placement of phonatory prosthesis.
* Age \> 18 years
* Written informed consent

Exclusion Criteria:

* Patients who have not undergone demolitive surgical treatment by total laryngectomy or who do not accept the placement of phonatory prosthesis.
* Patients who are unable to complete questionnaires/follow the rehabilitation pathway
Evaluation Of the BEAUTIBOND XTREME Adhesive in Class I and II Restorations: One-Year Results.

This randomized clinical trial aimed to evaluate the performance of the Beautibond Xtreme adhesive system under different bonding techniques. Patients over 18 years old with restorative needs were selected, and 152 teeth were randomized using the "Research Randomizer Program" for allocation into control groups (CI - Class I restoration with total-etch conditioning; CII - Class II restoration with total-etch conditioning) and test groups (TI - Class I restoration in self-etch mode; TII - Class II restoration in self-etch mode; TIII - Class I restoration with selective enamel etching; TIV - Class II restoration with selective enamel etching). The restorations were evaluated (USPHS criteria) regarding anatomy, integrity, marginal staining, color, roughness, secondary caries lesions, postoperative sensitivity, and retention. Two calibrated examiners (Kappa test 0.84), blinded to the treatments, conducted evaluations for up to one year.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older
* Occlusal stability supported by molars, Presence of at least one premolar or one molar with Class I/II cavities suitable for direct restoration or restoration replacement
* Ability to attend evaluation and regular maintenance appointments
* No clinical symptoms or radiographic signs suggesting pulp involvement
* No periodontal pockets or compromised biological space invasion
* Ability to perform absolute isolation of the operative field and subsequent restoration of the cavity with composite resin
* Active carious lesion
* Occlusal/occlusoproximal surface of molars and premolars, with a radiographic image showing shallow, medium, or deep dentin involvement, which is preventing the patient from effectively controlling bacterial biofilm, or showing some type of sensitivity
* Cavity preparation margins (cavosurface) in enamel or dentin.

Exclusion Criteria:

* Poor oral hygiene control
* Patients undergoing orthodontic treatment
* Pregnant or lactating women
* Oral complications such as: bruxism, other parafunctional habits reinforcing the diagnosis of TMD (temporomandibular disorders), periodontal problems
* Pregnant or breastfeeding women
* Presence of uncontrolled systemic diseases
* Patients at high risk for caries.
Clinical and MRI Finding of The Temporomandibular Joint Posterior Disk Displacement

the study aimed to evaluate the clinical and MRI finding of TMJ with posterior disk displacement with predication of the risk factors

: the study aimed to evaluate the clinical and MRI finding of TMJ with posterior disk displacement with predication of the risk factors. Study design: this retrospective study included patients diagnosed as TMJ internal derangement and all the patients examined by MRI from 2008 to 2019. Cases with loss of continuity of articular disk or the posterior attachment of the disk were considered as positive cases.

Eligibility Criteria:
Inclusion Criteria:

- patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University

Exclusion Criteria:

* Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous ﬁbrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.
Reusing Needles for Subcutaneous Insulin Injection in Patients With Type 2 Diabetes

A randomized clinical trial (RCT) will be carried out to compare the reuse or not of needles in patients with type 2 diabetes (T2DM) that use insulin. Two groups will be studied: a group that will not reuse the needles and a group that will reuse the needles five times. The aim of this study is to evaluate related outcomes such as bruises, infection, lipodystrophy, pain and glycemic control, whether or not to reuse insulin delivery needles in patients with T2DM who use insulin.

Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic disease with increasing incidence worldwide. It is well demonstrated in the literature that adequate glycemic control can reduce the incidence of chronic complications. The Brazilian Ministry of Health must provide patients with diabetes with the necessary resources for optimal glycemic control. However, this supply is often not enough and the population ends up reusing needles and lancets. According to the Brazilian National Health Surveillance Agency (ANVISA) and the manufacturers, it is recommended to use the needle for insulin application only once, but a report from the Brazilian Society of Diabetes shows that half of the patients disregard this rule - some reuse each needle up to five times. Studies show that patients do not like carrying extra needles when they are away from home, are reluctant to carry containers to dispose used needles, and decide that it is not worthwhile worth buying a new needle for each injection. Others describe that injections from reused needles are not noticeably more painful as long as they do not reuse them excessively. Finally, some patients believe that disposing of a needle after use is ecologically wasteful because metal and plastic must be incinerated. A randomized clinical trial will be carried out to compare the reuse or not of needles in patients with diabetes who use insulin. Primary outcomes as skin complications, local pain, glycemic control will be evaluated at baseline and after 4, 8 and 12 weeks and secondary outcomes will also be evaluated as quality of life, insulin application technique, frequency of capillary blood glucose tests, adherence to treatment, quality of needles, microbiological contamination and cost-utility analysis of after needle reuse.

Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM
* Over 18 years of age
* Reuses each syringe at least three times for insulin application.

Exclusion Criteria:

* Use of insulin pens
* Pregnant women
* Patients undergoing chemotherapy
* Use of anticoagulants
* Clotting disorders, lesions or skin changes
Online Psychoeducation for Intolerance of Uncertainty

Randomized control trial examining the efficacy of an online intolerance of uncertainty focused psychoeducation intervention.

Randomized control trial examining the efficacy of an online intolerance of uncertainty (IU) focused psychoeducation intervention among females elevated in IU.

Eligibility Criteria:
Inclusion Criteria:

* Elevated intolerance of uncertainty at baseline

Exclusion Criteria:

* Patients would be excluded if they endorsed suicidal ideation/intent that required hospitalization.
Fluid Intake in Kidney Failure

Patients with renal impairment are usually advised to increase their fluid intake. There is currently, however, no evidence supporting this recommendation. In contrast,high fluid intake could be dangerous if urine excretion is reduced. In this study the researchers investigate whether increasing fluid intake from 2 to 4 litres per day has any influence on long-term renal outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with native kidney disease or chronic kidney transplant failure
* An effective glomerular filtration rate (eGFR) according the MDRD formula between 20 and 75ml/min/1.73m2
* Ejection fraction \>20%
* Absence of liver cirrhosis or ascites
* No evidence of active glomerulonephritis or immunosuppressive therapy if native kidney disease
* Acute transplant rejection
* Urinary protein excretion below 3g/d
* Age between 18 and 70 years.

Exclusion Criteria:

* Therapy resistant edema
* Severe pulmonary disease
* Mean arterial pressure (MAP) \> 120 mm Hg
* Pregnancy
* Kidney transplantation within three months prior to randomization
DC-CIK Combined With TACE in the Treatment of Hepatocellular Carcinoma

Evaluation of DC-CIK cells combined TACE treatment for HCC

60 patients with Hepatocellular Carcinoma, who had received Transcatheter Arterial Chemoembolization (TACE) , will be randomly divided into group A (receive DC-CIK+ TACE treatment) or group B (just receive TACE), and the randomize ratio will be 1:1.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old;
* Histologically confirmed with Hepatocellular Carcinoma at stage I-II;
* Patients who can accept Transcatheter Arterial Chemoembolization ;
* Patients who have a life expectancy of at least 3 months;
* Patients who have a Child-Pugh:A/B; .Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.

Exclusion Criteria:

* White blood cell \<3 x 10\^9/L,Platelet count \<75 x 10\^9/L;BUN and Cr more than normal limits on 3.0 times ;
* Known or suspected allergy to the investigational agent or any agent given in association with this trial;
* Pregnant or lactating patients;
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
* Patients who are suffering from serious autoimmune disease;
* Patients who had used long time or are using immunosuppressant;
* Patients who had active infection;
* Prior use of any anti-cancer treatment in 30 days;
* Now or recently will join another experimental clinical study ;
* History of organ allograft;
* Other situations that the researchers considered unsuitable for this study