cyrilzakka/clinical-trials huggingface dataset:
Perflutren Protein-Type a Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients with Liver Cancer

This phase II trial studies how well perflutren protein-type A microspheres and contrast-enhanced ultrasound work in improving response to radioembolization therapy in patients with liver cancer. Ultrasound contrast agents, such as perflutren protein-type A microspheres, use gas microbubbles to improve image quality. Using contrast-enhanced ultrasound imaging will "pop" these microbubbles and cause tumors to become more sensitive to radiation therapies.

PRIMARY OBJECTIVE:

I. Characterize the ability of localized ultrasound contrast agent destruction to improve hepatocellular carcinoma (HCC) response to yttrium Y-90 (Y90) radioembolization.

SECONDARY OBJECTIVE:

I. Determine if contrast-enhanced ultrasound estimated tumor perfusion can reliably predict HCC response to radioembolization 1-14 days post treatment.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive perflutren protein-type A microspheres intravenously (IV) over 10 minutes and undergo contrast-enhanced ultrasound (CEUS) over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.

GROUP II: Patients undergo standard of care yttrium Y-90 radioembolization.

After completion of study treatment, patients are followed up at 1 month and at 3-4 months.

Eligibility Criteria:
Inclusion Criteria:

* Be scheduled for sub-lobar radioembolization therapy of a previously untreated HCC mass \< 6 cm visible on grayscale ultrasound
* Be medically stable
* If a female of child-bearing age, have a negative pregnancy test prior to each ultrasound exam
* Have signed informed consent to participate in the study

Exclusion Criteria:

* Females who are pregnant or nursing
* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:

  * Patients on life support or in a critical care unit
  * Patients with unstable occlusive disease (e.g., crescendo angina)
  * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
  * Patients with uncontrolled congestive heart failure (New York heart Association \[NYHA\] class IV)
* Patients with recent cerebral hemorrhage
* Patients with known sensitivities to albumin, blood, or blood products
* Patients with known hypersensitivity to perflutren
* Patients with known cardiac shunts
* Patients with known congenital heart defects
* Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary embolism
* Patients with respiratory distress syndrome
* Patients with a history of bleeding disorders
* Patients with bilirubin levels \> 2 mg/dL
Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years

This study focusing on sound therapy in patients with fibromyalgia is a single-centre, prospective, randomized study which evaluates the improvement or not of painful symptoms following relaxation sessions with sound therapy.

Sound therapy consists in sound use as therapy and appears to mitigate or even relieve some symptoms.

The SonoMyal study intends to compare the effects of relaxation sessions with sound therapy delivered by tuning forks to a control group who will benefit from relaxation sessions without tuning fork activation, in a population of women with fibromyalgia.

The treatment consists in one session per week during 3 weeks, for a total of 3 sessions. Questionnaires to assess pain, anxiety and the ability to let go will be completed by patients before the beginning of the first session and at the end of the last session.

The main objective of the study is to assess with a Visual Analogue Scale of pain if 3 relaxation sessions with sound therapy delivered by tuning forks can improve pain perception in patients with fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 30 and 60
* Fibromyalgia diagnosed according to the criteria of the combined Widespread Pain Index (WPI) and the Symptom Severity Scale (SSS) of the American College of Rheumatology ; and this whatever the previous analgesic medication and whatever the symptomatology
* Able to express her consent prior to participation in the study
* Affiliated to or beneficiary of a social security regimen

Exclusion Criteria:

* Total deafness in one or both ears (patients with age-related presbycusis can be included)
* Pregnant women
* Patient under judicial protection (guardianship, curatorship...) or safeguard of justice
Evaluation of Nutritional Scores as Predictive Factors of Postoperative Outcome After Pancreatic Surgery

Patients scheduled for major pancreatic surgery will be screened for malnutrition by five screening scores chosen depending on their clinical applicability. After surgery, it will be evaluated which score predicts the best complications.

Patients scheduled for major pancreatic surgery (pancreaticoduodenectomy, distal resection, total resection) will be screened for malnutrition by the following screening scores: Nutritional Risk Screening Score 2002; Subjective Global Assessment; Malnutrition Universal Screening Tool; Mini Nutritional Assessment and Short Nutritional Assessment Questionnaire.

The postoperative outcome will be recorded, and the predictive value of each score will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 90 years undergoing major pancreatic resections (pancreaticoduodenectomy, distal pancreatic resection, total pancreatic resection) are eligible for inclusion. All patients are informed orally about all aspects of the trial. All conditions leading to primary pancreatic resection are eligible.

Exclusion Criteria:

* patients undergoing minor pancreatic resections.
Study of Probiotic Potential of Lactobacillus Strains in the Upper Respiratory Tract After Nasal Spray Application

Probiotics are defined as "live micro-organisms that, when administered in adequate amounts, confer a health benefit to the host" (Hill et al, 2014). These microbes are generally applied in the gastrointestinal tract via fermented food products or capsules. In previous research, the investigators isolated bacterial strains with potential probiotic properties for the upper respiratory tract based on in vitro laboratory tests, in vivo mice experiments and genome sequencing.

In this study, the investigators want to deliver the Proof-of-Concept that the most promising isolated strain, Lactobacillus casei AMBR2 (LAMBR2) and the well-documented probiotic strain Lactobacillus rhamnosus GG (LGG) also have interesting properties in humans, i.e. that these strains are able to -temporarily- persist in the upper respiratory tract of healthy volunteers and CRS patients after daily nasal application via a nasal spray for 2 weeks. In addition, the investigators aim to explore whether the application of these strains has an impact on the nasopharyngeal microbiome via 16S rRNA amplicon sequencing and dedicated qPCR analysis.

Therefore, bacterial DNA from nasal swabs will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Furthermore, the concentration of the Lactobacillus and specific pathogens will be monitored via qPCR.


Eligibility Criteria:
Inclusion Criteria:

* CRS patient group: CRS diagnosed

Exclusion Criteria:

* no patients with trisomy 21
* no pregnant women
* no breastfeeding women
* no acute or chronic airway infections (except for CRS patients in CRS patient group)
* no cancer
* no autoimmune diseases
Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders

The primary aim of the study is to investigate whether a novel mobile App-based behavioral intervention in pregnant women can: (1) prevent and/or decrease the incidence of perinatal mood disorders (2) decrease the severity and/or duration of perinatal mood disorders in affected participants (3) increase access of pregnant women to behavioral intervention and support tools (4) increase the satisfaction of pregnant women with their prenatal care.

Perinatal depression is an episode of major or minor depression that occurs during pregnancy or in the 12 months after birth; it affects about 10% of new mothers. Postpartum depression accounts for 12.5% of psychologically related hospitalizations among women.

In 2019, the United States Preventive Services Task Force (USPSTF) recommended screening pregnant women to identify those at risk for perinatal depression and refer them for counseling. The USPSTF recommendation is based on growing literature indicating that counseling women at risk for perinatal depression reduce the risk of having an episode of major depression by 40%.

Supporting that, multiple studies have shown that cognitive-behavioral intervention and mental health care adjuvant therapy can effectively improve the condition of patients with postpartum depression. Finally, access to care has also been shown to be an important factor in determining the success of any intervention. Women across high and low-risk groups often have barriers to treatment due to stigma, shame, and fear to disclose symptoms to health providers

In this research, the investigators aim to investigate whether a novel mobile App-based behavioral intervention can meaningfully increase access and demonstrate a beneficial effect in preventing anxiety and depression in the postpartum period. Furthermore and adding to the existing literature in post-partum depression, this study aims to investigate the role of "positive intelligence", an integrative positive cognitive behavioral therapy, as a tool in the prevention and treatment of perinatal mood disorders.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and speak English
* Have a low-risk singleton pregnancy with more than 24 weeks of gestation
* Have smartphone with internet access
* Failure to meet criteria for a diagnosis of MDD in the last two months

Exclusion Criteria:

* Physical or mental disorders which would interfere with their ability to participate in the study
* High-risk pregnancy
* Give birth to a newborn at still-birth or a newborn with congenital anomalies and/or Medical complications that require special care in hospital
* Infant has a birth weight lower than 2,500 grams
* Infant has a 5-minute Apgar score lower than 7
Sport Therapy and Osteopathy Manipulative Treatment in ALS

This project assessed muscle oxidative metabolism and fatigue in patients affected by amyotrophic lateral sclerosis (ALS) undergoing to three months of individualized cardiovascular and strength training. Muscle oxidative metabolism and strength will be assessed by non-invasive methods, such as near-infrared spectroscopy (NIRS) and mechanomyography (MMG). NIRS is a technique giving indications on the capacity of oxygen extraction of muscles during exercise. MMG allows analyzing the pattern of motor unit recruitment and related fatigue. The investigators will also assess the effects of training on pain tolerance and quality of life (QoL) by the Brief Pain Inventory and the McGill Quality of Life questionnaires, using the validated Italian versions. Patients will be assessed longitudinally before (time T0) and after three months of individualized training (time T1). After one month of de-training (time T2) the investigators will assess the hypothetic persistence of any treatment-related effect. The effect of three months-osteopathic treatment (osteo) on pain and QoL will be assessed as well.

Single blind pilot trial assessing the efficacy and side effects of active training or osteopathic manipulative treatment in ALS.

Interventions will be administered for three months (plus one month without intervention) by specialized personnel.

Primary outcome measures will include: exercise tolerance and muscle oxygen extraction capacity, side effects. Secondary outcome measures will include: pain, QoL and disease progression scales.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of ALS
* early stages of disease
* able to perform exercise with major muscle groups.

Exclusion Criteria:

* non-invasive ventilation (NIV)
* tracheostomy
* coronaropathy
* ongoing infectious diseases
* cognitive deficits.
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study

This randomized controlled trail will evaluate the efficacy and safety of a simultaneous therapeutic carbohydrate restriction and treatment with the Sodium-Glucose-Transporter-2-Inhibitor dapagliflozin in comparison to the standard of care treatment in patients with chronic kidney disease and prediabetes or type 2 diabetes mellitus.

Participants will be randomized 1:1. The interventional group will be educated on how to implement a therapeutic carbohydrate restriction (50-100 grams of carbohydrates per day). Regarding safety, the patients of the interventional group will be provided with continuous glucose monitoring systems and blood ketone meters. The participants of the control group will continue to receive the standard of care therapy for the treatment of chronic kidney disease and prediabetes or type 2 diabetes mellitus. Both groups will be treated with dapagliflozin.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney Disease Stage KDIGO 3a-4 (eGFR eGFR 25-59 mg/min/1.73m²)
* Prediabetes or Diabetes according to the Guideline of the American Diabetes Association (HbA1c \>5,7 percent, or fasting glucose values \> 100 mg/dL, or glucose levels \> 140 mg/dL at 2h during an oral glucose tolerance test)
* Being overweight (Body Mass Index \> 25.0 kg/m²)
* Being able to independently:
* - Perform measurements of blood glucose and ketone levels
* - Use a continous glucose monitor
* - Contact the study team

Exclusion Criteria:

* Patients who are allergic to SGLT-2-Inhibitors
* Patients with autoimmune diabetes (Typ 1 or LADA)
* Patients with pancreoprivic diabetes
* Patients with a history of ketoacidosis or lactate acidosis
* Patients with severe hypoglycemic episodes in the 6 moths prior to inclusion
* Patients with bariatric surgery (in the past or planed)
* Patients with nephritic range proteinuria (\>3,5g of Albumin/day)
* Patients with active malignant diseases
* Pregnant or breastfeeding patients
EFFECT of KINESIO TAPING and LASER THERAPY in PATIENT with LYMPHEDEMA on GIRTH MEASUREMENT

find out the difference in the effect of kinesio taping and low level laser therapy on 66 patients with post mastectomy lymphedema as regards the following outcomes:

1.girth measurement between the upper limbs 2.) SPADI 3) hand grip strength 4)the quality of life by cancer specific questionnaire.

60 females with BCRL will be recruited in this study for 4 weeks , their age ranged from 400 to 55 years old with stege 1,2 lymphedema and randomly divided into 3 equal groups: 2) study group (A) include 20 females with unilateral BCRL will receive kinesio taping plus manual lymphatic drainage , exercise and advices 3) study group (B) include 20 females with unilateral BCRL will receive low level laser therapy plus manual lymphatic drainage , exercise and advices 4) study group (C) include 20 females with unilateral BCRL will receive kinesio taping plus low level laser therapy and manual lymphatic drainage , exercise and advices regards the following outcomes:

1.girth measurement between the upper limbs 2.) SPADI 3) hand grip strength 4)the quality of life by cancer specific questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* persistence of lymphedema following mastectomy or breast conservative surgery for at least 3 months

  * minimum volume difference of 200 mL or an average difference in arm circumference of 2 cm or 10% between healthy and affected limbs.
  * Femal with unilateral lymphedema from 40 to 55 years old

Exclusion Criteria:

* • Any disease lead to swelling

  * Medication especially diuretics
  * allergy
  * infection
  * pregnancy
  * heart band kidney disease
  * bilateral lymphedema
  * skin disease
  * chronic inflammatory disease
LIpitor and biGuanide to Androgen Delay Trial

This study is a randomized trial examining the administration of a combination of biguanide metformin and atorvastatin ("Lipitor") to men who are experiencing rising prostate-specific antigen (PSA) levels, despite having undergone radical therapy (surgery and/or radiation).


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Histologically confirmed adenocarcinoma of the prostate
* History of radical therapy (i.e., radical prostatectomy, radiotherapy, brachytherapy or prostatectomy with salvage radiotherapy)
* Serum testosterone levels 8.0 nmol/L (230 ng/dL) or greater
* Not currently undergoing treatment for hyperlipidemia or diabetes mellitus
* LDL-cholesterol levels 5 mmol/L or lower
* HgA1c 6.5% or lower
* PSA levels between 2 and 5 ng/mL

Exclusion Criteria:

* Subjects that have been treated for prostate cancer with any of the following:

  i. Cytotoxic chemotherapy; ii. Hormonal therapy within past 3 years; iii. Oral glucocorticoids; iv. Gonadotropin-releasing hormone (GnRH) analogues (e.g., leuprolide, goserelin, degarelix)
* Past treatment with the 5-α reductase inhibitors finasteride and dutasteride within past 5 years
* Past treatment with drugs with antiandrogenic properties (e.g., flutamide, bicalutamide, ketoconazole, progestational agents) within 6 months prior to screening
* Use of metformin or statins within past 2 years
* Planned or concurrent use of metformin, sulfonylureas, thiazolidinediones or insulin for any reason
* Known hypersensitivity or intolerance to metformin or atorvastatin
* Any clinically significant laboratory abnormalities (e.g., severe renal or hepatic impairment) which in the judgment of the investigator would affect the patient's health or the outcome of the trial
* Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association (NYHA) class III or IV, history of any type of acidosis, habitual intake of 4 or more alcoholic beverages per day)
* Abnormal liver function test
* Abnormal organ and marrow function
Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses

The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while reducing or eliminating the pain that patients sometimes experience during conventional PDT treatment. The main questions it aims to answer are:

* Will the application of the nanoemulsion (10% ALA gel), in the absence of occlusion, still achieve significant inflammation and lesion clearance?
* Will shortened incubation times of Ameluz still achieve significant inflammation and lesion clearance?
* Will the new test regimens achieve reduced pain during illumination?
* Will the new test regimens be safe?

Participants will be randomly assigned to one of three treatment regimens, which will determine the length of time that the topical medication will incubate on the face before red light exposure in PDT treatments. The incubation period will be either 10 minutes, 20 minutes, or 60 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Minimum of 10 actinic keratoses lesions on the face.
* Female subjects must not become pregnant during the study
* Subjects must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Pregnant or nursing.
* Using any topical treatment on their AKs; must stop at least one month prior.
* Currently undergoing treatment for other cancers with medical or radiation therapy.
* Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
* Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.
Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

A phase 2, multicenter, double-blind, parallel group, placebo-controlled, randomized clinical study, designed to compare the efficacy, safety, and tolerability of 2 dose levels of CBD and a matching placebo for the treatment of subjects with Social Anxiety Disorder (SAD).


Eligibility Criteria:
Inclusion Criteria:

* Clinically predominant diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) SAD
* LSAS score of 70 or higher
* Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method. Male subjects must also agree to use highly effective methods of contraception.
* Read, understand, and sign the informed consent form.
* No significant physical health abnormalities based on physical exam, ECG and laboratory tests.

Exclusion Criteria:

* Other current psychiatric disorder as the clinically predominant diagnosis.
* Lifetime diagnosis of schizophrenia or any other psychosis, MDD with psychotic features, intellectual disability, autism spectrum disorders, bipolar disorder type 1, and cannabis use disorder
* Previous 6 months diagnosis of Post-traumatic stress disorder, obsessive compulsive disorder, moderate to severe alcohol use disorder, and substance abuse disorder (except tobacco use disorder or mild alcohol use disorder)
* Severe MDD
* Use of oral psychoactive medications or beta adrenergic antagonists in the past 4 weeks, or depot neuroleptics within 12 weeks
* Electroconvulsive therapy within 6 months, psychotherapy or transcranial magnetic stimulation within 3 months
* Clinically significant abnormality or clinically significant unstable medical condition
* Impaired liver function
* Significant risk of suicide or homicide
* Pregnancy/lactation
* Sensitivity to CBD or excipients
* Current cannabis use; past frequent cannabis use
* Illegal drug use
Brief Internet-Based Acceptance and Commitment Therapy Intervention for Parents in the Postpartum

It is common for parents in the postpartum period (the first twelve months following childbirth) to experience psychological difficulties, particularly low mood. Acceptance and Commitment Therapy (ACT) is an evidence-based intervention that aims to cultivate psychological flexibility; the ability to stay in contact with the present moment regardless of unpleasant thoughts, feelings and bodily sensations, while choosing one's behaviours based on values. Acceptance and Commitment Therapy (ACT) is effective in reducing depression in the general population, including brief ACT interventions. However, the effectiveness of ACT interventions in the postpartum period is not yet fully established.

This study aims to investigate the feasibility (recruitment source, rate and attrition rate), acceptability (usability, usefulness and satisfaction) and the potential effectiveness (to inform the required sample size for a fully powered randomised control trial) of a four week internet-based ACT intervention for postpartum parents on depression.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years
* Have a child under 12 months
* Scoring 10 or above on the Edinburgh Postnatal Depression Scale
* Access to the internet through a computer, tablet or phone
* Fluency in English

Exclusion Criteria:

* None