cyrilzakka/clinical-trials huggingface dataset:
Intracavernous Injection of Autologous Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction Resistant to Oral Treatment in Patients With Type I Diabetes

Diabetes is a major concern in public health because of its high frequency and its negative consequences. Erectile dysfunction (ED) is present, regardless of age, in 50 to 75% of men with diabetes. It is related to endothelial dysfunction and a decrease in smooth muscle and nerve cells. In type 1 diabetic patients, ED is part of the chronic complications of microangiopathy. Current therapies are exclusively symptomatic with moderate efficacy, estimated between 44 and 56%. The administration of culture-grown medullary mesenchymal stem cells (MSCs) would be a curative treatment and have the advantage of being single injection.

However, the data in the literature do not allow to define the optimal dose of MSC in this indication. In addition, the feasibility of this procedure is not known at present.

The aim of this study is to evaluate the tolerance and the efficacy of intracavernous injection of autologous MSC (bone marrow-derived MSCs) administered in a 4-dose-escalating design in patients from 18 to 50 years old with complicated type 1 diabetes mellitus and erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetic man
* Aged from 18 to 50 years
* Having a diabetes evolving for at least 10 years
* Presenting at least one severe manifestation of microangiopathy, with or without dysautonomia: diabetic retinopathy, diabetic or vascular nephropathy, diabetic neuropathy, diabetic foot
* Presenting an erectile dysfunction refractory to oral treatment (sildenafil, tadalafil ...)
* IIEF-5 score less than or equal to 10

Exclusion Criteria:

* Any intercurrent event that does not allow the injection of aMSC
* Violation of the protocol by self erectile dysfunction medication
* Withdrawal of the protocol
Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction

To determine whether treatment with sacubitril/valsartan provides a superior effect on aortic characteristic impedance compared to enalapril in patients with heart failure and reduced ejection fraction (left ventricular ejection fraction \[LVEF\] ≤ 40%) after 12 weeks of treatment. The primary endpoint is the change in aortic characteristic impedance (Zc = dP/dQ in early systole) between baseline and Week 12.


Eligibility Criteria:
Inclusion Criteria:

* History of HTN and one of the following at BOTH screening and pre-randomization:

  1. SBP \>105 mm Hg on antihypertensive medication.
  2. SBP \>/= 140 mm Hg and NOT on antihypertensive medication.
* NYHA class I-III heart failure and with reduced ejection fraction \</= 40%, as determined by any local measurement made within the past 12 months using echocardiography, MUGA, CT scanning, MRI, ventricular angiography or single-photon emission computed tomography (SPECT), provided no subsequent measurement above 40%. Patients who have had an intervening medical event (e.g. myocardial infarction) or procedure (e.g. revascularization, cardiac resynchronization), must have a reassessment of EF ≥ 3 months following the event to ensure that eligibility criteria are still met.
* On stable doses of treatment with guideline-directed therapy, other than ACEis and ARBs prior to randomization.

  1. If the patient is currently taking an ACEi, a 36-hour washout is required prior to randomization (Visit 2).
  2. If the patient is currently taking an ARB, they must discontinue the ARB before initiation of study treatment however washout is not required.
* On an optimal medical regiment of diuretics and background medications to effectively treat co-morbidities such as HTN, DM, and coronary artery disease.

Key Exclusion Criteria:

* History of hypersensitivity to any of the study drigs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to ACEis, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
* Previous history of intolerance to sacubitril and valsartan, ACEi or ARB standard of care doses despite appropriate and gradual up-titration.
* History of angioedema, drug-related or otherwise.
* Requirement of treatment with both ACE inhibitor and ARB.
* Current or prior treatment with sacubitril and valsartan.
Affect Management for Early Adolescents

Adolescents are at risk for HIV because of sexual and drug use behavior initiated during early adolescence, and those with mental health problems appear to be particularly susceptible. Problems with managing emotions may make it difficult for early adolescents to make good decisions about sexual and substance use behaviors. This project will develop and evaluate interventions for early adolescents with mental health issues. An intervention focused on teaching affect management skills will be compared to an intervention addressing a variety of health topics to determine which intervention best reduces risk behavior among this at-risk population.


Eligibility Criteria:
Inclusion Criteria:

* Seventh graders identified by counselors at participating public school.

Exclusion Criteria:

* Adolescent is HIV positive.
* Adolescent is developmentally delayed.
* Adolescent is pregnant.
* Adolescent has a history of sexual crime.
Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children?

With Institutional ethics board and Health Canada approval, pediatric patients (ages 3-12) undergoing tonsillectomy or adenotonsillectomy (under standardized anesthesia) will be randomized to receive dextromethorphan hydrobromide (1mg/kg orally) 30 min preoperatively and again 8 hours postoperatively OR placebo (syrup identical in taste, appearance and volume) at the same time points. The primary outcome is an integrated assessment of perioperative pain scores and opioid use for 24 hours postoperatively. Secondary outcomes include nausea, vomiting, respiratory depression, and bleeding for 24 hours postoperatively. Our hypothesis is that dextromethorphan will decrease the incidence/severity of post-tonsillectomy pain. The improved pain control will be apparent through reduced opioid consumption and integrated pain scores. This will result in a reduced incidence of opioid-related side effects and adverse events.

With Institutional ethics board and Health Canada approval and parental consent and child assent, pediatric patients (ages 3-12) undergoing tonsillectomy or adenotonsillectomy (under standardized anesthesia) will be randomized to receive dextromethorphan hydrobromide (1mg/kg orally) 30 min preoperatively and again 8 hours postoperatively OR placebo (syrup identical in taste, appearance and volume) at the same time points. The primary outcome is an integrated assessment of perioperative pain scores and opioid use for 24 hours postoperatively. Pain scores were collected preoperatively at rest and then at 1,2,3,8,9,10 and 24 hours postoperatively using the validated Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). Secondary outcomes include nausea, vomiting, respiratory depression, and bleeding recorded by blinded observers for 24 hours postoperatively.

Our hypothesis is that dextromethorphan will decrease the incidence/severity of post-tonsillectomy pain. The improved pain control will be apparent through reduced opioid consumption and integrated pain scores. This will result in a reduced incidence of opioid-related side effects and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's (ASA) physical classification I and II
* tonsillectomy or adenotonsillectomy
* admission to extended postoperative care unit

Exclusion Criteria:

* use of monoamine oxidase inhibitors, serotonin reuptake inhibitors or tricyclic antidepressants
* requirement of preoperative sedation
* recent dextromethorphan use (\<24 h before surgery)
* intolerance, sensitivity or contraindication to any agents used in the study
* pre-existing chronic pain or chronic analgesic use
* body mass index (BMI) for age percentile greater than 90
* confounding procedural factors which might affect the validity of the data
* inability to adhere to study protocol
* contraindication to volatile anesthetics
Reconstruction of Pathological Changes of the Ophthalmic Artery in Patients With Retinal Artery Occlusion

Retinal artery occlusions (RAO) cause deterioration in visual acuity and visual fields. In computational fluid dynamics (CFD) studies \[1\] 10% of ascending emboli caused RAO, the residual 90% embolized into the cerebral arteries. As only 20% of patients with RAO had a history of stroke, there is a discrepancy between CFD-studies and clinical observations. Mead et al. \[2\] postulated small emboli being washed into the cerebral arteries without causing clinical symptoms of stroke, whereas similar emboli being washed into the ophthalmic artery would cause RAO.

There is a discrepancy between CFD-study results and clinical observations in RAO patients, indicating that there could be a high number of RAO-patients having had cerebral ischemies without symptoms of stroke (as postulated by Mead et al.\[2\]).

Purpose of the present study is to evaluate hemodynamic pathological changes at the ophthalmic artery origin in patients with RAO detected with an already existing CFD-model

Retinal artery occlusions (RAO) cause deterioration in visual acuity and visual fields. Emboli from plaques of the carotid artery, aortic arch or vegetations of the cardiac valves are the main reasons for RAO. In computational fluid dynamics (CFD) studies \[1\] 10% of ascending emboli caused RAO, the residual 90% embolized into the cerebral arteries. As only 20% of patients with RAO had a history of stroke, there is a discrepancy between CFD-studies and clinical observations. Mead et al. \[2\] postulated small emboli being washed into the cerebral arteries without causing clinical symptoms of stroke, whereas similar emboli being washed into the ophthalmic artery would cause RAO. Hayreh et al. \[3\] reported plaques of the carotid artery to be the main reason for emboli causing RAO.

There is a discrepancy between CFD-study results and clinical observations in RAO patients, indicating that there could be a high number of RAO-patients having had cerebral ischemies without symptoms of stroke (as postulated by Mead et al.\[2\]). A recently published report showed ischemic cerebral lesions in 38% of patients with RAO without neurological symptoms \[4\]. The fact, that the 3-year risk of patients with RAO to develop stroke is doubled \[5\], underlines further associations between RAO and stroke.

Purpose of the present study is to evaluate hemodynamic pathological changes at the ophthalmic artery origin in patients with RAO detected with an already existing CFD-model

References (detailed references are provided in the reference section) :

\[1\] Leisser et al., \[2\] Mead et al., \[3\] Hayreh et al., \[4\] Lee et al., \[5\] Chang et al.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed RAO
* Older than 21 years
* Informed consent

Exclusion Criteria:

* Women in reproductive age
Complications of Ethanol-amine Oleate Intralesional Sclerotherapy

The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations in pediatric patients

Maxillofacial Venous malformations cause many functional and esthetic complications in children, intralesional sclerotherapy is the best choice of treatment; and Ethanol-amine Oleate has been the most commonly used sclerosing agent.

The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations

Eligibility Criteria:
Inclusion Criteria: maxillofacial venous malformation

-

Exclusion Criteria:

1. Patients with lung, liver, or kidney diseases
2. Patients with Klippel-Trenaunay syndrome
3. Patients mental or physical disabilities
LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression

Postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. This pilot study evaluates the effectiveness of a novel mobile app called LoVE4MUM, developed based on Cognitive Behavioral Therapy and Psychoeducation principles, in preventing postpartum depression. The pilot trial involves 64 mothers randomly assigned to receive either standard care or standard care plus the LoVE4MUM. Primary outcome is improvement in depression, with secondary outcomes including mental health literacy and automatic negative thoughts. This research aims to provide initial evidence on the potential of mobile health tools to support maternal mental health, paving the way for future accessible and effective interventions.

Postpartum depression (PPD) is a significant mental health issue. Traditional support systems remains challenging and mHealth intervention provides an opportunity to access for support.

The primary objective of this study is to preliminarily assess the effectiveness of a developed mobile application called LoVE4MUM in prevention of postpartum depression. The study will employ a single-blinded, pilot randomized controlled trial (RCT) design involving a sample of 64 mothers. Participants will be randomly assigned in a 1:1 ratio to one of two groups: the intervention group, which will receive standard postpartum care plus LoVE4MUM mobile application, or the control group, which will receive standard postpartum care alone. The primary outcome measure will be the effectiveness of the mobile application in improving symptoms of postpartum depression among mothers. Secondary outcome measures will include changes in postpartum mental health literacy scores and negative automatic thoughts frequencies.

Through the systematic evaluation of the LoVE4MUM mobile application in conjunction with standard postpartum care, this pilot RCT aims to generate preliminary evidence regarding the efficacy and feasibility of using mHealth tools for preventing postpartum depression.

Eligibility Criteria:
Inclusion Criteria:

* mothers with EPDS score 9-\<12
* mothers with access to smartphone and internet connectivity
* continue routine postpartum care at the government health facilities
* literate in english and malay

Exclusion Criteria:

* history of drug abuse
* diagnosis of depressive illness or any other mental health illness
* undergoing treatment for mental health
* infant born with intrauterine death or died immediately after birth
Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.

This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy.

A total of 459 patients were randomly assigned to 2 treatment arms- 234 patients in the Pexa-Vec followed by sorafenib treatment group and 225 patients in the sorafenib only treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Histological/cytological diagnosis of primary HCC
* Advanced stage HCC (Barcelona Clinic Liver Cancer \[BCLC\] Stage C or B per American Association for the Study of Liver Disease \[AASLD\] guidelines)
* At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using a dynamic imaging technique (arterial phase of triphasic computerized tomography \[CT\] scan, or dynamic contrast-enhanced magnetic resonance imaging \[MRI\]), and injectable under imaging-guidance (CT and/or ultrasound)
* Child-Pugh Class A
* Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Adequate hematological, hepatic, and renal function:
* Additional inclusion criteria exist

Exclusion Criteria:

* Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma
* Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
* Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation
* History of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening
* Bulky disease patients - tumors encompassing \>50% of the liver volume and / or inferior vena cava invasion
* Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including high-dose corticosteroids
* Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
* History of severe eczema (as determined by the Investigator) requiring medical treatment
* Additional exclusion criteria exist
Trehalose in Subjects With Neuronal Ceroid Lipofuscinoses

Neuronal Ceroid Lipofuscinoses (NCL) or Batten's disease are the most common juvenile neurodegenerative disease, characterized by early blindness, movement disorders, cognitive and behavioral impairment, epilepsy, and retinopathy.

This study aims to collect clinical and laboratory data of patients with NCL taking Trehalose.

This study aims to collect clinical and laboratory data of patients with NCL taking Trehalose.

Eligibility Criteria:
Inclusion Criteria:

* NCL genetic diagnosis (mutation in genes CLN3 or CLN6)
* Signed informed consent

Exclusion Criteria:

* Other concomitant neurodegenerative diseases.
* Therapeutic and eating changes in the last four months prior to the study
* Unstable clinical conditions (myoclonus worsening, instability in sleep, parenteral nutrition)
* Refusal to sign the informed consent
Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee

The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Eligibility Criteria:
Inclusion Criteria:

* subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition,
* clinical diagnosis of OA of the knee 1 year or longer,
* subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of \< 5 mg oxycodone (or equivalent) per day,
* subjects whose OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy.

Exclusion Criteria:

* subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study,
* subjects who are allergic to buprenorphine or who have a history of allergies to other opioids,
* subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.

Other protocol-specific inclusion/exclusion criteria may apply.
Analgesic Effect of Paracetamol in Patients With Femur Fracture: is Intravenous Better Than Oral?

The purpose of this study is to monitor severe pain for femur fracture after treatment with paracetamol IV or OR.

The investigators enrolled 170 consecutive patients with femur fracture and severe pain. The patients received an initial analgesic treatment with paracetamol orally (OR) or intravenously (IV). The primary outcome was the reduction of pain of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1). Secondary endpoints included the reduction of pain of at least 2 points on the VAS scale at the 4 th hour (T4), the need of rescue therapy and the number of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients admitted to the ED of Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
* Femur Fracture
* Patients who signed the informed consent
* Able to take analgesic therapy both orally (OR) and intravenously (IV)
* Able to define pain by VAS

Exclusion Criteria:

* Age \<18 years
* Allergy to paracetamol
* Unable to take analgesic therapy both orally (OR) and intravenously (IV)
* Unable to define pain by VAS
Using Magnetic Resonance (MR) to Understand the Effect of Erythromycin on Bowel Motility

Magnetic Resonance Imaging (MRI) has proven to be a valuable imaging technique for suspected small bowel disease. This technique depends, in part, on adequate distension of the small bowel. This is accomplished by administering large volumes of a non-absorbable oral contrast material prior to the examination, which typically produces excellent distension of the distal small bowel and stomach, but poor distension of the proximal small bowel. Erythromycin is a common antibiotic that is known to promote stomach emptying and is used to treat diabetics with gastroparesis (poor stomach emptying.) The hypothesis of this study was that erythromycin will increase gastric emptying and hence improve small and large intestinal distention during MRI.

Gastric, small, and large intestinal volumes were assessed with MRI after ingestion of a low concentration of barium sulfate solution (1350 mL) and randomization to erythromycin 200 mg i.v.) or placebo in 40 healthy volunteers. Magnetic Resonance Images of the abdomen were acquired with a torso phased array coil and a 1.5 tesla magnet.

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy adult volunteers without known gastrointestinal disease
* Aged 18-70 years
* Able to provide written informed consent before participating in the study
* Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria:

* Known allergy to erythromycin;
* Use of drugs that have known contraindication with erythromycin (concomitant therapy with astemizole, cisapride, pimozide, or terfenadine)
* Corrected QT interval on EKG \>460 msec
* Certain medications (i.e., theophylline, digoxin, oral anti-coagulant, benzodiazepine, 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors) will either be excluded from the study or, if medically safe, will be asked to discontinue the medication for 4 half-lives before beginning the study.
* Use of medications that alter GI motility e.g., narcotics, medications with significant anticholinergic effects
* Pregnant or breast-feeding females
* Known claustrophobia
* Known family history of sudden death or congenital QT prolongation
* Presence of pacemaker, internal defibrillator, or other non-MR compatible device
* Patients with known metal present within their abdomen