cyrilzakka/clinical-trials huggingface dataset:
Effects of 10 mg Monacolins on Vascular Health: a Clinical Trial

This will be a double-blind randomized clinical trial carried out on subjects with suboptimal control of LDL-cholesterolemia, following a Mediterranean diet, and treated with a red yeast rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order to evaluate the middle-term effects on vascular health evaluated by non invasive methods (Vicorder(R) apparatus)


Eligibility Criteria:
Inclusion Criteria:

* LDL-cholesterol between 130 and 190 mg/dL

Exclusion Criteria:

* Secundary prevention for cardiovascular disease
* Type 2 diabetes
* Assumption of lipid-lowering drug or dietary supplements
* Previous intolerans to read yeast rice including dietary supplements
Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery

The purpose of this study is to explore patient and partner experiences with sexual dysfunction following radical prostatectomy, in order to understand its effects on sexual and non-sexual intimacy. This will enable us to provide assistance in the future to individuals experiencing similar circumstances.

We are studying the impact of sexual dysfunction following radical prostatectomy on patient and partners' experiences of intimacy. Research with men in post-radical prostatectomy recovery indicates 25%-75% experience sexual dysfunction. Many patients experience anxiety and distress related to sexual difficulties. These experiences may progress and result in long-term problems in the relationship between patients and their partners. Despite apparent levels of effectiveness, up to half of the patients who turn to sexually assistive aids after surgical removal of the prostate discontinue use of the aids within one year. Additionally, difficulties in communicating about sexual impairments can significantly interfere with the couples' ability to achieve successful adaptation. We are interested in studying patient and partner experiences with sexual dysfunction in order to understand its effects on sexual and non-sexual intimacy.

Participation in this study will involve completing 6 confidential face-to-face interviews on three separate occasions (3-6 months, 12-15 months, and 21-24 months post-surgery). On each occasion, participants will be required to take part in a "couple's" interview with his/her partner, as well as an individual interview. The interviews will provide participants with the opportunity to discuss the impact of sexual dysfunction on mood, thoughts, and communication with their partners. Demographic information will be collected at the initial interview. As well, at each of the 3 time points, participants will also be asked to complete a questionnaire package containing 6 psychological questionnaires. All questionnaires and interview material will be kept strictly confidential.

Eligibility Criteria:
Inclusion Criteria:

* Radical prostatectomy treatment for prostate cancer at Princess Margaret Hospital or Etobicoke General Hospital
* At least 3 months, but less than 6 months post-radical prostatectomy
* Experience sexual dysfunction as a result of radical prostatectomy
* Must have an intimate partner and be able to participate as a couple

Exclusion Criteria:

* Detectable prostate specific antigen (PSA) post-radical prostatectomy
* Patient or partner unable to speak English
* Patient or partner unwilling to allow interviews to be recorded
* Patient or partner unwilling to participate
Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX

This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females between the ages of 18 and 45
2. Subjects who are non-smokers
3. Subjects with body weights with range of 154-220 lbs.

Exclusion Criteria:

1. Females who are pregnant or lactating
2. Subjects with a history of any clinically significant disease or condition affecting a major organ system
3. Subjects with ECG abnormalities
4. Subjects who have tested positive for hepatitis B, hepatitis C or HIV
5. Subjects who have had a diagnosis of alcohol or substance dependence with the past 12 months
6. Subjects with positive urine results for drugs of abuse.
Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer

Dutasteride is used in the treatment of benign prostate enlargement (BPH).It inhibits conversion of testosterone (T) into the more potent dihydrotestosterone (DHT) to stop prostate (and possibly prostate cancer) growth. DHT regulates the expression of certain genes in the prostate. The pharmacodynamics of DHT reduction in the prostate were never investigated until now, as every measurement would require prostate tissue retrieval, which is medically and ethically unacceptable. A recently developed test is able to quantitatively measure gene expression in prostate-borne cells, in urine sediments after prostate massage. By measuring this gene expression in patients using dutasteride, it has become possible to assess the pharmacodynamics of gene expression reduction, which is representative for the pharmacodynamics of DHT reduction. Repeated prostate tissue sampling has therefore become unnecessary. This newly gained knowledge will lead to a better understanding of the action of dutasteride and will possibly help improve treatment of symptomatic BPH (Benign Prostatic Hyperplasia) and PrCa (Prostate Cancer)in the future.

A randomized, open-label, parallel-group pilot study, to assess the pharmacodynamic effect on dihydrotestosterone regulated gene expression, longitudinally and in a dose dependent manner, of 0.5mg or 3.5mg dutasteride administered orally once daily, for three months in men with symptomatic benign prostatic hyperplasia or during the period between baseline and radical prostatectomy in men with biopsy-proven, clinically localized prostate cancer.

Eligibility Criteria:
Inclusion criteria:

* Symptomatic BPH, or:

Biopsy proven, localised (cT1 or cT2) prostate cancer scheduled for radical operation

* Able to swallow oral medication

Exclusion criteria:

* Inability to void spontaneously (eg. dependence on catheter etc.)
* History of (prior) prostate cancer Previous prostatic surgery
Treatment of Hidradenitis Suppurativa Using Etanercept

Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HS for \> 6months defined as tender and/or painful, red nodules and/or plaques (confluent nodules) with or without scarring, foul odor, or draining sinuses clinically with HS
* Localizes to skin folds including any of axillx, breast, abdomen and groin
* active disease
* Negative pregnancy test within 7 days before the first dose of study drug
* Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study

Exclusion Criteria:

* Concurrent active infection including tuberculosis
* Concurrent therapy or therapy 30 days prior with systemic corticosteroids, systemic immunosuppressants, systemic retinoids or ant-TNF agents
* Severe comorbidities (diabetes mellitus requiring insulin, Q F of any severity, MI, unstable angina eectoris, uncontrolled hypertension, oxygendependent severe pulmonary disease, history of cancer \*thin 5_ years except cutaneous basal cell or squamous cell carcinoma or in situ cervical carcinoma, history of TB or TB exposure, chronic hepatitis B or C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy
* Currently enrolled or enrolled within 90 days prior in any trial for treatment of HS
* Known HIV positive
* Contraindication to etanercept as defined in package insert
Study on Clinical Outcome of Vascular Inflow Occlusion in Open Liver Resection

This study aims to evaluate whether applying inflow vascular occlusion in modern liver resection is associated with better clinical outcome.

Eligible patients are randomly assigned to the two surgical techniques: with or without the application of inflow vascular occlusion.

Patients outcome including liver function recovery, operative time and blood loss are compared.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Child-Pugh Class A or B

Exclusion Criteria:

* Informed consent not available
* Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal vein embolisation
* Presence of hepatic artery thrombosis, previous transarterial therapy like TACE, or transarterial internal radiation
* When portal vein resection is anticipated
* Emergency hepatectomy
* Ruptured hepatocellular carcinoma
* Rehepatectomy (repeated liver resection)
* Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver
* When concomitant bowel or bile duct resection is anticipated
The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly

This is an observational, retrospective, national multicenter study aimed to evaluate the impact and efficacy of Time To Switch (TTS) from first-line to second-line medical therapy in Acromegaly.

The study will retrospectively collect clinical, laboratory and anamnestic data of approximately 100 patients evaluated at the UOs involved in the study in last 5 years and 6 months.

Acromegalic patients which neurosurgical intervention was not completely effective or contraindicated or rejected by the patient and for which first-line medical therapy with first-generation somatostatin analogues (octreotide LAR or lanreotide) did not result in disease control and switched to second-line medical therapy will be enrolled. The TTS is the time defined in days and months from the observation that disease is no longer biochemically controlled, defined by the presence of GH levels ≥1 μg/L and IGF-1\>1.3×ULN (upper limit of normal), during 1st line therapy, and the start of 2nd line therapy line.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women (age ≥ 18 years) affected by acromegaly, including those of childbearing age
* Patients inadequately controlled with first generation somatostatin analogues (GH ≥1 μg/L and IGF-1 \>1.3×ULN)
* Second line medical treatment (Pasireotide; Pegvisomant only; combination Pegvisomant + 1st generation SSA) after use of first-line medical treatment
* At least 12 months of follow up during 2nd line therapy
* Signature of the informed consent to the study

Exclusion Criteria:

* age ≤18 years
* Pregnant and/or breastfeeding women
* Patients unable to understand and sign the Informed Consent
Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia

Mild cognitive impairment and Alzheimer's disease are conditions that involve memory difficulties. Transcranial direct current stimulation is a type of brain stimulation. It may help improve these memory difficulties. However, it works better on active brain areas. This study looks at if combining exercise and applying current to important parts of the brain can help improve memory in people with Mild Cognitive Impairment or Alzheimer's disease.

Objectives: To assess the efficacy of a combined exercise and tDCS treatment for improving cognitive outcomes in mild cognitive impairment and mild Alzheimer's disease.

Study Design: Eligible participants will be randomized to one of three interventions: Exercise and tDCS, Treatment as usual (TAU/exercise education) and tDCS, or Exercise and sham tDCS. Participants randomized to an exercise group will undergo exercise, followed by either sham or active tDCS. Participants randomized to TAU will receive written information in accordance with the Canadian Physical Activity Guidelines for older adults and tDCS for the same duration. Cognition, neuropsychiatric symptoms and blood samples for biomarker analysis will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥50 years of age
* DSM-5 criteria for major or mild neurocognitive disorder due to AD or mixed AD/vascular disease
* Mild severity of impairment (standardized Mini-Mental State Examination (MMSE) score ≥19)
* Read and communicate in English

Exclusion Criteria:

* Change in cognitive enhancing medications (ChEIs and/or memantine) less than 3 months prior to study screen
* Change in anticonvulsants or psychotropic medications less than 1 month prior to study screen
* Currently taking benzodiazepines
* Presence of metal implants that would preclude safe use of tDCS (e.g. pace-maker)
* Significant neurological condition (e.g. epilepsy, Parkinson's disease, multiple sclerosis)
* Current psychiatric disorders (e.g. schizophrenia, bipolar disorder, depression, psychosis) or current substance use disorder
* Medical contraindications to increasing activity level according to the Canadian Society of Exercise Physiology Questionnaire
Memory Aid for Informed Consent in Alzheimer's Research

The purpose of this trial is to test whether a memory and organizational aid in the form of a document that summarizes and simplifies a study's key points can improve the decision-making abilities and competency of mild to early moderate Alzheimer's disease (AD) patients.

Studies of mild to moderate Alzheimer's disease (AD) patients reveal substantial variation in their ability to participate in an informed consent process. No published data show techniques that help an AD patient to participate in an informed consent. This research will address this issue by performing a randomized trial to test whether a memory and organizational aid can improve the decision-making abilities and competency of AD patients.

This study will recruit 80 patients with mild to early moderate AD, and 30 non-demented elderly persons. The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home. The AD patients will be randomized to receive either the standard informed consent process or the intervention of the standard informed consent process plus the memory and organizational aid. All non-demented elderly individuals will receive the standard informed consent process. The interviewer will administer the protocol to participants and ask questions that will assess participant capacity to understand, appreciate, reason, and make a choice concerning enrollment in the hypothetical study.

Eligibility Criteria:
Inclusion Criteria:

* Live within one hour drive of the University of Pennsylvania's Memory Disorders Clinic
* Education equivalent to 6th grade level
* Corrected visual acuity of at least 20/70
* Speak English
* Diagnosed with possible or probable AD, or non-demented
* MMSE (Mini Mental State Exam) \>= 18
A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.

This is a double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of three different doses (0.5, 1 and 2 mg TID) of Larazotide Acetate as an adjunct to gluten-free diet in the treatment of patients with celiac disease (CD). The diagnosis of CD must have been established by jejunal biopsy as well as serology at some point in time prior to entry into the study. Patients must have symptoms despite being on a gluten-free diet as defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or more than 2.0.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months
* measurable serology at screening
* CeD GSRS score of ≥ 2.0 prior to randomization
* experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache)
* willing to maintain current diet gluten-free diet throughout the duration of the study.

Exclusion Criteria:

* refractory celiac disease or severe complications of celiac disease (eg, EATL, ulcerative jejunitis, perforation, etc.)
* chronic active GI disease other than celiac disease
* diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study
* hemoglobin value \< 8.5 g/dL
Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication

The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.


Eligibility Criteria:
Inclusion Criteria:

- Stable claudication symptoms

Exclusion Criteria:

* Lower extremity amputation
* Signs or symptoms of critical leg ischemia (CLI)
* Uncontrolled hypertension
* Tachycardia
* Poorly controlled diabetes
* Hypercholesterolemia
RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use

- and -

To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

The study is a prospective, multi-center, global registry of Boston Scientific neurostimulation systems for pain.

The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a successful trial outcome, may progress to permanent implant of a neurostimulation system. Individualization of neurostimulation therapy for pain will be determined according to investigator discretion and site routine care, and in accordance with inclusion and exclusion criteria.

Eligibility Criteria:
Key Inclusion Criteria:

* Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
* Signed a valid, IRB/EC-approved informed consent form
* 18 years of age or older

Key Exclusion Criteria:

* Contraindicated for Boston Scientific neurostimulation system
* Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Extracorporeal Shockwave Therapy vs Mesotherapy in the Treatment of Myofascial Pain Syndrome: a Case-control Study

Myofascial Pain Syndrome (MPS) is a disorder of the musculoskeletal system manifested by referred pain associated with functional limitation, muscle contractures, and possible neuralgic manifestations; this condition is characterized by the presence of "trigger points". The goal of this case-control study was to compare the effects and benefits of treatment with ESWT vs Mesotherapy in myofascial pain syndrome. The main question it aims to answer is: what is the best rehabilitation project-program between ESWT and mesotherapy for patients with myofascial syndrome? A case-control study was conducted at the U.O.C. of "Recovery and Functional Rehabilitation" A.O.U.P. "P. Giaccone" of Palermo from February 2022 to Dicember2023. Patients were randomized into 2 groups: in group "A", No. 5 sessions of focal ESWT were given weekly; in group "B", No. 5 sessions of Mesotherapy with administration of Thiocolchicoside fl 4mg/2ml and Mepivacaine fl 10mg/1ml were given weekly. Patients in group "A" and group "B" were evaluated at baseline (T0), after 5 sessions (T1) and one month after the end of treatment (T2). Researchers will compare patients treated with ESWT and patients performing mesotherapy to see if there are real differences in terms of pain reduction and improved quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age 35-65 years
* Diagnosis of myofascial syndrome
* NRS at T0 ≥ 4
* Written informed consent

Exclusion Criteria:

* Pregnant patients
* Patients with malignancies already diagnosed or in the process of diagnostic definition
* Coagulation disorders and/or therapy with anticoagulants
* Skin lesions and/or local infections
* Contraindications and/or allergies to the active ingredients of Mesotherapy.
Video Consultation to Reduce Drug Interactions Among Patients Initiating Oral Anti-Cancer Drugs

This is a non-randomized prospective pilot intervention study to assess the feasibility of a onetime pharmacist-led video consultation for medication review and patient education among patients initiating an oral anti-cancer drug. In addition, investigator will evaluate reductions in polypharmacy, potential DDIs, and patient self-efficacy by comparing these variables for each patient before and after the video consultation.

In this study, the investigator will be evaluating a 30-minute pharmacist-led video consultation to provide education about patients new oral anti-cancer drug (OACD) and help identify and manage potential drug-drug interactions alongside your oncologist. While OACDs offer both clinical benefits and added convenience when compared to traditional intravenous chemotherapy, they also present a number of potential challenges. One critical challenge involves the increased risk of taking multiple oral medications daily. Patients taking multiple medications can result in harmful effects due to unexpected drug interactions, as well as patient confusion regarding when to take specific medications. Given the relatively recent rise in available OACDs, little is known about the extent of this issue

Eligibility Criteria:
Inclusion Criteria:

* Adults age ≥18 years
* Patients must have access to a smartphone, tablet, or computer to facilitate a video visit, or be willing to come into the hospital to borrow a tablet for the visit
* Patients must have received a prescription for a new oral anti-cancer drug within 4 weeks of enrollment, not administered as part of a clinical trial
* Patients must take at least three prescribed, standing oral medications in addition to their newly prescribed anti-cancer drug

Exclusion Criteria:

* Patients who do not speak English or Spanish
* Patients without cognitive capacity to give informed consent for participation
* Patients uncomfortable with using video-based technology
GUT LINK: A Study of a Care Pathway Across Primary and GI Specialty Care

It can be challenging for Primary Healthcare Providers (PHCPs) to differentiate between IBS and more serious illnesses involving the GI tract, such as Crohn's disease, ulcerative colitis, or cancer. To help with diagnosis and treatment of IBS, evidence-based guidelines have been developed. However, they are not commonly used in primary care practice and PHCPs and patients often feel that GI specialist evaluation and endoscopy is required. The development of care pathways and clinical practice guidelines is essential to support the investigation and management of digestive diseases, such as IBS.

The current pilot study is designed to assess the implementation and early comparative effectiveness of a Clinical Care Pathway for lower GI tract symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Must be a general practitioner
* Have a family practice in Nova Scotia, Canada
* Utilize the platform 'virtual hallway' as part of current referral practices
* Deliver care to patients with lower GI complaints

Exclusion Criteria:

* None