cyrilzakka/clinical-trials huggingface dataset:
A Phase 2a Study To Evaluate VMB-100 In Females With Stress Urinary Incontinence

The study drug VMB-100 is an mRNA encoding for IGF-1. It is administered by injection into the urethra sphincter, and taken up by the muscle cells. The IGF-1 acts to promote muscle regeneration in the sphincter, which is expected to improve the function of the sphincter and thereby alleviate incontinence (urinary leakage).

Versameb AG (Sponsor) is developing VMB-100 for the treatment of stress urinary incontinence (SUI), and mixed urinary incontinence (MUI) with a predominant stress component, a common and debilitating condition that significantly impacts quality of life, and for which there are currently no approved pharmacological therapies available in the US.

The drug substance of VMB-100 is a mRNA encoding human insulin-like growth factor-1 (IGF-1). VMB-100 is administered as a transurethral injection into the urinary sphincter muscle. The injected mRNA is taken up by the muscle tissue cells and serves as a template for the translation of the protein IGF-1.

Insulin-like growth factor-1 is secreted into the extracellular space, where it acts to promote muscle regeneration of the urinary sphincter via auto- and paracrine activation of downstream pathways in a localized manner.

The current understanding in urology is that reduced maximum urethral closure pressure (MUCP) is the factor most strongly associated with SUI. This implies that improving function of the closure muscles would have therapeutic merit in both SUI as well as MUI with a predominant stress component.

No treatment which restores the physiology (regenerates the urinary sphincter muscle) is currently available. Given IGF-1's role in regenerating/maintaining muscle tissue women with SUI may benefit from a localized increase in IGF-1 levels in the urinary sphincter to regenerate muscle and restore sphincter function, thus alleviating the incontinence.

Eligibility Criteria:
Main inclusion criteria:

* Pre- or peri-menopausal female subject between 18 and 55 years of age
* Body mass index (BMI) of 19 to 35 kg/m2
* Active SUI of moderate severity for at least 6 consecutive months documented in medical history
* Refractory to standard of care measures
* Must not be pregnant, lactating, or actively trying to become pregnant.

Main exclusion criteria:

* Any concurrent condition or any clinically significant abnormality at Screening which in the opinion of the Investigator may affect the interpretation of safety or efficacy data or which otherwise contradicts participation in a clinical study with VMB-100
* Unwilling to undergo transvaginal sonography or cystoscopy
* Urodynamic detrusor overactivity
* History of urinary urge incontinence of neurogenic etiology.
* History of or planning for pelvic radiation.
* History of use of any bulking agent or Botox to treat SUI in the past 12 month.
* History of urethral sling, anterior prolapse repair, and/or other SUI procedures or surgical procedures affecting continence.
* Taking any medications that are known to have an effect on urinary continence or medications that may exacerbate incontinence
Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study

This study is designed as a 9-month extension of the original study (PROSPER-FM). The purpose of the extension study is to assess the long-term (up to 1 year) response to a digital therapy in the treatment of fibromyalgia.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant has completed participation in the PROSPER-FM study and was assigned to the Digital ACT Arm
* Participant is willing and able to comply with all protocol-specified requirements

Key Exclusion Criteria:

* Based on the investigator's judgment, any new diagnosis of acute or chronic disease/condition since participant's enrollment in PROSPER-FM study that may impact the outcome of this study
* Severe depression at the final visit of the PROSPER-FM study (measured by BDI-II)
* Increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS") at the final visit of the PROSPER-FM study
Association Between Renal Reserve Function and Progression of Renal Function to Predict CKD Risk in Thai Elderly

This study investigates renal functional reserve in elderly.

The prevalence of CKD in elder is high as age has been a variable in eGFR equation. eGFR by calculation always declines in parallel with age. The assumption that a persistent over 3 months of eGFR less than 60 mL/min/1.73m2 define CKD with risk of progression and need refer to nephrologist may not necessary true in aging population. We study renal functional reserve in elderly population who risk of CKD progression and ESRD is the highest prevalence in human life cycle and explore whether renal functional reserve can be used as ad additional marker of CKD progression in elderly.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \> 60 years at screening
* Patient willing to participate in the study and can provide inform consent
* Patient have residual kidney function ≤ 90 ml/min/1.73m2 by CKD-EPI equation

Exclusion Criteria:

* Patient active smoking
* Patient have Charlson comorbidity index \> .....
* Patient active cancer
* Patient contraindications for blood collection
* Patients with a history of hypersensitivity to cimetidine or amino acid IV solution
Canadian Adult Congenital Heart Disease Intervention Registry

The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of care processes and outcomes in five most common ACHDi interventions by enabling prospective and retrospective registry-based studies to answer important clinical practice and policy-relevant questions.

The goal of this study is to establish a rigorously developed registry to enable an impactful research agenda in adults with congenital heart disease interventions (ACHDi). The clinical and patient-reported information captured in the Registry will allow researchers to evaluate care processes and outcomes in five most common ACHDi interventions including transcatheter closure of atrial septal defects, closure of patent foramen ovale, coarctation of aorta stenting, percutaneous pulmonary valve implantation, and complex catheterization.

In 2019, we established the Canadian Research Network for ACHD Interventions (CRN-ACHDi), a national ACHD research network bringing together researchers, providers, patients, and policymakers from 4 provinces (Alberta, British Columbia, Ontario and Quebec) to improve patient experiences and outcomes through i) a national registry with modern data platform; ii) a rigorously established national research priorities agenda; and iii) a strong collaborative and multidisciplinary research environment.

The C-ACHDi Registry will provide opportunities for researchers to ask clinical practice and policy-relevant research questions that are supported by high quality data. In addition, it will provide an opportunity for patients to contribute data for meaningful and high quality clinical and translational research. The C-ACHDi Registry will provide a base for conducting registry-based studies (e.g., prospective experimental, prospective and retrospective observational) in the future as well as a foundation for benchmark and quality improvement activities.

Eligibility Criteria:
Inclusion Criteria:

* participants must be 18 years or older referred for intervention for one of five ACHD conditions including diagnostic catheterization for complex ACHD patients (Tetralogy of Fallot, Fontan, and transposition of the great vessels, single ventricle, truncus arteriosus); transcatheter closure of atrial septal defects; transcatheter closure of patent foramen ovale; coarctation of aorta stenting, and percutaneous pulmonary valve implantation.

Exclusion Criteria:

* participants below the age of 18
* participants residing outside of Canada
Thromboprophylaxis in Pregnant Women in Hospital: A Prospective Clinical Trial

Hospitalization in pregnancy and childbirth greatly increases the thromboembolic risk of these patients. The application of a protocol for assessing the risk of VTE reduces mortality and morbidity of these phenomena.

Thromboembolic events are among the leading causes of maternal morbidity and mortality in pregnancy / postpartum period. They are the leading cause of maternal death in developed countries. Risk factors for venous thromboembolism (VTE) during pregnancy and postpartum as family history or personal history of VTE, thrombophilia, age over 35, obesity and high parity has been the most studied. One of the main risk factors is hospitalization, which increases up to 20 times the risk of VTE.

Objective: The objective of the study is to identify early risk factors for VTE in hospitalized pregnant women and institute appropriate prophylaxis to reduce the incidence and morbidity.

Methods: A prospective study that will evaluate all pregnant women admitted for clinical treatment and / or surgery in the Department of Obstetrics and Gynecology, Clinics Hospital, University of São Paulo through the application of a thromboprophylaxis protocol with risk assessment score. The patient in whom prophylaxis would be indicated are those with scores greater than or equal to 3. The drug to be used is enoxaparin and the dose to be used depends on the weight of the patient.

It will be further assessed: adverse effects of treatment with enoxaparin, protocol failure in the group treated and untreated (without anticoagulation) and bleeding incidence in the untreated group.

Risk score description: score 3 - previous thrombosis/thromboembolism, homozygous mutations, combined thrombophilia risk factors, antiphospholipid syndrome, cancer(stomach, pancreas, lung), inflammatory conditions, lupus, sickle cell disease, nephrotic syndrome, heart disease; Score 2 - Protein C deficiency, Protein S deficiency, heterozygous F5 Leiden, heterozygous F2 G20210A mutation, cancer(last 6 months), chemotherapy(last 6m), immobility, bed rest \>4d prior to C-section, current serious infections, BMI≥40 kg/m2 , age≥40y, lung disease(cyanosis), postpartum hemorrhage \>1L; Score 1 - age ≥ 35 and ≤39 y, parity ≥3, multiple pregnancy, hyperemesis, gross varicose veins, smoker ≥20, surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women hospitalized.

Exclusion Criteria:

* Previous use of anticoagulation
Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

This study will evaluate the effect of PF-04136309 in patients with chronic hepatitic C virus infection and abnormal liver enzymes.

Study recruitment was stopped on Dec 15, 2011 due to difficulty in enrolling the targeted number of patients. Subjects currently enrolled into the study will complete the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The new anticipated Last Subject Last Visit (LSLV) is February 2012.

Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV infection
* ALT \>1.5 but \<10 times upper limit of normal

Exclusion Criteria:

* Decompensated or severe liver disease defined by one or more of the following criteria:

Prior liver biopsy showing cirrhosis.

* International Normalized Ratio (INR) greater than or equal to 1.5.
* Total bilirubin greater than or equal to 1.5X ULN, or \>2X ULN for unconjugated bilirubin.
* Serum albumin below normal.
* ALT or aspartate aminotransferase (AST) \>10 x ULN.
* Evidence of portal hypertension including splenomegaly, ascites, encephalopathy, and/or esophageal varices.
* Presence of human immunodeficiency virus (HIV).
* Co-infection with hepatitis B virus (HBV).
* Co-infection with Epstein Barr Virus (EBV) and/or Cytomegalovirus (CMV).
Effects of a Limited Almond Consumption After a Weight Loss Plan on Weight Maintenance

The purpose of this study is to assess the effects of limited portion of almond consumption after a successful weight loss by a comprehensive weight loss plan (NovinDiet Plan) on weight maintenance in obese female adults.


Eligibility Criteria:
Inclusion Criteria:

* female
* 18-45 years of age.
* Body mass index (BMI) between 23-30 kg/ m² who lost at least 10% of her initial weight by the diet plan.
* Must be able to have moderate exercise.
* Must be interested to keep weight loss.

Exclusion Criteria:

* No Allergy to nut products
* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months.
* Taking medications that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.
Continuous Renal Replacement Therapy Doses in Critically Ill Patients with Acute Kidney Injury

Acute kidney injury in critically ill patients admitted to the ICU is a common complication associated with high mortality or long-term chronic kidney damage. Some of these patients require continuous renal replacement therapy (low-intensity hemodialysis for 24 hours) until renal function recovery is achieved.

Continuous Renal Replacement Therapy (CRRT) is a crucial treatment for ICU patients with acute renal failure. It offers continuous toxin removal and prevents fluid accumulation in the patient's body. The therapy not only eliminates toxins but also physiological substances, including micronutrients and essential elements for cellular metabolism and organ function.

Currently, there is limited information available to adjust the renal therapy dose and avoid or balance the loss of these substances without causing toxin accumulation. Some studies suggest that high doses of therapy do not provide benefits and increase complications.

The objective of this study is to evaluate two doses of continuous renal therapy in terms of internal environment control (sodium, potassium, and acids and bases), micronutrient loss, and toxin elimination. After 48 hours of therapy, patients will be assigned to continue with a dose equal to the initial dose or a decrease in the initial dose. These two options are part of the current standard practice in our center.

Patients participating in the study will be randomly assigned one of the continuous renal therapy doses. The study is open, so treating physicians will always know the therapy the patient is receiving and can freely adjust it if deemed necessary.

The intervention duration is 96 hours, after which the dose will be at the discretion of the treating medical team. A follow-up will be conducted through medical records or phone calls approximately 90 days after starting therapy.

The risks for the patient are minimal, as toxin elimination monitoring will be even more intensive than usual. The study plans to include approximately 100 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Acute renal failure (AKIN 3) requiring Continuous Renal Replacement Therapy
* Requirement of vasoactive drugs (norepinephrine \> 0.1 mcg/kg/min)
* Written informed consent (patient or family)

Exclusion Criteria:

* Lack of informed consent.
* Possibility of using plasma exchange or MARS therapy at the at the time of inclusion.
* Baseline renal function with an estimated glomerular filtration rate (CKD-EPI) less than 30 ml/min.
TD-1792 in Gram-positive Complicated Skin and Skin Structure Infection

The purpose of this study is to determine whether TD-1792 is safe and effective when used to treat complicated skin and skin structure infections caused by Gram-positive bacteria.

TD-1792 is compared to vancomycin for the treatment of cSSSI.

Eligibility Criteria:
Inclusion Criteria:

* major abscess requiring surgical incision and drainage,infected burn, deep/extensive cellulitis, infected ulcer, wound infections
* requires at least 7 days of intravenous antibiotic treatment

Exclusion Criteria:

* more than 24 hours of antibiotic therapy
* moderate or severe liver disease
* severely neutropenic
* baseline QTc \> 500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy
Immunogenicity of Cholera Vaccine in Children With IBD

Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
* no vaccination against cholera in the past,
* written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.

Exclusion Criteria:

* serious exacerbation of inflammatory bowel disease defined as Paediatric Ulcerative Colitis Activity Index (PUCAI) \> 65 points for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) \> 40 points for patients with Crohn's disease.
Different Regimens of Vitamin D in Treatment of Children With Chronic Liver Disease

The primary aim is to assess the efficacy of two different Vitamin D regimes in the treatment of vitamin D deficiency in children with chronic liver disease. The secondary aim is to evaluate the effect of vitamin D on liver fibrosis utilizing fibroscan..

• In this study, the investigators are going to find out the optimum regimen to be used for effective treatment of vitamin D deficiency in those patients and to study the effect of vitamin D treatment on liver fibrosis.

Vitamin D is a hormone involved in the regulation of mineral homeostasis. It protects skeletal integrity and modulates cell growth and differentiation . It is lipid soluble in nature and interacts with vitamin D receptors and regulates the expression of more than 200 genes, mostly involved in apoptosis, cell growth, and cell differentiation .

Fibroscan: as a non-invasive imaging study for measuring liver cirrhosis by transducer probe-induced elastic share wave that propagates through liver tissue to measure its velocity. It is a promising noninvasive method for detection of cirrhosis in patients with chronic liver disease. Therefore, fibroscan can be used regarding the decision of treatment and follow-up of patients with cirrhosis for screening and detection of the complications . In our study the investigators will assess liver fibrosis before and after vitamin D therapy using fibroscan.

Group A: who received stoss parenteral vitamin D therapy (200.000 IU) once followed by 600 IU/ day orally (equivalent to RDA as maintenance).

Group B: who received 50.000 IU/ week vitamin D orally for four weeks followed by the maintenance dose.

The total duration of therapy was 6 months in both groups .

Eligibility Criteria:
Inclusion Criteria:

Children below the age of 18 with chronic liver disease.

Exclusion Criteria:

* Patients with concomitant renal affection.
* Patients who are on anticonvulsant therapy.
* Patients who lost follow up
* Patients refuse to participate at any time throughout the study period.
* Non-compliant patients for more than 50% of time.
Drug Interaction With Genes in Parkinson's Disease

This observational study aims at identifying gene modifiers of Parkinson Disease (PD) and of treatment response and adverse events of antiparkinsonian drugs. Six hundred PD patients will be followed annually for up to 5 years. A biological collection will be associated with a full clinical assessment of motor and non motor symptoms, medical and treatment history, environmental factors. The association between candidate gene polymorphisms and disease or treatment complications will be analyzed.

Title : Drug interaction with genes in Parkinson Disease

Objective:

To identify genes associated to disease and treatment complication and response.

Number of subjects: 500

Study duration : 6 years

Design:

Prospective cohort with biological collection

Primary objective:

Identification of genes which polymorphism or haplotype is associated with a complication of Parkinson disease, directly or with the interaction of treatment.

Secondary objectives:

* Prevalence and incidence of disease or treatment complications
* Clinical risk factor for disease or treatment complications
* Biomarkers of disease progression, disease or treatment complications

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age \> 18.
* Parkinson Disease according to UKPDSBB criteria
* PD diagnosis \< 6 years
* Informed consent

Exclusion Criteria:

- Atypical parkinsonism
My Mobile Advice Program: A Randomized Pilot Feasibility Study

The purpose of this pilot study is to evaluate the acceptability and feasibility of the proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).

Investigators will develop and pilot test a prototype of the MyMAP intervention.The intervention is designed to help smokers better manage issues known to reduce treatment adherence (withdrawal symptoms, medication side-effects, low motivation, and inadequate behavioral skills for medication adherence) and to facilitate greater communication between patients and providers so clinicians can provide appropriate oversight of medication use, intervene when medically necessary, and address patient concerns that may otherwise lead to non-adherence or early treatment termination.

Eligibility Criteria:
Inclusion Criteria:

* An invited member of Group Health, a health care system in the Pacific Northwest
* Plan to remain enrolled in Group Health for the next 6 months
* aged 18 - 65
* Eligible for smoking cessation treatment through Group Health insurance coverage
* smoke \>= 10 cigs a day
* speak and read in English
* willing to use varenicline and no contraindications for this medication
* ready to quit smoking
* have a smart phone with internet access
* willing to receive study texts and emails
* receive care at a Group Health clinic and have electronic medical records in this system
* fill prescriptions through the Group Health pharmacy
* agree to use birth control while taking study medication, if there is a risk of pregnancy

Exclusion Criteria:

* lifetime history of dementia
* psychosis or bipolar disorder based on self-report or medical record review
* hearing, comprehension or visual limitations that preclude full study participation
* current use of other forms of tobacco
* any medical contraindication for varenicline use
* documented history of suicidal ideation/intent