cyrilzakka/clinical-trials huggingface dataset:
Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer

Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and tolerability study to determine the safe dose of PEGPH20 to use in combination with gemcitabine in Stage IV previously untreated pancreatic cancer patients.

Phase 2: Randomized, double blind study to compare the effect of overall survival of gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated pancreatic cancer patients.

PEGPH20 is a PEGylated version of human recombinant PH20 hyaluronidase that, in preclinical studies, has been shown to remove HA from the extracellular matrix surrounding tumor cells by depolymerizing this substrate. 87% of pancreatic ductal adenocarcinomas (PDA) overexpress HA. PDA tumor tissue may be especially sensitive to the HA-degradation properties of PEGPH20 and thus more responsive to the cytotoxic effects of a given dose of gemcitabine. Modifying the extracellular environment to increase the penetration and efficacy of anti-cancer agents represents a novel approach to treating pancreatic cancer and may provide important therapeutic outcomes in patients with Stage IV Previously Untreated Pancreatic Cancer.

This Phase 1B/2 study will assess safety, tolerability, treatment effect, and various PK/PD endpoints.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients with histologically confirmed Stage IV adenocarcinoma of the pancrease previously untreated for metastatic disease
* One or more metastatic tumors measurable on CT scan per RECIST 1.1 criteria
* Life expectancy of at least 3 months
* Signed, written IRB/EC-approved informed consent
* A negative serum pregnancy test, if female

Key Exclusion Criteria:

* Known brain metastasis
* New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 12 months
* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
* Known allergy to hyaluronidase
* Women currently pregnant or breast feeding
Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer

Immune checkpoint inhibitors (ICI) have revolutionized cancer treatment and are now approved for various types of cancer. The most common side effects of ICI are immune-related adverse events which can affect any organ or system in the body. Recently, concerns have also risen about cardiovascular effects of ICI. Retrospective studies showed an 4-5 times increased risk of developing an arterial thromboembolic event.

The mechanisms driving the ICI-associated risks of arterial thromboembolic events such as myocardial infarction and stroke, are unclear. Since the risk of a thromboembolism appears to be increased already during the first months after initiation of ICI, immune-related hypercoagulability or (autoimmune) antiphospholipid antibodies may play a role, but data to support this are lacking. The longer-term risk of arterial thromboembolism may be predominantly driven by (accelerated) atherosclerosis, a chronic low-grade inflammatory disease of the larger arteries. Therefore, we assess the effect of ICI on progression of coronary non-calcifid plaque volume by using computed tomography angiography (CCTA).


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of the following tumor types, any stage: esophageal, gastric or junction cancer, colorectal cancer, non-small cell lung carcinoma, melanoma, renal cell carcinoma
* Prior to start of new therapy (i.e. immune checkpoint inhibitor, chemotherapy or follow-up in case of esophageal cancer)
* Age ≥ 50 years

Exclusion Criteria:

* ICI therapy in previous 12 months
* Suspected or confirmed viral, fungal, or bacterial infectious disease
* Use of immunosuppressive therapy prior to ICI start
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2
* Known allergy to iodinated contrast agents
* Atrial fibrillation
Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Autologous Dermal Fibroblasts

Treatment of patients with non-healing wounds and trophic ulcers using local LED phototherapy with local transplantation of autologous dermal fibroblasts

During the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous dermal fibroblasts in the wound.

The positive outlook for the effectiveness of photodiode therapy with dermal fibroblasts is due to the following:

* the ability of fibroblasts to stimulate tissue regeneration
* positive results of preclinical studies of the method of treatment of long-term non-healing wounds in animals (rats).

Twelve patients were included in the study. Dermal fibroblasts were isolated from the skin patients, cultured and then transplanted back to the wound.

The therapeutic dose of cells was 50k per cm2 of the wound area. Follow up patients monitoring was performed at 1, 2 and more months after injection.

Eligibility Criteria:
Inclusion Criteria:

* Trophic Ulcers
* Chronic non-healing wounds

Exclusion Criteria:

* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders
* pregnancy
Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.

This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation, and will have one additional blood sample taken during the study. The anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* patients participating in study ML17225.

Exclusion Criteria:

* N/A.
HABIT-ILE in Adults With Chronic Stroke (HABIT-ILE Stroke)

Using a randomized controlled trial design, the possible changes induced by the intensive treatment program "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" will be studied in functional, everyday life activities and neuroplastic assessment of adults with chronic stroke.

Using a randomized controlled trial design, the possible changes in neuroimaging, motor function, motor learning and everyday life activities of adults with chronic stroke (\> 6 months) after participating of the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) will be studied. Changes, scored by participants in case of questionnaires and by experts in the case of tests, will be observed comparing participants after their regular care/treatment and after receiving HABIT-ILE. Motor function, learning and daily life activities will be correlated with neuroplastic changes.

Eligibility Criteria:
Inclusion Criteria:

* hemiparetic patient with a chronic stroke (over 6 months of evolution)
* age 40 to 90 years old inclusive
* ability to follow instructions and complete testing according to the age.

Exclusion Criteria:

* alcohol/drug abuse
* pregnancy
* major cognitive impairment interfering with the study (severe aphasia, psychiatric conditions)
* uncontrolled health issues (cardiac/renal failure)
* contraindications to perform MRI assessments (Metal implants, etc.)
Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.

Permanent ventricular pacing may be complicated with ventricular dyssynchrony and subsequent pacing-induced cardiomyopathy. We hypothesized that left bundle branch area pacing may prevent the development of pacing-induced cardiomyopathy in patients with permanent atrial fibrillation requiring permanent ventricular pacing.

Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.

They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation.

They will be prospectively followed during 6 months.

Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.

They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing confirmed according to electrocardiographic parameters. Atrioventricular node ablation will be performed the following day through a femoral venous approach.

Perioperative data and potential complications will be collected. Patients will be prospectively followed during 6 months. They will have clinical examination, 12-lead ECG, and an echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Permanent atrial arrhythmia
* Symptoms related to an insufficient rate control under optimal medical therapy

Exclusion Criteria:

* Indication of prophylactic defibrillator
* Already implanted with a cardiac device
Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia

Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to predict pathogens involved in VAP (in comparison with the concomitant endotracheal secretions surveillance). These subglottic and tracheal secretions culture surveillance will be masked to the investigators of the DEMETER Study.

This ancillary study will be performed in 14 centers participating to the DEMETER study


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours
* Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage will be available during the SSD period of the trial
* Information delivered

Exclusion Criteria:

* Previous inclusion in the study
* Patients moribund at the Intensive Care Unit admission
* Pregnant, parturient or breast-feeding woman
* Patient hospitalized without consent and/or deprived of liberty by court's decision
* Patient under guardianship or curators
* Lack of social insurance
* Concomitant inclusion in a trial on VAP prevention
* Patient with no comprehension of the French language
Behavioral Interventions to Target Self-Control

Low self-control has been associated with a number of unhealthy behaviors with low treatment success. Alternative non-pharmacological approaches have the potential for enhancing self-control. This pilot study will investigate if the practice of yoga and/or health and wellness education improve self-control in the context of nicotine addiction, and will set the stage for larger clinical trials using behavioral interventions to supplement or replace existing treatments and increase the rates of recovery from disorders in which low self-control is a susceptibility factor.


Eligibility Criteria:
Inclusion Criteria:

* should smoke a minimum of 10 cigarettes/day
* be fluent speaking and reading English
* in good physical health
* intend to quit smoking
* capable of abstaining from smoking for 12-14 hours
* should have easy daily access to a computer and/or other internet-enabled device

Exclusion Criteria:

* current alcohol or substance use disorder (except nicotine)
* pregnancy
* history of psychosis or bipolar disorder
* current use of a behavioral or pharmacologic tobacco treatment
* any untreated medical or psychiatric condition that might compromise their safety during participation in the study (e.g. high blood pressure, diabetes, BMI \>35)
The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate

This study is to compare the efficacy and safety of ozarelix 15 mg given intramuscular (IM) 2 weeks apart on the improvement of symptoms and the duration of improvement for up to 6 months in men with Benign Prostatic Hypertrophy (BPH) who are over 50 years of age.

This study is to compare the improvement in symptom scores, peak flow rate and quality of life in men suffering from lower urinary tract symptoms (LUTS) secondary to Benign Prostatic Hypertrophy (BPH) following treatment with ozarelix. Ozarelix is compared to placebo and injections given 14 days apart. Patients are followed for 6 months and both safety and efficacy assessed at monthly visits. Additionally, the impact of treatment on erectile function, if any, as well as Prostate-Specific Antigen (PSA) and Testosterone levels will be monitored.

The screening period of 7 days. The duration of the study is 40 weeks, including a 28-day placebo run-in phase (eligible participants entered a placebo run-in phase in which placebo is administered twice over a 2 week period \[Day -28 and Day -14\] and participants are assessed to establish baseline values approximately 14 days following the second placebo injection), study drug is administered on Days 0 and 14 followed by 34 weeks of observation after the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

- All of the following questions must be answered "Yes" at Visit 1 in order for the participant to participate in the study.

* Is the participant at least 50 years old?
* Does the participant have clinical signs and symptoms consistent with BPH?
* Does the participant have an IPSS 13 at screening (prior to placebo run in)?
* Does the participant have a peak urinary flow rate (Qmax) of 4-15 milliliter/second (mL/sec) established on a voided volume of at least 125 mL?
* Is the participant willing to agree not to use any other approved or experimental pharmacologic BPH treatments including alpha blockers, 5-alpha reductase inhibitors, anti-cholinergic preparations or herbal preparations at any time during the study?

Exclusion Criteria: All of the following questions must be answered "No" at Visit 1 in order for the participant to participate in the study.

* Does the participant have a history of prostate cancer or a serum PSA \>10 nanograms per milliliter (ng/mL)?
* Has the participant had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy?
* Does the participant have a prevoid total bladder volume assessed by ultrasound \> 550 mL?
* Does the participant have a residual urine volume \> 350 mL by ultrasound?
Statin Therapy in the Treatment of Sepsis

Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years old
* Hypotensive requiring vasopressors
* Suspected Infection

Exclusion Criteria:

* Pregnant
* Liver Failure (ALT or AST \> 120)
* Rhabomyolysis (CPK \> 3x normal)
* Comfort care measures status
* Chronic Liver Disease (Cirrhosis)
* Use of Cyclosporin, Digoxin, Statins
* Patients who are unable to take medications by mouth or NGT
Exploratory Study of Plaque Regression

Despite the availability of several classes of very effective drugs available to treat heterozygous Familial Hypercholesterolemia (HeFH), there remains a large unmet medical need for new, effective and well tolerated therapies. There are a number of therapies given on a chronic basis to reduce long term risk, such as statins, fibrates, niacin, omega 3 fatty acids, resins, cholesterol absorption inhibitors and antiplatelet or anticoagulant drugs, but subjects with heterozygous Familial Hypercholesterolemia remain at high risk for cardiovascular events. There is still a need for acute therapies that can lead to rapid pacification of unstable plaque in order to reduce the risk of these events. This study will assess the effects of CER-001 , a recombinant human Apo-A-1 based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by 3Tesla MRI (3TMRI)and intravascular ultrasound (IVUS) evaluations in patients with HeFH.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female subjects at least 18 years old
* Subject presents heterozygous FH, known CHD and receiving maximally tolerated lipid modifying therapy, at stable doses for at least 3 months
* LDL-C of \> 110 mg/dl
* Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS

Exclusion Criteria:

* Confirmed diagnosis of homozygous FH
* Significant health problems (other than cardiovascular disease) in the recent past including blood disorders, cancer, or digestive problems
* Female subjects not meeting the study definition of non child-bearing potential
* Use of an investigational agent within 30 days of the first CER-001 dose
* Receiving current lipid apheresis
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306

The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy young and elderly male and female volunteers following oral administration of repeated rising doses, given once daily over 14 days to young healthy genotyped and elderly healthy male/female volunteers.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male/female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy

Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral stimulation with chenodeoxycholic acid in the same subjects before and after elective cholecystectomy

Lack of FGF19 and elevated 7-alpha-hydroxy-colestenone (C4) is associated with the bile acid diarrhoea (BAD), a disease with increasing estimated of prevalence.

BAD is occasionally triggered by cholecystectomy and FGF19 and C4 is known to be affected by cholecystectomy. The investigators are exploring if FGF19 after oral stimulation can be developed to a universal test for BAD, and need to know how the proposed test is affected by cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* planned elective cholecystectomy

Exclusion Criteria:

* small bowel resection
* right sided hemicolectomy
* known chronic diarrheal disease (celiac disease, lactose malabsorption, Inflammatory bowel diseases, incl microscopic colitis)
* pregnancy
* wish for pregnancy within next three months
* allergy to eggs
* allergy to constituents in Xenbilox (capsules with chenodeoxycholic acid)
* acute cholecystitis within two months
* chronic cholecystitis
* cirrhosis of the liver
* suspected obstructive choledocholithiasis
* icterus
Prevalence and Treatment of Anal Incontinence (AI) in Primiparous Women

Traumatic tears of the sphincter ani muscles after delivery may result in symptomatic urinary and anal incontinence, particularly in primiparas.

The efficacy of pelvic floor muscle exercise (PFME) in treating urinary incontinence (UI)is well documented, however, to date there is little evidence to support the efficacy of PFME in treating symptomatic anal incontinence.

This project consists of three separate studies. The prevalence survey/ study (1), investigates the prevalence of symptomatic anal incontinence among primiparas at Ostfold Hospital Trust Fredrikstad, Norway and St Olav's Hospital, Trondheim University Hospital, Norway, and the results in this study will form the basis of the two identical randomized controlled trials (RCT) investigating the treatment efficacy of PFME two groups of postpartum women. Women reporting symptomatic anal incontinence at six months postpartum (2) and women who have sustained a traumatic 3rd or 4th degree tear of the sphincter ani muscles during delivery (3), respectively, are randomized to an intervention group receiving PFME treatment for six months, or a control group. All RCT participants will undergo examination of PFM strength and activity, as well as anal ultrasound prior to randomization and after the intervention period.

The recruitment in RCT ( 2) has been lower than expected (49/72). Due to financial reasons and problems with logistics and preparations for the main hospital (Ostfold Hospital Trust) moving into a new hospital, we were unable to extend the recruitment period in study 1. In RCT (3) AI was not an inclusion criterion. However, as both RCTs had the same outcome measure; anal incontinence, and a joint randomization process, stratified on hospital site and whether the participants had sustained an obsteric anal sphincter injury at delivery or not, the results from these studies will be reported together.

Eligibility Criteria:
Inclusion Criteria:

* primiparas aged 18 years or over with adequate knowledge of the Norwegian Language (prevalence study)
* Primiparas (Prevalence study and RCT 2)
* Women with obstetric anal sphincter injury with primary repair at delivery (RCT 3)

Exclusion Criteria all studies:

* Inadequate knowledge of the Norwegian language
* Diabetes mellitus
* Irritable bowel syndrome
* Neurological diseases such as Multiple Sclerosis
* Previous abdominal/colon surgery

In RCT studies:

Women who have already started pelvic floor muscle training postpartum due to severe anal incontinence or pelvic floor dysfunction
Lower Urinary Tract Symptoms After Intravesical Therapy

With this prospective, observational study, we would like to investigate the effect of instillation therapy using BCG or mitomycin C on short- and long-term irritative and obstructive lower urinary tract symptoms using validated questionnaires. The study will objectify the lower urinary tract symptoms and thereby provide better recommendations for therapy with mitomycin C or BCG.


Eligibility Criteria:
Inclusion Criteria:

* Urinary bladder carcinoma requiring instillation therapy
* Complete resection of the tumor
* No intravesical chemotherapy in the last 3 months

Exclusion Criteria:

* Patients who are unable to complete the questionnaires
* Patients who are not willing to participate
* Patients with contraindications for instillation therapy (allergic reactions, immunosuppression)
Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer

The purpose of this trial is to determine the safety of hMN14 at different dose levels in the treatment of either colorectal or breast cancer.


Eligibility Criteria:
Disease Characteristics:

* Histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma
* Measurable lesion diagnosed by CT scan
* Recurrent/metastatic disease considered surgically unresectable.

Prior/Concurrent Therapy:

* Chemotherapy: Patients who either have failed at least one regimen of standard systemic therapy, or are clinically asymptomatic and are not presently being considered for chemotherapy (Enrollment must occur at least 4 weeks beyond last treatment)
* Other: Prior treatment with investigational agents is excluded unless follow-up is completed and patient is off study

Patient Characteristics/Inclusion Criteria:

* Performance Status: Patients with a Karnofsky performance status \> 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months.
* Hematopoietic: WBC \>/= 3000 mm3, neutrophils \>/= 1500 mm3, platelets \>/= 75,000, CEA \< 300 ng/mL
* Hepatic: Serum bilirubin \</= 2.0 mg/dL, ALT \< 2.5 x IULN
* Cardiovascular: Patients with LVEF \>/= 40% by required MUGA/2D-ECHO study.
* Pulmonary: Patients with FEV1 \>/= 60% by required Pulmonary Function Tests
* Other: Patients agreeing to use a medically effective method of contraception during and for a period of 3 months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent. Patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.