cyrilzakka/clinical-trials huggingface dataset:
Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

The purpose of this study is to determine the effective dose of the Aeris BLVR System in patients with advanced emphysema.

Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.

Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. This study will evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.

Eligibility Criteria:
Inclusion Criteria include:

* Clinical diagnosis of advanced emphysema
* Age \> 18 years at the time of initial presentation
* Clinically significant dyspnea (MRC Dyspnea \>/= 2)
* Laboratory tests within protocol-specified ranges
* Pulmonary function tests

Exclusion Criteria include:

* Alpha-1 protease inhibitor deficiency verified by a serum level of \<80mg% or knowledge of PI\*ZZ genotype
* Tobacco use within 16 weeks of the initial clinic visit
* Body mass index \< 15 kg/m2 or \> 35 kg/m2
* Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
* Allergy to fish or pork products or sensitivity to tetracycline
* FEV1 \<20% predicted with DLCO \<20% predicted or homogeneous disease
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain (MK-2295-005)

This study is being conducted to evaluate the safety and tolerability of the drug and to evaluate its efficacy compared to placebo and to ibuprofen in the treatment of postoperative dental pain in male patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients in generally good health who are scheduled to have two or more third molars removed, at least one of which is partially or completely embedded in bone and is a mandibular impaction

Exclusion Criteria:

* Patient has a temperature of 37.5C or greater prior to dosing
* Patient has participated in another clinical study within the last 4 weeks
Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population

The normal values of a Multichannel Intraluminal Impedance (MII)-pH study can vary between ages, gender, race and different values of body mass index (BMI). This fact can cause new modifications in the normal values such as making new scales for different age groups or BMI groups.

Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never experienced reflux related symptoms and are in between the same ranges of age and BMI of our gastroesophageal reflux disease (GERD) patient population.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults between the ages of 33-65
* BMI range of 23.9 - 38.9
* Ability to give consent to participate in study

Exclusion Criteria:

* History of extraesophageal reflux disease symptoms such as chronic or acute cough and/or throat clearing and /or non-cardiac chest pain.
* History of gastroesophageal reflux disease (GERD) such as heartburn and/or regurgitation.
* History of proton pump inhibitor (PPI) usage ten days prior to the procedure (MII-pH) or H2RA's two days prior to MII-pH and antacids usage on the procedure day.
* History of thoracic, gastric or esophageal surgery.
* Histories of Diabetes Mellitus, neurological disorders, gastrointestinal disease, taking medication that alter the intragastric acidity or esophageal motility.
* Pregnancy or nursing mothers.
* Alcohol consumption \>40g/day, smoking \>10cigarettes/day.
Welchol as Monotherapy for Type 2 Diabetes Mellitus

The current study investigates Welchol as monotherapy to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well tolerated and efficacious.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects \>= 18 years of age;
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol.
* Diagnosis of Type 2 Diabetes Mellitus;
* HbA1C \>= 7.5% and =\< 9.5 % at screening;
* Fasting C-peptide \>0.5 ng/mL at screening;
* Drug naïve (no prior treatment with OAD) or having received no pharmacologic therapy for diabetes for the 3 month period prior to screening;
* Clinically stable in regards to medical conditions other than type 2 diabetes;
* Concomitant medications must be at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period; and
* Fasting glucose =\< 240 mg/dL at randomization

Exclusion Criteria:

* A history of type 1 diabetes and/or a history of ketoacidosis;
* History of bowel obstruction;
* History of hypertriglyceridemia-induced pancreatitis;
* Fasting serum triglyceride concentrations \>500 mg/dL;
* History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal (GI) motility disorders, or major GI surgery;
* History of insulin use of \>= 2 weeks duration in the previous 3 months or a total of \> 2 months of insulin therapy at any time prior to screening;
* Two or more fasting self-monitored blood glucose (SMBG) levels \>240 mg/dL during the placebo lead-in period.
* Previous treatment with a bile acid sequestrant, including Welchol within the 3 months prior to screening;
* Body mass index (BMI) \>40 kg/m2;
* Weight loss \> 3% in prior 3 months; and
* LDL \<60 mg/dL.
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)

Hypofractionated radiosurgery with 5 fractions is considered standard of care for localized prostate cancer. The investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 3 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late GU and GI toxicity ≥ grade 2 after 1 year amounts to 8.4% and 1.3% and is significant lower than 16.4% and 5.7% currently.

Experimental radiosurgery of the prostate with 3 fractions each with 9.5 -10.5 Gy (total application rate of 28.5-31.5 Gy) based on risk grading.

Planned visits are: Baseline, visits at every radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).

Eligibility Criteria:
Inclusion Criteria:

* Localised, histopathologically confirmed Prostate Cancer (cT1-T2c N0 M0)
* Gleason-grade ≤7, ISUP Grade Group 1-3
* Guideline-based staging
* Age ≥ 18 years
* PSA \< 20 ng/ml
* Volume of the prostate \< 80 cm³
* IPSS-Score ≤ 12
* Written informed consent

Exclusion Criteria:

* History of prior pelvic radiotherapy
* Previous transurethral resection, laser enucleation or prostate ablation
* Contraindication to MRI or Fiducial marker implantation (e.g. gold allergy)
* Relevant comorbidity thought to adversely affect treatment compliance
* Legal incapacity or lack of informed consent
Prevalence of Echocardioghraphic and ECG Changes in Patients With Acute Pancreatitis and Its Impact on Outcome.

Cardiovascular system involvement with acute pancreatitis has been described before in the form of ECG changes and echocardiographic findings. However the correlation between these changes and the outcome of acute pancreatitis has not been and whether they can be used to predict mortality in these patients has been controversial.In the current study our aim is to detect echocardioghraphic and ECG changes in acute pancreatitis and investigate the significance of these changes on prognosis.

Acute pancreatitis is a relatively common disease with significant morbidity and mortality. About 75% of pancreatitis is caused by gallstones or alcohol. The Atlanta classification of acute pancreatitis has been used to differentiate between severe and mild cases of acute pancreatitis. According to this classification, patients are diagnosed with severe acute pancreatitis if they show evidence of organ failure, Local complications (eg, necrosis, abscess, pseudocyst), Ranson score of 3 or higher or APACHE score of 8 or higher. Severe acute pancreatitis has a wide range of affection on nearly all body systems with various degrees of affection than affect both the clinical picture and the prognosis of the disease. the cardiovascular system involvement has been described before ,in the form of ECG changes (sinus tachycardia, arrhythmias, conduction abnormalities.. ) and echocardiographic findings (diastolic,systolic or combined dysfunction, wall motion abnormalities, pericardial effusion..). However the correlation between these changes and the outcome of acute pancreatitis has not been and whether they can be used to predict mortality in these patients has been controversial.In the current study our aim is to detect echocardioghraphic and ECG changes in acute pancreatitis and investigate the significance of these changes on prognosis.

Eligibility Criteria:
Inclusion Criteria:

* all patients with acute pancreatitis aged more than 18 yrs admitted to Al-raghy ICU of all etiologies

Exclusion Criteria:

* patients less that 18 years
* patients above 80 years
* patients with known cardiac disease
* patients with pre-existing diabetes, chronic renal failure or malignancy.
* patients with underlying chronic pancreatitis
0,9% NaCl Effect on Kidney Function and Glycocalyx in Patients Operated on for Primary Hiparthrosis

The purpose of this study is to determine if chloride is nephrotoxic using 0,9% saline versus Plasma-Lytein in patients having primary hip replacement surgery. The outcome is found measuring bio markers, vasoactive hormones and salt regulation. And to measure syndecan as a marker for glycocalyx degradation.

Hypothesis:

Chloride has a nephrotoxic effect, which can be shown partially by measuring bio markers for tubular injury in urine, partially by the changes in tubular transport of sodium and water in different parts of the nephron. This can be demonstrated using isotone sodium solutions with a lower chloride concentration in this study plasma-lyte versus normal isotone saline.

Klorid has a toxic effect on the glycocalyx layer and leads to a rise in syndecan 1 and simultaneously a change in Salt Blood Test either by a direct simulation and ANP levels in plasma or as a consequence of the hyperchloremic acidosis. This can be demonstrated using isotone sodium solutions with a lower chloride concentration in this study plasma-lyte versus normal isotone saline.

Purpose:

The purpose is to observe changes in bio markers, vasoactive hormones and salt regulation in patients randomized to either 0,9% saline or plasma-lyte undergoing primary uncemented hip replacement surgery.

Design:

40 patients undergoing primary uncemented hip replacement surgery will be randomized to either 0,9% saline or plasma-lyte for standard fluid resuscitation and blood loss replacement in this controlled and double blinded study. The patients will deliver a 24 hour urine sample before surgery and approximately 10 days after. From the start of the surgery and to the day after all urine will be collected and blood samples will be taken.

Perspective:

If chloride is found to be nephrotoxic it could lead to a general change in fluid resuscitation recommendations in critically ill patient, patients with kidney disease and patients undergoing surgery. It will also expand our knowledge about the permeability of the blood vessels.

Eligibility Criteria:
Inclusion Criteria:

* Indication for uncemented primary hiparthroplasty
* age \< 60

Exclusion Criteria:

* Blooddonation or transfusion during the last month
* Not willing to participate
* estimated GFR below 30ml/min
* type 1 diabetes
Spatial Radiogenomics of Ovarian Cancer

The biological spatial and temporal heterogeneity of High Grade Serous Ovarian Carcinoma (HGSOC) severely impacts the effectiveness of therapies and is a determinant of poor outcomes.

Current histological evaluation is made on a single tumour sample from a single disease site per patient thus ignoring molecular heterogeneity at the whole-tumour level, key for understanding and overcoming chemotherapy resistance. Imaging can play a crucial role in the development of personalised treatments by fully capturing the disease's heterogeneity.

Radiomics quantify the image information by capturing complex patterns related to the tissue microstructure. This information can be complemented with clinical data, liquid biopsies, histological markers and genomics ("radiogenomics") potentially leading to a better prediction of treatment response and outcome. However, the extracted quantitative features usually represent the entire tumour, ignoring the spatial context.

On the other hand, radiomics-derived imaging habitats characterize morphologically distinct tumour areas and are more appropriate for monitoring the changes in the tumour microenvironment over the course of therapy. In order to successfully incorporate the habitat-imaging approach to the clinic, histological and biological validation are crucial. However, histological validation of imaging is not a trivial task, due to issues such as unmatched spatial resolution, tissue deformations, lack of landmarks and imprecise cutting. Patient-specific three-dimensional (3D) moulds are an innovative tool for accurate co-registration between imaging and histology. The aim of this study is to optimize and integrate such an automated computational 3D-mould co-registration approach in the clinical work-flow in patients with HGSOC. The validated radiomics-based tumour habitats will also be used to guide tissue sampling to decipher their underlying biology using genomics analysis and explore novel prediction markers.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected HGSOC scheduled to undergo primary debulking surgery (PDS) or interval debulking surgery (IDS) will be recruited in the study. Prior histopathological confirmation of HGSOC will be required for IDS. The PDS cases without prior histological diagnosis will be selected on the basis of clinical suspicion (elevated serum CA125 and CT imaging).

Exclusion Criteria:

* Patients less than 18 Years old
* Pregnancy
* Non-serous high grade epithelial ovarian cancer (serous low grade, mucinous, clear cell carcinoma, endometrioid or non-epithelial ovarian cancer)
* Early stage disease (I and II stage)
* CT or MRI scan not available
Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease

Adalimumab, a treatment which blocks tumor necrosis factor (TNF), was tested to see if it changed levels of urine biomarker levels, tissue inhibitor of metalloprotease-1 (TIMP1), and monocyte chemoattractant protein-1 (MCP1). Results may help develop individualized treatment options for future patients with TNF-driven focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD).


Eligibility Criteria:
Inclusion Criteria:

* Kidney biopsy confirmed Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
* For Minimal Change Disease patients only, history of resistance to corticosteroid therapy
* Increased urinary excretion of biomarkers of Tumor Necrosis Factor (TNF) activation (MCP1/Cr and/ or TIMP1/Cr) at study screening
* eGFR\>30 ml/min/1.73 m2 at screening
* Urine protein:creatinine ratio ≥1.5 g/g at screening
* Weight \>15 kg
* Stable therapy with angiotensin converting enzyme inhibitors, angiotensin receptor blockers, and oral immunosuppression agents for at least 30 days prior to enrollment
* Birth control use in females of child bearing potential
* Informed consent and assent if applicable

Exclusion Criteria:

* Kidney or other solid organ or bone marrow transplant recipient
* Allergy or intolerance to investigational agent
* Secondary Focal Segmental Glomerulosclerosis (FSGS)
* Severe obesity
* Live virus vaccine in the past 3 months
* Malignancy, current or in the past 5 years
* Active local or systemic bacterial, fungal or viral infection
* Active or latent Hepatitis B, Hepatitis C, HIV, or tuberculosis
* History of demyelinating disease, e.g. Multiple Sclerosis or Guillain-Barre
* History of heart failure
* Active liver disease
* Systemic lupus erythematosus or ANA \> 1:80
* History of inflammatory bowel disease, e.g. ulcerative colitis or Crohns disease
* Cyclophosphamide in past 90 days, Rituximab in the past 180 days
* Pregnancy or nursing
* Blood white blood cell count \<4,500/mm3; Hg \<9 g/dL; Platelet count \<150,000/mm3 at enrollment. - Use of an erythropoiesis stimulating agent will not be an exclusion criterion.
* Concurrent use of interleukin-1 antagonist (Anakinra), other TNF blocking agent, methotrexate or abatacept
* Diabetes Mellitus
Knee Joint Icing and Knee-extension Strength

With this study the investigators wish to (1) investigate the acute effect of knee joint icing on knee-extension strength shortly after total knee arthroplasty (TKA); and (2) investigate the acute effect of knee joint icing on knee pain, knee joint circumference and functional performance shortly after TKA.

As knee joint icing had no acute effect on knee-extension strength in the present study, prolonged icing may have an effect on one or more of the parameters, and further studies are needed to determine the potential beneficial effects of cooling after TKA.

Eligibility Criteria:
Inclusion Criteria:

* primary unilateral total knee arthroplasty

Exclusion Criteria:

* inability to speak and understand Danish
* inability to perform the measurements due to other diseases
Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery

The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a retrospective, single arm, multi-center trial. Up to 100 patients at up to 10 centers will be enrolled. Angiographic assessment of vessel patency at immediate post-procedure as measured by TIMI scores and procedural serious adverse events are assessed and recorded.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of a peripheral or visceral arterial occlusion or embolus (TIMI 0-1) prior to treatment.
* Treatment with components of the Penumbra and/or Indigo System.

Exclusion Criteria:

* Participation in another clinical investigation that may confound the results of the study.
Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy

Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.

The primary objective of this study is to evaluate the hypothesis that implantable cardioverter defibrillator (ICD) therapy would decrease the risk of death from any cause in comparison to optimal heart failure (HF) care without ICD insertion in patients with NIDCM, left ventricular ejection fraction (LVEF) ≤35% and presence of myocardial fibrosis on cardiac magnetic resonance (CMR) imaging.

Eligibility Criteria:
Inclusion Criteria:

* NIDCM (idiopathic or familial)\*
* LVEF ≤35% and presence of fibrosis on CMR
* Diagnostic CMR scan
* Age ≥18 years
* Written informed consent
* Ability to give informed consent

Exclusion Criteria:

* ICM \[previous myocardial infarction, previous percutaneous coronary intervention\]
* Other cardiomyopathies (hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathies \[e.g. cardiac amyloidosis, cardiac sarcoidosis, hemochromatosis and iron overload cardiomyopathy\], left ventricular non-compaction cardiomyopathy, reversible cardiomyopathies \[Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy\].
* Myocarditis
* Contraindication for CMR at study entry (including severe claustrophobia, pacemaker or ICD, metallic cerebral or intracranial implants, known allergy to gadolinium)
* Severe renal insufficiency (creatinine clearance \<30 mL/min)
* Current pacemaker or defibrillator in situ
* Current indication for device therapy (e.g. secondary prophylaxis after aborted SCD)
* Renal impairment defined as an eGFR \<30 milliliters
* Age \<18 years
* Patients presenting with pregnancy
* Patients without informed consent
* Participation in another randomized trial
* Life expectancy \<2 years
Apatinib and Etoposide Capsule Versus Apatinib in Patients With Platinum Resistant Ovarian Cancer

The study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) or apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with apatinib (375 mg qd).


Eligibility Criteria:
Inclusion Criteria:

1. Female patients, ≥18 Years.
2. Epithelial ovarian, fallopian tube or primary peritoneal cancer
3. Platinum refractory and resistant disease (disease progression during platinum therapy or within \<6 months of platinum therapy)
4. EOCG performance status of 0-2

Exclusion Criteria:

1. Non-epithelial tumours
2. Ovarian tumours with low malignant potential
3. Surgery (including open biopsy) within 4 weeks before starting study therapy or anticipated need for major surgery during study treatment
4. Evidence of rectosigmoid involvement by pelvic examination, bowel involvement on computed tomography, or clinical symptoms of bowel obstruction.
The Effect of Terlipressin on Intesitnal Function in Septic Shock Patients

Terlipressin becomes a vasopressin for septic shock. But some studies found it may lead to severe intesitnal complications such as intestinal ischemia. The investigators study was designed to find the effect of terlipressin on intestinal function in septic shock patients.


Eligibility Criteria:
Inclusion Criteria:

* septic shock

Exclusion Criteria:

* shock due to other reasons
* diagnosited intesitinal ischemia