cyrilzakka/clinical-trials huggingface dataset:
PBASE System Idiopathic Rhinitis Clinical Investigation

The purpose of this study is to evaluate the performance of the PBASE system, in terms of the efficacy of treatment in patients with idiopathic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent (\>12w) symptoms of idiopathic rhinitis dominated by nasal congestion (± secretion) for an average of at least 1 h per day for at least 5 days during a period of 14 days
* Having nasal congestion as major symptom, and a nasal congestion score of at least 2 (scale 0-3)
* Male or female 18 - 65 years
* Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history and physical examination.
* Willing and able to provide written informed consent prior to participation in the clinical investigation
* Willing and able to comply with all study related procedures

Exclusion Criteria:

* Patients with Allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or RAST
* Ongoing respiratory tract infection including nasal cavity at inclusion (treatment visit 1)
* Systemic steroid treatment less than 4 weeks before the inclusion in the study
* Patients with a history of nasal surgery like: septoplasty, cosmetic surgery, conchal surgery or any other nasal surgery except closed reposition for nasal fracture
* History of frequent nose bleeds or a condition that increases the risk of excessive bleeding
* Pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination
* Current malignancy of any kind
* Known allergy to polyvinylchloride or medicinal liquid paraffin
* Any disease, condition (medical or surgical) which, in the opinion of the investigator, might compromise the study results, or would place the subject at increased risk.
* Any implant with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulation, spinal stimulator, bone growth stimulator, or cochlear implant or any other implant in the head-, and neck region.
* Previous treated with radiation on the face, head or neck regions
* Female patients who are pregnant or nursing, or become pregnant at any time from inclusion of the study until end of the 8 week follow-up visit
* Female patients: unwilling to use adequate contraceptive from the signing of the informed consent until end of the 8 week follow-up visit
* Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer
Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia

This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA) who have had an inadequate response (or were intolerant to) treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be collected from each eligible participant initiated on tocilizumab treatment by their treating physician according to approved label for 6 months from start of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Severe RA.
* Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
* Participants initiating treatment with tocilizumab on their physician's decision (in accordance with the local label), including participants who started treatment with tocilizumab within the 8 weeks prior to the enrolment visit.

Exclusion Criteria:

* Tocilizumab treatment more than 8 weeks prior to the enrolment visit.
* Previous tocilizumab treatment in a clinical trial or for compassionate use.
* Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab.
* History of autoimmune disease or any joint inflammatory disease other than RA.
Study to Optimize Insulin Treatment by Basal Regimen With Insulin Glargine in Type-2-Diabetic Patients Previously Uncontrolled on Premixed Insulin

Primary objective:

To show an improvement in HbA1c control after 4 months of treatment with insulin glargine + Oral Anti Diabetic (OAD) in patients previously uncontrolled on premixed insulin (with OAD)

Secondary objective:

Improvement of Fasting blood glucose (FPG) after 4 months treatment (% of patients treated to target HbA1c ≤7.0% and/or FBG≤6.0mmol/L). Frequency of hypoglycemic episodes, quality of life with basal+ OAD regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus inadequately controlled at least 3 months on premixed insulin with 1 or 2 OADs
* 7.5 ≤ HbA1c ≤ 9.5%
* FPG ≥6.7 mmol/L
* History of Diabetes mellitus ≤10 years
* Premix insulin daily dosage ≤ 50 IU/Day

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Former treated on TZD
* Pregnancy / Lactation
* Creatine ≥1.5 mg/dl
* Hepatic disease, jaundice,or ALT/AST≥ 2.5 times of normal range
* Hormone therapy,
* Acute status of Diabetes complications
* Severe concomitant disease or complications with high risk of unexpected fatal events, like Myocardial Infarct, stroke, heart failure.
* Allergic to insulin glargine or any ingredient
* Participation in another clinical trial within 3 months

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Endothelial Function in Prehypertension

In the frame of this proposal investigators will test the hypothesis that high normal blood pressure (prehypertension; PreHT) induces systemic endothelial dysfunction and endothelial activation in both micro- and macrocirculation, reduces re-endothelialization potential of human endothelial progenitor cells (EPCs) and increases the level of endothelial extracellular vesicles (EVs), which are accompanied by increased oxidative stress level. Furthermore, initial vascular and left ventricle (LV) remodeling contributes to changes in systemic hemodynamics and may be influenced by altered regulatory role of renin-angiotensin system (RAS) and autonomic nervous system (ANS) in PreHT but otherwise healthy individuals. To distinguish high normal blood pressure effect from those considered normal or high, study will be performed in three groups of individuals: prehypertensive (BP 130-139/85-89 mmHg), hypertensive (stage I, BP 140-150/90-100 mmHg), and controls (BP less than or equal to 129/85 mmHg). Altogether, the impairment of normal vascular relaxation mechanisms, endothelial activation as well as vascular and LV remodeling could play crucial role in increased cardiovascular risk and CVDs incidence in PreHT individuals. Moreover, the prognostic significance of assessing endotehlial dysfunction in hypertension (as well as in PreHT) is yet to be established.


Eligibility Criteria:
Inclusion Criteria:

* adults of both sexes with normotensive, prehypertensive and grade I hypertension blood pressure values

Exclusion Criteria:

* cardiovascular diseases, but grade I hypertension (BP 140-150/90-100 mmHg)
* diabetes
* kidney disease
* cerebrovascular diseases
* peripheral artery disease
* taking oral contraceptives or any drugs that could affect the endothelium
Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol

The purpose of this study was to evaluate the safety and efficacy of domestic injection paclitaxel (albumin binding type) in patients with advanced digestive tract tumors,and to further explore the possible predictors of efficacy.In order to provide more effective chemotherapeutic drugs, prolong survival time and improve quality of life for patients with advanced digestive tract tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years with advanced esophageal cancer, gastric cancer, pancreatic cancer and gallbladder (duct) confirmed histologically by albumin paclitaxel chemotherapy regimen;
2. ECOG PS 0-2；
3. Expected survival time ≥3 months;
4. According to RECIST1.1, at least one measurable lesion exists；
5. The level of organ function must meet the following requirements（1）Blood routine examination standards must be met：HB≥90 g/L；ANC≥1.5×109/L； PLT≥80×109/L；（2）Liver function should meet the following criteria TBIL≤1.5×ULN；AST≤2.5×ULN；（3）Renal function should meet the following criteria: CrCL≥60 ml/min；

Exclusion Criteria:

1. Pregnant or lactating women；
2. Had a history of other primary malignancies within 5 years, with the exception of cured basal cell skin cancer and cured cervical cancer;
3. Active brain metastasis or severe disease;
4. Grade 1 peripheral neuropathy (judged according to NCICTC standard for adverse reactions);
5. Patients with allergy to research drugs, albumin or previous allergies;
6. Severe mental or neurological disorders affecting the presentation or observation of adverse reactions;
7. The investigator considers that there is any condition that may impair the subject or cause the subject to fail to meet or perform the study requirements.
Adrenergic Cholinergic Enteric Measures/Mapping

Patients seen who had autonomic and enteric profiling (Adrenergic, Cholinergic, Enteric Measures/Mapping=ACEM_ from 2012-2019 at the University of Louisville.

1. Patients seen who had autonomic and enteric profiling (Adrenergic Cholinergic Enteric Measures/Mapping=ACEM) from 2012-2019 at the U of Louisville.
2. Results of the physiologic measures of ACEM had the results recorded.
3. ACEM is compared to standardized gastric emptying values as the primary measure.
4. ACEM is also compared to metabolic measures of weight, height and thus BMI as a secondary measure.
5. ACEM is aloes compared with standardized gastrointestinal symptoms by a traditional patient recorded outcome as another secondary measure.

Other sites may be added if they have identical IRB and/or data sharing agreements with the University of Louisville.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the symptoms suggestive of autonomic and/or enteric disorders.

Exclusion Criteria:

* Anatomic obstruction of the GI tract
* Pregnancy
* Inability of patient or guardian to sign informed consent, if needed
* Psychiatric disorders precluding assessment and treatment of the patient's GI condition.
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis

Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects and subjects with stable cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

Part A

* Healthy male adults ≥18 and ≤50 years of age at screening.
* Baseline FEV1 80-120% of predicted at Screening.
* Oxygen saturation of ≥ 96% on room air as determined by pulse oximetry at Screening.
* Screening laboratory tests within normal limits.

Part B

* Female and Male subjects who are ≥18 years of age and a confirmed diagnosis of CF.
* FEV1 \>50% of predicted.
* Oxygen saturation of ≥ 94% on room air as determined by pulse oximetry at Screening.
* Stable CF pulmonary disease as judged by the Investigator.

Exclusion Criteria:

Part A

* Any history of any form of lung disease or any systemic disease that may affect the lung or pulmonary function.
* Former regular smoker or has smoked tobacco or cannabis products within the last 30 days.
* Any history of any form of liver disease, renal disease, cardiac disease, hematologic disease, neurologic disease, atopy or any chronic condition.
* Participation in one or more healthy subject studies within the prior 3 months.

Part B

* Participation in a clinical trial involving receipt of an investigational product within the 30 days prior to screening.
* Female subjects who are pregnant (a negative serum pregnancy test must be demonstrated at screening), have a positive pregnancy test, are lactating or who plan to become pregnant within 90 days after dosing.
* Subjects requiring supplemental oxygen.
* Hemoptysis of \>5 mL within 12 weeks of screening.
* Listed for organ transplantation.
Effects of an Intervention Program Based on Pain Education in Patients With Chronic Pelvic Pain

The purpose of this study is to obtain imaging biomarkers based on changes in activity patterns and changes in brain connectivity obtained with the analysis of functional magnetic resonance imaging (fMRI) and tractography that are related to chronic pelvic pain


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 55 years
* Chronic pelvic pain diagnosis
* Pain duration \> 6 months
* Average pain intensity ≥ 6 during the previous week

Exclusion Criteria:

* Suspected or knowledge of actual organic pathology that requires medical or surgical treatment
* Psychiatric illness: major depression, bipolar syndrome...
* Patients with significant cognitive deficits
* Have pacemaker, metal prostheses or hearing aids incompatible with MRI
* Severe traumatic brain injury
* Previous cranial surgeries
* History of alcoholism
* Do not sign informed consent
An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer. Data will be collected from female participants treated with trastuzumab according to the Summary of Product Characteristics and local protocols. Duration of observation for each participant is from therapy initiation until permanent discontinuation for any cause.


Eligibility Criteria:
Inclusion Criteria:

* HER2-positive breast cancer
* Treated with trastuzumab in accordance with Summary of Product Characteristics and local protocols
* Written informed consent to data collection

Exclusion Criteria:

* Any contraindication to trastuzumab
* Clinically relevant cardiovascular disorder or disease
Fecal Microbial Transplantation in Severe Alcoholic Hepatitis

1. A subtype of Alcoholic hepatitis (AH), named severe alcoholic hepatitis (SAH) is associated with high short-term mortality (J Hepatol, 2019)
2. The only SAH treatment option - corticosteroids (CS) - are often contraindicated or ineffective (STOPAH Trial)
3. New treatment modalities for remaining patients are much needed
4. Fecal microbial transplantation (FMT) is one of the promising therapies
5. Investigators aimed to see if FMT improves survival in patients admitted with SAH, not responding to-, or non-eligible for CS.

* FMT via upper GI tract is provided to CS non-responders (NR) or non-eligible (NE) adult patients hospitalized with SAH (determined by the Lille-model).
* Modified version of the Sarin FMT protocol is used with microbiota material procured from unrelated healthy donors.

Eligibility Criteria:
Inclusion Criteria:

* consenting, adult
* severe form of acute alcoholic hepatitis (SAH)
* non-responder to corticosteroids according to the Lille model
* patients with SAH not eligible for corticosteroids based on their contraindications

Exclusion Criteria:

* active infection
* presence of untreated large / high-risk / bleeding esophageal varices
* too sick for any therapy / futility (chronic extrahepatic organ failures, no potential for recovery, etc)
* malignancy except for hepatocellular carcinoma in Milan criteria
An Observational Study to Investigate the Role of B Cells in Multiple Sclerosis

Multiple sclerosis (MS) typically afflict young people in their twenties, when they start a career and establish a family. The disease thus imposes a severe impact on quality of life and heavy economic burdens on society. Critical barriers to progress in the field are the lack of knowledge of relevant immune cell subsets driving the pathology and the targets of the immune response within the central nervous system. In this project, we will test the hypothesis that a subgroup of MS patients is defined by a genetically determined B cell response against specific antigenic epitopes. The hypothesis is based on our recent, pioneering results showing that approximately half of MS patients have a restricted population of B cells in the cerebrospinal fluid defined by polymorphisms in the constant heavy-chain of the immunoglobulin B cell receptor, the G1m1 allotype. Here, we aim to characterize the G1m1 B cells, to disentangle the genetic basis of the B cell response, and to identify the molecular targets.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms and brain MRI scans strongly suggestive of multiple sclerosis according to the 2017 McDonald revisions
* Intrathecal immunoglobulin G synthesis
* Age \> 18 years

Exclusion Criteria:

* Treatment with immunomodulatory drugs
Efficacy and Safety of Sodium Heparin in Patients (Cristália)

The objective of this study is to verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the FICT;
* Patients of both sexes;
* Patients aged above 18 years;
* Patients with cardiac surgery and requiring movement; AND
* Extracorporeal.

Exclusion Criteria:

* Patients with hematological disorders that compromise the surgical changes (eg myeloproliferative syndromes, anemia Hb \<11.0 g / dL,
* Platelets \< 150,000 mm3);
* Patients with disorders of hemostasis (INR\> 1.40) (rTTPA\> 1.40);
* Patients with renal dysfunction (creatinine\> 1.50);
* Patients with deep hyperthermia;
* Liver disease (AST and ALT\> 2 times that of the reference value);
* Patients with a history of allergy to heparin or protamine;
* Patients with history of heparin-induced thrombocytopenia;
* Tables infection (eg endocarditis, infection of immune human (HIV), hepatitis B and C, septicemia and pneumonia);
* Reoperations;
* Use of antiplatelet (clopidogrel and ticlopidine) for less than 7 days;
* Use of acetylsalicylic acid is less than 5 days;
* Use of low molecular weight heparin for less than 24 hours; OR
* Use of non-fractioned heparin for less than 12 hours.
Does Eliminating Coffee Avoid Fibrillation?

Given both the increasing population impact of atrial fibrillation (AF) and the widespread consumption of coffee in society, determining an associated benefit or risk of coffee consumption on AF is of great clinical relevance. This pilot study will evaluate the effect of randomly assigning participants undergoing electrical cardioversion to coffee abstinence or coffee consumption over a 6 month period. This pilot study will provide the first, randomized evaluation of coffee on AF outcomes and will provide important information on whether or not coffee has any effect on AF recurrence.

The purpose of this study is to assess how abstinence of coffee compared to continued consumption affects recurrent atrial fibrillation (AF) following electrical cardioversion. As one of the most consumed beverages in the world, whether coffee has any effect on health outcomes is of considerable interest to physicians, scientists, and individual consumers. While significant data exist on the potential impact of coffee on many cardiometabolic parameters, there is conflicting data on any role of coffee on AF.

Most studies so far have been observational in nature, limiting how much insight there is on the role of coffee on AF. This study proposes to directly compare AF outcomes for patients with AF that abstain from coffee versus those that continue coffee consumption.

A total of 200 AF patients undergoing electrical cardioversion will be enrolled in this study (100 per arm), and followed for up to 6 months post cardioversion. Differences in AF recurrence, symptoms, and development/recurrence of other arrhythmias will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 21 years of age
* Sustained AF
* Planned/scheduled direct current electrical cardioversion
* Consumption greater than or equal to one cup of coffee per day sometime in the past 5 years
* Willing and able to comply with coffee abstinence or continuation
* Life expectancy of at least 1 year
* Willing and able to return and comply with scheduled phone follow up visits
* Willing and able to provide written informed consent

Exclusion Criteria:

* Established allergy or adverse reaction to coffee
* Stated inability to comply with coffee abstinence or continuation
* AF ablation in preceding 6 months or planned in next 6 months
* Recent cardiothoracic surgery in preceding 3 months
* Cardioversion for atrial flutter rather than AF
* Pregnancy or desire to get pregnant within next 6 months.
* Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study
* Any other criteria, which would make the patient unsuitable to participate in this study as determined by the Principal Investigator (e.g., an uncontrolled drug and/or alcohol addiction)