cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. The safety and tolerability of canagliflozin will also be assessed.

This study will be a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), active-controlled (one of the treatments is an established effective treatment for type 2 diabetes mellitus), parallel-group (each group of participants will be treated at the same time), 5-arm (groups), multicenter study. Approximately 1,200 participants will be randomly assigned to the 5 treatment arms in a 1:1:1:1:1 ratio for 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise
* Not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (HbA1c) of more than or equal to 7 percent and less than or equal to 12.5 percent
* Have a screening visit HbA1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory
* Must have a fasting plasma glucose of less than or equal to 300 mg/dL (16.7 mmol/L) prior to randomization
* Must have a fasting fingerstick glucose of greater than 120 mg/dL (6.7 mmol/L) performed at home or at the study center prior to randomization

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* Fasting C-peptide less than 0.70 ng/mL (0.23 nmol/L) in participants for whom the investigator cannot reasonably exclude T1DM based upon clinical evaluation
* Repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dL (16.7 mmol/L) prior to randomization, despite reinforcement of diet and exercise counseling
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
* Has history of, or currently active, illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent before initiation of any study-related procedures.
* The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
* Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug.
* Outpatient status at enrollment and randomization.

Exclusion Criteria:

* Patients with a lifetime history of bipolar disorder; psychotic disorder or post-traumatic stress disorder.
* Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
* Patients with any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
* History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury.
* Pregnancy or lactation.
Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)

People with breast cancer often experience many short and long-term side effects as a result of both the cancer and the necessary treatments.

Receiving extra assessments and care from teams of multiple health professionals has been shown to be helpful for people with other health problems, such as heart disease. These 'multidisciplinary' teams may include nurses, doctors, pharmacists, dietitians, exercise therapists, counselors, and other specialists. Currently, the investigators do not know if receiving extra assessments from a multidisciplinary team is helpful for people receiving cancer treatment.

In this study, the investigators hope to learn the effect of extra assessments and early interventions from teams of health care professionals in people diagnosed with cancer, during and after the treatment period.

After initial assessments, participants will be randomized to multidisciplinary team intervention or usual care.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed malignancy (breast or lymphoma);
* scheduled to receive anthracycline and/or trastuzumab-based chemotherapy;
* age ≥ 18 years;
* willing to attend follow-up visits.

Exclusion Criteria:

* physical disability preventing exercise testing or DEXA scan;
* psychiatric disease or disorder precluding informed consent;
* participation in other cardiotoxicity or exercise intervention study;
* contraindication to anti-cancer therapy, including known heart failure, cardiomyopathy, or baseline LVEF \< 50%;
* previous anthracycline or trastuzumab-based therapy;
* previous radiotherapy to thorax.
HPV Prevalence in Transpersons - a Prospective Study

In this study, Human Papilloma Virus (HPV) prevalence will be determined once in the urine of 200 trans people. In addition, subjects will be asked to complete a questionnaire about their sexual orientation, which is adapted from the largest published study.

All transpeople who visit the outpatient clinic are asked to participate in the study. After being informed and signing the Informed Consent Form, the subjects are asked to give first-void urine and fill out the survey. The urine samples are sent pseudonymously to the University of Ljubljana for analysis. The subjects will be informed about their results within 3 weeks.If the result is positive, the subjects will be offered voluntary further care in our HPV outpatient clinic. However, this will take place outside the study. The data collected there can be used for further analyses.

Eligibility Criteria:
Inclusion Criteria:

* Transpeople
* Age over 18 years
* Sufficient knowledge of German

Exclusion Criteria:

* Age under 18 years
* Insufficient knowledge of German
Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.

An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as First line Treatment in Caucasian Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic non-small cell lung cancer (i.e. cancer that has spread from where it started) which is EGFR mutation positive
* Caucasian female or male patients aged 18 years or over
* Measurable disease, i.e. at least one lesion, not previously irradiated, as ≥ 10 mm in the longest diameter (≥ 15 mm in short axis for lymph node )

Exclusion Criteria:

* Prior adjuvant chemotherapy or other systemic anti-cancer treatment less than 6 month, or palliative radiotherapy less than 4 weeks prior to start of study treatment.
* Brain metastases or spinal cord compression, unless treated and stable without steroids
* Any clinically significant illness, which will jeopardize the patients' safety and their participation in the study.
Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Non-small lung cancer (NSCLC) is the leading cause of death in the world. Brain metastases are a frequent complication of NSCLC, especially in lung adenocarcinoma. 30-50% or more these patients will develop brain metastases at first time or during the treatment. Limited treatment options, whole brain radiotherapy (WBRT) combined with or without stereotactic radiosurgery (SRS) as the primary treatment approach, are available for brain metastases patients with poor survival. So the availability of effective therapies are therefore of great importance. Currently, two agents (erlotinib and pemetrexed) are reported more effective in lung adenocarcinoma patients with brain metastases. The heterogeneity of NSCLC tumors provides a strong rationale for using combination therapy with targeted agents that have different mechanisms of action, moreover different combination offering synergistic effects. So we investigate if erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Eligibility Criteria:
Inclusion Criteria:

1. Histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases
2. 18 years or older
3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 3 (poor PS caused by neurological symptom)
4. Appraisable intracranial disease, the presence of at least one lesion, and the longest diameter \> 5 mm by brain MRI
5. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L
6. Total bilirubin 1.5 x upper limit of normal (ULN)
7. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases
8. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
9. If received brain radiotherapy, patients included at least 8 weeks after the end of radiotherapy.

Exclusion Criteria:

1. Mixed non-adenocarcinoma cell lung cancer histology
2. Previous treatment with pemetrexed or tarceva
3. Be allergic to pemetrexed or tarceva
Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19

The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19.

This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent prior to performing study procedures unless they have a legally authorized representative (LAR)
* Confirmed coronavirus (SARS-CoV-2) infection
* Currently hospitalized or anticipated hospitalization requiring supplemental oxygen

Exclusion Criteria:

* In the opinion of at least two investigators, unlikely to survive for \>48 hours from screening
* Concurrent enrollment in a clinical trial with a cytokine inhibitor (targeting interleukin-6 (IL-6), Interleukin-6 Receptor (IL-6R), IL-1, or Janus kinase). Use of remdesivir is permitted.
* Currently on invasive mechanical ventilation.
* Hypotension defined as systolic blood pressure \< 90 mmHg on two sequential readings at least 4 hours apart
* Pregnant or breastfeeding
* Concurrent dual antithrombotic therapy (aspirin or P2Y12 inhibitor plus anticoagulation to treat deep venous thrombosis or pulmonary embolism (single antiplatelet or anticoagulant agent at prophylaxis or therapeutic dose is permitted)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times upper limit of normal, hemoglobin \< 8 grams per deciliter (g/dL), or platelets \<50,000 per cubic millimeter (mm3)
* History of recent major bleeding, defined in accordance with the criteria of the International Society on Thrombosis and Hemostasis (ISTH).
* Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
User Surveillance in Ulcerative Colitis

The aim of the non-interventional study is to document the daily doses in acute and remission therapy, the frequence of doses (1, 2, 3 or 4 times daily), when rectal dosage forms are added and, when and how long steroids are given.


Eligibility Criteria:
Inclusion Criteria:

* therapeutic need according to SPC
* written informed consent

Exclusion Criteria:

* contraindications according to SPC
Study of Rapastinel as Monotherapy in Patients With MDD

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
* Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
* Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
* If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria:

* DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
* Lifetime history of meeting DSM-5 criteria for:
* Schizophrenia spectrum or other psychotic disorder
* Bipolar or related disorder
* Major neurocognitive disorder
* Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
* Dissociative disorder
* Posttraumatic stress disorder
* MDD with psychotic features
* Significant suicide risk, as judged by the Investigator
Optimum Hand Position During Cardiopulmonary Resuscitation

The almost evidences of the optimal hand position during compression had been based on chest computed tomography (CT) or chest plain films of patients for investigating the effective location for compressing the left ventricle of the heart during cardiopulmonary resuscitation (CPR).

However every study was conducted at full inspired state of respiration. A prospective cohort study to evaluate the proper hand position during CPR based on expired respiratory state CT as the health screening would be needed.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* no history of heart or lung disease
* no history of chest or abdominal surgery

Exclusion Criteria:

* abnormal findings in LDCT, which might influence inspiration or expiration, were excluded after image interpretation by the board certified radiologists
Erector Spinae Plane Block Versus Paravertebral Block for Analgesia After Cardiac Surgery (PEPS)

The purpose of this randomized double-blind study is to compare the analgesic efficacy of the bilateral Erector Spinae Plane (ESP) block versus the bilateral Thoracic Paravertebral block (TPVB), by ultrasound-guided single injection in patients who underwent sternotomy for cardiac surgery.

Cardiac surgery causes moderate to severe postoperative pain during the first 24 - 48 post-operative hours. This pain is greatly increased by mobilization (respiratory physiotherapy) and leads to the consumption of morphine.

Appropriate analgesia, along with a reduction in morphine consumption are important factors in reducing morbidity after cardiac surgery and allow better postoperative rehabilitation.

Recently, the concept of multimodal analgesia has become established, which corresponds to ensuring optimal analgesia through the use of non-morphine drugs associated with locoregional analgesia.

During cardiac surgery, Paravertebral block (TPVB) technique is the first line of reference in our establishment. Lately, a new approach of blocking the intercostal nerves called Erector Spinae Plane block (ESP) has been discovered. It is a technique that seems simpler and safer than TPVB.

Until now, the analgesic efficacy of the ESP block compared to TPVB after cardiac surgery by sternotomy has never been studied.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing any (scheduled) surgery of the heart (valve or coronary surgery) via a median sternotomy
* Physical status classification (ASA) ≤3
* Patients benefiting from a Social Security scheme or benefiting from it through a third party

Exclusion Criteria:

* Emergency cardiac surgery
* Exclusion criteria related to cardiac surgery with thoracotomy, occurrence of aortic dissection, redo surgery.
* Aortic counterpulsation
* Preoperative cardiogenic shock
* LVEF\< 30%
* Severe preoperative chronic or acute renal failure with creatinine clearance less than 30 mL / min according to the MDRD formula
* Pre-existing psychiatric pathology, including addiction to opioids
* Physical or intellectual incapacity to use a PCA
* Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opioids)
* Contraindication for performing the paravertebral block and Erector of the spine (ESP): Infection at the site of injection, severe hemostasis disorder, thoracic spinal pathology making the procedure difficult or dangerous to operate
* Obese patient (BMI\> 30kg / m2) with poorly perceived thoracic spinous processes.
* vulnerable patients(Pregnant or breastfeeding women, persons benefiting from enhanced protection, namely persons deprived of their liberty by a judicial or administrative decision, adults under legal protection).
Efficacy of NIV Masks in COPD

A randomized controlled pilot study to compare the efficacy and tolerability of a two different NIV masks on carbon dioxide in participants with stable chronic obstructive pulmonary disease (COPD) with chronic type II respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* A doctor's diagnosis of COPD
* PtCO2 ≥45mmHg on transcutaneous monitor at baseline measure
* Oxygen saturation measured by pulse oximetry (SpO2) ≥85%
* Fits the study mask
* Can tolerate the therapy

Exclusion Criteria:

* FEV1/FVC ≥70%
* Body mass index \>35
* Hypercapnia considered to be primarily due to Obesity Hypoventilation syndrome and/or Obstructive Sleep Apnea
* Any condition which makes NIV contra-indicated as per BTS guidelines based on clinical judgement
Correlation Between Laboratory Markers and Origin of New Brain Ischemic Lesions After Carotid Stenting

New brain ischemic lesions are detected in about 50% of patients undergoing carotid artery stenting (CAS). The aim was to assess correlation between selected laboratory markers and occurrence of new brain infarctions after CAS.

Methods: All consecutive patients 1) with internal carotid artery stenosis \>70%, 2) indicated to CAS, 3) with signed informed consent were enrolled to the prospective study during 16 months. All patients used dual antiplatelet therapy (acetylsalicylic acid \[ASA\] 100 mg + clopidogrel 75 mg per day) at least 7 days before CAS. Neurological examination and brain magnetic resonance imaging (MRI) were performed before and 24 hours after CAS in all patients. Venous blood samples were collected within 24 hours before CAS in all patients: hematology + reticulocytes, coagulation markers (PT, APTT, INR, Fbg, Clauss), vWF antigen, PAI-1 activity, PAI-1 polymorphism 4G/g, Multiplate (ASA and clopidogrel resistance test). Blood samples for the assessment of anti Xa activity were collected during CAS. T-test was used for statistical evaluation.

Eligibility Criteria:
Inclusion Criteria:

patients

1. With internal carotid artery stenosis \>70%
2. Indicated to CAS
3. With signed informed consent. Able to use (acetylsalicylic acid \[ASA\] 100 mg + clopidogrel 75 mg per day) at least 7 days before CAS

Exclusion Criteria:

* Contraindication for magnetic resonance imaging
Cyclophosphamide Therapy for Refractory Antibody-Mediated Rejection (AMR) in Kidney Transplants

The study hypothesis is that short-term low dose cyclophosphamide therapy will be effective in resolving inflammation in patients with late phase antibody-mediated rejection refractory to current standard of care treatment.

There is no consensus on the optimal treatment of de novo donor specific antibody-mediated rejection. Optimizing baseline immunosuppression (calcineurin inhibitor (CNI), anti-proliferative agent, and anti-inflammatory) is considered foundational but is insufficient. Pulse steroids are routinely used. A number of immunosuppressive approaches have been tried in uncontrolled trials. The strongest evidence, at least for early antibody-mediated rejection (\< 6 months from transplant), exists for plasmapheresis, with or without low dose IVIg, or high dose IVIg alone. However, as noted in a recent FDA workshop, "while the literature suggests that \[these agents\] have evidence of efficacy for the management of acute antibody-mediated rejection, and could be considered as standard of care, treatment regimes have not been standardized or optimized." Moreover the evidence supporting efficacy of this approach in late, as opposed to early antibody-mediated rejection is distinctly lacking.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a living or deceased donor kidney transplant
* Failed current standard of care for late antibody-mediated rejection
* Persistent de novo donor specific antibody and a concurrent biopsy with histologic evidence of acute antibody-mediated inflammation
* Adults with reproductive potential must agree to use approved methods of birth control while in the study

Exclusion Criteria:

* Leukopenia (WBC) \< 3.0 x 109/L
* Creatinine Clearance less than or equal to 25 ml/min/1.73m2
* HCV or HBV positive
* BKV or CMV viremia assessed by PCR
* Any active infection
* Use of other investigational drugs within 4 weeks of study
* Pregnancy/breast feeding/unwilling or unable to take birth control
* Active malignancy
* de novo DSA occurring equal to or greater than15 years after kidney transplant
* Screening biopsy with equal to or greater than cg2 on Banff criteria
* Cumulative/lifetime dose of cyclophosphamide, including anticipated total study dose (calculated according to Creatinine Clearance and mg/kg/day) equal to or greater than 36 g.
* Any condition that, in the opinion of the investigator, would pose risk to the subject's safe participation in the study