cyrilzakka/clinical-trials huggingface dataset:
Chidamide Combined With VDDT Regimen in the Relapse and Refractory Diffuse Large B Cell Lymphoma

This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide combined with VDDT(vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide) in relapsed and refractory patients with diffuse large B-cell lymphoma(DLBCL).

There are one third of diffuse large B-cell Lymphoma patients suffering relapse and refractory, which are the major cause of death among these patients. Vinorelbine，liposomal doxorubicin，mitoxantrone, dexamethasone and thalidomide have been used in the therapy of patients who failed with Second-line treatments in our center. This regimen is well tolerated but the effect needs to be improved. Chidamide，a histone deacetylase inhibitor has been approved for the treatment of refractory T-cell lymphoma in China. The goal is to assess the efficacy and safety of chidamide combined with VDDT（vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide） in relapse and refractory patients with diffuse large B-cell Lymphoma.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as diffuse large B-cell Lymphoma based on the 2008 WHO classification of tumors of haematopoietic and lymphoid tissues
2. Failed with second-line therapy
3. Having at least one measurable lesions
4. Age between 18 to 75 years old
5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1
6. Neutrophils more than 1.5\*10\^9/L; Platelets more than 90\*10\^9/L Hemoglobin: more than 90g/L.
7. Life expectancy no less than 3 months
8. No receiving chemotherapy in 4 weeks before enrollment
9. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Pregnant ，lactating and patients at reproductive age who refuse to practice contraception
2. QTc prolonging \>450ms，ventricular tachycardia，atrial fibrillation，cardiac conduction block， myocardial infarction in less than 1 year， congestive heart failure，coronary heart disease which needs medication.
3. Organ transplant recipients
4. Active bleeding
5. Thrombus，embolism，cerebral hemorrhage，cerebral infarction
6. Important organ operation in less than 6 weeks
7. Abnormal liver function（Note：total bilirubin \>1.5 times the upper limit of normal，AST or ALT \>2.5 times the upper limit of normal （Note：5 times the upper limit of normal for patients with liver involvement）），abnormal renal function（Note：serum creatinine \>1.5 times the upper limit of normal），fluid and electrolyte disorders
8. Mental illness or unable to sign the informed consent
9. Drug addiction history or alcoholism which may interfere the experimental results.
10. Researchers determine unsuited to participate in this trial
11. Known allergy to any kind of study drugs
Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers

Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on renal function and perfusion in 16 healthy subjects.

Analysis of the effect of i.v. VAS203 on renal function and perfusion in healthy subjects.

Primary objective:

Possible adverse effect of VAS203 on the Renal Plasma Flow (RPF) and the Glomerular Filtration Rate (GFR) during and after 6 hours of constant-rate iv. infusion of 10 mg/kg VAS203.

Secondary objective:

To analyse the effects of VAS203 on

* filtration fraction
* hemodynamics (afferent and efferent resistance, intraglomerular pressure)
* markers of kidney injury and renal function
* systolic, mean and diastolic brachial blood pressure
* Plasma Pharmacokinetic of VAS203 and its first metabolite.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent in writing available.
2. Willing and able to comply with all requirements of the study.
3. Male, 18 and 45 years (inclusive).
4. Subject has a body weight between 60 kg and 100 kg, extremes included.
5. BMI 18 to 27 kg/m2.
6. Non-smoker
7. Serum creatinine within reference range (≤1.2 mg/dL) and Cockroft-Gault Clearance \> 90 ml/min
8. Good general health as judged by the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure and pulse rate) and clinical laboratory parameters (clinical chemistry, hematology, and urinalysis)

Exclusion Criteria:

1. Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgment).
2. Serum glutamate oxaloacetate transaminase or glutamate-pyruvate transaminase \> 2-times above the upper limit of normal range.
3. Subject with Cockcroft-Gault clearance \< 90 ml/min.
4. Clinically significant history of cardiovascular disease or any known present cardiovascular disease.
5. History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
6. Office blood pressure at screening higher than 160/100 mmHg, or lower than 95/55 mmHg.
7. Office heart rate at screening after at least 5 minutes outside the range of 50- 99 beats per minute (inclusive).
8. Concomitant use of OTC medication within 1 week prior to dosing, except use of paracetamol (up to 2 g/day).
9. Participation in any other clinical study within 30 days prior to inclusion in this -
Institut Paoli Calmettes Acute Leukemia Database

Database of Institut Paoli-Calmettes patients diagnosed with Acute Leukemia


Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of acute leukemia

Exclusion Criteria:

* Non applicable
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System

The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial aneurysms.

The data will be collected in consecutive subjects treated with the commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CORDIS ENTERPRISE™ VRD during the index procedure. While only limited inclusion or exclusion criteria are specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up up to 6 months. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the VRD placement, coiling procedure, application of antiplatelet medication and any other medical therapy to be provided according to local usual practice.

Eligibility Criteria:
Inclusion Criteria:

* The subject must be \>= 18 years of age and less than 80 years.
* Diagnosis of a ruptured (Hunt and Hess Grade I - III) or unruptured intracranial aneurysm at the time of the treatment
* Subject (or his/her legal representative) provides written informed consent for the use of his/her peri-procedural and follow-up data

Exclusion Criteria:

* Diagnosis of Hunt and Hess Grade IV or V subarachnoid hemorrhage at the time of the treatment
* Severe co-morbidity associated with a life-expectancy of less than six months
* Poor neurological status at baseline
* Known allergies to Nitinol metal
* Known allergies to aspirin, heparin, ticlopidine, or clopidogrel or unable or unwilling to tolerate therapy
* Participation in an investigational drug or another device study is only allowed after written approval of the coordinating investigator or Cordis Medical Monitor.
* Implantation of an intracranial stent associated with the symptomatic distribution within 12 weeks prior to the index procedure
* Implantation of carotid stent associated with the symptomatic distribution within 12 weeks prior to the index procedure
* Atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
Postpartum Urinary Retention With Essential Oils (PURE)

The purpose of this study is to examine the effectiveness of peppermint oil to promote voiding and reduce urinary catheterization among postpartum women.


Eligibility Criteria:
Inclusion Criteria:

* postpartum patients at Mount Carmel East, Mount Carmel West, and Mount Carmel St. Ann's Hospital
* 18 years or older
* able to read and understand English
* unable to spontaneously void within 6 hours after vaginal delivery or within 6 hours after straight catheter or within 6 hours after catheter removal for cesarean delivery.

Exclusion Criteria:

* patients who have an allergy to peppermint oil
* patients who have asthma
* patients who report sensitivity to smells
* patients who have a clinical condition which precludes walking/use of standard toilet
Virtual Reality Rehabilitation in Patients With Total Knee Replacement

Impaired proprioceptive accuracy could be a risk factor for progression of gait limitations in knee osteoarthritis patients, even after the Total Knee Replacement (TKR). Recent studies on Virtual Reality (VR) in rehabilitation show its efficacy in restoring proprioceptive capacity, postural control and gait. However, literature lacks such studies in TKR patients. This preliminary study aims to evaluate the efficacy of a VR system for the enhancement of motor skills in TKR patients compared to a traditional approach of rehabilitation.

In this randomized controlled trial (RCT), the randomization of the sample will be performed by a local software and in a single blind design. Forty patients will be enrolled and after giving the informed consent, assigned to two groups :

* the experimental group (VRG), which will be undergone to treatment with virtual reality for the recovery of load distribution and proper gait pattern;
* the control group (CG), which will be undergone to a traditional rehabilitation addressed to recovery of correct gait pattern for the same time period as VRG.

Both treatments consist in 15 sessions, at least 5 per week , each lasting 45 minutes. Both VRG or CG will last for 21 days from the start of treatment.

All patients, in adjunction to Virtual Reality Rehabilitation (EG) or Traditional Rehabilitation (CG), will execute a global rehabilitation project, consisting in Physiotherapy, Physical Therapies for pain and inflammation control, and Occupational Therapy, personalized by a multidisciplinary rehabilitation team for a minimum of 150-180 minutes per day, and according to their clinical conditions for them.

The purposes of this study in detail are:

1. Observing differences in the distribution of the bi-podalic load in the group that performs a re-education with virtual reality compared to those who perform the traditional treatment.
2. Observing differences in the recovery time of a correct pattern of gait in the group that performs a re-education with virtual reality compared to those who perform a traditional treatment.
3. Observing changes in neurophysiological patterns in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* recruitment and initial assessment within 10 days of surgery;
* monolateral knee arthroplasty in election;
* collaborating patients who are able to perform the proposed exercise;
* good cardiovascular compensation;
* cognitively intact;
* able to provide informed consent;

Exclusion Criteria:

* no severe cognitive / behavioral deficit;
* refusal or inability to provide informed consent;
* presence of sever cardiorespiratory co-morbidities;
* peripheral and /or central neurological deficits;
* visual deficits;
* presence of serious osteo-arthro-muscular diseases at controlateral lower limb against the prosthetic side;
* complication at surgical wound
Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern

This non-interventional study will compare the clinical outcomes in women with an event of severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an event of severe postpartum haemorrhage not treated with NovoSeven®. The study will be a single centre retrospective cohort study of women with an event of severe postpartum haemorrhage, defined as 1.5 L of blood loss within 24 hours of delivery, in the period of 2005-2016.


Eligibility Criteria:
Inclusion Criteria:

* Females
* sPPH, defined as continuous bleeding of more than 1500 mL within 24 hours after delivery
* Inclusion in one of the four cohorts (historical cohort 1, historical cohort 2, study cohort and new cohort)

Exclusion Criteria:

* There are no exclusion criteria
Myocardial Fibrosis and Inflammation in Liver Cirrhosis

The aim of this clinical prospective study is to assess structural and functional myocardial changes in patients with liver cirrhosis after implantation of transjugular intrahepatic portosystemic shunt (TIPS).


Eligibility Criteria:
Inclusion criteria:

* liver cirrhosis with evaluation of TIPS implantation
* patients who are 18 years of age or older

Exclusion criteria:

* underlying cardiac disease, e.g. known myocardial infarction, previous myocarditis, congenital heart disease, cardiomyopathies of other causes known underlying disease witt potential cardiac involvement, e.g. storage disease (e.g. hemochromatosis, Fabry disease), inflammatory (e.g. sarcoidosis), endocrinological (e.g. diabetes mellitus, hyper-/hypothyroidism), autoimmune (e.g. systemic lupus erythematosus, dermatomyositis, rheumatoid arthritis), therapeutic (chemotherapy).
* patients with contraindication for contrast-enhanced MRI
* pregnant and breastfeeding women
Efficacy and Safety Evaluation of Hyperthermic Baths in the Treatment of Seizures in Children With CDKL5 Deficiency

The primary objective of this research is to study the efficacy and safety of hyperthermic baths as adjunctive therapy for reducing the frequency of seizures in CDKL5 deficiency.

This project aims to include 8 participants, and evaluate the effectiveness and safety of hyperthermic baths in patients with CDKL5 deficiency through A single-center, preliminary feasibility clinical trial. It is expected to provide new therapeutic options for patients with CDKL5 deficiency with alternative treatment options.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of CDKL5 deficiency, including molecular confirmation of a pathogenic or likely pathogenic CDKL5 variant and refractory seizures
* Male or female participants aged 6 months to less than 6 years
* Parent(s) or LAR willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures
* Failure to control seizures despite appropriate trial of 1 or more anti-seizure medications at therapeutic doses
* Have a history of at least 16 countable seizures per 4 weeks during the 8 weeks prior to screening. Countable seizures will be defined by the following:Seizures with or without impairment of consciousness with a clear motor component, including generalized tonic-clonic, focal to bilateral tonic-clonic, atonic, bilateral clonic, bilateral tonic, focal motor seizures with or without impaired awareness, or infantile spasms. Clusters of infantile spasms/tonic seizures will be counted as a single seizure.
* Participants should be on a stable regimen of anti-seizure medications for ≥ 4 weeks prior to the screening visit, without a foreseeable change in dosing for the duration of the DB phase.
* Vagus nerve stimulator (VNS) are permitted, but should be implanted for 1 year prior to screening and settings should be unchanged throughout the study.
* Parent/caregiver is able and willing to maintain an accurate and complete daily seizure eDiary for the duration of the study.

Exclusion Criteria:

* Any history of previous brain disease (trauma, etc.) that likely to precipitate seizures.
* Tissue damage (eczema, etc.) in the area where hyperthermic baths will be applied on the skin.
* Seizures associated with hyperthermic baths.
* Presence of any clinical condition that in the opinion of the principal investigator makes the patient not suitable to participate in the trial.
Effectiveness of Acupuncture for Breast Cancer Related Lymphedema

This multicenter placebo-controlled trial focuses on the efficacy and safety of acupuncture on breast-cancer related lymphedema. 200 participants will be recruited, and randomized in two groups: the real acupuncture group and the sham acupuncture group.

In the theory of Traditional Chinese Medicine (TCM), Breast Cancer Related Lymphedema (BCRL) is classified as "edema", and is considered to be caused by qi (chi) deficiency and blood stagnation. Acupuncture, as an ancient therapy in TCM, is thought to have the efficacy to stimulate the transformation of qi and drainage of dampness, and is widely used for various diseases including edema in China. Early clinical trials as well as our own clinical observation have demonstrated that acupuncture can ameliorate limb swelling and decrease lymphedema. However, no randomized placebo-controlled trial has been performed to evaluate this efficacy of acupuncture. Therefore, this study aimed to evaluate the safety and potential efficacy of acupuncture to treat chronic upper-limb lymphedema.

Eligibility Criteria:
Inclusion Criteria:

* women who completed all primary and adjuvant treatments.
* age between 20 and 45.
* BMI between 18 and 28.
* unilateral lymphedema resulting from surgery for breast cancer.
* mild to moderate lymphedema, with 10% to 40% increase in volume compared to the unaffected arm based on perometry evaluation.
* with no evidence of recurrence.

Exclusion Criteria:

* bilateral lymphedema.
* history of bilateral axillary lymph node dissection.
* serious lymphedema, with over 40% increase in volume compared to the unaffected arm based on perometry evaluation.
* pregnant women.
* unable to adhere to the protocol or the treatment schedule.
* recurrent breast cancer or other malignancies.
* current use of chemotherapy or radiation.
* current use of diuretic drugs like Diosmin, or other investigational drugs.
Follow-up Study on the Antibody Response to Hepatitis B, Acellular Pertussis Toxin and Inactivated Poliovirus Antigens 1 Month After the 4th Hexavac® Vaccination in Healthy Children, Who Participated in NeisVac-C Study 216

The primary aim of the study is to show that the antibody response to hepatitis B, acellular pertussis toxin and inactivated poliovirus antigens after the 4th vaccination with Hexavac® is not influenced by the concomitant administration of NeisVac-C.


Eligibility Criteria:
Inclusion Criteria:

Study subjects who completed study 216 will be eligible for participation in this study if:

* they received all 3 vaccinations with Hexavac during study 216 and the 4th Hexavac vaccination outside the study
* the subject's parent(s)/legal guardian(s) understands the study and has provided written informed consent for his/her child's study participation;
* a blood draw was performed after the 3rd vaccination during study 216.

Exclusion Criteria:

Study subjects will be excluded from participation in this study if:

* they have received any vaccination containing hepatitis B, poliovirus or acellular pertussis toxin antigens other than Hexavac
* they have received a blood transfusion or immunoglobulins during the period from 28 days prior to the 4th Hexavac vaccination until study entry
* they have received another vaccine during the period from 28 days prior to the 4th Hexavac vaccination until study entry
* they are concurrently participating in or have participated in a clinical trial with an investigational medicinal product since the completion of study 216
* they suffer from a disease (e.g. autoimmune disease) or were undergoing a form of treatment that may be expected to influence immunological functions since the completion of study 216
* they have received systemic corticosteroids during the period from 28 days prior to the 4th Hexavac vaccination until study entry.
A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject

The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive
* Signed informed consent

Exclusion Criteria:

* Women
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease including peptic ulcer

Other protocol inclusion/exclusion criteria may apply
MabThera (Rituximab) in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma

Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Participants, who were not treated previously for DLBCL, will receive MabThera in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy according to registered indication. Patients will be followed up for safety and efficacy evaluation in accordance with routine practice. The study will be non-interventional and by its design purely observational. All treatments prescribed during the observation period will be at the treating physician's discretion and will be prescribed according to package labeling, within approved indication and local approval status of respective drugs.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cluster of differentiation antigen 20 (CD20) positive Diffuse Large B-Cell Lymphoma according to the World Health Organization/Revised European-American Classification of Lymphoid Neoplasms (WHO/REAL) classification
* Age \> or =18 years
* Performance status \< or = 2 on the Eastern Cooperative Oncology Group (ECOG) scale
* Women of child-bearing potential must agree to use effective contraception for the entire treatment period and during the 12 months thereafter

Exclusion Criteria:

* Transformed lymphoma (secondary to "low-grade" follicular lymphoma)
* Grade 1, 2 or 3a follicular lymphoma
* Primary or secondary central nervous system (CNS) involvement
* Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer
* Major surgery (excluding lymph node biopsy) within 28 days prior to registration.
* Poor renal function: Serum creatinine \> 2.0 mg/dl (177 micromol/L)
* Pregnancy
* Poor hepatic function: total bilirubin \> 2.0 mg/dl (34 micromol/L), aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) or alanine transaminase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) or alkaline phosphatase (AP) \> 3 x the upper limit of normal unless these abnormalities are related to lymphoma.
* Known human immunodeficiency virus (HIV) infection or active viral hepatitis, specifically hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
* Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial
* Life expectancy \< 6 months
* Known sensitivity or allergy to murine products
* Treatment within a clinical trial within 30 days prior to trial entry
An Observational Study of Peginterferon Alfa-2a in Combination With Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis

This prospective observational study will evaluate the efficacy and safety of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including participants with compensated liver cirrhosis, in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Serologically confirmed chronic hepatitis C (CHC), hepatitis C virus (HCV) RNA detectable
* Compensated liver cirrhosis (Child-Pugh Class A) included
* Initiating combined therapy with peginterferon alfa-2a and ribavirin

Exclusion Criteria:

* Human immunodeficiency virus (HIV) co-infection
* Contraindications for combined therapy according to actual prescribing information