cyrilzakka/clinical-trials huggingface dataset:
BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)

Adult patients with chronic lymphocytic leukaemia who experience a relapse after at least two prior treatment regimens may be enrolled in this trial. The trial will examine whether monotherapy with BI 836826 is safe and tolerable at escalating dose levels.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of relapsed or refractory chronic lymphocytic leukaemia.
2. At least two prior treatment regimens for chronic lymphocytic leukaemia.
3. At least one criterion for active disease as defined by the International Workshop on CLL.
4. Absolute lymphocyte count lower than 200 x 10\^9/l .
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2.
6. Age 18 years or older.
7. Written informed consent which is consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and local legislation.

Exclusion criteria:

1. Treatment with anti Cluster of Differentiation (CD) 20 therapy within 4 weeks, or alemtuzumab within 8 weeks, or any cytotoxic antileukemia therapy within 2 weeks, Ibrutinib or Idelalisib within 1 week prior to the first administration of the trial drug.
2. Prior allogeneic stem cell transplantation.
3. Active autoimmune haemolytic anemia.
4. Active autoimmune thrombocytopenia.
5. Known transformation to an aggressive B-cell malignancy.
6. Concurrent treatment with relevant doses of systemic glucocorticosteroids.
7. Prior history of malignancy other than chronic lymphocytic leukaemia (exceptions to this rule are defined in the clinical trial protocol).
8. Aspartate aminotransferase or alanine aminotransferase \> 2.5 x upper limit of normal.
9. Total bilirubin \> 1.5 x upper limit of normal.
10. Absolute Neutrophil Count \< 1.000/µl.
11. Platelets \< 25.000/µL.
12. Estimated Glomerular Filtration Rate \<45 mL/min.
13. Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher.
14. Significant concurrent disease.
15. Any infectious disease requiring treatment at the time of enrolment or within the previous 2 weeks.
16. Hepatitis B or C.
17. Human Immunodeficiency Virus (HIV) infection.
18. Cytomegalovirus (CMV) viremia.
19. Women of childbearing potential not using a highly effective method of birth control during the trial until one year after the last dose.
20. Pregnancy or breast feeding.
21. Known or suspected active alcohol or drug abuse.
22. Treatment with another investigational drug within the past four weeks before start of therapy or concomitantly with this trial.
23. Prior treatment with BI 836826.
24. Patients unable to comply with the protocol
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

This protocol posting deals with objectives \& outcome measures of the extension phase at year 11 to 15.

This is a long-term follow-up study at Years 11, 12, 13, 14 and 15 after primary vaccination with GSK Biologicals' hepatitis A/hepatitis B vaccine (three-dose schedule, 3 different lots). To evaluate the long-term antibody persistence, volunteers will be bled at Years 11, 12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

No additional subjects will be recruited during the course of this long-term study.

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 11, 12, 13, 14 or 15), he/ she will be offered an additional vaccine dose.

Eligibility Criteria:
Inclusion Criteria:

* Subjects participating in this study should have received three-dose primary vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.
* Written informed consent will be obtained from each subject before the blood sampling visit of each year
Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer

This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as well as to gather data for the design of future studies.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with initial presentation of organ confined prostate cancer (clinical stage ≤ T2b)

  * Negative metastatic workup with bone scan and CT abdomen/pelvis, within 6 months of study treatment, if indicated by PSA \>10
  * Age 40 years to 85 years of age
  * Multi-parametric MRI at UCLA within 6 months of study treatment, demonstrating a

    * Region of interest (ROI) of MRI suspicion level 3 or higher
    * ROI located proximal to the external sphincter by a margin of at least 2 cm
  * Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 MRI-ultrasound fusion targeted biopsy cores from above MRI-derived ROI

    * Histologically-confirmed adenocarcinoma from targeted biopsy cores (≥ 2 cores)
    * Overall Gleason score not to exceed 3+4
  * Subjects desire focal therapy and declined conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
  * Signed informed consent for the LITT treatment through the 12 month follow up visit

Exclusion Criteria:

* Any significant cancer outside of MRI target (ROI) area, defined as Gleason score \> 3+4
* \< 10 years life expectancy
* American Society of Anesthesiologists (ASA) criteria of IV or higher
* Unfit for conscious sedation anesthesia
* Active bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, INR or platelet count (as determined by institutional lab parameters) at the time of screening
* Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
* Active urinary tract infection
* Prostate abscess, chronic or acute prostatitis, or neurogenic bladder
* Any prior treatment for prostate cancer

  * Radical prostatectomy
  * Radiation therapy (external beam or brachytherapy)
  * Cryotherapy
  * High intensity focused ultrasound treatment
  * Photodynamic therapy
  * Androgen deprivation therapy
* Prior prostate, bladder neck, or urethral stricture surgery

  * Any prostate debulking procedure, including: transurethral resection of prostate, photovaporization, or electrovaporization
  * Transurethral incision of bladder neck
  * Urethral stricture dilation or reconstruction
* Any current 5-alpha reductase inhibitors (history of use ≥ 6 months prior to MRI is acceptable)
* Prior significant rectal surgery (hemorrhoidectomy is acceptable)
* Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
* History of inflammatory bowel disease
* Urinary tract or rectal fistula
* Any contraindication to MRI (contrast allergy severe claustrophobia, MRI-incompatible prosthesis)
Acceptability and Tolerability of Ketone Supplements and Effects of BHB Concentrations in Young Adults

Assess the acceptability and tolerability of two different commercially available ketone supplements and determine their effects on capillary blood concentrations of the ketone beta-hydroxybutyrate and glucose in young adults.

Past findings suggest that raising ketone concentrations through the use of a ketogenic diet (high-fat, moderate-protein, low-carbohydrate) is effective for preventing weight gain and decreasing appetite. However, strict adherence to this diet is difficult, and ending the diet can result in the regaining of body weight. Our group has investigated the effects of various ketone supplements in both rodents and humans. Past results of our group and that of our colleagues suggest that ketone supplements have the ability to increase ketone concentrations in the blood, decrease appetite, lower body weight, and maintain lean body mass. Exogenous ketones may serve as an alternative to the ketogenic diet by increasing concentrations of ketones without the need for adherence to a strict diet. However, little is known about ketone supplements as it relates to their tolerability and efficacy. For example, the taste of these supplements is unacceptable to some individuals and it is unclear if ketone supplements provide an adequate approach to raise and maintain circulating ketone concentrations as observed with the ketogenic diet. This information will be valuable before launching larger-scale human trials.

Ketone supplements (KE1 and KE4) will be obtained from KetoneAid (Falls Church, VA). Participants will be asked to drink (5g and 10g) of each supplement separated by at least 3 days. Capillary blood samples will be measured using a handheld device to measure circulating beta-hydroxybutyrate (BHB) and glucose concentrations while a questionnaire will be used to assess the acceptability and tolerability of the ketone supplements.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18-25 years of age
* In generally good health
* Able and willing to attend study visits (once every 3 days for \~2 weeks)
* BMI 18.5-29.9

Exclusion Criteria:

* Pregnant
* Has preexisting medical conditions, including Type 2 diabetes, heart disease, or cancer
* BMI ≥ 30
PENG Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture

Clinical controled trial to compare between pericapsular Nerve Group Block and Fascia Iliaca Block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods.

Pain is a major problem that has to be dealt with in case of hip fracture, as it resembles an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy.

With the introduction of ultrasound in regional anesthesia and peripheral nerve blocks, regional analgesia float to the surface as a substitute for opioids with less side effects. Of the many techniques to provide regional analgesia for hip fractures; fascia iliaca block was widely used with good results. In 2018 Pericapsular Nerve Group Block was introduced to provide regional analgesia for hip fractures with interesting results.

In this study the investigators are going to compare Pericapsular Nerve Group Block and Fascia Iliaca Block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods.

Eligibility Criteria:
Inclusion Criteria:

1. Patient acceptance.
2. Accepted mental state of the patient.
3. Gender: both sexes.
4. Age above 65 years old.
5. Body mass index 18.5-35 kg/m2.
6. ASA physical status II and III.
7. Unilateral hip fracture assigned for surgical fixation.
8. Expected duration of surgery ≤ 3 hours.

Exclusion Criteria:

1. Associated trauma or multiple fractures.
2. Peripheral neuropathy.
3. Coagulopathy.
4. Infection at site of injection.
5. Allergy to the drugs used in the study.
6. Advanced kidney, liver or heart disease.
Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)

Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma

Charité University Medicine Berlin is currently the only German University Hospital with an available capacitive radiofrequency electromagnetic field treatment device. While there is retrospective data available regarding the assumed effectiveness and low toxicity profile of radiofrequency electromagnetic field treatment for various solid tumors including liver cancer, there is no prospective data available on the combined effect of first-line palliative double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma. The investigators aim to conduct a feasibility trial and plan to compare the results with data of a prospective trial with a comparable patient population who received double immune checkpoint inhibition alone.

Eligibility Criteria:
Inclusion Criteria:

* Treatment with combined Anti-PD-L1 and Anti-CTLA-4 antibodies
* Written informed consent prior to any study procedure
* 18 years or older
* Histologically confirmed HCC
* HCC not amenable to curative (including resection or ablation) or locoregional (including TACE) therapies
* No prior systemic therapy for HCC
* Compensated liver function, as defined by a Child-Pugh score ≤ B7
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Measurable disease by Response Criteria in Solid Tumors (mRECIST and RECIST v1.1) criteria
* Body weight of \> 30 kg
* Women of childbearing potential with negative pregnancy test and agreement for adequate birth control if conception is possible
* If present HBV and HCV managed according to the local institutional practice

Exclusion criteria:

* Arterioembolic event including a stroke or myocardial infarction within 3 months prior to randomization Severe / unstable angina, or symptomatic congestive heart failure as defined by NYHA III/IV
* Cardiac pacemakers / ICD
* Large metal implants in the treatment area
* Current evidence of coagulopathy or bleeding diathesis
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Decompensated liver function as defined by Child Pugh ≥ B8
* Patients on a liver transplantation list
* Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy
* Uncontrolled autoimmune or inflammatory disorders
* Patient not able for supine positioning (e.g. due to pain)
* Significantly altered mental status
* Pregnancy and breastfeeding
Randomized Trial Comparing Terazosin 5 mg Daily and Doxazosin GITS 4 mg Daily for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up

The purpose of the study is to compare two alpha blockers, terazosin and doxazosin GITS, in achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or avoiding a TURP.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 or above
* Admitted for AUR due to BPH with PVR of 500 ml or more

Exclusion Criteria:

* Previous history of TURP
* Use of alpha blockers within recent 8 months
* Renal impairment (serum creatinine \>140 umol/l)
* Poor premorbid state
Effects of Low-intensity Interval Walking With Blood Flow Restriction on Functional Capacity in Multiple Sclerosis

The aim of the study is to evaluate the safety, feasibility and initial efficacy of an interval-based walking training at low speed performed with blood flow restriction (BFR) on gait speed and functional impairments in patients with Multiple Sclerosis (MS).

Patients with severe MS will be recruited at outpatient rehabilitation clinics (University Hospital of Ferrara). Eligible participants will be randomized to interval walking training with BFR (the experimental group) or conventional exercise therapy (the control group) according to a blocked-randomization stratified by gender with 1:1 ratio. Both groups will receive 12 rehabilitative sessions over 6 weeks, for a 2 sessions/week pattern.

The experimental group will undergo interval-based walking training at a slow speed according to a walk:rest ratio of 1:1 for a total of 6 minutes, to be repeated 5 times. Blood flow restriction, applied to the proximal thigh, will be set at a maximum of 40% of systolic blood pressure. The control group will be treated with conventional therapy.

Changes in gait speed, endurance, balance, lower limbs strength and quality of life will be assessed at baseline, at the end of training, and at follow up.

The proposed training modality has never been tested in patients with MS and, if the hypotheses were supported by the results, might be a novel tool to improve muscle strength with a positive impact on gait disabilities, balance and quality of life for patients with MS.


Eligibility Criteria:
Inclusion Criteria:

* primary and secondary progressive MS patients according to the diagnostic MS criteria revised by Polman et al.
* Male and females, aged 18 to 65 years;
* Severe gait impairments, defined by an Expanded Disability Status Scale (EDSS) ranging from 5.5 to 6.5;
* Lack of MS worsening in the previous three months prior to the intervention period;
* Cognitive functioning to provide informed consent identified by a Mini-Mental Status Examination (MMSE) score = 24/30.

Exclusion Criteria:

* Neurologic conditions in addition to MS that may affect motor function and other medical conditions likely to interfere with the ability to complete safely the study protocol, independently from the group assignment;
* Considerable muscle spasticity, defined by a Modified Ashworth Scale (MAS) score \> 3 or contractures that may limit range of motion or function for hip, knee or ankle flexors/extensor;
* Relapsing of MS-related conditions or changes in drug therapy or any other confounding factor during the study;
* Rehabilitation treatments or Botulinum toxin injections during the three months preceding the start of the study.
* Intermittent claudication and peripheral artery disease
* Contraindication to exercise training (e.g., unstable angina, congestive heart failure)
Bioequivalence of Two Tablet Forms of MK0974 (0974-045)

This study will evaluate the bioequivalence of two solid dose formulations of MK0974.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health
* Subject is a non-smoker
* Subject is willing to comply with the study restrictions

Exclusion Criteria:

* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of cancer
* Subject is a nursing mother
* Subject has or has a history of any disease or condition that might make participation in the study unsafe or that might confound the results of the study
Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)

The purpose of the investigators' study is to determine whether the production of heat shock proteins has an effect on the development and the outcome of acute renal failure in children.

A prognostic factor for the development of acute renal failure (ANR) in children would be very valuable for therapy regulation. So-called chaperones out of the family of heat shock proteins (HSP) are promising candidates which are involved in the development of ANR as well. This could be a starting point for the development of new therapeutic approaches.

ANR occurs in up to 50 percent of all critical ill patients and has a high rate of morbidity and mortality despite advances in symptomatic therapy. Following severe sepsis, septic shock or other shocks, combined with multiple organ failure, the ANR is an autonomous prognosis worsening factor.

Should the results of our study show a correlation between the production of HSP and the outcome of children with ANR, further studies would be required, to examine the pathophysiological relevance of HSP in ANR. We would then be able to determine a high risk population for ANR. A modulation of ANR therapy might be a result of further studies.

Eligibility Criteria:
Inclusion Criteria:

* Between 0 and 18 years of age.
* Either severe sepsis, shock of any origin or asphyxia.
* Operated patients with operative or post-operative transfusion requirement of at least 0.5 x 80 ml/kg body weight of erythrocyte concentrate.

Exclusion Criteria:

* Existing affection of the kidney.
* Kidney transplantation.
* Missing written consent of the parents or guardian (if applicable).
A Study to Assess the Safety, Pharmacodynamics, and Immunogenicity of PXVX0047

PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine \[A549 Cells\], Live, Oral) is an investigational vaccine in development for the indication of active immunization against adenovirus infection. The primary goals of this Phase 1 study are to evaluate safety, pharmacodynamics (viral shedding), and immunogenicity of PXVX0047.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18 to 35
* Seronegative for Ad4 and Ad7 by CPE-based assay
* (if female of childbearing potential) Using an acceptable method of contraception
* If male, subject agrees to use a highly effective method of contraception with female sexual partners of childbearing potential
* Able and willing to provide informed consent for study participation

Exclusion Criteria:

* Current acute febrile illness
* Current acute gastrointestinal illness
* Clinically significant cardiac, respiratory, or gastrointestinal disease
* (if female of childbearing potential) Pregnant or nursing, or who plan to become pregnant or nurse during the study
* Persons with occupations which may create an increased risk of transmission of vaccine virus (including but not limited to health care workers, child or elderly care providers, food handlers or preparers) who also have expected occupational contact with children less than 7 years of age, pregnant or nursing women, women of childbearing potential not using an acceptable method of contraception, or chronically ill or immunosuppressed individuals through Day 29.
* Expected household contact with children less than 7 years of age, pregnant or nursing women, women of childbearing potential not using an acceptable method of contraception, or chronically ill or immunosuppressed individuals through Day 29.
* Laboratory evidence of infection with Hepatitis B/C or HIV.
* History of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.
* Inability to swallow capsules or tablets whole without chewing or crushing.
* Immunosuppressed individuals, including those treated or planned to be treated with systemic immunosuppressive medications within the 30 days prior to enrollment through 30 days after study treatment.
* Concomitant or planned use of other vaccines, investigational agents, cidofovir, ribavirin, or medications expected by the Investigator to have antiviral activity against adenovirus within 30 days prior to enrollment through Day 29.
* Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject.
* Any other condition that, in the opinion of the Investigator, may interfere with the conduct of the study or the validity of the data.
APROVE : Irbesartan in Hypertension

Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan in ambulatory Hypertensive patients


Eligibility Criteria:
Inclusion Criteria:

* Patient with mild or moderate hypertension defined with arterial diastolic pressure (PAD) at sit position between 90 mmHg and 110 mmHg and arterial systolic pressure (PAS) at sit position between 140 mmHg and 180 mmHg.
* Patient diagnosed after 3 consultations within 2 months who has never been under treatment and responding to the required conditions for hypertension treatment with irbesartan. This patient must has been under proper but insufficient hygieno dietetic diet
* Patient who has been under a none satisfied antihypertensive treatment, and for whom this treatment was stopped at least 2 weeks prior to inclusion.
* Patient with a laboratory analysis (urinary sediment- Na -K- creatinine, total cholesterol) and ECG during the month prior to inclusion.

Exclusion Criteria:

* Severe Hypertension defined by PAS \> 180mmHg and/or PAD \> 110 mmHg.
* Isolated systolic Hypertension
* Secondary Hypertension
* Arterial stenosis on unique kidney - arterial bilateral kidney stenosis
* Non-surgically sterilized women or non-menopaused women.
* Confirmed sodic depletion.
* Hypersensitivity to Irbesartan.

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