cyrilzakka/clinical-trials huggingface dataset:
Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)

Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.

Purpose:

Phase I:

To Evaluate the safety of different doses of zosuquidar.

Phase II:

This study is designed to study the safety and effectiveness of zosuquidar when given with daunorubicin and cytarabine in newly diagnosed AML patients.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed acute myeloid leukemia
* Ages 55-75 years

Exclusion Criteria:

* Acute promyelocytic leukemia (FAB M3)
* Patients must not have received prior chemotherapy for AML.
* Prior exposure to anthracycline
* Use of any investigational agent within 4 weeks prior to enrollment into the study

For Phase II:

* Patients must be P-glycoprotein positive
Quality of Life and Liver Metastases

An increasing aggressiveness in the surgical approach of colorectal liver metastases is observed. This seems only justified when, besides prolongation of survival, also the health status of patients is considered. The aim of this prospective study is to investigate the impact of surgery on health-related quality of life in this specific patient population operated for colorectal liver metastases.Furthermore, as the indications for hepatic resection are broadened and patients with more extensive liver disease are operated on, the chance of non operable disease at laparotomy will increase. The effects of such an event on HRQol are also studied.

In a prospective study several patients groups were identified. Patients undergoing liver resection and/or local ablative therapy. Patients with non operable disease at (explorative) laparotomy and outpatients with non operable disease as shown during work up for liver resection. Several validated instruments on HRQoL were ompleted preoperatively (baseline), a half month after operation and then every three months.

Eligibility Criteria:
Inclusion Criteria:

colorectal liver metastases (operable and non operable disease) and participation by means of filling in quality of life instruments

Exclusion Criteria:

drop out and therefore loss of quality of life instruments
Annual Study to Investigate Inactivated Subunit Influenza Vaccine for the 2006/2007 Influenza Season in Europe.

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent.
* Healthy and aged \>= 18 and \<= 60 years or \>= 61 years of age.
* Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire.

Exclusion Criteria:

* Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
* Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways.
* Having experienced a documented serious systemic reaction after previous influenza vaccination.
* Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage.
* Having received vaccination against influenza within the previous six months before Visit 1.

Exclusion criteria only for female subjects aged \>=18 and \<=60 years and of childbearing potential:

* Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding.
* Absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra Uterine Device, double barrier method).
Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs)

The purpose of the study is to find out whether the drug celecoxib has beneficial effects on people with pre-cancerous lesions of the pancreas.

Efforts at finding a successful chemotherapy for pancreatic cancer have been disappointing. Some patients are at increased risk of pancreatic cancer or may have pre-malignant pancreatic lesions which predispose them to later pancreatic cancer development. In these individuals, chemopreventative measures may block future development of pancreatic cancer. Human tissue studies, cell culture and animal models of pancreatic cancer strongly suggests that cyclooxygenase-2 (COX-2) may be a successful target for chemoprevention. COX-2 is overexpressed in human pancreatic cancers. Elevated COX-2 expression correlates with progression of premalignant precursors of pancreatic cancer in development models of hamster pancreatic cancer. Human tissue studies confirm increases in COX-2 expression with progression of premalignant precursors called intraductal papillary mucinous neoplasms (IPMNs) and pancreatic intraepithelial neoplasms (PanINs). Moreover, COX-2 inhibitors appear to have chemopreventative efficacy in the PC-1 homograft model of hamster pancreatic cancer. Demographic studies have suggested COX-2 inhibitors may confer protection from pancreatic cancer. We propose to conduct a pilot/phase II trial to determine the chemopreventative effects of the COX-2 inhibitor celecoxib in patients with premalignant pancreatic lesions.

Patients registered to the study will take celecoxib twice daily for 6-8 weeks prior to surgery (if patient decides to have surgery for his/her condition). If subject is not a surgical candidate or puts off surgical treatment, subject will take celecoxib for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of IPMN
* ECOG Performance status of 0, 1, or 2
* Adequate liver function, bilirubin \< 1.5 times ULN, ALT or AST \< 2.5 times ULN
* Adequate renal function: creatinine \< 1.8
* Must be at least 18

Exclusion Criteria:

* Use of COX-2 selective inhibitors within the last month
* More than occasional use of NSAIDS in last month (occasional use defined as up to twice weekly dosing)
* CA19-9 levels 1.5 times the ULN
* Active pancreatitis
* Taking sulphonylureas, fluconazole or lithium concomitantly
Povidone Iodine vs AVEnova: A Pre-injection Disinfection Study (PAVE Study)

To compare the efficacy and comfort of two FDA approved pre-injection antiseptics when used for intravitreal injections.

Intravitreal injection of medicine has become the most common ocular procedure billed to Medicare. One of the main problems with this procedure is the postoperative discomfort due to the need to disinfect the eye with Povidone Iodine (PI). This disinfectant lowers the risk of endophthalmitis, but is very rough on the corneal epithelium, producing a type of corneal abrasion in many patients that is very uncomfortable in the first few days after injection. Many patients refuse the PI disinfection even though avoiding it increases the risk of endophthalmitis with the procedure. Recently another disinfectant has been FDA approved specifically for the eye to treat blepharitis and dry eye. Avenova (Av), a dilute solution of hypochlorous acid, is used several times a day for these conditions. Some practices have begun using it for PI sensitive patients before an intravitreal injection as it is FDA-approved for disinfecting peri-ocular structures. A recent in vitro study was published showing that it is superior to PI in kill times for bacteria cultured for endophthalmitis cases. Some physicians say it is superior to PI with respect to patient comfort, however, to date, there is little literature about its use for intravitreal injection. The objective of this study is to assess comfort levels between the two FDA-approved disinfection options and to compare disinfection rates between PI and Av. The hypothesis is that Av will be as effective or more effective in elimination ocular pathogens as PI and will be significantly more comfortable for patients.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be receiving same day bilateral injections of an anti-VEGF agent for any ophthalmic condition.
* Subject must be fluent in English.

Exclusion Criteria:

* Under 18 years old.
* Subjects with an allergy or adverse reaction to Povidone Iodine or Avenova.
Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig

Patients with chronic lymphocytic leukemia (CLL) are at increased risk of infections as compared to age matched controls, with infections being a major cause of morbidity and mortality. Previous studies have shown that patients with CLL have both hypogammaglobinemia and impaired humoral immunity as defined by vaccine responses to both polysaccharide and peptide antigens. Attempts at decreasing infections in CLL have included therapy with prophylactic antibiotics and intravenous immunoglobulin. In general clinical practice and in previous studies, patients have started IV immunoglobulin replacement therapy if they have a history of serious infection or hypogammaglobinemia (defined as Immunoglobulin G below 500-600 g/dL), but vaccine responses have not been evaluated. This study will identify CLL patients with humoral immunodeficiency by checking both Ig levels and vaccines responses. In patients with impaired humoral immunity, the investigators will use subcutaneous immunoglobulin replacement to show this intervention will increase Ig levels, protective antibody titers, and be well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic lymphocytic leukemia
* Medically stable, with expected survival of \> 1 year
* Able to understand and willingness to sign a written informed consent
* Able to comply with study procedures

Exclusion Criteria:

* Previously diagnosed primary immunodeficiency
* Additional immunosuppressive states as assessed by the primary or co investigators
* Ongoing therapy with Ig replacement
* Serum IgG \< 500 mg/dL
Reliability and Validity of a Digital Version of a Structured Interview for Children and Adolescents (Kinder-eDIPS)

The Kinder-eDIPS is a digital version of the Kinder-DIPS (Diagnostisches Interview bei Psychischen Störungen im Kindes- und Jugendalter), a structured interview to assess a variety of the most frequent psychological disorders in children and adolescents. In this study, the reliability, validity and acceptance of the Kinder-eDIPS will be tested in both a clinical and a non-clinical sample.

The Kinder-eDIPS is a digital version of the Kinder-DIPS (Diagnostisches Interview bei Psychischen Störungen im Kindes- und Jugendalter), a structured interview to assess a variety of the most frequent psychological disorders in children and adolescents. The interview is administered by trained clinicians with children/adolescents and one of their primary carers. The reliability, validity and acceptance of former versions of the Kinder-DIPS (Kinder-DIPS for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and DSM-III) have been studied. The aim of the present study is to test the reliability, validity and acceptance of the newly developed digital version of the Kinder-DIPS, the Kinder-eDIPS, in both a clinical and a non-clinical sample.

Eligibility Criteria:
Inclusion Criteria:

* sufficient knowledge of the German language

Exclusion Criteria:

-
IBI310 (Anti-CTLA-4) in Combination With Sintilimab in Patients With Non-small-cell Lung Cancer (NSCLC)

This is an open label, multicenter, phase Ib study evaluating IBI310 (anti-CTLA-4) in combination with Sintilimab in patients with advanced, recurrent or metastatic non-small-cell lung cancer (NSCLC)


Eligibility Criteria:
Eligibility Criteria:

1. Aged ≥18 years;
2. ECOG 0 \~ 1;
3. Histologically /cytologically confirmed R/M NSCLC;
4. Adequate organ and bone marrow function;
5. Expected survival ≥12 weeks;
6. Female subjects of childbearing age or male patients whose sex partners are women of childbearing age should take effective contraceptive measures throughout the treatment period and within 6 months after the last administration;
7. Subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol.
8. At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).

Exclusion Criteria:

1. Had tumors other than NSCLC within the past 5 years.
2. Had allogeneic organ or stem cell transplantation.
3. The presence of uncontrolled life-threatening illness
4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
5. Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
6. HIV positive.
7. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
8. Severe, uncontrolled medical conditions and infections.
9. At the same time using other test drugs or in other clinical trials.
10. Refusal or inability to sign informed consent to participate in the trial.
11. Other treatment contraindications.
12. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
13. Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
14. Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.
Virtual Reality Goggle Utilization for Venipuncture Distraction

This is a randomized non-blinded trial evaluating the effect of virtual reality goggles on perceived pain and anxiety scores during venipuncture on hospitalized children ages 5-21. We will randomized patients to either standard of care (including Lidocaine 2.5%/Prilocaine 2.5% cream as a topical anesthetic 60-240 minutes prior to venipuncture) or standard of care plus virtual reality goggles.

Study personnel will identify patients on CHAM 6 and CHAM 8 scheduled for lab draw prior to child life rounds and subsequently ask the health care providers if there are any patients that are not developmentally or physically appropriate to use the VR equipment. They will then screen and consent the patients approximately 1 hour prior to the Child Life rounds (see appendix A \& B). Patients aged 12-17 years old who are able to read the form will be asked to fill out an assent form (see appendix C) and patients aged 5-12 years old and those unable to read the form will be read the assent form to ensure verbal assent. Those patients who consent to the study will be randomized to a VR arm and non VR arm using computer generated randomization. Lidocaine 2.5%/Prilocaine 2.5% cream will be placed on all patients that have consented to the study by the patient's nurse if they don't already have it applied. After consent and assurance of topical anesthetic application, a brief demographic questionnaire (see appendix D) will also be completed. For efficiency and feasibility, two study personnel will screen and consent families, assist with VR set up and removal, and conduct post procedure assessment.

Eligibility Criteria:
Inclusion Criteria:

patients aged 5-21 years old admitted to the 6th floor of the inpatient unit who are scheduled for a venipuncture during morning phlebotomy rounds

Exclusion Criteria:

Patients developmentally or physically not appropriate to use the VR equipment as determined by their parent, guardian or healthcare provider, if there is discomfort related to wearing the goggles (for example: recent neurosurgery, migraines, hardware on head), patient have photosensitive seizures or infectious concern such as scabies, lice, COVID-19 that can't reliably be disinfected.

Patient (\>18) or Parent or guardian (for patient \< 18) that does not speak English, Spanish or Arabic will be excluded.

If patient refuses Lidocaine 2.5%/Prilocaine 2.5% cream use they will also be excluded from the study.

-
FR in Stored Plasma

The folate receptor (FR) is a cell over expressed on the surface of certain cancers, this occurs most frequently in ovarian cancers. Some normal tissues also express the FR, however in these normal tissues, the FR is usually located on the tissue surface that is inaccessible to circulating drugs. As such, drugs which target the FR may potentially be used to target cancers which overexpress the FR while reducing toxicity to normal tissues. Therefore the ability to measure FR levels from different cancer types may help to select patients who are most likely to benefit from treatment with FR targeted therapies. Once such drug BGC945 is currently being tested in preclinical study at the Institute of Cancer Research

FR may be released from the cancer cells in the blood. We have developed a method in the laboratory which has been able to measure the FR obtained from cancer cells in culture which has been added into blood. We would like to study if this method is able to measure the FR in stored plasma samples obtained from patients with ovarian cancer, so that it may be developed as a method for selecting patients for FR-target treatments such as BGC 945.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ovarian cancer who have given informed consent to have blood collected for the plasma bank in the 'Pharmacogenetics and proteomics studies in patients receiving novel anticaner agents' study.

Exclusion Criteria:

* Patients who have withdrawn consent form their blood stored within the 'Pharmacogenetics and proteomics studies in patients receiving novel anticancer agents' study to be used for research.
Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation

The goal of this Interventional Study is to develop and test the Indian Adaptation of Melodic Intonation Therapy (MIT) for Indian patients in with post-stroke Non-Fluent Aphasia (PSNFA). The main question\[s\] it aims to answer are: • To develop the MIT Indian Adaptation tool and check its feasibility • To compare the MIT with standard speech rehabilitation in patient with PSNFA. Participants will undergo Speech Rehabilitation according to the developed module and the standard treatment will be given in the comparator arm. The speech recovery at 12 weeks will be compared in both treatment arms.

The study will be done in two stages:

* Stage 1 (Intervention formulation): A battery for therapy will be formulated with the help of SLT in conjunction with the expert(s) in Indian music, neurologist, and physiologist. In a series of physical and online meetings, the duration, frequency, and content of the therapy programme will be formulated. The stage(s) at which NIRS will be conducted will also be decided. This will not involve any patient recruitment and should be finished in three months.
* Stage 2 (Feasibility phase): The feasibility run will be done in 10 eligible patients. With further adaptations depending upon the experience in the feasibility phase, the pilot phase will be conducted, in which the treatment arms will be randomized.
* Stage 2 (Pilot phase): Assuming standard error of measurement for participants with aphasia as 4.33 points with a 5-point difference considered clinically meaningful for the Western Aphasia Battery (WAB), and considering that no such prior study is there, 30 patients in intervention and control arm would be initially taken. Therefore, the total sample size 10+30+30=70 patients.

  * The randomization will be done in 1:1 ratio, via a computer-generated random number sequence which will be in a sealed opaque envelope. The allocation will be concealed, and the treatment arm will be revealed after the patient has been screened and has consented for the study.
  * The outcome assessment will be by a blinded assessor, who will be a co-investigator in the study.

Eligibility Criteria:
Inclusion Criteria:

All of the following

1. Age ≥18 years of age
2. Stroke with non-fluent aphasia, within one year of ictus
3. Imaging evidence suggestive of ischemic or hemorrhagic stroke of dominant hemisphere
4. Patient is alert and able to follow simple commands (should not have global aphasia)
5. Motivated caregiver
6. Informed and signed consent

Exclusion Criteria:

Any of the following:

1. Patients with a history of a previous stroke other than the index event, which can explain the aphasia.
2. Any clinical condition (e.g., short life expectancy, coexisting disease) or other characteristics that preclude appropriate follow-up in the study (e.g., distant residence, no family support)
3. Patients participating in any therapeutic intervention clinical trials evaluating poststroke recovery
4. Use of psychotropic drugs that interfere with patient evaluation
Longitudinal Description of Hemorrhoidal Pathology

Hemorrhoidal disease is a common cause of gastroenterology visits. In the United States, it is considered the 3rd most common gastrointestinal diagnosis with nearly 4 million scheduled or emergency visits. In France, self-reported questionnaires estimate that one person in five has suffered at least one hemorrhoidal attack in the past year.

Hemorrhoidal disease significantly alters the quality of life, can be life threatening in case of heavy bleeding and has a significant economic impact.

However, there are still many unknowns regarding the different types of hemorrhoidal disease, its symptoms, its natural history, its etiology, its triggering and promoting factors, the associated pathologies, the therapeutic indications, etc.

In addition, the therapeutic management is not consensual, especially since the therapeutic arsenal is constantly expanding over the last 20 years with the advent of minimally invasive surgical techniques.

The aim of the work is to answer some of these questions on the basis of a prospective cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Consecutive patients consulting for hemorrhoidal disease at the proctology department of the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) between January 1, 2020 and April 30, 2020
* French-speaking patient

Exclusion Criteria:

* Patient objecting to participation in the study
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection