HiTZ/Multilingual-Medical-Corpus · Datasets at Hugging Face

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- Contra indication to octreotide and everolimus

- Women of child-bearing age who are using no effective means of contraception

- Pregnant or breast-feeding women or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes

- Patients receiving other investigational agents or who received an investigative drug or therapy within the last 30 days.

- Known intolerance or hypersensitivity to octreotide, everolimus or other rapamycin (sirolimus, temsirolimus)

- Uncontrolled diabetes mellitus defined by HbA1c>8.5%

- Patients who have any severe and/or uncontrolled medical condition:

unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to inclusion, serious uncontrolled cardiac arrhythmia, active or uncontrolled severe infection, cirrhosis, chronic active hepatitis or chronic persistent hepatitis, severely impaired lung function (spirometry and Diffusing Capacity of the lung for carbon monoxide 50% or less of normal and O2 saturation 88% or less at rest on room air), active, bleeding diathesis

- Patients receiving chronic treatment with immunosuppressive agent

- Patients with a known history of HIV seropositivity

- Patients who have a history of another primary malignancy ≤ 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.

- Females patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control.

ASSESSMENT OF THE MINIMAL RESIDUAL DISEASE IN DLBCL FROM CELL-FREE CIRCULATING DNA BY NGS:
This is a prospective descriptive monocentric study whose purpose is to describe the clonal evolution of the mutational pattern in cfDNA of a cohort of patients with Diffuse Large B-Cell Non-Hodgkin Lymphomas (DLBCL) before, during and after standard treatment
To determinate and to describe the clonal evolution, 30 DLBCL cases with available matched tumor DNA and plasma will be collected and analyzed by routinely applicable next generation sequencing (NGS) at the time of diagnosis, at mid treatment, at the end of treatment and at 12 months after diagnosis.
Inclusion Criteria:

- Age up to 18 years old

- With a diagnosis formally established of DLBCL or transformed straightaway follicular lymphoma or 3B grade follicular lymphoma or Burkitt-like lymphoma

- Eligible to a treatment by immunochemotherapy like R-CHOP, R-ACVBP or R-CHOP like

- First line of treatment

- Being able to benefit from standard extension assessment ( Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) and bone marrow biopsy with a bone marrow aspiration)

- Written informed consent

- Tumor biopsy used for diagnosis available

Exclusion Criteria:

- Patient who cannot receive polychemotherapy like R-CHOP, R-ACVBP, or R-CHOP like

- Patient who cannot benefit from standard extension assessment and follow-up by with Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)

- Pregnant or breast-feeding woman

- Guardianship, curatorship

- Patient who cannot follow the medical procedures of the study for geographic, social, psychological,linguistic or physical reasons

TIMING OF HCG ADMINISTRATION IN IUI CYCLES:
Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.
Women will be randomly divided into 3 groups; the first group will undergo IUI at the time HCG administration, the second group will undergo IUI 12 hours after HCG administration and the third group will undergo IUI 34-36 hours after HCG administration.
Inclusion Criteria:

- Mild male factor infertility or unexplained infertility.

Exclusion Criteria:

- Advanced male factor infertility.

- Polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria.

- Endometriosis.

- Tubal disease.

- Uterine abnormalities or myoma.

- Previous uterine surgery.

- Metabolic or hormonal abnormalities.

ULTRASOUND-GUIDED ARTERIAL CATHETERIZATION IN PEDIATRIC PATIENTS:
Investigators designed a prospective randomized controlled study to compare the long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial catheterization in pediatric patients younger than 5 years old.
Inclusion Criteria:

- Surgery under general anesthesia

- Requires invasive arterial blood pressure monitoring

Exclusion Criteria:

- Infection/hematoma/skin disease/arteriovenous fistula/recent catheterization scar in radial artery or posterior tibial artery

- Peripheral vascular disease

- Congenital aortic disease

A PHASE 2 DOSE-FINDING STUDY OF TAK-272 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND MICROALBUMINURIA:
The primary objective of this study is to test the efficacy and safety on daily oral doses of TAK-272 5 mg, 20 mg, 40 mg and 80 mg in patients with type 2 diabetes mellitus and microalbuminuria by randomized, double-blind, placebo-controlled, parallel-group comparison in order to determine the clinical dose of TAK-272.
This is a phase 2 dose-finding study to test the efficacy and safety on daily oral doses of TAK-272 5 mg, 20 mg, 40 mg and 80 mg in patients with type 2 diabetes mellitus and microalbuminuria by randomized, double-blind, placebo-controlled, parallel-group comparison in order to determine the clinical dose of TAK-272. In addition, by defining a candesartan cilexetil 8 mg group as a reference group under double-blinded fashion, clinical benefits of TAK-272 will be exploratorily determined.
Inclusion Criteria:

- In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements

- Contra indication to octreotide and everolimus

- Women of child-bearing age who are using no effective means of contraception

- Pregnant or breast-feeding women or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes

- Patients receiving other investigational agents or who received an investigative drug or therapy within the last 30 days.

- Known intolerance or hypersensitivity to octreotide, everolimus or other rapamycin (sirolimus, temsirolimus)

- Uncontrolled diabetes mellitus defined by HbA1c>8.5%

- Patients who have any severe and/or uncontrolled medical condition:

unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to inclusion, serious uncontrolled cardiac arrhythmia, active or uncontrolled severe infection, cirrhosis, chronic active hepatitis or chronic persistent hepatitis, severely impaired lung function (spirometry and Diffusing Capacity of the lung for carbon monoxide 50% or less of normal and O2 saturation 88% or less at rest on room air), active, bleeding diathesis

- Patients receiving chronic treatment with immunosuppressive agent

- Patients with a known history of HIV seropositivity

- Patients who have a history of another primary malignancy ≤ 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.

- Females patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control.

ASSESSMENT OF THE MINIMAL RESIDUAL DISEASE IN DLBCL FROM CELL-FREE CIRCULATING DNA BY NGS:

This is a prospective descriptive monocentric study whose purpose is to describe the clonal evolution of the mutational pattern in cfDNA of a cohort of patients with Diffuse Large B-Cell Non-Hodgkin Lymphomas (DLBCL) before, during and after standard treatment

To determinate and to describe the clonal evolution, 30 DLBCL cases with available matched tumor DNA and plasma will be collected and analyzed by routinely applicable next generation sequencing (NGS) at the time of diagnosis, at mid treatment, at the end of treatment and at 12 months after diagnosis.

Inclusion Criteria:

- Age up to 18 years old

- With a diagnosis formally established of DLBCL or transformed straightaway follicular lymphoma or 3B grade follicular lymphoma or Burkitt-like lymphoma

- Eligible to a treatment by immunochemotherapy like R-CHOP, R-ACVBP or R-CHOP like

- First line of treatment

- Being able to benefit from standard extension assessment ( Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) and bone marrow biopsy with a bone marrow aspiration)

- Written informed consent

- Tumor biopsy used for diagnosis available

Exclusion Criteria:

- Patient who cannot receive polychemotherapy like R-CHOP, R-ACVBP, or R-CHOP like

- Patient who cannot benefit from standard extension assessment and follow-up by with Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)

- Pregnant or breast-feeding woman

- Guardianship, curatorship

- Patient who cannot follow the medical procedures of the study for geographic, social, psychological,linguistic or physical reasons

TIMING OF HCG ADMINISTRATION IN IUI CYCLES:

Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.

Women will be randomly divided into 3 groups; the first group will undergo IUI at the time HCG administration, the second group will undergo IUI 12 hours after HCG administration and the third group will undergo IUI 34-36 hours after HCG administration.

Inclusion Criteria:

- Mild male factor infertility or unexplained infertility.

Exclusion Criteria:

- Advanced male factor infertility.

- Polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria.

- Endometriosis.

- Tubal disease.

- Uterine abnormalities or myoma.

- Previous uterine surgery.

- Metabolic or hormonal abnormalities.

ULTRASOUND-GUIDED ARTERIAL CATHETERIZATION IN PEDIATRIC PATIENTS:

Investigators designed a prospective randomized controlled study to compare the long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial catheterization in pediatric patients younger than 5 years old.

Inclusion Criteria:

- Surgery under general anesthesia

- Requires invasive arterial blood pressure monitoring

Exclusion Criteria:

- Infection/hematoma/skin disease/arteriovenous fistula/recent catheterization scar in radial artery or posterior tibial artery

- Peripheral vascular disease

- Congenital aortic disease

A PHASE 2 DOSE-FINDING STUDY OF TAK-272 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND MICROALBUMINURIA:

The primary objective of this study is to test the efficacy and safety on daily oral doses of TAK-272 5 mg, 20 mg, 40 mg and 80 mg in patients with type 2 diabetes mellitus and microalbuminuria by randomized, double-blind, placebo-controlled, parallel-group comparison in order to determine the clinical dose of TAK-272.

This is a phase 2 dose-finding study to test the efficacy and safety on daily oral doses of TAK-272 5 mg, 20 mg, 40 mg and 80 mg in patients with type 2 diabetes mellitus and microalbuminuria by randomized, double-blind, placebo-controlled, parallel-group comparison in order to determine the clinical dose of TAK-272. In addition, by defining a candesartan cilexetil 8 mg group as a reference group under double-blinded fashion, clinical benefits of TAK-272 will be exploratorily determined.

Inclusion Criteria:

- In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements