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

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SAFETY, TOLERABILITY AND PHARMACOKINETIC STUDY OF MB12066 IN HEALTHY MALE VOLUNTEERS:
The purpose of this study is to investigate the safety and tolerability of MB12066 after multiple dose and to investigate the pharmacokinetic characteristics of MB12066 after multiple dose.
Inclusion Criteria:

- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures

- Healthy Korean male volunteers, age ranged 20 to 45 years

- A subject with body weight between 60 kg (inclusive) and 90 kg (exclusive) and body mass index (BMI) between 18.5 (inclusive) and 25 (exclusive). ☞ BMI (kg/m2) = weight (kg) / {height (m)}2

- Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (unless the investigator considers the deviation to be irrelevant for the purpose of the study)

Exclusion Criteria:

- A subject with history of allergies including drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies

- A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease

- A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug

- A subject whose hemoglobin(Hb) level < 12 g/dL

- A subject with fasting plasma glucose (FPG) level < 70 mg/dL or ≥ 126 mg/dL

- A subject whose systolic blood pressure (SBP) ≤ 90 mmHg or ≥ 140 mmHg, diastolic blood pressure (DBP) ≤ 40 mmHg or ≥ 90 mmHg or pulse rate (PR) ≥ 100 /min after at least 5 min sitting

- A subject with history of drug abuse

- A subject who has taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied.)

- A subject who has participated in any other clinical trial either for investigational or marketed drugs within 8 weeks before the study drug administration

- A subject who has donated or had loss of ≥ 400 mL of blood within 8 weeks prior to start of administration of study drug

- A subject who consumes more than 21 units of alcohol per week or unable to stop drinking throughout the study period

- A smoker (except for whom quitted smoking prior to the drug administration for at least 3 months)

- A subject who heavily takes caffeine or caffeine-containing products, grapefruit, grapefruit juice, grapefruit-containing products

- A subject with unusual dietary habit

- A subject who was previously assigned to treatment during this study

- The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons

THE STUDY OF THE NONUNION OF LONG TUBULAR BONE:
The purpose of the study to supplied the diagnostic and treatment criteria of the nonunion of the long tubular bone after treatment of Intramedallery nailing
Inclusion Criteria:

1. The patient who had the nonunion of long tubular bone

2. The patient who was the age of 14 ~ 65 years old.

3. The patient who complete the follow-up conditions.

4. The patient who has independent behavior ability.

5. The patient who volunteered for signed informed consent

Exclusion Criteria:

1. Infectious nonunion of the long turubar bone

2. Pathological fracture.

3. The immune system disease.

4. Cancer

COMBINATION OF EVEROLIMUS AND OCTREOTIDE LAR IN AGGRESSIVE RECURRENT MENINGIOMAS:
To determine if combination of everolimus and octreotide exert an anti-tumoral activity in recurrent and/or aggressive meningiomas growth with limited adverse effects.
Inclusion Criteria:

- Male and Female patients ≥ 18 years old with no maximum limited of age

- Histologically proven meningioma grade II and III; grade I meningioma may also be included, if progression is documented (see criteria 3), particularly in case of skull base location

- Progression is defined on 2 different MRI as an increase of meningioma's surface ≥ 5% by 3 months period (i.e. an increase of 5% over 3 months, 10% over 6 months, 15% over 9 months…) or as the apparition of a new unequivocal neurological symptom related to the meningioma. We considered as a new unequivocal neurological symptom a new occurring neurological symptom as, for instance, hemiparesia, oculomotor nerve palsy, visual loss, facial nerve palsy, facial neuralgia, directly related to meningioma and suggesting meningioma growth with increase of meningioma compression on neurological structures despite no increasing size on MRIs.

- Patients must have failed surgery, and not amenable to a new curative intended surgery

- Patients must have failed radiotherapy and/or radiosurgery

- Prior chemotherapy is allowed, if progression under the cytotoxic agent is clearly documented. An interval of 4 weeks after the last administration of the cytotoxic agent is warranted. Number of prior chemotherapies is not limited.

- Patients who have given their written consent

- Patients affiliated to a social insurance regime

- Adequate bone marrow function as shown by: Absolute Neutrophil Count ≥ 1.5 x 109/L,

- Platelets ≥ 100 x 109/L, Hb >9 g/dL

- Adequate liver function as shown by; serum bilirubin ≤ 1.5 x Upper Limit of Normal; International Normalized Ratio < 1.3; alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x Upper Limit of Normal - Adequate renal function: serum creatinine ≤ 1.5 x Upper Limit of Normal - Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L and fasting triglycerides ≤ 2.5 x Upper Limit of Normal. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after dyslipidemia treatment initiation.

Exclusion Criteria:

- Patients with symptomatic lithiasis

SAFETY, TOLERABILITY AND PHARMACOKINETIC STUDY OF MB12066 IN HEALTHY MALE VOLUNTEERS:

The purpose of this study is to investigate the safety and tolerability of MB12066 after multiple dose and to investigate the pharmacokinetic characteristics of MB12066 after multiple dose.

Inclusion Criteria:

- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures

- Healthy Korean male volunteers, age ranged 20 to 45 years

- A subject with body weight between 60 kg (inclusive) and 90 kg (exclusive) and body mass index (BMI) between 18.5 (inclusive) and 25 (exclusive). ☞ BMI (kg/m2) = weight (kg) / {height (m)}2

- Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (unless the investigator considers the deviation to be irrelevant for the purpose of the study)

Exclusion Criteria:

- A subject with history of allergies including drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies

- A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease

- A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug

- A subject whose hemoglobin(Hb) level < 12 g/dL

- A subject with fasting plasma glucose (FPG) level < 70 mg/dL or ≥ 126 mg/dL

- A subject whose systolic blood pressure (SBP) ≤ 90 mmHg or ≥ 140 mmHg, diastolic blood pressure (DBP) ≤ 40 mmHg or ≥ 90 mmHg or pulse rate (PR) ≥ 100 /min after at least 5 min sitting

- A subject with history of drug abuse

- A subject who has taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied.)

- A subject who has participated in any other clinical trial either for investigational or marketed drugs within 8 weeks before the study drug administration

- A subject who has donated or had loss of ≥ 400 mL of blood within 8 weeks prior to start of administration of study drug

- A subject who consumes more than 21 units of alcohol per week or unable to stop drinking throughout the study period

- A smoker (except for whom quitted smoking prior to the drug administration for at least 3 months)

- A subject who heavily takes caffeine or caffeine-containing products, grapefruit, grapefruit juice, grapefruit-containing products

- A subject with unusual dietary habit

- A subject who was previously assigned to treatment during this study

- The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons

THE STUDY OF THE NONUNION OF LONG TUBULAR BONE:

The purpose of the study to supplied the diagnostic and treatment criteria of the nonunion of the long tubular bone after treatment of Intramedallery nailing

Inclusion Criteria:

1. The patient who had the nonunion of long tubular bone

2. The patient who was the age of 14 ~ 65 years old.

3. The patient who complete the follow-up conditions.

4. The patient who has independent behavior ability.

5. The patient who volunteered for signed informed consent

Exclusion Criteria:

1. Infectious nonunion of the long turubar bone

2. Pathological fracture.

3. The immune system disease.

4. Cancer

COMBINATION OF EVEROLIMUS AND OCTREOTIDE LAR IN AGGRESSIVE RECURRENT MENINGIOMAS:

To determine if combination of everolimus and octreotide exert an anti-tumoral activity in recurrent and/or aggressive meningiomas growth with limited adverse effects.

Inclusion Criteria:

- Male and Female patients ≥ 18 years old with no maximum limited of age

- Histologically proven meningioma grade II and III; grade I meningioma may also be included, if progression is documented (see criteria 3), particularly in case of skull base location

- Progression is defined on 2 different MRI as an increase of meningioma's surface ≥ 5% by 3 months period (i.e. an increase of 5% over 3 months, 10% over 6 months, 15% over 9 months…) or as the apparition of a new unequivocal neurological symptom related to the meningioma. We considered as a new unequivocal neurological symptom a new occurring neurological symptom as, for instance, hemiparesia, oculomotor nerve palsy, visual loss, facial nerve palsy, facial neuralgia, directly related to meningioma and suggesting meningioma growth with increase of meningioma compression on neurological structures despite no increasing size on MRIs.

- Patients must have failed surgery, and not amenable to a new curative intended surgery

- Patients must have failed radiotherapy and/or radiosurgery

- Prior chemotherapy is allowed, if progression under the cytotoxic agent is clearly documented. An interval of 4 weeks after the last administration of the cytotoxic agent is warranted. Number of prior chemotherapies is not limited.

- Patients who have given their written consent

- Patients affiliated to a social insurance regime

- Adequate bone marrow function as shown by: Absolute Neutrophil Count ≥ 1.5 x 109/L,

- Platelets ≥ 100 x 109/L, Hb >9 g/dL

- Adequate liver function as shown by; serum bilirubin ≤ 1.5 x Upper Limit of Normal; International Normalized Ratio < 1.3; alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x Upper Limit of Normal - Adequate renal function: serum creatinine ≤ 1.5 x Upper Limit of Normal - Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L and fasting triglycerides ≤ 2.5 x Upper Limit of Normal. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after dyslipidemia treatment initiation.

Exclusion Criteria:

- Patients with symptomatic lithiasis