linjc16/ctgov huggingface dataset:
A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan and Ifosfamide. Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.

Official Title
-----------------
A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Belotecan and Ifosfamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically or cytologically confirmed extensive disease of Small cell lung cancer no prior chemotherapy or radiotherapy for lung measurable lesion for RECIST over 18 years ECOG 0 2 expected life span more than 3 months Exclusion Criteria: acute or active infection uncontrolled cerebral nerve symptoms or metastasis significant myocardial infarction or cardiac disease within 12 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Belotecan and Ifosfamide<br> | Drug: Belotecan and Ifosfamide<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTD (maximal tolerated dose) |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLT(dose-limiting toxicity) |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SCLC, belotecan, Ifosfamide
Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis

Study Overview
=================
Brief Summary
-----------------
One useful effect of early intravitreal corticotherapy is to diminish inflammatory complications after endophthalmitis, which may cause, at least in part, serious complications (retinal detachment, macular edema) which are, more than the infection, causes of the complications seen after acute endophthalmitis.

Official Title
-----------------
Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis.

Conditions
-----------------
Post-operative Endophthalmitis

Intervention / Treatment
-----------------
* Procedure: Intravitreal injection of Betamethasone + antibiotics
* Procedure: Intravitreal injection of antibiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients male or female with no age limit Hospitalized for the diagnosis and treatment of acute endophthalmitis following cataract surgery Who had given their consent after being informed about intravitreal corticotherapy Exclusion Criteria: Patients who refused or were unable to give their consent Prior intravitreal corticotherapy
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with corticoids<br> | Procedure: Intravitreal injection of Betamethasone + antibiotics<br> <br> |
| Other: without corticoids<br> | Procedure: Intravitreal injection of antibiotics<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the evolution of visual acuity |  | up to12 months |
Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.

Official Title
-----------------
Study to Determine the Pharmacokinetics of a Single 14C-labeled Intravenous Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose to Postmenopausal Women With Osteopenia or Osteoporosis

Conditions
-----------------
Osteopenia, Osteoporosis

Intervention / Treatment
-----------------
* Drug: risedronate
* Drug: alendronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have medical history documentation verifying postmenopausal status of at least 2 years (natural or surgical). If not documented, confirmation will be required using estradiol < 20 pg/mL and follicle stimulating hormone (FSH) > 40 IU/mL; have osteopenia or osteoporosis (< 1.002 g/cm2 Lunar or < 0.882 g/cm2 Hologic) as determined by DXA of the lumbar spine (AP or PA view, L1-L4). This corresponds to a T-score of approximately < -1.5. Exclusion Criteria: any clinically significant out-of-range laboratory values and vital signs, a clinically significant cardiovascular, hepatic, renal, or parathyroid disease, in the opinion of the Investigator a known hypersensitivity to bisphosphonates

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks | Drug: risedronate<br>* 0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks followed by another 14C-labeled risedronate followed weekly by 35 mg risedronate for 3 weeks<br>|
| Active Comparator: 2<br>0.45 mg 14C-labeled alendronate, followed 7 days later with oral 70 mg of alendronate once a week for 52 weeks | Drug: alendronate<br>* 0.45 mg 14C-labeled alendronate, followed 7 days later with oral 705 mg alendronate once a week for 52 weeks followed by another 14C-labeled alendronate followed weekly by 70 mg alendronate for 3 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare urinary excretion and serum concentration-time profiles of 14C-labeled risedronate and alendronate over 52 weeks. |  | 52 weeks |
The Effect of Cinnamon on HbA1c Among Adolescents With Type I Diabetes

Study Overview
=================
Brief Summary
-----------------
the purpose of this study is to determine if cinnamon improves glucose control among adolescents with type 1 diabetes mellitus.

Detailed Description
-----------------
Widespread achievement of glucose control remains an elusive goal for adolescents with Type 1 diabetes. Previous research has suggested that cinnamon may be effective at improving glucose control in type 2 diabetes. To date, no research has investigated the effect of cinnamon on type 1 diabetics. If the addition of a simple, natural, pill to a standard insulin regimen can significantly improve glucose control, the clinical implications would be substantial. Comparison: Using a prospective, double-blind, placebo-controlled design, 72 adolescent type I diabetics were treated with cinnamon (1 gram/day) or an equivalent appearing placebo for 90 days. HbA1c, total daily insulin intake, and adverse events were recorded and compared between groups.

Official Title
-----------------
The Effect of Cinnamon on HbA1c Among Adolescents With Type I Diabetes

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: cinnamon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Type 1 diabetes for > 18 months prior to enrollment, Age 13-18 years at the time of enrollment Presenting to the clinic for routine care, No hospital admissions for medical or psychiatric reasons in the 12 months prior to enrollment, Accessible by phone, Not pregnant. Exclusion Criteria: (1) Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cinnamon|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Daily Insulin |  |  | 
| Carbohydrate/insulin dose |  |  | 
| Hypoglycemic events |  |  | 
| Compliance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cinnamon, Type 1 Diabetes, Adolescent, HbA1c
Muscle Mass or Muscle Function as a prédictive Tools for Outtcomme in Chronic Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to compare the association of muscle mass and functionality with mortality among chronic haemodialysis the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C reactive protein and decrease in serum albumin) on voluntary muscle strength impairment and phyiscal activity. the relationship between voluntary muscle strength and mortality the relationship between voluntary muscle strength and physical activity

Detailed Description
-----------------
Aim of this study is to compare the association of muscle mass and functionality with mortality among chronic haemodialysis the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C reactive protein and decrease in serum albumin) on voluntary muscle strength impairment and phyiscal activity. the relationship between voluntary muscle strength and mortality the relationship between voluntary muscle strength and physical activity

Official Title
-----------------
Retrospective Study : Muscle Mass or Muscle Function as a prédictive Tools for Outtcomme in Chronic Dialysis Patients

Conditions
-----------------
Chrnoic Haemodialysis Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: chronic kidney disease patient with extrarenal replacement therapy by hemodialysis for at least 3 months stable clinical condition (absence of infection, stroke or acute decompensation) Exclusion criteria: chronic kidney disease without extrarenal replacement therapy history of renal transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at 2 years | Mortality at 2 years | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic kidney disease, muscle strength, muscle mass, lean body mass, physical activity
Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Russia

Study Overview
=================
Brief Summary
-----------------
EPICOR-RUS is a multi-centre, observational, prospective, longitudinal cohort study which will include patients, in a real-life setting, who are hospitalized for acute coronary syndrome (ACS) within 24 hours of symptom onset and who have a final diagnosis of Unstable Angina (UA), ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI). Patients will undergo clinical assessments and receive the standard medical care as determined by the treating cardiologist. Patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the EPICOR-RUS observational study.

Official Title
-----------------
Long-tErm Follow-uP of Antithrombotic Management Patterns In Acute CORonary Syndrome Patients in RUSsia

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be 18 years of age or older of either gender or race Diagnosis of STEMI, NSTEMI or UA confirmed using the following definitions Exclusion Criteria: UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or gastrointestinal (GI) bleeding or post-Percutaneous coronary intervention (PCI). UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons. Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances). Already included in the EPICOR-RUS study. Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy. Current participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients hospitalized and diagnosed with UA, STEMI or NSTEMI | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short- and long-term medication and treatment prescribed by physicians in real-life setting |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcome (Cardiovascular events) |  | up to 2 years | 
| quality of life (EQ-5D questionnaire) |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Coronary Syndrome, antithrombotic management, STEMI, NSTE-ACS
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older

Official Title
-----------------
A 3-Way Cross-Over, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Pharmacologic Effects of a 7-Day Exposure to Darifenacin 15 mg o.d. and Tolterodine ER 4 mg o.d on Cardiovascular Parameters in Healthy Subjects 50 Years of Age and Older

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Darifenacin
* Drug: Tolterodine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females ≥ 50 years Body mass index equal to or greater than 18.5 kg/m2 and less than 35.0 kg/m2 Exclusion Criteria: Known or suspected allergy to tolterodine ER or darifenacin or their components Subjects with irregular day and night patterns such as night shift workers Significant medical problems know to affect heart rate (ie., hypertension, hypotension, history of heart failure, history of pulmonary disease, etc.) History of any malignancy within the past 5 years, with the exception of localized basal cell carcinoma of the skin Pregnant or nursing women Subjects with diseases such as urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, severe renal insufficiency, etc. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Darifenacin | Drug: Darifenacin<br>* Darifenacin tablets 15 mg once daily<br>* Other names: Enablex;|
| Active Comparator: 2<br>Tolterodine | Drug: Tolterodine<br>* Tolterodine extended release (ER) 4 mg once daily<br>|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* Placebo tablet once daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean heart rate per 24 hours following exposure to darifenacin 15 mg o.d. and tolterodine ER 4 mg o.d., at baseline and Day 7 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of darifenacin and tolterodine compared to placebo on mean heart rate per 24 hours, at baseline and Day 7 |  |  | 
| Effects of darifenacin, tolterodine and placebo on other cardiovascular parameters at baseline and Day 7 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart rate, overactive bladder
The Influence of Head and Neck Position on the Oropharyngeal Leak Pressure Using Air-Q SP Airway

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the changes of the oropharyngeal leak pressure of the air-Q self-pressurizing masked laryngeal airway in the different head and neck positions. Moreover, the adequacy of ventilation will be assessed in the different head and neck positions.

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Procedure: Neutral head position
* Procedure: Flexed head position
* Procedure: Extended head position
* Procedure: Rotated head position
* Device: Air-Q SP Airway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients aged over 20 yrs who are scheduled for surgery under general anesthesia Exclusion Criteria: anticipated difficult intubation body mass index more than 30 km/m2 history of gastroesophageal reflux disease history of esophageal operation cervical spine disease mass in the oral cavity or neck

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neutral<br>The patient's head will be in neutral position. | Procedure: Neutral head position<br> <br> Device: Air-Q SP Airway<br> <br> |
| Experimental: Flexed<br>The patient's head will be flexed. | Procedure: Flexed head position<br> <br> Device: Air-Q SP Airway<br> <br> |
| Experimental: Extended<br>The patient's head will be extended. | Procedure: Extended head position<br> <br> Device: Air-Q SP Airway<br> <br> |
| Experimental: Rotated<br>The patient's head will be rotated. | Procedure: Rotated head position<br> <br> Device: Air-Q SP Airway<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal leak pressure | The oropharyngeal leak pressure was measured by closing the expiratory valve of the circle system at fixed O2 flow 3L/min and 40 cmH2O | Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak airway pressure |  | Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway | 
| Fiberoptic bronchoscope grade |  | Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway |
Development of a Diagnostic Kit for FLT3-ITD in Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
FLT3 overexpression in acute myeloid leukemia (AML) is often caused by mutations in this gene. These mutations cause constitutive phosphorylation of FLT3 proteins leading to increased proliferation and survival, decreased apoptosis and resistance to chemotherapeutic agents in AML cells. There are two major types of FLT3 mutations- internal tandem duplication (ITD) and point mutation at 835th amino residue. AMLs with FLT3 mutations have worse prognosis and are often resistant to conventional chemotherapy. Several small molecule compounds targeting FLT3 have been in the market or in clinical trials. Therefore, identification of these mutations at the time of diagnosis will provide a better prognostic prediction, might guide the treatment selection and follow-up strategies. In this study, the investigators will develop a sensitive molecular assay to detect FLT3 mutations for future clinical application. The investigators will collect 100 AML samples with at least 20 samples with known FLT3 mutations. The investigators will compare this assay with commonly used methods and standardize the procedure to meet the requirement of clinical pathology laboratory with reasonable cost.

Official Title
-----------------
Development of a Diagnostic Kit for FLT3-ITD in Acute Myeloid Leukemia

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed diagnosis of acute myeloid leukemia Exclusion Criteria: non
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FLT3-ITD, acute myeloid leukemia, FLT3, D835