linjc16/ctgov huggingface dataset:
Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out how safe and effective the combination of Mylotarg in combination with cytarabine is in treating patients with Acute Myeloid Leukemia and advanced Myelodysplastic Syndrome over the age of 60 years.

Detailed Description
-----------------
To evaluate the safety and efficacy of gemtuzumab ozogamicin in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years. Patients eligible for treatment will receive the following: Mylotarg at 6 mg/m2 on day 1 as a 2 hour intravenous infusion Cytarabine at 100 mg/m2/day as a continuous intravenous infusion daily for 7 days

Official Title
-----------------
Phase II Evaluation of Gemtuzumab Ozogamicin in Combination With Cytarabine in Untreated Patients Above the Age of 60 Years With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome

Conditions
-----------------
Acute Myeloid Leukemia, Myelodysplastic Syndrome

Intervention / Treatment
-----------------
* Drug: Mylotarg
* Drug: Cytarabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic diagnosis of AML or advanced MDS No prior cytotoxic treatment for AML. (patients may have been treated with prior biologic therapy) Patients with MDS or AML that has evolved from MDS, could have received prior low-dose cytotoxic therapy (i.e. azacytidine or low-dose ara-C). Exclusion Criteria: Uncontrolled or severe cardiovascular disease or pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mylotarg|6 mg/m2 on day 1|
|Drug: Cytarabine|100 mg/m2 given as continuous infusion daily for 7 days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and efficacy of gemtuzumab ozogamicin (Mylotarg) in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years. |  | From entry until 30 days post treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Rescue High Frequency Oscillatory Ventilation in Newborns Who Do Not Respond to Conventional Ventilation

Study Overview
=================
Brief Summary
-----------------
Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive to conventional mechanical ventilation both in children and newborns, there is no data on its success and the factors that affect its success in the literature.

Detailed Description
-----------------
Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive to conventional mechanical ventilation both in children and newborns, there is no data on its success and the factors that affect its success in the literature. The aim of the study is to define the factors that affect the success of HFOV in newborns who do not respond to conventional mechanical ventilation through an online registry among neonatal intensive care units in Turkey.

Official Title
-----------------
Rescue High Frequency Oscillatory Ventilation in Newborns Who Do Not Respond to Conventional Ventilation

Conditions
-----------------
Acute Mechanical Ventilatory Failure

Intervention / Treatment
-----------------
* Device: HFOV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients switched to HFOV in case of unresponse to conventional ventilation stay on HFOV for at least 4 h Exclusion Criteria: any congenital anomaly HFOV duration less then 4 h

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survived<br>Patients who are treated with HFOV at least for 4 h in case of unresponse to conventional ventilation and survived. | Device: HFOV<br>* HFOV is a kind of respiratory support with a rate higher than physiological but with lesser volume.<br>|
| Death<br>Patients who are treated with HFOV at least for 4 h in case of unresponse to conventional ventilation but died. | Device: HFOV<br>* HFOV is a kind of respiratory support with a rate higher than physiological but with lesser volume.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cut-off gestational age for survival |  | 3 months | 
| Cut-off birthweight for survival |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rescue, high frequency oscillatory ventilation, newborn
Parental Representations of the Impact of the Use of Screens on Their Preschool Children Health and Development.

Study Overview
=================
Brief Summary
-----------------
The main objective of this study was to evaluate the distribution of parental representations concerning the use of screens by preschool children, expressed in qualitative surveys: perceptions of screens as a source of learning, a source of appeasement, a source of behavioral difficulties and a source of reduction in the social interactions of young children. The hypothesis of this study was the representations expressed in the qualitative studies were the reflection of the opinion of a majority of parents of young children.

Official Title
-----------------
Parental Representations of the Impact of the Use of Screens on Their Preschool Children Health and Development. An Opinion Survey of Parents of 1096 2-6-years-old Children

Conditions
-----------------
Parenting

Intervention / Treatment
-----------------
* Behavioral: parental representations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parents of 2-6-years-old preschool children Exclusion Criteria: Minor parents

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parents of 2-6-years-old children<br>Parents of preschool children in Nancy agglomeration | Behavioral: parental representations<br>* parental representations of the impact of the use of screens on their preschool children health and development<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| screens as a source of learning, of appeasement, of behavioral difficulties and of reduction in the social interactions of young children | questionnaire | baseline (J0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screens, preschool children, parenting education, social perceptions
Observational Study of Iris Tumors

Study Overview
=================
Brief Summary
-----------------
This is an observational study using OCT angiography to assist with tumor characterization in melanotic and amelanotic iris lesions. OCT angiography data from healthy eyes will be compared to eyes with various types of iris tumors.

Official Title
-----------------
Observational Study of Iris Tumors

Conditions
-----------------
Iris Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for tumor group: Eyes with diagnosis of melanotic or amelanotic iris tumors Inclusion Criteria for healthy control group: Eyes without iris defects or lesions Exclusion Criteria (both groups): Inability to give informed consent Inability to maintain stable fixation for OCT imaging Inability to commit to required study visits Eyes with concurrent retinal diseases, glaucoma, or conditions that in the opinion of the investigators might affect iris circulation Mature cataracts if found to limit visual potential to worse than 20/40

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Iris Tumors<br>This group will consist of 50 adults age 18 or older who have been diagnosed with either melanotic or amelanotic iris tumors. Iris tumor diagnosis will be confirmed by biopsy when possible or based upon clinical features (if patient declines biopsy or if not medically indicated) according to standard-of-care guidelines. | |
| Healthy Controls<br>This group will consist of 50 adults age 18 and older who have healthy eyes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Thickness in Benign vs Malignant Iris Lesions | OCT/OCTA will be used to compare tumor thickness measurements against the conventional Ultrasonic Biomicroscopy (UBM) device. Tumor thickness will be measured in millimeters, and growth of 0.5 mm or greater will be used to differentiate malignant from benign lesions. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Area in Benign vs Malignant Iris Lesions | Tumor area will be measured by OCT/OCTA in mm2 and compared against conventional UBM measurements. | 6 months | 
| Tumor Volume in Benign vs Malignant Iris Lesions | Tumor volume will be measured by OCT/OCTA in mm3 and compared against conventional UBM measurements. | 6 months | 
| Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures | Vessel density and tortuosity will both be measured in % occupied by flow pixels on OCT/OCTA. | 6 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angiography, Iris, Tumor, Melanoma, Optical Coherence Tomography (OCT)
Study Evaluating MST-997 in Advanced Malignant Solid Tumors

Study Overview
=================
Brief Summary
-----------------
MST-997 is a taxane analog with the potential to treat subjects with a variety of tumor types. Preclinical data demonstrated that MST-997 inhibited tumor growth when administered intravenously (IV). This phase 1 dose escalation study is designed to evaluate the safety and tolerability of if IV MST-997 formulated in Polysorbate 80 Diluent can be safely administered on a weekly basis.

Official Title
-----------------
A Phase 1 Dose-Escalation Study of Intravenous MST-997 Formulated in Polysorbate 80 Diluent Administered Weekly in Subjects With Advanced Malignant Solid Tumors

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: MST-997


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of malignant solid tumor with measurable disease Life expectancy of at least 12 weeks ECOG (Eastern Cooperative Oncology Group) performance status of 0,1,or 2 Exclusion Criteria: Recent major surgery, radiation therapy or anti-cancer treatment History of any other prior malignancy within last 5 years

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
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MST-997|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety, tolerability and MTD (maximum tolerated dose) of MST-997. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary pharmacokinetic information on the pharmacokinetics (during cycle 1) abd anti-tumor activity (assessed approximately every 8 weeks) of on MST-997 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malignant tumor
The Treatment of Lenalidomide in Patients With POEMS Syndrome

Study Overview
=================
Brief Summary
-----------------
Lenalidomide is a immunomodulatory drug derived from thalidomide, without neurotoxicity. Lenalidomide blocks the increased secretion of interleukin-6, tumor necrosis factor alpha and vascular endothelial growth factor (VEGF). The association with dexamethasone increased Lenalidomide response rate. More recently the efficacy of Lenalidomide has been reported in a patient with POEMS (POEMS:polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome with improvement of clinical condition and reduction of vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6) level.

Official Title
-----------------
Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome

Conditions
-----------------
POEMS Syndrome

Intervention / Treatment
-----------------
* Drug: Lenalidomide and dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of POEMS syndrome based on published diagnostic criteria Exclusion Criteria: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

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: Lenalidomide plus Dexamethasone<br>RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg). | Drug: Lenalidomide and dexamethasone<br>* RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of clinical efficacy of Lenalidomide for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg)) in patients with POEMS syndrome after 6 cycles. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the safety and the activity. |  | one year |
Population Pharmacokinetic Study of Colistin in Patients Infected With Multiresistant Gram-negative Bacteria

Study Overview
=================
Brief Summary
-----------------
Nosocomial infections have become a major health problem. They induced important use of antibiotics which is a preponderant factor for the development of bacterial resistance. The multi-resistance to antibiotics affects primarily Gram-negative bacteria. Some strains (as Acinetobacter or Pseudomonas) have become resistant to almost all antibiotics currently available, and the use of old molecules as Colistin may be the only alternative. However, there are few reliable data about Colistin and its PK characteristics. These data are essential to optimize its administration. The aim of the present study is to evaluate the pharmacokinetics of Colistin and its prodrug, colistimethate (CMS) after intravenous administration of Colistimethate alone or combined with inhaled Colistin in severely ill patients infected with multiresistant gram-negative bacteria

Conditions
-----------------
Gram-negative Bacteria

Intervention / Treatment
-----------------
* Drug: colimycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 to 85 years Patients with nosocomial infection justifying Colistin. Exclusion Criteria: Patients who received Colistin within 7 days prior to its inclusion, whatever the dosage or the route of administration Known hypersensitivity to Colistin or products of the polymyxin family Personal and family history for myasthenia Positive serology for HBV, HCV and HIV Positive pregnancy test or currently lactating

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

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

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
-----------------
patients infected with with multiresistant gram-negative bacteria
PINS Stimulator System for Patients With Treatment Resistant Depression

Study Overview
=================
Brief Summary
-----------------
Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging (fMRI)to evaluate the influence of acupuncture on patients, which will be afford objective evidence for the mechanism of Acupuncture on depression.

Official Title
-----------------
PINS Stimulator System for Patients With Treatment Resistant Depression

Conditions
-----------------
Treatment-Resistant Depression

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is aged ages 20-70 years Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria First episode onset before age 45 Current episode > 12 months duration In the current episode: Documented resistance (i.e. persistence of the major depressive episode) to a minimum of 4 adequate depression treatments from at least 3 different treatment categories (e.g. SSRI's) SNRI's, TCA's, MAO-inhibitors, Mirtazipine, Nefazodone, Trazodone, Bupropion, lithium augmentation, thyroid augmentation, ECT); Adequacy of treatments as defined by a score of at least 3 according to the amended Antidepressant Treatment History Form (ATHF) criteria Hamilton Depression Rating Scale (HDRS) of > 20 at 3 separate baseline visits, rated by 2 separate psychiatrists, Baseline 2 and Baseline 3 HDRS scores cannot improve ≥ 25% Exclusion Criteria: Patients with hearing impairment Failures of important organs and in severe conditions Be reluctant or disabled to receive neuropsychological assessments; Participate in other clinical trial Has a life expectancy of < 1 year The investigator and/or enrollment review committee, would preclude participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation<br>Stimulation is on | Device: Deep Brain Stimulation<br> <br> * Other names: PINS Stimulator System;|
| Sham Comparator: Placebo<br>Stimulation is off | Device: Deep Brain Stimulation<br> <br> * Other names: PINS Stimulator System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Hamilton Depression Rating Scale-17 |  | 1, 3, 6 and 12 months of stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of all adverse events |  | 1, 3, 6 and 12 months of stimulation |