linjc16/ctgov huggingface dataset:
Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the ease of use, preference, and safety after 8 weeks subcutaneous administration of EutropinPen Inj. in patients pretreated with recombinant human growth hormone by reusable device.

Official Title
-----------------
A Multi-center, Open, Single-arm, Switch-over, Prospective, Phase IV Study to Assess the Ease of Use, Preference, and Safety After 8 Weeks Subcutaneous Administration of EutropinPen Inj. in Patients Pretreated With Recombinant Human Growth Hormone by Reusable Device

Conditions
-----------------
Short Stature, Idiopathic, Infant, Small for Gestational Age, Growth Hormone Deficiency, Chronic Renal Failure, Turner Syndrome

Intervention / Treatment
-----------------
* Drug: Somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who has been using reusable device growth hormone injection in recent 3 months at least for 6 weeks Subjects who meets the indication of EutropinPen inj. Exclusion Criteria: Subjects who has diseases below on screening visit Diabetes Malignant tumor Epiphyseal closure Chronic kidney disease (recieved kidney transplantation) Acute respitory failure

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 15 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 |
| --- | --- |
| Other: Eutropin pen inj.<br> | Drug: Somatropin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire. |  | Day 57 | 
| Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire. |  | Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefits of EutropinPen inj. assessed by a questionnaire | Ease of use Unit High dose packing Grip Design Less pain | Day 57 | 
| Fear assessed by a questionnaire | Ask of fearness how the child feels about the needle | Screening, Day 57 | 
| Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire | Ask ease of use at each injection step (1 5 pts) Preparation time for injection | Screening, Day 57 | 
| Treatment compliance of EutropinPen Inj. (%) |  | Day 57 |
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with topotecan chemotherapy in patients with advanced solid tumours

Official Title
-----------------
A Phase I, Open-Label, Study of the Safety and Tolerability of KU-0059436 and Topotecan in the Treatment of Patients With Advanced Solid Tumours

Conditions
-----------------
Malignant Solid Tumors

Intervention / Treatment
-----------------
* Drug: KU-0059436 (AZD2281)(PARP inhibitor)
* Drug: Topotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological diagnosis of advanced solid tumour for which no suitable effective therapy exists; Evaluable disease Adequate bone marrow, hepatic and renal function Exclusion Criteria: Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry; major surgery with 4 weeks of entering the study Heavily pre treated patient > 2 previous chemotherapy regimens for metastatic disease Co-existing active infection

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Topotecan + KU-0059436 | Drug: KU-0059436 (AZD2281)(PARP inhibitor)<br>* oral<br>* Other names: Olaparib;Drug: Topotecan<br>* intravenous infusion<br>* Other names: Topotecan hydrochloride;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan |  | assessed at each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the dose limiting toxicity of the combination therapy |  | assessed at each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malignant solid tumours, Poly(ADP ribose), polymerases
Identification of Prognostic Factors and New Therapeutic Targets in Cutaneous Lymphomas

Study Overview
=================
Brief Summary
-----------------
Cutaneous lymphomas are a heterogeneous group of extra-nodal lymphomas. The prognosis of cutaneous lymphomas is extremely variable from one subject to another. In the majority of cases, there is no cure for cutaneous lymphomas. Cutaneous lymphomas primarily affect the skin, and secondarily the blood, lymph nodes and possibly other organs. The discovery of new molecular prognostic factors will allow a better identification of patients at high risk of aggressive evolution and the implementation of a personalized therapeutic strategy. The identification of new therapeutic targets is necessary in order to develop new innovative treatments for cutaneous lymphomas.The primary objective is to identify novel molecular prognostic factors associated with 5-year overall survival in cutaneous lymphoma.

Official Title
-----------------
Identification of Prognostic Factors and New Therapeutic Targets in Cutaneous Lymphomas

Conditions
-----------------
Cutaneous Lymphoma

Intervention / Treatment
-----------------
* Other: Biologic Samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years old Informed consent signed by the patient Suspicion of primary cutaneous lymphoma or confirmed lymphoma according to WHO/ISCL/EORTC criteria Exclusion Criteria: Patient under guardianship or curatorship Lack of affiliation to social security

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with primary cutaneous lymphoma<br> | Other: Biologic Samples<br>* An additional punch from lesion skin as part of a skin biopsy performed as part of routine care. an additional blood sample will be collected for research during a blood test performed as part of the patient's routine care. In patients with clinical superficial lymphadenopathy or detected by imaging, and undergoing a superficial lymph node biopsy as part of the care, a core biopsy will be dedicated to research.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 5 years | 
| Progression free survival |  | 10 years | 
| Overall survival |  | 10 years |
Measurements of Breast Tissue Optical Properties

Study Overview
=================
Brief Summary
-----------------
Approximately twelve percent of the women in the United States will develop breast cancer, the most common form of cancer affecting women, with 183,000 new cases projected for 1995. Despite the increasing incidence, the age-adjusted death rate from carcinoma has remained relatively stable. Although the reason for this has not yet been demonstrated, this stability may be a direct consequence of early detection and improved therapy. Screening mammography as an early detection technique has been shown to reduce mortality by 23%. Mammographic abnormalities that go on to biopsy show 24% being positive for malignancy with great variability (6-75%). Breast biopsy is an expensive procedure with the risks of anesthesia and surgery which may be obviated by more specific non-invasive testing.

Detailed Description
-----------------
Diffuse Optical Spectroscopic Imaging a new method for quantitative characterization of the optical properties of tissues. The diagnostic tools utilize anomalies in the transmission of diffusing near infra-red light for the rapid detection of oxygenated and deoxygenated hemoglobin, near infra-red absorbing drug levels, blood volume changes, and scattering properties in tissues. Diffuse Optical Spectroscopic Imaging measurements of breast tissue optical properties probe is similar in shape to an ultrasound probe. The imaging can measurements on different areas of the breast including diseased location and normal area. Optical measurements can guided by co-registered ultrasound measurements for the purpose of determining lesion size and location. Each measurement will require about 5-60 seconds to record the data and calculate optical properties. The process will be repeated until an adequate number of measurements are performed and measurements take 30 to 90 minutes. The researcher can determine that breast optical properties on demographic information, such as age and menopausal status as well as medical history.

Official Title
-----------------
Measurements of Breast Tissue Optical Properties

Conditions
-----------------
Accessory; Breast Tissue

Intervention / Treatment
-----------------
* Device: Diffuse Optical Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-pregnant woman age 18 yrs and older. Exclusion Criteria: pregnant woman and younger than 18 yrs of age.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Diffuse Optical Spectroscopy|Breast properties scanning|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthy Breast |  | up to 4 weeks |
Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life

Study Overview
=================
Brief Summary
-----------------
Some patients with dry eye may have severe disabling neuropathic pain. They describe spontaneous pain, dysesthesia, hyperalgesia or even allodynia. It is classical to note an important discordance between the high intensity of the symptoms and the poverty of the clinical signs. These pains are often unrecognized and therefore often not sufficiently treated. A significant impact on patient's quality of life may occur. The concept of ocular neuropathic pain being relatively recent, few studies have focused on the subject at present. Our study aims to shed light on these pains in patients consulting for dry eyes at the Ophthalmological Foundation A. de Rothschild. The objective of our study is to describe precisely the characteristics of neuropathic eye pain and the visual, general and psychological repercussions in these patients.

Official Title
-----------------
Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life

Conditions
-----------------
Pain, Dry Eye Syndromes, Neuralgia, Quality of Life

Intervention / Treatment
-----------------
* Other: Questionnaires on pain and quality of life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 years or older, Presenting at least one of the following symptoms: spontaneous pain, burning sensation in eye, dysesthesia, allodynia, hyperalgesia French language-skills Exclusion Criteria: Severe corneal or palpebral damage explaining current pain

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 |
| --- |
|Other: Questionnaires on pain and quality of life|Patients will be asked to complete several questionnaires about their pain and the impact on their quality of life. They will complete the questionnaires in the ophthalmology consultation room or at home and return it by mail (or present it at the next consultation). Patients will be asked to complete several questionnaires : Questionnaire about the characteristics of ocular neuropathic pain (7 items) DEQ-5 (Dry Eye Questionnaire) ODI (Ocular Surface Disease Index) BPI (Brief Pain Inventory) HADS (Hospital Anxiety and Depression Scale)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores obtained with each questionnaires. |  | baseline |
Care Pathway for Children With Autism Spectrum Disorder Included in the ELENA Cohort

Study Overview
=================
Brief Summary
-----------------
Autism Spectrum Disorder (ASD) is lifelong neurodevelopmental disorder that affect social communication and interaction and includes limited and repetitive patterns of behavior (DSM 5). In France, national guidelines about practices recommends early and specific interventions but care pathway are not well described for ASD children. The national health insurance information system record demographic data, medical condition, and reimbursed drug over 98% of the French population. In addition, the ELENA cohort is a large cohort of children with ASD followed for 6 years. Data collected include clinical characteristics of children (IQ, severity of ASD...) and parents (educational level, professional status...). The first objective of this project is to identify patterns of care trajectories using data from ELENA cohort matched to data from national health insurance information system. Secondary objectives are to examine the links between patterns of care trajectories and clinical characteristics, social environment of autistic children.

Official Title
-----------------
Care Pathway for Children With Autism Spectrum Disorder Included in the ELENA Cohort : Matching to the National Health Data System

Conditions
-----------------
Autism Spectrum Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Included in ELENA Cohort Exclusion criteria: - Opposable to reuse data

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- | --- |
| Care pathway | Care pathway will be built from administrative database from birth to 2019 | 1 day | 
| Clinical characteristics | Clinical, social and environmental data of children from ELENA cohort | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Care pathway, Health administrative database
Postoperative Epidural Analgesia in Spine Fusion Surgery

Study Overview
=================
Brief Summary
-----------------
we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL + Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and mobilization maneuvers.

Official Title
-----------------
Postoperative Epidural Analgesia in Spine Fusion Surgery

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: 0.125% Bupivacaine HCL @ 4-5 ml/h
* Drug: 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h
* Drug: 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing spine fusion surgery. Exclusion Criteria: Drug addiction. Intraoperative dural tear. Uses of opioids drug for any reason in the previous 48 hours. Mental dysfunction. Spinal fusion for any infectious or malignant causes.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine<br>0.125% Bupivacaine HCL @ 4-5 ml/h | Drug: 0.125% Bupivacaine HCL @ 4-5 ml/h<br> <br> |
| Active Comparator: Bupivacaine, Morphine<br>0.125% Bupivacaine HCL , Morphine sulphate 3 mg @ 3-5 ml/h | Drug: 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h<br> <br> |
| Active Comparator: Bupivacaine, Fentanyl<br>0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h | Drug: 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain | • Pain will be assessed using the VAS ranging from 0 (no pain) to 10 (worst imaginable pain). Pain will be evaluated at rest, while coughing, and during mobilization. Maneuvers of particular clinical importance for postoperative mobilization (alone and with help) will be chosen: Turning in bed, standing in front of the bed and walking, and using the toilet without help. The time needed until the patient can first successfully perform these maneuvers will be documented. | first 3 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of patients' satisfaction | verbal rating score will be used (4 = very satisfied, 3 = satisfied, 2 = neutral, 1 = dissatisfied, and 0 = very dissatisfied). | First 3 postoperative days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative, spine surgery
Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined With Gemcitabine in Patients With Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
This is an open-label, randomized phase II trial comparing treatment with a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly Gemzar® (Gemcitabine) to treatment with Gemzar® alone. The primary objectives of this study are to determine the toxicity and safety profile of the combination of SGN-15 and Gemzar®, to estimate the clinical response rate and to estimate the duration of response of this combination therapy administered to patients with advanced ovarian cancer, compared to treatment with Gemzar® alone.

Official Title
-----------------
A Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Gemzar® Versus Single-Agent Gemzar® in Patients With Advanced Ovarian Cancer

Conditions
-----------------
Ovarian Neoplasms

Intervention / Treatment
-----------------
* Drug: SGN-15 (cBR96-Doxorubicin Immunoconjugate)
* Drug: Gemzar (Gemcitabine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Brief Overview of Inclusion Criteria: Patients must have pathologically confirmed ovarian cancer, which is advanced or recurrent carcinoma, who have failed at least two, but no more than three prior therapies for metastatic disease Patients must have > 20% Lewis-y antigen expression documented by immunohistochemistry LVEF > 50% by echo or MUGA Must be platinum resistant as defined by: Progression while on initial platinum therapy or Progression while on retreatment with initial platinum regimen or Relapse < 6 months after initial therapy Brief Overview of Exclusion Criteria: Patients who have had prior therapy with Gemzar® Cumulative anthracycline exposure > 300 mg/m2 More than three prior chemotherapy regimens for ovarian cancer (Retreatment with Taxane/Platinum after initial combination is considered only one regimen)

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SGN-15 (cBR96-Doxorubicin Immunoconjugate)|nan|
|Drug: Gemzar (Gemcitabine)|nan|

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

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