linjc16/ctgov huggingface dataset:
Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the anti-tumor activity of the combination of experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast cancer. Anti-tumor activity will be determined by looking at changes in tumor size on CT or MRI scans. Additional goals of this study are to look at patient safety, to determine how long the study drugs (larotaxel and Herceptin®) stay in the patient's body and what effects the study medications may have on each other, and to find out how long patients remain cancer free on this study treatment.

Official Title
-----------------
Open Label, Uncontrolled, Study of XRP9881 (Larotaxel) in Combination With Weekly Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)

Conditions
-----------------
Advanced Breast Cancer, Breast Cancer, Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: larotaxel (XRP9881)
* Drug: trastuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of breast cancer Evidence that cancer has spread beyond its original location or has come back and cannot be removed by surgery No more than one prior treatment for advanced disease Her2 positive status Adequate liver and kidney function No remaining severe harmful effects to prior treatments Exclusion Criteria: Certain heart condition Pregnant Women History of another cancer except some skin cancers and cervical cancer Taking other treatments for your cancer at the time you enter the trial

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Larotaxel + Trastuzumab<br> | Drug: larotaxel (XRP9881)<br>* administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)<br>Drug: trastuzumab<br>* administered as a 90-minute IV infusion on Day 1 of every week (qw)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response measured |  | every 2 cycles during treatment phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival and Overall Survival |  | measured every 3 weeks during study treatment, then every 6 weeks after a patient has stopped the study treatment until the patient's cancer worsens, then every 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Herceptin, Taxane, Breast Cancer
Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare, prospectively, the quality of life of patients with cleft lip and palate before and after orthognathic surgery. This is done through two validated questionnaires: OHIP-14 (Oral Health Impact Profile) and OQLQ (Orthognathic Quality of Life Questionnaire) Improving the quality of life is the goal of any functional treatment. The demonstration of its improvement would validate the validity of this additional surgery for patients with cleft lip and palate.

Official Title
-----------------
Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context

Conditions
-----------------
Palate, Cleft

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man and woman ; Age: adolescents (12-17 years) and adults; Specific medical conditions: cleft lip and palate, malocclusion Non-opposition of the patient Patient willing to comply with all procedures of the study and its duration Exclusion Criteria Cancellation of orthognathic surgery Impossibility to receive enlightened information, impossibility to participate in the totality of the study, impossibility to complete only the questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
| Change of the OQLQ (Orthognathic Quality of Life Questionnaire) questionnaire score between the preoperative assessment and at 6 months postoperatively. | The OQLQ questionnaire is composed of 22 items that can be rated from 0 to 4. The score varies from 0 to 88. This questionnaire is specific to the evaluation of quality of life in relation to orthognathic surgery. | between the preoperative assessment and at 6 months postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of OHIP-14 questionnaire score (Oral Health Impact Profile) between preoperative evaluation and at 6 months postoperatively. | The questionnaire is a non-specific questionnaire assessing quality of life in relation to general oral health. It is composed of 14 questions that can be scored from 0 to 4. The score varies from 0 to 56. | between the preoperative assessment and at 6 months postoperatively. | 
| Change of OQLQ (Orthognathic Quality of Life Questionnaire) by type of orthognathic surgery | the type of orthognathic surgery performed = monomaxillary versus bimaxillary | at 6 months | 
| Change of OHIP-14 (Oral Health Impact Profile) by type of orthognathic surgery | the type of orthognathic surgery performed = monomaxillary versus bimaxillary | at 6 months |
Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.

Official Title
-----------------
Multicenter, Double-blind, Randomized, Parallel Group Study on Efficacy and Safety of Enteric-coated Mycophenolate Sodium vs. Mycophenolate Mofetil in de Novo Chinese Renal Transplant Recipients

Conditions
-----------------
Renal Transplant

Intervention / Treatment
-----------------
* Drug: Mycophenolate sodium (enteric coated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipients of first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant, treated with cyclosporine and corticosteroids as primary immunosuppression. Exclusion Criteria: Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ Patients who have received an investigational drug within four weeks prior to study entry Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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: Mycophenolate sodium (enteric coated)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of EC-MPS compared to MMF in Chinese patients as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant recipients. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy proven acute rejection within six months of treatment in de novo renal transplant recipients |  |  | 
| Other variables of efficacy: chronic rejection, graft loss, death. |  |  | 
| Safety of EC-MPS as measured by incidence of adverse events and serious adverse events. |  |  |
A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.

Detailed Description
-----------------
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.

Official Title
-----------------
A Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient Patients

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: PHA-794428


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients with severe AGHD. Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months. Exclusion Criteria: AGHD patients with uncontrolled pituitary tumor growth. Tumors within 3 mm of the optic chiasm. Patients with diabetes mellitus.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: PHA-794428|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder status at visits 9 (week 4) and 14 (week 7), where responder is defined as a patient who has achieved an IGF-1 level above the mid-point of the age-related normal range. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PD and glycemic control |  | At weeks 4 and 7 | 
| Change in PK concentrations. |  |  | 
| ALT, AST greater than 3.0 times ULN at any visit |  |  | 
| Anti-hGH and anti PHA-794428 antibody production |  |  | 
| Change in body weight |  | At week 4 and follow-up | 
| Injection site reactions |  |  |
Sun Protection Factor Assay (SPF Assay 104/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987517


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: BAY987517<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987517<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z44-036)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque.

Official Title
-----------------
Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina

Conditions
-----------------
Coronary Artery Diseases

Intervention / Treatment
-----------------
* Other: 18-F Sodium Fluoride Uptake in Positron emission tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 20 Acute coronary syndrome or stable angina Exclusion Criteria: Contraindications to the use of heparin, aspirin, clopidogrel, stainless metal, contrast media Acute ST segment elevation myocardial infarction within 12hours, heart failure, cardiac shock Any serious medical comorbidity such that the subject's life expectancy is less than 24 months Ejection fraction less than 30 Serum creatinine level of 1.5mg/dl and over Vasculitis Unwillingness or inability to cooperate or to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: stable angina pectoris or acute coronary syndrome<br> | Other: 18-F Sodium Fluoride Uptake in Positron emission tomography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized 18F-NaF uptake value within the culprit plaque |  | At the time of diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography |  | at the time of diagnosis | 
| The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography |  | at the time of diagnosis | 
| The relationship between 18F-NaF uptake value and biomarkers | hs-CRP, Troponin-I | at the time of diagnosis | 
| The relationship between 18F-NaF uptake value and invasive imagings | Intravascular ultrasound, Optical coherence tomography | at the time of diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
18-F Sodium Fluoride, Acute coronary syndrome, Stable Angina
TGV:Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the impact of the use of a quick diagnostic test of infection with RSV and influenza virus on the assumption of clinical responsibility of the children consulting at the Paediatric Emergency Unit.

Official Title
-----------------
Exploratory Study of the Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit and Their Impact on the Assumption of Responsibility of the Suspect Children of a Viral Infection

Conditions
-----------------
Influenza, Respiratory Syncytial Viruses

Intervention / Treatment
-----------------
* Device: RSV respi-strip and Quick-vue influenza


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age less than 5 years Isolated fever and/or Infection of the higher air routes (congestive otitis, feverish rhinitides, tracheitis or laryngitis) and/or infection of the lower air routes (cough, pneumonia, bronchitis, asthma) Signed consent form Exclusion Criteria: Evocative clinical of a urinary and/or bacterial infection Purulent acute otitis media Typical acute bronchiolitis Suspicion of acute lobar pneumonia Acute gastro-enteritis Anginas Serious chronic respiratory pathology Other infection whose etiologic viral diagnosis is established Congenital or acquired immunizing deficits Congenital cardiopathy

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: RSV respi-strip and Quick-vue influenza|Assessments of 2 quick diagnostic tests in the emergency unit during children's care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessments of quick diagnostic test of the Influenza virus and the SRV to measure the utility and the impact of those tests on the care of children in emergency unit |  | time of support at the emergnecy unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza A, Influenza B, RSV
Evaluation of a Medical Food for Chronic Wounds

Study Overview
=================
Brief Summary
-----------------
The study objective is to compare outcomes in subjects with a diabetic foot ulcer after 16 weeks of consuming a medical food versus a calorically similar control drink.

Official Title
-----------------
Evaluation of a Medical Food for Chronic Wounds

Conditions
-----------------
Foot Ulcer, Diabetic

Intervention / Treatment
-----------------
* Other: Medical Food
* Other: Drink mix calorically similar to experimental product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-pregnant diabetic neuropathic foot ulcer ABI> 0.7 Exclusion Criteria: uncontrolled DM collagen vascular disease or autoimmune disease wound infection; recent therapies with steroids growth factor or bioengineered tissue radiation therapy treatment with antibiotics within 1 week, Charcot's arthropathy of the foot active malignancy renal function impairment liver failure planned surgery myocardial infarction within 3 months malnutrition substance abuse taking conflicting oral nutritional supplements

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: #1 Medical food<br> | Other: Medical Food<br>* twice daily<br>* Other names: AN0806A;|
| Placebo Comparator: #2 Control<br> | Other: Drink mix calorically similar to experimental product<br>* twice daily<br>* Other names: AN0806B;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL |  | 16 weeks | 
| Wound healing measures |  | 16 weeks | 
| Incidence of complications |  | 16 weeks | 
| Clinical outcome data |  | 16 weeks |