linjc16/ctgov huggingface dataset:
The Efficacy of RAD 001 as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium

Study Overview
=================
Brief Summary
-----------------
A study to determine the efficacy of Everolimus(Afinitor®) as third line therapy in patients with transitional cell carcinoma of the urothelium which failed or progressed after two lines of chemotherapy

Official Title
-----------------
A Multicentre Phase III Trial to Determine the Efficacy of RAD 001 (Everolimus, Afinitor) as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium Which Failed or Progressed After First Line Chemotherapy

Conditions
-----------------
Urothelial Cancer

Intervention / Treatment
-----------------
* Drug: Everolimus (Afinitor®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Male or female aged more than 18 years Histologically proven transitional cell carcinoma of the urothelium Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy Recurrence or progression after at least one chemotherapy regimen and for unresectable/advanced disease No more than 2 lines of previous chemotherapy.. Measurable disease (RECIST criteria) Previously irradiated lesions are not considered measurable- ECOG performance status of 0, 1 or 2 Exclusion Criteria: No prior treatment with anti cancer agents, including radiotherapy, in the last 4 weeks. No currently active CNS involvement No pregnancy. Women of child bearing potential must have a negative pregnancy test. No uncontrolled diabetes No symptomatic coronary artery disease, myocardial infarction within the last six months, congestive cardiac failure greater than New York Heart Association (NYHA) class II, uncontrolled or symptomatic cardiac arrhythmia

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: Afinitor<br>Treatment by Afinitor 10 mg per day | Drug: Everolimus (Afinitor®)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival rate at 12 weeks | If a patient has not had an event, Progression-free survival is censored at the date of last adequate tumor assessment. | 3 months |
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women receiving the drug therapeutically.

Official Title
-----------------
An Open-label, Multiple-dose, Milk-only Lactation Study in Lactating Women Receiving Linaclotide Therapeutically

Conditions
-----------------
Breast Feeding, Constipation, Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: linaclotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be a lactating female who has been actively breastfeeding or pumping for at least 4 weeks Be already taking linaclotide therapeutically for Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC) Weaning must not be underway Be willing to breastfeed or pump regularly during the study to maintain milk supply and discontinue breastfeeding for the 24-hour period of breast milk collection Exclusion Criteria: Clinically significant disease state in any body system, except for the indication being treated with linaclotide Any structural abnormality of the gastrointestinal (GI) tract, or a disease or condition that can affect GI motility Participation in any other clinical investigation using an experimental drug within 90 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- |
| Experimental: linaclotide<br>Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration | Drug: linaclotide<br> <br> * Other names: Linzess;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk |  | From Baseline (Day 1) to Day 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Linzess
BENEFIT Extension Study

Study Overview
=================
Brief Summary
-----------------
To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.

Official Title
-----------------
Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b (Betaseron, BAY86-5046)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients randomized and treated at least once in study 304747 Exclusion Criteria: Medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 50 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 |
| --- | --- |
| Group 1<br> | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* Standard Therapy for Multiple Sclerosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study |  | End of Study |
Volume Responsiveness Before SBT Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the performance of volume responsiveness in predicting the outcome of mechanical ventilation weaning in critically ill patients.

Detailed Description
-----------------
82 patients, 61 succeed and 21 failed

Official Title
-----------------
Volume Responsiveness Before Spontaneous Breath Trial Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients

Conditions
-----------------
Weaning Failure

Intervention / Treatment
-----------------
* Device: PLR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mechanical ventilation Exclusion Criteria: pregnancy or breast-feeding tracheostomy at baseline myasthenia gravis or acute polyradiculoneuropathy end-stage chronic illness

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 |
| --- | --- |
| successful weaning<br>the SUCCESS of SBT or not need for reintubation or noninvasive ventilation within 48 h following extubation | Device: PLR<br>* passive leg raising test was done before and at the end of SBT<br>* Other names: passive leg raising;|
| failed weaning<br>the failure of SBT or the need for reintubation or noninvasive ventilation within 48 h following extubation | Device: PLR<br>* passive leg raising test was done before and at the end of SBT<br>* Other names: passive leg raising;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of cardiac index |  | 30 minutes |
The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if taking supplemental DHA improves measures of processing speed and executive function in teen and adult women with PKU.

Official Title
-----------------
The Impact of Docosahexaenoic Acid on Neuropsychological Status in Females With Phenylketonuria

Conditions
-----------------
Phenylketonuria

Intervention / Treatment
-----------------
* Dietary Supplement: Docosahexaenoic Acid
* Dietary Supplement: Corn/soy oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females Phenylketonuria Ages 12 years and older Able to complete neuropsychological testing Exclusion Criteria: Pregnancy Currently taking DHA supplement

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA supplementation<br> | Dietary Supplement: Docosahexaenoic Acid<br>* Capsules providing 10 mg DHA/kg body weight/day taken once daily<br>* Other names: DHASCO-S;|
| Placebo Comparator: corn/soy capsule, no DHA<br> | Dietary Supplement: Corn/soy oil<br>* Capsules taken once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive processing speed |  | 0 months, 4.5 months | 
| Executive function |  | 0 months, 4.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and red blood cell DHA concentrations |  | 0 months, 4.5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phenylketonurias, Docosahexaenoic Acids, Neuropsychological Tests, Female, Adolescent, Adult
Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Patients with ER+/HER2- breast cancer (presumably the luminal A subtype) could potentially avoid the standard chemotherapy use. Letrozole Plus Low-Dose Metronomic Capecitabine may offer similar efficacy and less toxicity to standard chemotherapy in ER+/HER2- breast cancer patients.

Official Title
-----------------
Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Letrozole Plus Low-Dose Metronomic Capecitabine
* Drug: EC-T


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -women (age 18-70 years) with clinical T2-3 N0-1 M0 ER-positive (ER) allred score 4-8，and progesterone receptor-positive (PgR) ，HER2-negative adequate bone marrow reserve (WBC count, 3.5 *109/L; platelets, 100*109/L; hemoglobin, 10g/dL), hepatic function (AST/ALT bilirubin and alkaline phosphatase levels 1.25 the upper limit of normal value), and renal function (serum creatinine 1.25 the upper limit of normal value). Luminal A/ lymph node positive breast cancer or Luminal B breast cancer patients Exclusion Criteria: (a) male patients; (b) patients with inflammatory breast cancer or distant metastasis; (c) patients who were previously treated with chemotherapy, radiation therapy or prior treatment with AIs or antiestrogens for breast cancer; (d) patients with a second concomitant neoplasm; and (e) patients who could not meet the eligibility criteria.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Letrozole Plus Low-Dose Metronomic Capecitabine<br> | Drug: Letrozole Plus Low-Dose Metronomic Capecitabine<br>* Letrozole Plus Low-Dose Metronomic Capecitabine<br>|
| Active Comparator: EC-T<br> | Drug: EC-T<br>* Epirubicin/Cyclophosphamide Followed by Docetaxel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate | objective response rate (ORR) measured by breast ultrasound monthly | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
letrozole, metronomic, capecitabine, neoadjuvant, chemotherapy, ER+/HER2-
An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the burden of respiratory disease in outpatient settings among 32 to 35 weeks' gestational age (wGA) infants in the USA who did not receive RSV prophylaxis during the infants' first RSV season.

Detailed Description
-----------------
The primary objective is to determine the burden of RSV disease in outpatient settings among 32 to 35 wGA infants in the USA who did not receive RSV prophylaxis, as measured by rate of RSV-associated outpatient lower respiratory tract illness (LRI) during the infants' first RSV season.

Official Title
-----------------
An Observational Prospective Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants (32 to 35 Week Gestational Age) - Outcomes and Risk Tracking Study (The Report Study)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature at birth (from 32 weeks and 0 days to 35 weeks and 6 days GA) Age 6 months or less at the time of screening, and born in May 2009 through January 2010 for Season 1, or May 2010 through February 2011 for Season 2 Written informed consent and any locally required authorization (eg, HIPAA), obtained from the subject's parent/or guardian prior to performing any protocol-related procedures. Exclusion Criteria: Receipt of any RSV prophylactic agent: at any time prior to study participation Participation in studies of investigational RSV prophylaxis or RSV therapeutic agents Presence of bronchopulmonary dysplasia,hemodynamically significant congenital heart disease, congenital neuromuscular or congenital airway defects Any condition that, in the opinion of the investigator, would limit life expectancy to less than 6 months
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 |
| --- | --- |
| 1<br>32 to 35 WGA Infants less than six months of age by RSV season peak. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the incidence rate of outpatient RSV LRI during the RSV season, with RSV LRI determined by real time RT-PCR |  | Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of RSV-associated emergency department (ED) visits during the RSV season |  | 2009-2010; 2010- 2011 | 
| Rate of RSV-associated hospitalization during the RSV season |  | 2009-2010; 2010-2011 | 
| Rate of risk factors for RSV-associated outpatient LRI, hospitalization, and ED visits |  | 2009-2010; 2010-2011 | 
| Rate of risk factors for RSV infection |  | 2009-2010; 2010-2011 |
Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

Study Overview
=================
Brief Summary
-----------------
To assess the overall response rate to docetaxel plus CDDP as neoadjuvant chemotherapy prior to surgery, followed by adjuvant docetaxel plus CDDP in chemonaive patients NSCLC Stage IIIa and IIIb.

Official Title
-----------------
Phase II Study Evaluating Docetaxel and CDDP as Neoadjuvant Chemotherapy Prior to Surgery, Followed by Adjuvant Docetaxel Plus CDDP in Chemonaive Patients With NSCLC Stage III

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Drug: Docetaxel Plus CDDP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed NSCLC, respectable NSCLC stage IIIa T1-2 N2 or or unresectable stage IIIb 2.KPS>70% 3.Hb>10g/dl,ANC>2.0x109/L,Plt.>100x109/L4.T-bil.<1xULN,creatinine<1xULN,creatinine clearance >60 ml/min,GPT/GOT<2.5xULN,ALP<5xULN Exclusion Criteria: 1.Brain meta.2..Prior surgery,R/T, C/t or immunotherapy for NSCLC

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: docetaxel and cisplatin<br>docetaxel 36mg/m2 and cisplatin 75mg/m2 | Drug: Docetaxel Plus CDDP<br>* docetaxel 36mg/m2 and cisplatin 75mg/m2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | every cycle during 2nd-6th cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resectability |  | resectability after treatment | 
| progression free survival |  | progression free survival after 1 year | 
| overall survival |  | overall survival at 1 year |
High-dose L-Carnitine and Diaphragmatic Function Assessed by Ultrasonography in Patients With Respiratory Failure.

Study Overview
=================
Brief Summary
-----------------
L-Carnitine supplementation has been shown to boost muscular performance in several studies. In hemodialysis patients with muscular weakness, fatigue, or cramps/aches, after L-carnitine treatment, about two-thirds of patients had at least some improvement in muscular symptoms . L-Carnitine was also found to improve the left ventricular ejection fraction (LVEF) in hemodialysis patients with cardiac morbidity who had significantly reduced LVEF in echocardiography before supplementation. Moreover, L-Carnitine has been shown to improve muscular function and exercise performance in athletes in several studies

Official Title
-----------------
Effect of High-dose L-Carnitine Supplementation on Diaphragmatic Function Assessed by Ultrasonography in Critically Ill Patients With Respiratory Failure: a Randomized Clinical Trial

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Drug: L Carnitine ( low dose)
* Drug: L-Carnitine ( high dose)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 21 years old or greater Both genders have respiratory failure either of the primary medical origin or in the post-surgical course. Not in need of mechanical ventilation Exclusion Criteria: Renal failure on regular dialysis Hypothyroidism Seizures End-stage liver disease Mechanical ventilation History or discovered allergy to L-carnitine, pivampicillin, and other pivalate-conjugated antibiotics.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>maintenance dose of L- carnitine 6 gm/day to keep normal level (normal L-carnitine level is normal 25-50 mmol/L) | Drug: L Carnitine ( low dose)<br>* will receive a maintenance dose of L- carnitine 6 gm/day to keep normal level (normal L-carnitine level is normal 25-50 mmol/L)<br>|
| Experimental: experimental group<br>high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level. | Drug: L-Carnitine ( high dose)<br>* will receive a high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound diaphragmatic function | Diaphragmatic excursion by ultrasound | at days 7 |