linjc16/ctgov huggingface dataset:
Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine: The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. Whether Pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long. To see if patients feel better while taking Pemetrexed plus Gemcitabine.

Official Title
-----------------
ALIMTA Plus Gemcitabine as Front-line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer: A Phase II Clinical Trial

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Pemetrexed
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy. Have received no prior chemotherapy for Non-Small Cell Lung Cancer. Have at least one measurable lesion. Have an adequate performance status. Sign an informed consent. Exclusion Criteria: A female who is pregnant or breastfeeding. Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed. Treatment with radiation therapy within the last 4 weeks. Brain metastasis that is uncontrolled. Active infection or other serious condition.

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

| Intervention/Treatment |
| --- |
|Drug: Pemetrexed|nan|
|Drug: Gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the objective tumor response rate of gemcitabine plus pemetrexed in patients with advanced or metastatic non-small-cell lung cancer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess time to objective tumor response for responding patients |  |  | 
| To assess duration of response for responding patients |  |  | 
| To assess time to treatment failure for patients |  |  | 
| To assess progression free survival of patients |  |  | 
| To assess time to progressive disease for patients |  |  | 
| To assess survival time for patients |  |  | 
| To characterize the toxicities of gemcitabine plus pemetrexed in this patient population |  |  |
A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The study will determine the maximal tolerated dose (MTD) of panobinostat administered in combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients with relapsed or refractory acute myeloid leukemia (AML).

Official Title
-----------------
A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia

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

Intervention / Treatment
-----------------
* Drug: panobinostat/LBH589B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cytopathologically confirmed diagnosis of AML according to WHO criteria, excluding acute promyelocytic leukemia. First relapsed AML Primary refractory AML defined as failure to respond to initial induction chemotherapy (no CR) or recurrence within 6 months of initial CR. Age more than 18 years ECOG performance status < 2 Exclusion Criteria: Prior treatment with deacetylase inhibitor Concurrent therapy with any other investigational agent Patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study. Clinical symptoms suggesting CNS leukemia LVEF below 45% Other protocol-defined inclusion/exclusion criteria may apply

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: LBH589<br> | Drug: panobinostat/LBH589B<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose limiting toxicity (DLT) |  | 1 cycle (1 cycle = 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency, severity and duration of Adverse Events (AE) using CTCAE version 3.0 |  | During maximal three LBH589/chemotherapy cycles and subsequent optional single-agent LBH589 treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myeloid leukemia, AML, relapsed acute myeloid leukemia, refractory acute myeloid leukemia
Purification of Testis-Stimulating Factor in Precocious Puberty

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: Purify and characterize a testis-stimulating factor in the blood of adult volunteers who had precocious puberty as boys.

Detailed Description
-----------------
PROTOCOL OUTLINE: Subjects are treated for 2 months with depot injections of leuprolide acetate every 4 weeks and testosterone replacement every 2 weeks. Hormone levels are tested every other week. If luteinizing hormone and follicular-stimulating hormone levels are at or below detection on day 56, blood is drawn for a testis-stimulating factor bioassay and subsequent factor purification and characterization. Volunteers are asked to repeat this 2-month procedure no more than 2 times every 12 months.

Conditions
-----------------
Precocious Puberty

Intervention / Treatment
-----------------
* Drug: leuprolide
* Drug: testosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Adult men diagnosed with precocious puberty (familial testotoxicosis) as boys

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: leuprolide|nan|
|Drug: testosterone|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
-----------------
endocrine disorders, precocious puberty, rare disease
A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes

Study Overview
=================
Brief Summary
-----------------
Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart review after delivery. Inclusion Criteria: English speaking pregnant woman >15 weeks gestation undergoing an exam for ruptured membranes Exclusion Criteria: Known placental previa Active vaginal bleeding

Official Title
-----------------
A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes

Conditions
-----------------
Evidence of Ruptured Membranes in Women Greater Than 15 Weekd

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complaint of ruptured membranes IUP > 15 weeks gestation English speaking, over the age of 18yrs old Exclusion Criteria: active bleeding placenta previa

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evidence of ruptured membranes |  | up to delivery of infant |
The Accuracy of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly

Study Overview
=================
Brief Summary
-----------------
The aim of this research was to examine the accuracy of translated Chinese version of Swallowing Dysphagia Questionnaire and to evaluate the prevalence of dysphagia and its clinical manifestation in patients over 65 years old.

Official Title
-----------------
The Accuracy of Chinese Version of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly

Conditions
-----------------
Deglutition Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) age over 65 years old; (2) does not use enteral tube feeding; (3) no serious mental or cognitive conditions; no aphasia Exclusion Criteria: (1) age under 65; (2) use enteral tube feeding; (3) subjects with serious mental or cognitive conditions or aphasia (4) Allergy to barium sulfate suspension

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| elderly patients with dysphagia<br> | |
| elderly patients without dysphagia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swallowing Disturbance Questionnaire | Chinese version of Swallowing Dysphagia Questionnaire consists of 15 questions regarding oral and pharyngeal stage of dysphagia. Subjects are asked to fill out the questionnaire concerning current state and during the past year using a 4-point scale. | At the baseline | 
| Videofluroscopy Swallowing Study (VFSS) | VFSS studies are conducted using 4 different consistencies: thin liquid, nectar-thick liquid, puree, and cookie. Subjects are asked to take 2 trials for each consistency to assess if any oral or pharyngeal dysphagia occurs. | At the baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical water test | Each subject takes 3 trials of 3cc-water using a dropper. Then sequential water drinking is assessed (about 60-70 ml). We assess: coughing, choking, voice changes. At least one symptom means dysphagia. | At the baseline | 
| Mini-Mental State Examination (MMSE) | Mini-Mental State Examination was used to identify subjects' cognitive state.The following four cut-off levels should be employed to classify the severity of cognitive impairment: no cognitive impairment=24-30; mild cognitive impairment=19-23; moderate cognitive impairment=10-18; and severe cognitive impairment<9. | At the baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, screening
DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease

Study Overview
=================
Brief Summary
-----------------
Purpose: The purpose of this study is to evaluate the Delay Alternating with Nutation for Tailored Excitation (DANTE) SPACE sequence in clinical studies to determine whether it can provide more useful information for clinical diagnosis. Participants: 100 participants with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI will be recruited. Procedures (methods): Patients with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI who will have an additional non-FDA approved sequence (DANTE SPACE) added to their clinical scan. The investigational sequence requires less than 15 minutes and will be added following the standard MRI sequence.

Official Title
-----------------
DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease

Conditions
-----------------
Intracranial Vascular Disease

Intervention / Treatment
-----------------
* Device: DANTE SPACE sequence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 and older Concern for intracranial vascular disease Scheduled to undergo a clinical vessel wall MRI Exclusion Criteria: Claustrophobia Implanted metallic devices, parts, vascular clips, or other foreign bodies. Known hypersensitivity to gadolinium contrast or to any component of gadolinium contrast refractory to standard medications (antihistamines, steroids) Impaired kidney function (serum creatinine level > 1.8 mg/dL or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis. Any woman who is pregnant or has reason to believe she is pregnant via self report

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DANTE SPACE MRI Sequence<br>Participants will receive an additional DANTE SPACE sequence with their clinical MRI | Device: DANTE SPACE sequence<br>* investigational MRI sequence less than 15 minutes<br>* Other names: Delay Alternating with Nutation for Tailored Excitation (DANTE);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Utility for Visualizing Pathology | The primary objective is to determine the percent of participants with a visible region of interest. | Baseline |
Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma

Study Overview
=================
Brief Summary
-----------------
Patients with stage-I multiple myeloma are treated with a vaccine made from their own immune cells (dendritic cells) and their own myeloma protein. Vaccinations are given on 5 occasions every 4 weeks. The aim is to induce an immune reaction against the malignant myeloma cells in order to slow down or cure the disease.

Official Title
-----------------
Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma

Conditions
-----------------
Multiple Myeloma, Plasmocytoma

Intervention / Treatment
-----------------
* Biological: autologous idiotype-protein pulsed dendritic cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: multiple myeloma stage I (Salmon & Durie) no cytoreductive pre-treatment Exclusion Criteria: myeloma stages II-III asecretory disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: s.c. vaccination<br>vaccine given subcutaneously | Biological: autologous idiotype-protein pulsed dendritic cells<br>* Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks<br>|
| Experimental: i.v. vaccination<br>vaccines are given intravenously | Biological: autologous idiotype-protein pulsed dendritic cells<br>* Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific T-cell proliferation/cytokine secretion |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of T cells |  | pre and post vaccination | 
| monoclonal protein |  | pre and post vaccination | 
| plasmacells in bone marrow |  | pre and post vaccination | 
| vital signs |  | pre and post vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dendritic cells (DC), idiotype (Id), immunotherapy
Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics

Study Overview
=================
Brief Summary
-----------------
Following previous positive experience with regulated CITA-RNPT of infected CIEDs, we suggest increasing the number of recruited patients and that CITA-RNPT can be administered prophylactically to patients prior to replacement of previously treated CIEDs, immuno-compromised patients, and others.

Official Title
-----------------
Prospective Evaluation of the Efficacy and Safety of Continuous In-situ Ultra High-dose Antibiotics (CITA) and Minimally Invasive Surgery (MIS) Utilizing Regulated Negative Pressure-assisted Wound Therapy (RNPT) in the Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: CITA-RNPT
* Procedure: Extraction of infected CIED


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High-risk patients for CIED infections CIED infections Exclusion Criteria: Systematic infection

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infected CIED and Infection-Prone Patients Prior to CIED Implantation<br>Administration of high-dose antibiotics (CITA) | Drug: CITA-RNPT<br> <br> |
| Active Comparator: Infected CIED extraction<br>Extraction of infected CIED | Procedure: Extraction of infected CIED<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lack of CIED Infection |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Resynchronization Therapy Devices
A Blood Based Diagnostic Test for Coeliac Disease

Study Overview
=================
Brief Summary
-----------------
Persons with coeliac disease treated with a gluten free diet will be asked to give blood for a new diagnostic blood test. In this test investigators will use multimerized HLA bound to different gliadin-peptides (tetramer) and with the help of a flow-cytometer identify (along with other relevant T-cell-markers) gluten specific T-cells. Investigators believe that these cells will be present in persons with coeliac disease regardless of gluten-intake. Investigators will compare their findings with two control groups; Persons on a gluten free diet where celiac disease is excluded (gluten sensitive group) and persons on a gluten containing diet (healthy control group). In the initial and main study investigators will look at HLA DQ2.5 individuals, which comprise >90% of all persons with coeliac disease.

Official Title
-----------------
A Blood Based Diagnostic Test for Coeliac Disease

Conditions
-----------------
Coeliac Disease, Non Coeliac Gluten Sensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HLA DQ2.5 positives in primary blinded study (other HLA-types ie DQ8 and DQ2.2 in later unblinded study) In gluten free group: Diagnosis must be confirmed by duodenal biopsy done after sufficient time on gluten containing diet and participant must have followed a glutenfree diet since. Exclusion Criteria: Drugs that influence the immune system used last three months Infected with Hepatitis B, C or HIV Pregnant

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 |
| --- | --- |
| Coeliac<br>Persons with coeliac disease on a gluten free diet where diagnosis is confirmed by duodenal biopsy. | |
| Non coeliac gluten sensitive<br>Persons on a gluten free diet where coeliac disease is excluded by duodenal biopsy. | |
| Healthy control group<br>Persons on a gluten containing diet without known coeliac disease. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of the tetramer test in differentiating persons with coeliac disease from controls by the use of tetramer staining for gluten specific T-cells and flowcytometry |  | Upto 20 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gluten, Tetramer