linjc16/ctgov huggingface dataset:
Evaluation of the QuantiFERON-TB Test.

Study Overview
=================
Brief Summary
-----------------
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

Detailed Description
-----------------
The objective of the study was to enroll patients who have clinical signs/symptoms strongly indicating TB and who are receiving of have to start the treatment for active TB, and test the variants of the CST001 assay to support the evaluation of clinical sensitivity.

Official Title
-----------------
Evaluation of the 4th Generation QuantiFERON-TB Test (CST001) for the Detection of Tuberculosis Infection

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Device: CST001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical symptoms consistent with a high probability of having TB disease Receiving, or are likely to receive, therapy for active TB Confirmed tuberculosis by either AFB smear and culture testing, or Nucleic Acid Amplification methods and culture testing. Between 18 and 70 years of age. Exclusion Criteria: Taken therapy for active TB or latent TB for more than 14 days Culture confirmation of M. tuberculosis not obtained

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic<br>Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. | Device: CST001<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity | To evaluate the clinical sensitivity of the CST001 assay in patients who have clinical signs/symptoms strongly indicating TB disease and who are receiving or have to start treatment for active TB, and whom Mycobacterium tuberculosis (MTB) is confirmed by bacteriological culture. Patients included in the testing either had a positive acid-fast bacillus (AFB) smear of have MTB in a specimen detected by nucleic acid amplification (NAA) of MTB complex Polymerase Chain Reaction (PCR), and who have received treatment for no more than 14 days upon enrollment. | At time of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TB, Tuberculosis
Efficacy of T2259 in DED

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.

Official Title
-----------------
Comparison of the Performance and Safety of T2259 Versus Vismed Multi in Dry Eye Patients With Superficial Keratitis.

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Device: T2259
* Device: Vismed multi


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion Criteria: Signed and dated informed consent Male or female aged from ≥ 18 years old Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection Main exclusion Criteria: Far best-corrected visual acuity≤2/10 Severe Blepharitis

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T2259<br>1 drop in each eye 2 to 4 times daily | Device: T2259<br>* Sodium Hyaluronate and Trehalose<br>* Other names: Sodium Hyaluronate and Trehalose;|
| Active Comparator: Vismed Multi<br>1 drop in each eye 2 to 4 times daily | Device: Vismed multi<br>* HA<br>* Other names: Sodium Hyaluronate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15) | Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome) | Baseline and Day 35 |
Long Term Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the long term safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant

Official Title
-----------------
A Two-year Extension to a One-year, Multicenter, Partially Blinded, Double Dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: FTY720


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients who completed the 12 month core study Patients who gave written informed consent to participate in the study Exclusion Criteria Not applicable Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FTY720|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant |  |  | 
| Permanent resumption of dialysis within 36 months post transplant |  |  | 
| Surgical removal of graft within 36 months post transplant |  |  | 
| Death within 36 months post transplant |  |  | 
| Withdrawal of consent, death, or lost to follow up within 36 months post transplant |  |  | 
| Serum creatinine, calculated creatinine clearance and urine-protein/creatinine ratio at Months 18, 24, 30 and 36 |  |  | 
| FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36 |  |  | 
| Absolute lymphocyte count at Months 18, 24, 30 and 36. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical examinations at Months 18, 24, 30 and 36 |  |  | 
| Vital signs at Months 18, 24, 30 and 36 |  |  | 
| Electrocardiogram at Months 24 and 36 |  |  | 
| Chest X-ray Months 24 and 36 |  |  | 
| Safety laboratory tests 18, 24, 30 and 36 |  |  | 
| Ophthalmic evaluations 18, 24, 30 and 36 |  |  | 
| AEs and SAEs |  |  | 
| FTY720/CsA levels at Months 18, 24, 30 and 36 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transplantation, kidney, and organ transplant.
ONO-4538 Phase II Rollover Study (ONO-4538-98)

Study Overview
=================
Brief Summary
-----------------
This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.

Official Title
-----------------
A Multicenter, Open-label, Phase II Pan-Tumor Study in Patients Who Have Participated in Trials to Investigate Efficacy and Safety of ONO-4538 as Monotherapy or in Combination With Other Therapies and Are Continuing ONO-4538 Treatment (ONO-4538-98)

Conditions
-----------------
Pan-tumor

Intervention / Treatment
-----------------
* Drug: ONO-4538
* Drug: oxaliplatin
* Drug: S-1
* Drug: capecitabine
* Drug: bevacizumab
* Drug: temozolomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials Participant who is eligible for ONO-4538 monotherapy or in combination with other therapies as per the clinical trials, and/or investigator-assessed clinical benefit Exclusion Criteria: Participant judged to be incapable of providing consent for reasons such as concurrent dementia Participant judged by the investigator to be inappropriate as participants of this study

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONO-4538 Monotherapy cohort<br>480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice | Drug: ONO-4538<br>* IV infusion over 30 minutes<br>|
| Experimental: Combination therapy cohort<br>ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin [SOX] therapy , Capecitabine + Oxaliplatin [CapeOX] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study. | Drug: ONO-4538<br>* IV infusion over 30 minutes<br>Drug: oxaliplatin<br>* IV infusion over 2 hours<br>Drug: S-1<br>* Administered orally twice daily<br>Drug: capecitabine<br>* Administered orally twice daily<br>Drug: bevacizumab<br>* IV infusion over 30 minutes<br>Drug: temozolomide<br>* Administered orally once daily for 5 days every 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (Aes) | (non) | From Day 1 up to 28 days after the end of the treatment phase |
Pulmonary Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
This will be a retrospective study and analysis of subjects who have undergone a hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC at any time between 01Jan2000 and 30Jun2011. This study will determine factors influencing pulmonary disease and associated treatment strategies.

Official Title
-----------------
Pulmonary Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation.

Conditions
-----------------
Post Hematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Other: Data Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients who have undergone a hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC at any time between 01Jan2000 and 30Jun2011. Age > 18 years Exclusion Criteria: Age <18 years Prisoners

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post hematopoietic stem cell transplantation<br>Patients who were seen post hematopoietic stem cell transplantation between 01Jan2000 and 30Jun2011 | Other: Data Collection<br>* Collection of data on patients who were seen at OSUMC at any time between 01Jan2000 and 30Jun2011 post hematopoietic stem cell transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A retrospective diagnostic review on pulmonary disease related to hematopoietic stem cell transplantation. | To determine factors influencing pulmonary disease related to HSCT. | Up to 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A retrospective treatment review on treatment strategies for pulmonary disease related to hematopoietic stem cell transplantation. | To review treatment strategies for pulmonary disease post transplant for effectiveness. | Up to 15 years |
Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
To compare the therapeutic effect between autologous serum and umbilical cord serum eyedrops in the treatment of severe dry eye syndrome.

Detailed Description
-----------------
Ninety-two eyes of 48 patients with severe dry eye syndrome (34 eyes of 17 patients with Sjögren's syndrome and 58 eyes of 31 patients with non-Sjögren's syndrome) were treated with either 20% autologous serum (41 eyes of 21 patients) or umbilical cord serum eyedrops (51 eyes of 27 patients). Symptom scoring, corneal sensitivity test, tear film break-up time (BUT), Schirmer test, tear clearance rate (TCR), corneal fluorescein staining, and conjunctival impression cytology were performed before and 1 month and 2 months after treatment.

Official Title
-----------------
Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: Umbilical cord serum eyedrops
* Drug: Autologous serum eyedrops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with severe dry eye syndrome who were refractory to conventional treatments and had symptoms of dry eye for more than 3 months Low tear film break-up time (BUT, < 5 sec) Low Schirmer test (5 mm) Positive fluorescein or rose bengal vital staining (≥ 3) Exclusion Criteria: Active ocular infection or inflammation not associated with dry eye Contact lens wear Ocular allergy Ocular surgery within the recent 3 months Lid or lash abnormalities Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 61 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Umbilical cord serum eyedrops|nan|
|Drug: Autologous serum eyedrops|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Rhinovirus Study With Lactobacillus Rhamnosus GG

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus rhamnosus GG during rhinovirus infection.

Conditions
-----------------
Respiratory Tract Infections [C08.730]

Intervention / Treatment
-----------------
* Other: Fruit juice with Lactobacillus rhamnosus GG, version 1
* Other: Fruit juice with Lactobacillus rhamnosus GG, version 2
* Other: Standard fruit juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female in general good health (stabilized chronic illnesses and regular medications are accepted, if not otherwise mentioned in the exclusion criteria) Age 18-65 years Serum neutralizing antibody titer of 1:4 or less for the challenge rhinovirus No clinically significant finding on the pre-study nasal examination Females must have a negative urine pregnancy test, and women of child-bearing potential must be using an effective method of birth control such as, but not limited to birth control pills, contraceptive foam, diaphragm, IUD, surgical sterilization, abstinence, or condoms Written informed consent must be obtained at enrollment into the study Exclusion Criteria: Suffer from or have a history of significant allergic rhinitis at the time of study Bronchial asthma or other lower respiratory tract diseases, such as chronic obstructive lung disease or emphysema Nasal abnormalities or other nasal pathology, such as irreversible nasal mucosal hypertrophy or severe nasal septum derivation Pregnancy or lactation History of alcohol abuse (regularly consumes 5 or more alcohol drinks per day) and/or drug abuse during the 12 month period immediately preceding study enrollment Daily smoking within the past 2 years Use of investigational product or participation in a device trial during the 30 day period immediately preceding study enrollment Previous participation in an experimental study with rhinovirus 39 Allergy to any ingredient in the study product Have, as determined by the investigator and/or the sponsor's medical monitor, any surgical or medical condition or take any medication or dietary supplement that could interfere with the interpretation of study results or jeopardize the safety of the subject

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Fruit juice with Lactobacillus rhamnosus GG, version 1|nan|
|Other: Fruit juice with Lactobacillus rhamnosus GG, version 2|nan|
|Other: Standard fruit juice|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Genetic and Electrophysiologic Study in Focal Drug-resistant Epilepsies

Study Overview
=================
Brief Summary
-----------------
Brain somatic mutations in genes belonging to the mTOR signaling pathway are a frequent cause of cortical malformations, including focal cortical dysplasia or hemimegalencephaly. The present study aims to search for brain somatic mutations in paired blood-brain samples and perform functional validation in children with drug-resistant focal epilepsy

Conditions
-----------------
Refractory Focal Epilepsy, Focal Cortical Dysplasia, Hemimegalencephaly, Tuberous Sclerosis, Mild Malformation of Cortical Development With Oligodendroglial Hyperplasia in Epilepsy (MOGHE)

Intervention / Treatment
-----------------
* Genetic: Sampling of blood, frozen resected tissues, and cerebrospinal fluid (CSF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with focal drug-resistant epilepsy including Focal Cortical Dysplasia, Hemimegalencephaly, Tuberous Sclerosis, Mild malformation of cortical development with oligodendroglial hyperplasia in epilepsy (MOGHE), Hypothalamic Hamartomas, Sturge-Weber syndrome, Rasmussen encephalitis, gliomas) Their parents who have signed informed consent 1) for their child's participation (for parents) and 2) for themselves Social security coverage or foreign regime recognized in France Exclusion Criteria: refusal to participate in the study contraindication to anaesthesia, to MRI or to surgery no medical insurance coverage

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 25 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 |
| --- | --- |
| Children undergoing epilepsy surgery at the Rothschild Foundation, Paris.<br>Sequencing of paired blood-brain DNA samples | Genetic: Sampling of blood, frozen resected tissues, and cerebrospinal fluid (CSF)<br>* Sampling of blood, frozen resected tissues, and cerebrospinal fluid (CSF)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qualitative genetic analysis | Detection of brain somatic mutations and functional studies | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refratory Focal Epilepsy, Focal Cortical Dysplasia, Cortical Malformation, Hemimegalencephaly, Tuberous sclerosis, Mild malformation of cortical development with oligodendroglial hyperplasia in epilepsy (MOGHE)
Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period.

Official Title
-----------------
A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets To Intravenous Zometa 4mg in Male Bisphosphonate-Naive Hormone Refractory Prostate Cancer Patients

Conditions
-----------------
Hormone-Refractory Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Zoledronic Acid 20mg Tablets
* Drug: Zoledronic Acid
* Drug: Zoledronic Acid 20mg Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray. Exclusion Criteria: Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)

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

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

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: B<br>MER-101 20mg Tablets Regimen 1 | Drug: Zoledronic Acid 20mg Tablets<br>* Oral enteric coated tablets, 20mg, weekly, 8 weeks<br>* Other names: MER-101;|
| Experimental: C<br>MER-101 20mg Tablets Regimen 2 | Drug: Zoledronic Acid 20mg Tablets<br>* Oral enteric coated tablets, 20mg, once a day for 4 consecutive days during week 1, weekly for weeks 5, 6, 7, 8<br>* Other names: MER-101;|
| Active Comparator: A<br>Zometa Injection | Drug: Zoledronic Acid<br>* Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks<br>* Other names: Zometa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on 4 markers of bone metabolism |  | Weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory |  | Monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, hormone resistant, bisphosphonate