linjc16/ctgov huggingface dataset:
Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System.

Detailed Description
-----------------
This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System. The study will include a minimum of 58 patients at a minimum of 3 sites in the United States. The study will enroll at a minimum of 5 subjects implanted with the occipital plate.

Official Title
-----------------
Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up (OCT PMCF)

Conditions
-----------------
Spinal Stenosis Occipito-Atlanto-Axial, Spinal Disease, Spinal Stenosis Cervical, Spinal Stenosis Cervicothoracic Region, Spinal Instability

Intervention / Treatment
-----------------
* Device: Streamline Occipito-Cervico-Thoracic Spinal Fixation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have had an implant of the OCT System. Exclusion Criteria: No exclusion criteria.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Streamline Occipito-Cervico-Thoracic Spinal Fixation System|Spinal Fixation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate time to demonstration of fusion. | Evaluate time to demonstration of fusion. | 12 months |
Satiety Response of White and Brown Rice Compared to Glucose Control

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that consumption of either white or brown rice will be more satiating than glucose control.

Detailed Description
-----------------
This study is an acute, randomized, repeated measures design with 20 subjects. Subjects will consume 3 test breakfasts, white rice, brown rice, or glucose control, each containing 400 calories. Treatments will be one week apart. After consumption of the controlled breakfast, subjects will complete visual analogue scales (VAS) for satiety response. Additionally, they will consume a pizza lunch and record food intake for the next 24 hours. Breath gas samples will be collected to estimate fermentation of fiber in the large intestine. Also, subjective data on gastrointestinal tolerance will be collected.

Official Title
-----------------
Satiety Response of White and Brown Rice Compared to Glucose Control

Conditions
-----------------
Food Selection

Intervention / Treatment
-----------------
* Other: White Rice, Brown Rice, Glucose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: inability to consume rice for breakfast

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: white rice<br>White rice | Other: White Rice, Brown Rice, Glucose<br>* white rice, brown rice, glucose<br>|
| Experimental: Brown rice<br>Brown Rice | Other: White Rice, Brown Rice, Glucose<br>* white rice, brown rice, glucose<br>|
| Experimental: Glucose<br>Glucose | Other: White Rice, Brown Rice, Glucose<br>* white rice, brown rice, glucose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety | Visual analogue scales (subjective measurements) | 4 hours following breakfast | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
satiety, obesity, food intake
Evaluation of a Noninvasive Fetal RHD Genotyping Test

Study Overview
=================
Brief Summary
-----------------
This study will collect whole blood samples from pregnant subjects who are RhD negative by serology to develop an assay for RHD determination of the fetus.

Official Title
-----------------
Evaluation of a Noninvasive Fetal RHD Genotyping Test

Conditions
-----------------
Rhesus D Genotype

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18-64 years of age Subject is female Subject is pregnant Subject is RhD negative Subject is between 10 and 28 weeks gestation Subject provides informed consent Subject agrees to provide neonatal RHD and sex outcome Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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 |
| --- | --- | --- |
| Fetal RHD determination from maternal whole blood |  | Between 10 and 28 weeks gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RhD negative, RhD disease, fetal nucleic acid, fetal DNA, cell free fetal DNA, Fetal RHD genotype
Genetic Causes of FSGS, Nephrotic Syndrome, or Kidney Failure

Study Overview
=================
Brief Summary
-----------------
The investigators are trying to learn more about the cause of kidney diseases such as Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic syndrome by studying genetics. The investigators are interested in discovering which genes play a role in causing a predisposition to FSGS/NS. The investigators also want to learn why FSGS/NS can run in families. Participation in our study involves a saliva sample and a urine sample that you can give from home. There is no cost to participate. All information is kept private and confidential. The investigators also like to include healthy volunteers (parents, spouses) if interested/available but of course this is completely optional.

Detailed Description
-----------------
The investigators welcome anyone (with or without a family history) with unexplained, non syndromic FSGS, nephrotic syndrome, or proteinuria to join the study. Participation involves a saliva (or blood if it is preferable) sample and urine sample (if applicable). There is no cost to participate and the study can be done from home in most cases.

Official Title
-----------------
Molecular and Genetic Analysis of Inherited Kidney Dysfunction

Conditions
-----------------
Focal Segmental Glomerulosclerosis, Nephrotic Syndrome, End Stage Renal Disease, Kidney Failure, Unexplained Proteinuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with FSGS (focal segmental glomerulosclerosis) Subjects with NS (nephrotic syndrome) Subjects with unexplained kidney failure (have had a transplant or on dialysis) Subjects with unexplained proteinuria Family members of a person with FSGS, NS, kidney failure, or unexplained protein in their urine Healthy volunteers Exclusion Criteria: Patients whose kidney disease is already explained by another syndrome such as (Branchio Oto Renal Syndrome or Alports syndrome) Patients who already know the genetic cause of their kidney disease
Sexes Eligible for Study
-----------------
All

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 |
| --- | --- | --- |
| To identify the genetic causes of FSGS, NS, and idiopathic proteinuria/ESRD in patients and families | This is an ongoing study for research purposes only. | 2035 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FSGS, NS, Kidney disease, Kidney failure, Renal disease, nephrotic syndrome, focal segmental glomerulosclerosis, familial kidney disease, minimal change disease, proteinuria
A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.

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

Intervention / Treatment
-----------------
* Drug: AL-38583 ophthalmic solution 0.05%
* Drug: AL-38583 ophthalmic solution 0.10%
* Drug: AL-38583 vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Composite corneal staining score of greater than 5 in one or both eyes. Schirmer II score of greater than 4 mm. OSDI score of greater than 23. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the test article or safe participation in this study. Other protocol-defined 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL-38583 0.05%<br>AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days | Drug: AL-38583 ophthalmic solution 0.05%<br> <br> |
| Experimental: AL-38583 0.10%<br>AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days | Drug: AL-38583 ophthalmic solution 0.10%<br> <br> |
| Placebo Comparator: AL-38583 vehicle<br>Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days | Drug: AL-38583 vehicle<br>* Inactive ingredients used as a placebo comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in sodium fluorescein corneal staining score |  | Baseline, up to Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in phenol red thread length |  | Baseline, up to Day 35 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye
Therapists to Administer Contingency Management-Therapist Phase - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to train therapists to administer contingency management (CM). This project will train up to 42 community-based treatment providers about the rationale for and the specifics of administering CM. Initial training will occur in 2-day workshops, followed by weekly supervision in delivery of CM with test cases. We expect that the majority of therapists will achieve high levels of competence and adherence in administering CM treatment within 3-5 test cases, as measured by ratings of audiotapes. To examine the efficacy of CM, each therapist who achieves adherence and competence in delivering CM will administer standard treatment alone or standard treatment plus CM to substance-abusing outpatients. In the CM condition, patients will have the opportunity to win prizes for submission of negative samples, and the treatment will be in effect for 12 weeks. In total, up to 200 patients will be randomly assigned to one of the two conditions. A research evaluator will conduct follow-up assessments, scheduled for 3, 6 and 9 months after treatment initiation.

Official Title
-----------------
Therapists to Administer Contingency Management-Therapist Phase

Conditions
-----------------
Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: Contingency management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Therapists who volunteer must have: at least one-year experience treating substance abusers, and at least 6 months employment at that center must commit to being available for both the workshop and individual training must be willing to allow random assignment of their patients to CM and non-CM treatments

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Contingency management|Rewards (prizes) for abstinence|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinalysis results |  | baseline and at each follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contingency management, substance abuse treatment
Impact on Patient Satisfaction About Realization of Ultrasound Dopplers at the Bed

Study Overview
=================
Brief Summary
-----------------
Organisation and logistic about realisation of vascular doppler ultrasound is something very eclectic . Need to shift patient from their bed , long waiting time and the effect on the hospital cost. That's why vascular yard aim to practise these doppler ultrasound directly in the patients' room in the bed. And like that evaluate the patient's satisfaction of this kind of coverage.

Official Title
-----------------
Impact on Patient Satisfaction About Realization of Ultrasound Dopplers at the Bed

Conditions
-----------------
Ultrasound Doppler

Intervention / Treatment
-----------------
* Procedure: echo doppler at the bed
* Procedure: echo doppler in the vascular exploration platform


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalized in vascular yard indication of ultrasound doppler accept to participate Exclusion Criteria: refuse to participate without ultrasound doppler indication.

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 |
| --- | --- |
| echo doppler at the bed<br> | Procedure: echo doppler at the bed<br>* we practise the echo doppler at the patient 's bed<br>|
| echo doppler in the vascular exploration platform<br> | Procedure: echo doppler in the vascular exploration platform<br>* as usual , practising echo doppler in the medical platform<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score of a satisfaction questionnaire | in the current practice every patient fill up a questionnaire named SAPHORA to evaluate their satisfaction | 24 hours |
The Efficacy of Three Months-prednisolone Therapy for Chronic Eosinophilic Pneumonia

Study Overview
=================
Brief Summary
-----------------
A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may be as effective as 6 months-therapy.

Official Title
-----------------
Phase 4, Randomized Study of Three Months-prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia

Conditions
-----------------
Eosinophilic Pneumonia, Chronic Disease

Intervention / Treatment
-----------------
* Drug: prednisolone 0.5 mg/kg/day for three months
* Drug: prednisolone 0.5 mg/kg/day for six months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy-proven chronic eosinophilic pneumonia Exclusion Criteria: Patients who received oral glucocorticosteroid (more than 10 mg) Immunosuppressive drug

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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: 1<br>prednisolone therapy for three months | Drug: prednisolone 0.5 mg/kg/day for three months<br>* period of treatment<br>* Other names: prednisolone;|
| Active Comparator: 2<br>prednisolone therapy for six months | Drug: prednisolone 0.5 mg/kg/day for six months<br>* period of therapy<br>* Other names: prednisolone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia |  | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia |  | Three years |
French National Observatory of Patients With Thymic Epithelial Tumor

Study Overview
=================
Brief Summary
-----------------
RYTHMIC (Réseau tumeurs THYMiques et Cancer) is a French nationwide network for TET with the objective of territorial coverage by regional expert centers and systematic discussion of patients management at national tumor board.

Detailed Description
-----------------
RYTHMIC (Réseau tumeurs THYMiques et Cancer) is a nationwide network for TET appointed in 2012 by the French National Cancer Institute. The objectives of the network are management of clinical tumor boards and central pathologic review of all cases. RYTHMIC Tumor Board is based on initial histopathological diagnosis. RYTHMIC is a comprehensive tool for research: to improve the management of patients to monitor dedicated actions to screen patients for future translational and clinical trials

Official Title
-----------------
French National Observatory of Patients With Thymic Epithelial Tumor

Conditions
-----------------
Thymic Epithelial Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with Thymic Epithelial Tumors Exclusion Criteria: histology other than Thymic Epithelial Tumors

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| histological type | histological type according to the WHO classification 2004/2015 | 5 years | 
| Masaoka-Koga stage | Masaoka-Koga stage | 5 years | 
| ITMIG/IASLC 2014/2015 stage | ITMIG/IASLC 2014/2015 stage | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questions raised at the national expert multidisciplinary tumor board | Diagnosis/Imaging, Surgery, Chemotherapy, Radiotherapy | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thymic Epithelial Tumor, Cohort study, IFCT
Comparative Pharmacokinetic Trial of RGB-03 and MabThera

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: MabThera (rituximab)
* Drug: RGB-03


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active Rheumatoid Arthritis Inadequate response or intolerance to other DMARDs and anti-TNFs Treatment with Methotrexate Exclusion Criteria: Previous treatment with rituximab Patients with systemic manifestations of rheumatoid arthritis Patients seropositive for HIV, HCV, HBV Female patients nursing 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RGB-03<br> | Drug: RGB-03<br> <br> |
| Active Comparator: MabThera (rituximab)<br> | Drug: MabThera (rituximab)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum concentration versus time curve (AUC) |  | 0-24 weeks |