linjc16/ctgov huggingface dataset:
Micardis® / MicardisPlus® Program for Therapy Optimization With Telmisartan in Cardiovascular Diseases (PROTEKT)

Study Overview
=================
Brief Summary
-----------------
Study to evaluate efficacy and tolerability of Micardis®/MicardisPlus® under usual daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the clientele of cardiologists, nephrologists, and diabetologists

Official Title
-----------------
Micardis® / MicardisPlus® PROTEKT (Program for Therapy Optimization With Telmisartan in Cardiovascular Diseases)

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Micardis®
* Drug: MicardisPlus®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Exclusion Criteria: Age < 18 years

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 |
| --- | --- |
| Hypertensive patients - Cardiologists<br> | Drug: Micardis®<br> <br> Drug: MicardisPlus®<br> <br> |
| Hypertensive patients - Nephrologists<br> | Drug: Micardis®<br> <br> Drug: MicardisPlus®<br> <br> |
| Hypertensive patients - Diabetologists<br> | Drug: Micardis®<br> <br> Drug: MicardisPlus®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure (SBP) |  | baseline, up to 6 months | 
| Change in diastolic blood pressure (DBP) |  | baseline, up to 6 months |
Rétrospective Evaluation of the Performance and the Safety of the Endoscopic Mucosectomy With Anchorage

Study Overview
=================
Brief Summary
-----------------
This safe and simple technique without extra cost would allow us to improve R0 resection ratio and so decrease relapses and the time between two different exams

Official Title
-----------------
Rétrospective Evaluation of the Performance and the Safety of the Endoscopic Mucosectomy With Anchorage of the Tip of the Loop

Conditions
-----------------
Polyps of Colon

Intervention / Treatment
-----------------
* Procedure: Endoscopic Mucosectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years old Other rectal or colic résections from 10 to 30 mm into the past Exclusion Criteria: Colitis, Crohn Disease or Ulcerative Colitis Intense fibrosis under the lesion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic Mucosectomy|Endoscopic Mucosectomy with anchorage of the tip of the loop|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the proportion of R0 resections of anchored mucosectomies from 10 to 30 mm colon and rectum lesions |  | One year |
Neuromuscular Electrical Stimulation and Strength Training in Patients With Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficiency of neuromuscular electrical stimulation and of resisted exercises on increasing quadriceps strength, decreasing pain and on recovering motor function of patients with knee osteoarthritis.

Official Title
-----------------
Neuromuscular Electrical Stimulation and Strength Training in Patients With Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: Neuromuscular Electrical Stimulation
* Other: ECR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American College of rheumatology criterion for osteoarthritis diagnosis Exclusion Criteria: Patients that have done knee replacement or are about to do. Patients with health conditions that are not compatible with the interventions Patients that have done intraarticular corticoid

Ages Eligible for Study
-----------------
Minimum Age: 38 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECR<br> | Other: ECR<br>* Resisted exercises<br>|
| No Intervention: Control<br> | |
| Experimental: NMES<br> | Other: Neuromuscular Electrical Stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quadriceps strength |  | Before and after an 8 weeks intervention | 
| Change in Pain |  | Before and after an 8 weeks intervention | 
| Change in Moving function |  | Before and after an 8 weeks intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quadriceps strength, osteoarthritis rehabilitation, NMES
Improving Access To Services to Community Based Outpatient Clinics (CBOC's)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the feasibility of delivering IPCT in three rural VA community based outpatient clinics (CBOCs).

Detailed Description
-----------------
We will first need to develop a more thorough understanding of the potential barriers associated with implementing this novel form of treatment in these settings by conducting focus groups at each facility. This information will then be used to modify the treatment, which will then be piloted with Veterans enrolled in these clinics who have panic disorder.

Official Title
-----------------
Improving Access To Services With An Intensive Two-Day Treatment For Panic

Conditions
-----------------
Panic Disorder

Intervention / Treatment
-----------------
* Behavioral: Intensive Panic Control Treatment (IPCT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OEF/OIF/OND Veteran with current diagnosis of panic disorder with or without agoraphobia (presence of other anxiety disorders is acceptable) Exclusion Criteria: Current substance dependence psychosis symptomatic bipolar disorder severe depression with suicidal intent or plan

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Intensive Panic Control Treatment (IPCT)|A manualized treatment that consists of psychoeducation about panic disorder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Panic Control Treatment (IPCT) | IPCT is a manualized treatment that consists of psychoeducation about panic disorder, behavioral exercises such as breathing retraining and interoceptive exposure to mimic symptoms during an actual panic attack, and cognitive restructuring (identifying thought distortions and replacing them with corrective thoughts based on realistic appraisals). | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Panic, Anxiety
Early Detection of Anaemia During the Maternity

Study Overview
=================
Brief Summary
-----------------
Estimate the efficiency of a strategy of premature screening of the maternal anaemia during the first quarter of pregnancy versus the usual strategy of screening of the anaemia during the sixth month.

Detailed Description
-----------------
A part of the patient will have a NFS and dosage of the cast-iron, during the results of the beginning of the pregnancy at the first quarter. The other part of the patients will have a NFS and at the first quater of the pregnancy. All the patient will have a NFS at the results of the sixth month of the pregnancy. A NFS will be done during the results at the end of the pregnancy like we do now. Then a NFS at 48 hours after the birth. A treatment with iron will be done and according to the results

Official Title
-----------------
The Early Detection of Anaemia During the Maternity Decreases the Anaemia at the End of the Maternity.

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Biological: dosage of the NFS and iron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every patient followed at the HME at the beginnig of the pregnancy Exclusion Criteria: pregnency women who don't speak french pregnancy women affected by béta thalassemia pregnancy woman having had a périconceptionnel treatment against the anaemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NFS and iron in the first quater<br>first arm: dosage NFS and iron during the beginning of the pregnancy then in the sixth month of pregnancy then in th delivery. | Biological: dosage of the NFS and iron<br>* a blood test will be made.<br>|
| Experimental: No NFS and iron in the first quater<br>second arm: dosage NFS and iron during the sixth month of pregnancy then in th delivery. No dosage of NFS and iron during the beginning of the pregnancy | Biological: dosage of the NFS and iron<br>* a blood test will be made.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary outcomes: is the rate of heamophilia at the end of the pregnancy. |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes: - the percent of treatment of intravenous irons during the pregnancy and the following layers. - the percent of transfusion and the following layers. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aneamia during the maternity, aneamia
Cirrhosis Registry of Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
Cirrhosis registry of consecutive adult consenting patients hospitalized with liver cirrhosis in the tertiary liver unit

Detailed Description
-----------------
On admission to F.D.Roosevelt Teaching Hospital / HEGITO Liver Unit (Div Hepatology, Gastroenterology and Liver Transplant), all the adult patients with liver cirrhosis are offered to participate. After providing informed consent, their demographic, clinical and laboratory / imaging data are uploaded by dedicated study person After discharge from the hospital, follow-up is recommended and uploaded to RH7 (if the follow-up visits take place at this institution [FDR]) Mortality data are uploaded from the national registry of dead on regular basis

Official Title
-----------------
Registry of Adult Consenting Patients Admitted to the Liver Unit With Liver Cirrhosis

Conditions
-----------------
Cirrhosis, Liver, Frailty, Ascites, Encephalopathy, Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver cirrhosis (primarily on clinical grounds) decompensating event leading to hospital admission informed consent Exclusion Criteria: declined consent

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Adults with liver cirrhosis admitted to hospital liver unit<br>Consenting adults admitted with liver cirrhosis; recorded/uploaded are demographic, clinical, laboratory and imaging data | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and type of decompensation of liver cirrhosis | Registrations reflect cirrhosis prevalence; decompensation are acute, chronic, or acute-on-chronic | 1 year | 
| Mortality | Record mortality in registered cirrhotics | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Record mortality in registered cirrhotics | 90-day | 
| Mortality | Record mortality in registered cirrhotics | 1 year | 
| Frailty | Measurement of the liver frailty index | On admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cirrhosis, decompensation, frailty
Systematic Registration of All Big Toe Prostheses Placed in Ghent University Hospital

Study Overview
=================
Brief Summary
-----------------
Systematic registration of all big toe prostheses placed in Ghent University Hospital for analyses of global results, comparison between different types of prostheses, ...

Official Title
-----------------
Systematic Registration of All Big Toe Prostheses Placed in Ghent University Hospital

Conditions
-----------------
Big Toe Prosthesis

Intervention / Treatment
-----------------
* Procedure: Registration of all big toe prostheses in Ghent University Hospital


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Big toe prosthesis Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Registration of all big toe prostheses in Ghent University Hospital|Registration of all big toe prostheses in Ghent University Hospital.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of big toe prostheses. | Developing a database of all big toe prostheses in Ghent University Hospital. | ongoing basis |
Oxaliplatin, 5-FU and Leucovorin in Combination With Oral Capecitabine for Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The combination of oxaliplatin, 5-FU, leucovorin, and capecitabine is hypothesized to retain and potentially improve upon the activity of the FOLFOX regimens. Additionally, the use of an oral rather than an infusional 5-fu regimen represents a clear advantage in terms of both patient convenience and lack of associated catheter-related complications.

Official Title
-----------------
A Phase II Study of Oxaliplatin, 5-fluorouracil, and Leucovorin in Combination With Oral Capecitabine in Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no prior treatment for metastatic disease PS 0-2 measurable disease Exclusion Criteria: neuropathy > or equal to grade 2 concomitant radiation therapy or other systemic cancer therapies brain mets

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: chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does the combination of oxaliplatin, 5-FU, leucovorin and capecitabine improve the activity of the FOLFOX regimens in metastatic colorectal cancer patients |  | Bi-monthly collection of information regarding tumor progression and overall survival. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is the oral drug an advantage in this patient population |  | Bi-monthly collection of information regarding tumor progression and overall survival |
Gene Expression in MS Patients Before and During Treatment With Interferon-beta

Study Overview
=================
Brief Summary
-----------------
Clinical and experimental evidences suggest that there is a variability in therapeutic response to immunomodulating therapies in Multiple Sclerosis patients. Microarrays is a technology that permits to monitor the expression levels of thousands of genes at a time. The specific aim of this study is to identify predictive factors of therapeutic response in MS patients treated with high-dose Interferon-Beta.

Official Title
-----------------
Gene Expression in MS Patients Before and During Treatment With High-dose Interferon Beta: Prospective Study for the Identification of Predicting Factors of Therapeutic Response.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of relapsing-remitting MS (McDonald criteria) age between 18-55 EDSS less or equal to 5.5 Exclusion Criteria: use of any other disease modifying drugs use of corticosteroids during 3 months before starting protocol clinical relapse during 1 month before starting protocol serious heart, renal, hepatic or haematological dysfunction defined by laboratory exams

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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 |
| --- | --- | --- |
| Gene Expression in MS Patients | Change in Gene Expression profile in MS Patients at 12 months of IFN beta 1a treatment | baseline and 12 months after IFN beta 1a treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, microarrays
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.

Official Title
-----------------
Multi-centre, Open-label, Non-randomised Single Dose Trial Investigating the Pharmacokinetics of N8 in Japanese Subjects With Haemophilia A

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A

Intervention / Treatment
-----------------
* Drug: turoctocog alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese subjects who have completed NN7008-3543 No detectable inhibitors to factor VIII Exclusion Criteria: Congenital or acquired coagulation disorders other than haemophilia A Planned surgery during the trial period Receipt of any investigational drug other than recombinant factor VIII (N8) within 30 days of trial product administration

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 66 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: recombinant factor VIII (N8)<br> | Drug: turoctocog alfa<br>* Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.<br>* Other names: recombinant factor VIII;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve |  | Infusion, 30 minutes | 
| Incremental recovery |  | Infusion, 30 minutes | 
| In vivo t1/2 |  | Infusion, 30 minutes | 
| Total clearance (CL) |  | Infusion, 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal concentration |  | at 15 minutes | 
| Area under the curve |  | from time zero to last | 
| Number of adverse events |  | from day -1 to day 3 (end of trial) |