linjc16/ctgov huggingface dataset:
Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that treatment with Trichuris suis ova will be safe and effective as an oral treatment of patients with relapsing multiple sclerosis.

Official Title
-----------------
Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study

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

Intervention / Treatment
-----------------
* Biological: Trichuris suis ova


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 19 and 55 years relapsing course of multiple sclerosis (relapsing-remitting or secondary progressive MS with relapses duration of the disease of at least 1 year no disease modifying therapy or unchanged immunomodulatory therapy for the last 3 months at least 2 documented relapses during the last 24 months with the last relapse within the last 12 months Exclusion Criteria: pregnancy or period of breastfeeding or missing adequate contraceptive protection for female premenopausal patients relapse in the last month prior enrolment treatment with steroids in the last 30 days previous treatment with mitoxantroneduring the last year previous treatment with cyclophosphamide or other intensive immunosuppression, total irradiation treatment with glatiramer acetate, azathioprine, IVIG or any other immunosuppressive or immunomodulatory drug apart from interferon-beta in the 6 months prior to enrolment cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension diabetes mellitus and other autoimmune diseases history of renal insufficiency stay in tropical areas during the last 3 months eosinophilia in the blood (> 0,45 billion/l) concurrent systemic infections

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trichuris suis ova<br> | Biological: Trichuris suis ova<br>* 2500 ova per dose, orally, every second week, during 12 weeks<br>* Other names: TSO;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI activity judged by the number of new or enlarging T2 lesions, number of Gd enhancing lesions and volume of T2 lesions |  | every 3. week. 3 MRI before treatment and 4 MRI during and after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple sclerosis, safety, MRI, immunological, Helminths, Trichuris suis
Characteristics of Patient Population With Endometriosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect and analyze data on the characteristics of women who are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as part of their standard medical care. Data collected will contribute to the development of guidelines for the surgical management of endometriosis. In addition, specimens will be collected for future testing regarding diagnosing, and/or staging of endometriosis, or suspected endometriosis, pain and infertility.

Detailed Description
-----------------
Patients seen at Saint Louis University Center for Endometriosis (which has offices locations at St. Mary's, St. Luke's and the SLU-UMG clinic - all of which are in the SLU Epic system), and operated on for endometriosis, suspected endometriosis, pain and/or infertility at St. Mary's hospital (only). A preoperative questionnaire will be provided to the subject. Questions from the survey include information on baseline demographics, severity and type of pain, and previous medical and surgical history. Operative data will also be collected and analyzed. A post-operative questionnaire will be administered to the participants at 6 months, and then at regular yearly intervals after the surgery by a secure on-line process using the RedCap software. Improvement in quality of life and pain scores will be analyzed. Specimens will also be collected and stored for future testing regarding diagnosing, and/or staging of endometriosis, suspected endometriosis, pain and infertility.

Official Title
-----------------
Characteristics of Patient Population With Endometriosis - A Prospective Database and BioBank

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients 13-55 years of age Anyone seen at the Center for Endometriosis Exclusion Criteria: Prior bilateral salpingo-oophorectomy post natural menopause Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.

Ages Eligible for Study
-----------------
Minimum Age: 13 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Endometriosis<br>Patients whom pathology results post surgery document endometriosis | Other: Questionnaires<br>* Patients will receive questionnaires yearly to follow their QOL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, pain and fertility | (QOL) endometriosis health profile (EHP-5) | every 12 months |
Lacosamid-i.v.-Register

Study Overview
=================
Brief Summary
-----------------
Lacosamide is a new antiepileptic drug (AED) marketed as Vimpat with three different formulations, tablets, oral syrup and a solution for intravenous infusion. Lacosamide is approved as adjunctive therapy in epilepsy patients with partial onset seizures with or without secondary generalization. The i.v. solution is used in patients in which oral administration is not possible or adequate. Bioequivalence with oral tablets and safety could be demonstrated in healthy volunteers and in patients switched from tablets to Lacosamide i.v. solution. A recently published study demonstrates the feasibility of single loading doses up to 300 mg. The aim of this Lacosamide i.v. registry is to collect systematically data on the safety, tolerability and administration procedures when Lacosmide i.v. is used in routine daily clinical practice, mainly in hospitals. These data will help treating physicians to optimize the use of Lacosamide i.v. in clinical routine.

Official Title
-----------------
Lacosamid-i.v.-Register

Conditions
-----------------
Epilepsy With Partial Onset Seizures With or Without Secondary Generalization

Intervention / Treatment
-----------------
* Drug: Lacosamide 10mg/ml


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: before any data are collected for any patient in this registry an ehtical committee must be notified of the registry and written data consent must be properly executed and documented Exclusion Criteria:

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 |
| --- | --- |
| Lacosamid-i.v. treatment<br> | Drug: Lacosamide 10mg/ml<br>* intravenous administration up to 10 days<br>* Other names: VimpatⓇ;|

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
-----------------
oral administration of Lacosamide is not possible or adequate
Early- and Late-onset Candidemia

Study Overview
=================
Brief Summary
-----------------
A timing diagnosis of candidemia is as important as the correct choice of empiric or targeted antifungal therapy. In the last years a growing body of knowledge has better characterized health-care associated (HCA) infections, which have been described in 2002 in outpatients with MRSA bloodstream infections. So far there is no compelling evidence that patients with HCA infections may develop candidemia before the usual timing of around 20-25 days after admission. Risk factors associated with HCA infections are represented by admission from long term chronic care facilities (LTCF), haemodialysis, previous admission or parenteral broad spectrum antibiotics. There are few data HCA features and early onset candidemias in the published literature. In this proposal, the investigators aim at studying early-onset candidemia in a retrospective study in one of the largest referral hospital in Italy with a consistent range of specialties ranging (bone marrow transplant, solid organ transplant, immunosuppressed patients, ICU, complex surgery). The investigators speculate that patients with candidemia diagnosed within 10 days (early-onset) by the admission have different risk factors and prognosis of those with a late diagnosis.

Official Title
-----------------
Early- and Late-onset Candidemia: A Retrospective Study

Conditions
-----------------
Candidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidemia diagnosed with positive blood culture either from a peripheral vein or CVC Exclusion Criteria: Candida isolated from a removed CVC tip will not be considered

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 |
| --- | --- |
| Candidemia patients<br>Patients with diagnosis of candidemia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Candidemia, Early-onset, Late-onset, Health-care associated, Nosocomial
The Influence of the 34C>T Variant in the AMPD1 Gene Ischemic Tolerance

Study Overview
=================
Brief Summary
-----------------
Previous epidemiological studies have shown that in cardiovascular patients, the 34C>T variant in the gene encoding for the enzyme Adenosine Mono Phosphate Deaminase (AMPD1) is associated with prolonged survival. The 34 C>T variant encodes a severely truncated, metabolically inactive protein. We hypothesize that during ischemia, in these patients AMP in preferentially converted into adenosine instead of IMP. Adenosine receptor stimulation, in turn, will increase resistance to ischemia-reperfusion in the myocardial tissue. To test this hypothesis, 7 male healthy volunteers heterozygous for the 34C>T variant will be selected from 100 healthy volunteers, which we have previously genotyped. These subjects will be compared with 7 matched control subjects. Individual ischemic tolerance will be assessed in the thenar muscle using 99mTc-Annexin A5 scintigraphy. Briefly, the circulation of the nondominant forearm will be interrupted for 10 minutes by inflation of an upperarm cuff to 200mmHg en concomitantly, the subjects will perform isometric rhythmic handgripping until exhaustion. Immediately upon reperfusion, 400 MBq of 99mTc-Annexin A5 will be administered intravenously. Finally, 1 and 4 hours post-injection, scintigrapghi imaging of both hand will be performed. Targeting of annexin A5 will be expressed as percentage difference between the experimental and control hand.

Official Title
-----------------
The Influence of the 34C>T Variant in the AMPD1 Gene on Individual Susceptibility for Ischemia-reperfusion.

Conditions
-----------------
AMPD, Ischemic Tolerance

Intervention / Treatment
-----------------
* Drug: systemic administration of 99mTc-HYNIC-Annexin A5
* Behavioral: 10 minutes of ischemic handgripping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male 18-40 years healthy AMPD1 34C>T variant (heterozygous) or matched control Exclusion Criteria: cardiovascular / pulmonary disease diabetes / hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: systemic administration of 99mTc-HYNIC-Annexin A5|nan|
|Behavioral: 10 minutes of ischemic handgripping|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 99mTc-Annexin A5 targeting |  |  |
Gallium-68 DOTATOC for Management of Neuroendocrine Tumors

Study Overview
=================
Brief Summary
-----------------
Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron emission tomography (PET scan). The material has already been shown to be better than the currently available imaging agents. This study is designed to evaluate the clinical impact of PET CT scanning using this agent in the evaluation and management of patients with NETs.

Detailed Description
-----------------
Patients with NETs will be evaluated by their own physicians. Before doing the PET scan using Gallium-68 DOTATOC, the physicians will be asked to describe the type of treatment that they would recommend. After the test is performed and the result reviewed, the physician will be asked to reevaluate the therapeutic and management options. Data will be analyzed to determine the impact of the testing on patient management. Gallium-68 has been designated an orphan drug due to the relative rarity of NETs. It is expected that the data collected from this and other similar trials will be used to provide data to the FDA regarding the safety and efficacy of this drug as an imaging agent for NETs and ultimately lead to FDA approval.

Official Title
-----------------
Gallium-68 DOTATOC for Management of Neuroendocrine Tumors

Conditions
-----------------
Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Drug: Gallium-68 DOTATOC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proven or suspected neuroendocrine tumor Physician referral for imaging Exclusion Criteria: Pregnancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gallium-68 DOTATOC|Imaging with Gallium-68 DOTATOC|

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
-----------------
neuroendocrine tumor, carcinoid tumor
Evaluation of Fast Track Rehabilitaion in Mini-invasive Lombar Arthrodesis

Study Overview
=================
Brief Summary
-----------------
Mini invasive spine surgery have become very common in the past years. Posterior arthrodesis associated to liberation have good functional results and doesn't present much complication cases. So that's why St Joseph Hospital spine surgeon have made the hypothesis that this kind of surgery can be associated to fast track surgery.

Official Title
-----------------
Evaluation of Fast Track Rehabilitaion in Mini-invasive Lombar Arthrodesis

Conditions
-----------------
Rehabilitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient accepting fast track réhabilitation for transforaminal lumbar interbody fusion age >18 hears Exclusion Criteria: Age >75 ASA score >2 long distance between house and hôpital socially isolantes pathology needed conventional hospitalisation psychiatric pathology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Percentage of passage to conventional hospitalization |  | week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of percentage of patients accepting fast track rehabilitation |  | day1 | 
| Early complication rate |  | day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spine
Experimental Medication For the Treatment of Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.

Detailed Description
-----------------
Protocol 04-001-01 The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD). The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication. Recruiting: Participants are currently being recruited and enrolled.

Official Title
-----------------
A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder

Conditions
-----------------
Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: experimental anti-anxiety drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD. Exclusion Criteria: No other primary psychiatric diagnosis besides GAD.

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: experimental anti-anxiety drug|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HAM-A Total Score | Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories. | Baseline to week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Double Blind, Placebo controlled, Safety and Efficacy, Generalized Anxiety Disorder
Use Of Fragmin In Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.

Official Title
-----------------
A Phase IIIb Open Label Study To Optimize The Single Bolus Dose Of Dalteparin Sodium For The Prevention Of Clotting Within The Extracorporeal System During Hemodialysis Procedures For Subjects With Chronic Renal Insufficiency: The Parrot Study

Conditions
-----------------
Chronic Renal Failure

Intervention / Treatment
-----------------
* Drug: Fragmin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic renal failure on hemodialysis Exclusion Criteria: significant comorbidities that would prevent a patient from completing the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Fragmin<br>Fragmin given according to the flexible dosing regimen outlined in the protocol | Drug: Fragmin<br>* variable dosing regimen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent of Successful HD Sessions | A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data. | 20 HD sessions (up to 4 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent of HD Sessions With an Acceptable Dose | A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time > 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial. | 20 HD sessions (up to 4 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fragmin, dalteparin, hemodialysis, anticoagulation, Renal Failure