linjc16/ctgov huggingface dataset:
Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease

Study Overview
=================
Brief Summary
-----------------
PRIMARY: To compare the frequency of and time to relapse of Cytomegalovirus (CMV) gastrointestinal disease following foscarnet induction therapy only versus induction plus maintenance therapy. SECONDARY: To determine frequency of and time to recurrence of gastrointestinal symptoms, response rate of pathological lesions, and incidence of nongastrointestinal CMV disease in this patient population.

Detailed Description
-----------------
Patients receive intravenous foscarnet either as induction only for 4 weeks or as induction for 4 weeks followed by maintenance for 22 weeks. All patients are followed for 26 weeks or until relapse.

Official Title
-----------------
Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease

Conditions
-----------------
HIV Infections, Gastrointestinal Diseases

Intervention / Treatment
-----------------
* Drug: Foscarnet sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: AIDS. CMV GI disease. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Non-GI CMV disease. Ulcerative colitis, inflammatory bowel disease, or other condition that may interfere with study results. Other GI pathogens. Concurrent Medication: Excluded: Drugs that may interact with foscarnet. Systemic acyclovir, ganciclovir, or acyclovir prodrug. Drugs known to affect renal function. Prior Medication: Excluded: Prior foscarnet in extremis. Investigational agents other than 3TC or d4T within 7 days prior to study entry.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Foscarnet sodium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Foscarnet, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
Levetiracetam for Painful Polyneuropathy

Study Overview
=================
Brief Summary
-----------------
Polyneuropathy of different etiologies is often associated with pain. The standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000 mg/day on pain in polyneuropathy

Official Title
-----------------
Double-blind, Randomised, Placebo-controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy

Conditions
-----------------
Painful Polyneuropathy

Intervention / Treatment
-----------------
* Drug: levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 20 to 0 years painful symptoms of polyneuropathy for at least 6 months confirmed diagnosis of polyneuropathy baseline pain score of 4 or more (0 to 10 point scale) pain at least 4 days a week adequate anticonceptive treatment for women with childbearing potential informed consent Exclusion Criteria: other cause of pain previous allergic reactions towards levetiracetam known adverse drug reactions on levetiracetam pregnancy severe disease inability to follow study protocol treatment with antidepressants, other anticonvulsants or opioids

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levetiracetam|Levetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period) |  | Daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain rated on 0 to 10 point numeric rating scales |  | Daily | 
| Pain subtypes rated on 0 to 10 point numeric rating scales |  | Daily | 
| Bruch-evoked pain |  | Baseline and end of each treament period | 
| Pin-prick evoked pain |  | Baseline and end of each treatment period | 
| Cold evoked pain |  | Baseline and end of each treatment period | 
| Health related quality of life(SF-36) |  | Baseline and end of each treatment period | 
| Pain related sleep disturbance |  | Daily | 
| Use of escape medication |  | Daily | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polyneuropathy, neuropathic pain, levetiracetam
A Study to Quantify Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)

Study Overview
=================
Brief Summary
-----------------
Pre-clinical evidence suggests that radiotherapy reduces tumour-associated vasculature. The investigators will conduct a single-arm prospective study to quantify the reduction in tumour vasculature post-radiotherapy

Official Title
-----------------
Reduction in Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)

Conditions
-----------------
Spine Metastasis

Intervention / Treatment
-----------------
* Radiation: Stereotactic body radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥21 years of age Proven metastatic disease, excluding haematological and germ cell neoplasms Life expectancy >3 months, Eastern Cooperative Oncology group (ECOG) 0-2 Exclusion Criteria: The patient must not have an allergy to gadolinium contrast that will limit the ability to image the tumour by MRI safely even with the use of premedication eGFR < 30 mL/min or if patient is suffering from acute renal insufficiency Prior radiotherapy to the specified region Recent surgery to affected spinal levels, or patients requiring immediate surgical intervention Spinal instability score (SINS) >12 Symptomatic cord compression (Bilksy grade 2 or 3), or worsening neurological deficits Body weight of more than 120kg Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Stereotactic body radiotherapy|Stereotactic body radiotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in vasculature | Reduction in vasculature measured by changes on Dynamic Contrast enhanced MRI | 3 month |
Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT

Study Overview
=================
Brief Summary
-----------------
To investigate the diagnostic value of ultralow-dose computed tomography in the detection of pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to standard-dose-CT.

Conditions
-----------------
Multiple Pulmonary Nodules, Pulmonary Emphysema

Intervention / Treatment
-----------------
* Radiation: Ultralow-Dose-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned normal dose-CT by clinical indication at our institution obtained informed consent Exclusion Criteria: planned lowdose-CT by clinical indication at institution no informed consent obtained age < 18 years pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ultralow-Dose-CT<br>Additional Ultralow-Dose-CT of the chest | Radiation: Ultralow-Dose-CT<br>* Patients undergoing thoracic normal dose-CT with undergo an additional Ultralow-Dose-CT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT | Difference in nodule detectability in Ultralow-Dose-CT compared to Standard-Dose-CT measured using McNemar test | Participants CT-scan will be read out on an average date of 6 weeks after the scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients BMI (Body mass index) |  | Measures assessed at time of read-out on an average date of 6 weeks after the scan | 
| Patients Nodule size (mm) |  | Measures assessed at time of read-out on an average date of 6 weeks after the scan |
Impact of Ultrasound Fetal Weight Estimation on Obstetrical Management and Maternal and Neonatal Outcomes

Study Overview
=================
Brief Summary
-----------------
The investigators wish to study the obstetrical data of pregnant women who had an ultrasound estimation of fetal weight and who delivered at the University Hospital of Strasbourg over the last 20 years. These retrospectively collected data are a valuable source of scientific information since they are real life data, currently of growing interest in the scientific community, and have a large volume and quality due to the number of years included and the variety of information collected in the computerized media records. From this study, the investigators hope not only to better understand the consequences of ultrasound screening for fetal growth, but also to improve its accuracy and to develop useful models in obstetrical decision making in order to decrease maternal and neonatal morbidity.

Official Title
-----------------
Impact of Ultrasound Fetal Weight Estimation on Obstetrical Management and Maternal and Neonatal Outcomes

Conditions
-----------------
Fetal Weight

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years of age). Female and with a single pregnancy Subject having had an ultrasound follow-up at HUS between 01/01/2000 and 31/12/2021 Subject who gave birth at HUS between 01/01/2000 and 12/31/2021 Subject who does not object to the reuse of her data for scientific research purposes Exclusion Criteria: Subject who has expressed opposition to the reuse of their data for scientific research purposes Multiple pregnancies Delivery before 24 weeks of amenorrhea Diagnosis of a malformative fetal pathology Diagnosis of fetal death in utero

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective study of maternal and neonatal clinical and ultrasound data for the development of an algorithm model useful in obstetrical decision making in order to decrease maternal and neonatal morbidity. |  | Files analysed retrospectively from January 01, 2000 to December 31, 2021 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstetrical Management, Maternal Outcomes, Neonatal Outcomes, Fetal Weight, Ultrasound Fetal Weight
Influence of the Shoulder Position on the Catheter Tip Location During Infraclavicular Subclavian Approach

Study Overview
=================
Brief Summary
-----------------
Infraclavicular approach of the subclavian veins is commonly used for central venous access. Aberrant locations of catheter tip are frequently quoted for this approach, but few studies have been performed to document the relationship between the shoulder position and catheter tip location. This prospective study was performed to assess the influence of the shoulder position on the safe and proper placement of infraclavicular subclavian catheters.

Conditions
-----------------
Catheter Tip Location

Intervention / Treatment
-----------------
* Procedure: neutral shoulder position
* Procedure: lowered shoulder position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients requiring central venous catheterization due to major procedures such as neurosurgery or thoracic surgery. Exclusion Criteria: chest deformities, coagulopathy, diaphragmatic dysfunction, pulmonary malformation, history of prior clavicle fracture, or infection over the puncture site.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>neutral shoulder position during infraclavicular subclavian catheterization | Procedure: neutral shoulder position<br>* neutral shoulder position during infraclavicular subclavian catheterization<br>|
| Experimental: group 2<br>lowered shoulder position during infraclavicular subclavian catheterization | Procedure: lowered shoulder position<br>* lowered shoulder position during infraclavicular subclavian catheterization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| location of the catheter tip |  | at the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catheterization success rate |  | immediately after catheterization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
catheterization success rate
Adhesiolysis in Chronic Abdominal Pain

Study Overview
=================
Brief Summary
-----------------
Laparoscopic adhesiolysis has been used in treatment of chronic abdominal pain. There has been only one previous controlled study, that stated laparoscopy alone had the same benefits than laparoscopic adhesiolysis. The aim of this study is to compare laparoscopic adhesiolysis with a placebo-procedure in chronic abdominal pain.

Official Title
-----------------
Laparoscopic Adhesiolysis in Treatment of Chronic Abdominal Pain - a Prospective Randomized Trial

Conditions
-----------------
Chronic Abdominal Pain

Intervention / Treatment
-----------------
* Procedure: Laparoscopic adhesiolysis
* Procedure: Placebo-surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-65 years abdominal pain at least 6 months previous abdominal surgery and/or significant abdominal trauma and/or abdominal infection ASA class I-II Exclusion Criteria: psychiatric disorder significant other somatic diseases (ASA class III-V) refusal to participate

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopy<br>laparoscopic adhesiolysis and application of Sprayshield spray to prevent further adhesions | Procedure: Laparoscopic adhesiolysis<br>* Laparoscopic adhesiolysis and Sprayshield<br>|
| Placebo Comparator: placebo-control<br>anaethesia and skin incisions without laparoscopy or related procedures | Procedure: Placebo-surgery<br>* skin incisions without laparoscopy or related procedures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  | 6 months |
Safety of Continuing Anti-platelet Agents During Colonoscopic Polypectomy: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
At our VA hospital, in general, it is the policy of our GI lab to not stop our patients anti-platelet therapy whenever they see us for a routine colonoscopy. We do this because we believe the risk of stopping these sort of medications outweigh the risks of a complication from a colonoscopy. Therefore, we are enrolling patients who are either on clopidogrel or prasugrel or not on any anti-platelet/anti-coagulant therapy that come to our GI lab routine colonoscopies. We perform the procedure just like we normally would and then follow-up with the patient 7 and 30 days after their procedure.

Conditions
-----------------
Post-polypectomy Bleeding, Anti-platelet Therapy, Colonoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting to the GI lab for elective colonoscopy Exclusion Criteria: Patients on Coumadin or other anti-coagulants Patients with Inflammatory Bowel Disease

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 |
| --- | --- |
| Control<br>Patients who are not on any anti-platelet/anti-coagulant therapy and present to our lab for a elective colonoscopy. | |
| Thienopyridine Users<br>Patients on Clopidogrel or prasugrel when they present for an elective colonoscopy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Hypotension Prediction Index: Correlations Between Invasive and Non-invasive Pressure Points.

Study Overview
=================
Brief Summary
-----------------
To evaluate the clinical performance of the Hypotension Prediction Index obtained from the continuous, non-invasive Clear Sight monitor.

Detailed Description
-----------------
To evaluate the clinical performance of the Hypotension Prediction Index obtained from the continuous, non-invasive ClearSight monitor.

Official Title
-----------------
Hypotension Prediction Index: Correlations Between Invasive and Non-invasive Pressure Points

Conditions
-----------------
Hypotension

Intervention / Treatment
-----------------
* Device: Non invasive arterial pressure monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Patients 18 years or older undergoing surgery with the use of general anesthesia and with planned arterial catheter placement and use of the HPI monitor. Exclusion Criteria: Adults unable to consent Individuals who are not yet adults ( infants, children teenagers) Pregnant Women Prisoners

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgery requiring Invasive arterial pressure monitoring<br>Patients undergoing elective surgery that requires Invasive arterial pressure monitoring as standard of care. | Device: Non invasive arterial pressure monitoring<br>* Non invasive arterial pressure monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPI | Hypotension Prediction Index obtained from continuous, non-invasive ClearSight monitor will not differ significantly from the HPI concurrently obtained from the standard of care invasive radial arterial pressure monitor | During surgical procedure |