linjc16/ctgov huggingface dataset:
Stroke Recovery Initiative - Registry for Stroke Research Studies

Study Overview
=================
Brief Summary
-----------------
The Stroke Recovery Initiative is a nation-wide participant recruitment registry that connects people who have had a stroke with researchers who are working to develop new approaches to improve recovery after stroke.

Detailed Description
-----------------
The Stroke Recovery Initiative at UCSF is designed to help people who have had a stroke to connect with researchers who are applying the latest science and technology to develop new treatments for stroke recovery. Anyone who is 18 years of age or older and has had a stroke may submit a survey to join. The self-reported information on the survey will be used to match participants to current or future stroke research studies and study personnel for each specific study may contact participants for further screening. Some studies are recruiting participants nationally, not just in the San Francisco Bay Area.

Official Title
-----------------
Stroke Recovery Initiative - Stroke Registry

Conditions
-----------------
Stroke, Acute Stroke, Ischemic Stroke, Hemorrhagic Stroke, Subarachnoid Hemorrhage, Cerebral Ischemia, Cerebral Infarction, Cerebral Stroke, Cerebral Vascular Accident

Participation Criteria
=================
Eligibility Criteria
-----------------
18 years of age or older Have suffered a stroke Have ongoing symptoms as a result of the stroke

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 |
| --- | --- | --- |
| Total Enrollment | Total Number of Participants in the Registry | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Acute Stroke, Ischemic Stroke, Hemorrhagic Stroke, Cerebral Ischemia, Cerebral Infarction, Cerebral Stroke, Cerebral Vascular Accident, Stroke Recovery
Intraarticular Antibiotic in TKA

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty and determine the serum concentrations of these antibiotics postoperatively.

Detailed Description
-----------------
Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria. Patients that qualify and sign consent will have tobramycin and vancomycin antibiotic powder placed into the knee during surgery. Postoperative drain fluid from the knee will be collected.

Official Title
-----------------
Prospective Study Investigating Antibiotic Elution From Free Intra-articular Vancomycin and Tobramycin After Cementless Total Knee Arthroplasty

Conditions
-----------------
Antibotics in Cementless Knees

Intervention / Treatment
-----------------
* Drug: Tobramycin Powder
* Device: Vancomyscin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis Exclusion Criteria: Diminished mental capacity Vancomycin allergy Tobramycin allergy Chronic kidney disease stage III and stage IV

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vancomycin Powder<br>All patients getting vancomycin to see concentration after 24hrs in knee drain and serum levels. | Device: Vancomyscin<br>* Everyone gets the vancomyscin powder.<br>|
| Experimental: Tobramycin Powder<br>All patients getting Tobramycin to see conceration after 24hrs in knee drain and serum levels. | Drug: Tobramycin Powder<br>* Everyone gets tobramycin powder.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Antibiotics in Cementless Knees Post op | 1. Determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty. | 1 hour, 4 hours, and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. | 2. Determine the serum concentrations of these antibiotics postoperatively | 1 hour, 4 hours, and 24 hours |
Rye Bread Trial; Antioxidative and Cholesterol Lowering Effects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the antioxidative effects of alkylresorcinols (AR), originating from the rye fiber, on serum LDL particles and the use of AR or it's metabolites as biomarkers for rye fiber intake and the effect of additional plants sterols, incorporated in the rye bread, on serum total and LDL cholesterol concentration.

Official Title
-----------------
Dietary Intervention Trial of Alkylresorcinols and Plant Sterols in High-Fibre Rye Bread and Their Effects on Serum Lipids in Normo- and Mildly Hypercholesterolemic Subjects

Conditions
-----------------
Hypercholesterol

Intervention / Treatment
-----------------
* Dietary Supplement: Rye-2008


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteer hemoglobin above 125 mmol/L in females, above 135 mmol/L in males Exclusion Criteria: taking drugs affecting plasma lipids or gastrointestinal track severe illness use of antibiotics within 3 months before entering the study use of vitamin pills or fish oil 1 month before entering the study pregnancy or lactating

Ages Eligible for Study
-----------------
Minimum Age: 20 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

Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sterol<br>Additional plant sterols incorporated in the rye bread | Dietary Supplement: Rye-2008<br> <br> |
| Placebo Comparator: control<br>No added plant sterol in the identical-looking rye bread | Dietary Supplement: Rye-2008<br> <br> |

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
-----------------
Rye fiber, Alkylresorcinols, Plant sterols, Cholesterol, Antioxidant, Effects of plant sterols in rye bread on serum lipids, Effects of alkylresorcinols in rye fiber on LDL particles
Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether prednisolone is more effective than placebo in the first six days after initiation of medication withdrawal therapy for a medication overuse headache. Another purpose is to study whether patients followed by a neurologist 1 year after withdrawal do better than patients followed by a general practitioner.

Detailed Description
-----------------
Data published BoeMG,Mygland A,Salvesen R; Neurology 2007 Jul 3;69(1):26-31

Official Title
-----------------
Medication Overuse Headache: A Randomised Double Blind Study of Prednisolone or Placebo in Withdrawal Therapy (Phase 3), and a Randomised 1 Year Follow up by Neurologist or General Physician After Successful Withdrawal Therapy

Conditions
-----------------
Headache

Intervention / Treatment
-----------------
* Drug: prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic daily headache and medication overuse fulfilling International Headache Society (IHS)-II criteria Exclusion Criteria: Pregnancy Age under 18 and over 70 years Major mental disorders

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Placebo in six days | Drug: prednisolone<br>* Prednisolone 60mg day 1 and 2 , 40mg day 3 and 4 , 20mg day 5 and 6<br>* Other names: Prednison, prednisolon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint was a calculated mean headache (MH), based on number of days with headache and mean intensity of headache during the first six days after withdrawal. |  | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days with zero or mild headache, days with moderate to strong headache, days without headache, Use of antiemetic drugs ,staying drug-free during the entire period. |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
migraine, analgesics, tension type headache
Diagnosis of Spontaneous Bacterial Peritonitis

Study Overview
=================
Brief Summary
-----------------
The study is aimed to revise the current criteria for the diagnosis of spontaneous bacterial peritonitis and the decisional thresholds to start treatment. The accuracy of current diagnostic tests will be compared with that of new tests, which could potentially become more accurate reference standards. This could lead to the definition of a more accurate and effective diagnostic algorithm.

Official Title
-----------------
Redefinition of Diagnostic Criteria for Spontaneous Bacterial Peritonitis: Assessment of Accuracy of Available Tests and of Reference Standard

Conditions
-----------------
Spontaneous Bacterial Peritonitis

Intervention / Treatment
-----------------
* Other: Diagnostic tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cirrhosis and ascites with clinical indication to carry out a diagnostic and/or therapeutic paracentesis. Exclusion Criteria: Etiology of ascites other than cirrhosis

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 |
| --- | --- |
| Patients with cirrhosis and ascites<br>Patients requiring diagnostic and/or therapeutic paracentesis. | Other: Diagnostic tests<br>* Leukocyte count by automated counters; reagent strips for leukocyte esterase and for lactoferrin; ascitic fluid pH; leukocyte cytometry; bacterial DNA detection and quantification.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the accuracy of current reference standard for the diagnosis of spontaneous bacterial peritonitis, i.e. neutrophil count in ascitic fluid of >250/mm3 as determined by microscopy, with alternative diagnostic tests. | Reference standard is neutrophil count in ascitic fluid of >250/mm3 as determined by microscopy. Alternative diagnostic tests are: Leukocyte count by automated counters; reagent strips for leukocyte esterase and for lactoferrin; ascitic fluid pH; leukocyte cytometry; bacterial DNA detection and quantification. Discrepancies between reference standard and alternative tests will be assessed by one month clinical follow up. | One month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spontaneous bacterial peritonitis.
The Malmö International Brother Study (MIBS)

Study Overview
=================
Brief Summary
-----------------
Existing data support the concept that a genetic predisposition for inhibitor development exists. The aim of the Malmö International Brother Study (MIBS) is to evaluate genetic factors associated with the development of inhibitory antibodies in patients with hemophilia.

Detailed Description
-----------------
Inhibitory antibodies to factor VIII develop in 10-15% of all patients with hemophilia A and in 25-30% of patients with the severe form of the disease after exposure to factor VIII concentrates. Both genetic and environmental risk factors for inhibitor development have been evaluated, but in most cases without consistent results. Among the genetic factors, an association between large rearrangements of the factor VIII and IX genes and a higher risk for inhibitors has been described. However, a majority of patients with null mutations, including the intron 22 inversion, do not develop inhibitory antibodies. It is obvious that other genetic markers influencing the immune response to replacement therapy in patients with hemophilia remain to be identified and the aim of Malmö International Brother Study (MIBS) is to characterize these factors.

Official Title
-----------------
The Malmö International Brother Study (MIBS)

Conditions
-----------------
Hemophilia A With Inhibitors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Mild, moderate or severe hemophilia A or B and one or more brothers with mild, moderate or severe hemophilia A or B Exclusion Criteria: -Absence of sufficient information to classify inhibitor status

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia A, Inhibitors
Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare systematic local infiltration with ropivacaine or placebo in patients undergoing repair of posterior vaginal wall prolapse. The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.

Official Title
-----------------
Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie

Conditions
-----------------
Vaginal Prolapse

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Isotonic NaCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eligible for elective repair of posterior vaginal wall prolapse able to speak and understand Danish able to give informed consent Exclusion Criteria: alcohol or medical abuse allergies to local anesthetics age < 18 yrs. intolerance to opioids

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Local Infiltration with Ropivacaine | Drug: Ropivacaine<br>* Local Infiltration Analgesia with 1 % Ropivacaine<br>|
| Placebo Comparator: 2<br>Local Infiltration with Placebo | Drug: Isotonic NaCl<br>* Local Infiltration with NaCl<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain during rest, coughing and ambulation |  | ½, 1, 2, 4, 8, 12 and 24 h postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Nausea and Vomitus |  | ½, 1, 2, 4, 8, 12 and 24 h postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pain, PONV
Molecular Biology of Polycythemia and Thrombocytosis

Study Overview
=================
Brief Summary
-----------------
Our study is designed to characterize the clinical picture and genetic pattern of Polycythemia and Thrombocytosis. The purpose of this project is to find a gene and its mutation that causes these disorders. When this is accomplished, new therapies to control and eventually cure the disorder can be designed.

Detailed Description
-----------------
Our hypothesis is that genes and their mutation are causative of certain types of polycythemia and thrombocytosis. These will be sought for by genetic and cell biology means. The purpose of the study is to identify the molecular defect of these disorders. 5-7 teaspoons of peripheral blood will be drawn on all study subjects. After DNA is obtained, linkage analysis and/or mutation analysis will be performed.

Official Title
-----------------
Molecular Biology of Polycythemia and Thrombocytosis

Conditions
-----------------
Polycythemia, Thrombocytosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with an elevated hemoglobin concentration (>18 in males and >16 in females) Subjects with an elevated platelet count (>450,000) Exclusion Criteria: Subjects who have a known acquired cause of polycythemia and thrombocytosis Subjects with heart disease, left to right heart shunt or severe pulmonary disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Affected Population<br>Subjects with an elevated hemoglobin concentration or an elevated platelet count | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the molecular defect of Polycythemic and Thrombocythemic disorders |  | Weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Familial and Congenital Polycythemia, Polycythemia, Molecular Biology, Genetics, Erythropoiesis, EPOR mutation, Thrombocytosis, Hypoxia
High-dose Chemotherapy With Hematopoietic Stem-cell Rescue for High-risk Breast Cancer: Long-term Follow-up

Study Overview
=================
Brief Summary
-----------------
Collection of follow-up data from the original trial patient cohort.

Detailed Description
-----------------
Collection of follow-up data from the original trial patient cohort by means of structured patient file abstraction, a questionnaire to the general practitioner, and registry consultations.

Official Title
-----------------
High-dose Chemotherapy With Hematopoietic Stem-cell Rescue for High-risk Breast Cancer: Long-term Follow-up of a Randomized Phase III Study

Conditions
-----------------
Breast Cancer Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolment in the original trial. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Overall survival | Overall survival according to the definition and analysis plan of the original study | 2 years | 
| Relapse-free survival | Relapse-free survival according to the definition and analysis plan of the original study | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiovascular events |  | 2 years | 
| Incidence of malignancies |  | 2 years |