linjc16/ctgov huggingface dataset:
Accuracy and Predictive Values for Colorectal Cancer of Quantitative FIT in Symptomatic Patients in Primary Care

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine accuracy and predictive values for colorectal cancer of a faecal quantitative immunochemical test (FIT) in unselected symptomatic patients presenting in primary care. Main reference test will be linkage to a nationwide colorectal cancer registry.

Detailed Description
-----------------
This is a nationwide multi-centre study in primary care, Sweden. Patients from the age of 40 years and above presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible. Consenting patients will fill out a short form on symptoms during last 4 weeks. They will provide 2 faecal samples from 2 different days. Samples will be analysed at any of three laboratories within 5 days using QuikRead go® (Aidian Oy). The analytical working range is 10-200 µg Hb/g faeces. The outcome will be reported as the concentration of first test (FIT 1) and highest concentration of two tests (FIT max). The outcome of the study FIT will remain within the study and GPs must request a separate FOBT for clinical purposes. Reference test will be linkage to the Swedish Colorectal Cancer Registry (with in practice complete coverage) after at most 2 years for all patients. Accuracy and predictive values will be determined and ROC-curves analysed. Some patients included in the study will be referred for colonoscopy for clinical reasons, and the outcome of FIT in relation to colonoscopy findings will be reported for this group as well.

Official Title
-----------------
Accuracy and Predictive Values for Colorectal Cancer of a Quantitative Faecal Immunochemical Test in Symptomatic Patients in Primary Care

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible. Exclusion Criteria: Referral for bowel examination for other reasons than symptoms. Not able to understand the instructions for participation.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Colorectal cancer | Linkage to cancer registry | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quantitative faecal immunochemical test, symptomatic, primary care
Retrograde Intrarenal Stone Surgery - A Method of Treating the ESWL Resistant Kidney Stone

Study Overview
=================
Brief Summary
-----------------
Is it possible to decrease the intrarenal pressure in the kidney during endoscopic management of kidney stone by topical administration of drugs? In order to secure fewer complications in ureteroscopic operations the pharmacological agent isoproterenol is tested on pigs and human to determine its potential of lowering intrarenal pressure.

Official Title
-----------------
RIRS - A Method of Treating the ESWL Resistant Kidney Stone

Conditions
-----------------
Kidney Stone, Ureteroscopy

Intervention / Treatment
-----------------
* Drug: Isoproterenol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for RIRS procedure Age > 18 years Normotensive Capable of understanding information given Exclusion Criteria: Previous myocardiac infarct Daily use of alpha- og beta- blocking medicine og calcium antagonists Use of NSAID the last 2 days Stone in the ureter Declared Known malignant disease in urinary tract Bladder disease Nephrostomies inserted JJ-catheters inserted Prisoners Pregnant Nursing mothers

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: Isoproterenol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal pelvic pressure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  |  | 
| Pulse |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney stone, ureteropyeloscopy, renal pelvic pressure
A Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma

Study Overview
=================
Brief Summary
-----------------
Based on results from earlier clinical trials, Pemetrexed may have antitumor activity as a first-line agent in the treatment of mesothelioma. Given this, it is hypothesized that Pemetrexed may be active in second-line mesothelioma in which the standard treatment is best supportive care. This study will compare survival of previously treated patients with malignant pleural mesothelioma who receive Pemetrexed plus best supportive care to the survival of similar patients who receive best supportive care alone.

Official Title
-----------------
A Randomized Phase 3 Trial Comparing ALIMTA Plus Best Supportive Care Versus Best Supportive Care Alone in Previously Treated Patients With Locally Advanced or Metastatic Malignant Pleural Mesothelioma

Conditions
-----------------
Mesothelioma

Intervention / Treatment
-----------------
* Drug: Pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven diagnosis of mesothelioma of the pleura. received only one prior systemic chemotherapy regimen for advanced or metastatic disease Performance status of 70 or higher on the Karnofsky Performance Status Scale Males or females at least 18 years of age Adequate organ function Exclusion Criteria: Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy Pregnancy or breastfeeding Brain metastasis Prior treatment with Pemetrexed Inability or unwillingness to take folic acid or vitamin B12 supplementation

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pemetrexed|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to compare the overall survival following treatment with Pemetrexed plus best supportive care versus best supportive care alone |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize and compare the toxicities of Pemetrexed/best supportive care and best supportive care alone in this patient population;to determine the objective-tumor response rate |  |  | 
| to compare time to event efficacy variables of both arms including:duration of response,time to objective tumor response,time to treatment failure,time to documented disease progression,progression-free survival |  |  | 
| to compare changes in the average symptom burden index between the Pemetrexed/best supportive care and best supportive care arms |  |  |
C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT

Study Overview
=================
Brief Summary
-----------------
Positron emission tomography combined with computed tomography using carbon-11 acetate (ACT PET/CT) may help detect lesions before treatment and evaluate response following therapy in patients with from multiple myeloma (MM). This study aimed to prospectively assess the clinical utility of ACT PET/CT in MM as compared to the commonly used F18-fluorodeoxyglucose(FDG).

Official Title
-----------------
C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT for Staging and Response Assessment

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Other: ACT PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 20 years of age previously untreated complete pre-treatment clinical staging including bone marrow examination written informed consent to participate in the study Exclusion Criteria: concurrent active malignant tumor(s) pregnant or breast feeding women non-compliant to PET/CT or to MRI marked renal impairment (contraindicated for contrast-enhanced MRI)

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT PET/CT<br>Dual-tracer ACT/FDG PET/CT and WB-DCE-MRI at baseline (pretreatment), post-induction and post-ASCT (if eligible) | Other: ACT PET/CT<br>* Old tracer but new indication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pretreatment lesion detection | Reference standards: bone marrow examination and whole-body dynamic contrast-enhanced MRI | Within 2 weeks before initiation of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-induction response assessment | Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any | Approximately 4 months after initiation of therapy depending on the regimen | 
| Post-ASCT response assessment | Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any | Approximately 3 months after ASCT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
C11-acetate PET/CT, Multiple myeloma, Pretreatment staging, Response assessment
The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease

Study Overview
=================
Brief Summary
-----------------
This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more effective in reducing the CMV viral load over time, as compared to standard treatment with IV ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®. Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until the CMV infection is no longer detectable, whichever is longer duration.

Official Title
-----------------
The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease

Conditions
-----------------
Cytomegalovirus

Intervention / Treatment
-----------------
* Drug: CMV Immune globulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal or renal/pancreas transplant patients who are diagnosed with symptomatic CMV infection receiving no more than 48 hrs of therapy prior to study enrollment Exclusion Criteria: serum creatinine <2.2 at the time of enrollment no prior use of CMV IgG

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cytogam in addition to standard of care (IV ganciclovir therapy) | Drug: CMV Immune globulin<br>* CMV IvIg 150mg/kg x 6 doses<br>|
| No Intervention: 2<br>Receive standard of care therapy (IV ganciclovir) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV viral load |  | 12 months |
A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care

Study Overview
=================
Brief Summary
-----------------
To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.

Detailed Description
-----------------
The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.

Official Title
-----------------
A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care

Conditions
-----------------
Haemophilia A, Haemophilia B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients with severe or moderate haemophilia A or haemophilia B. Treatment with Factor VIII/Factor IX products initiated at least 24 months before inclusion in the study. Informed consent is obtained from the patient or patient's legal representative (as applicable according to legal regulation). Exclusion Criteria: Confirmed positive inhibitor test detected in the past 24 months.

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- | --- |
| Total dose (IU) issued of Factor VIII during a 12 month period |  | - 12 month to Day 0 | 
| Total dose (IU) issued of Factor IX during a 12 month period |  | - 12 month to Day 0 |
Management of Placenta Accreta Spectrum

Study Overview
=================
Brief Summary
-----------------
placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it.

Detailed Description
-----------------
placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it. surgical management of placenta accreta short term follow up to the outcomes long term follow up

Official Title
-----------------
Management of Placenta Accreta Spectrum

Conditions
-----------------
Placenta Previa, Placenta Accreta

Intervention / Treatment
-----------------
* Procedure: Management of placenta accreta spectrum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All placenta accreta e high possibility of placenta accrete consent easy follow up visits Exclusion Criteria: bleeding tendency associated medical disorder hypertension, diabetes, preeclapsia..

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: All women with placenta praevia and previous scar in the uterus. Surgical management and follow up will be defined
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Management of placenta accreta spectrum|Conservative and radical (hysterectomy) treatment of placenta accreta. Follow up to the patients to detect the impact of treatment imposed A novel technique which early identification and repait of uterine wall defects resulted from invasion of the uterine wall by the placenta.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of the novel conservative management | Need to do peripartum hysterectomy or patient death | 3 hours | 
| Estimated amount of blood loss | The estimated amount of blood loss during and after surgery | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
placenta, accreta, praevia, hyterectomy, PPH
Effect of Pulmonary Rehabilitation on Fear of Falling in COPD Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to measure the impact of pulmonary rehabilitation program on fear of falling in COPD patients

Official Title
-----------------
Effect of Pulmonary Rehabilitation on Fear of Falling in COPD Patients

Conditions
-----------------
Copd

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients Exclusion Criteria: post surgical rehabilitation neurologic or orthopedic disorders limiting walking imbalance disorders inability to answer to the questionnaire refusal to participate. inability to perform the pulmonary rehabilitation program.

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 |
| --- | --- | --- |
| measure of fear of falling after a pulmonary rehabilitation | measure of fear of falling (FES-I) before and after a pulmonary rehabilitation program | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, pulmonary rehabilitation, fear of falling, evaluation
A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair

Study Overview
=================
Brief Summary
-----------------
Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clinical examinations. End point is postoperative pain and recurrences.

Official Title
-----------------
Randomized Multi Site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair.

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Lichtenstein's operation
* Procedure: Prolene Hernia System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary unilateral groin hernia in adult Exclusion Criteria: recurrence warfarin treatment bilateral groin hernia

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lichtenstein's operation<br>Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation to repair their groin hernia | Procedure: Lichtenstein's operation<br>* Lichtenstein's operation to repair primary unilateral inguinal hernia<br>|
| Active Comparator: Prolene Hernia System<br>Patients with a primary unilateral inguinal hernia are randomized to Prolene Hernia System to repair their groin hernia | Procedure: Prolene Hernia System<br>* Prolene Hernia System to repair primary unilateral inguinal hernia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain postoperative |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrences after groin hernia repair |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Lichtenstein, Prolene Hernia System, Postoperative pain, Recurrence