linjc16/ctgov huggingface dataset:
External Phase MRI in Diagnosis of OASI

Study Overview
=================
Brief Summary
-----------------
There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter lesion after birth can be challenging the total amount of women having obtained a sphincter lesion could be even grater. The aim of our study is to compare different tools in the diagnosis of obstetric anal sphincter injury. In doing so the investigators hope to achieve early diagnosis of this pathology and thus facilitate early treatment of a possible sphincter defect.

Detailed Description
-----------------
See the attacher research plan for a more detailed description

Official Title
-----------------
The Use of External Phase Array MRI, 3D Endoanal Ultrasound, and Manometry in the Diagnosis of Obstetric Anal Sphincter Injuries

Conditions
-----------------
Anal Sphincter Injury, Obstetrics Trauma

Intervention / Treatment
-----------------
* Other: Magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with OASI Exclusion Criteria: Under 18

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OASI patients<br>All patients older than 18 and a 3rd or 4th degree perineal tear during birth meet the inclusion criteria. All women who have obtained such a injury during birth in the Vaasa or Seinäjoki Central hospitals will be evaluated for eligibility. | Other: Magnetic resonance imaging<br>* The extent of obstetric anal sphincter injury will be evaluated using MRI, endoanal ultrasound and anal manometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of MRI and endoanal ultrasound in diagnosis of obstetric anal sphincter injury | Comparison of anal sphincter characteristics (length, thickness at 3 and 9 o'clock) and placement of the possible rupture with both imaging modalities | 6 months to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OASI, MRI, Faecal incontinence, Obstetric anal sphincter injury
ASXL-Related Disorders Registry

Study Overview
=================
Brief Summary
-----------------
A registry focused on the natural history, management and treatment of patients with Bohring-Opitz Syndrome (ASXL1), Shashi-Pena Syndrome (ASXL2) and Bainbridge-Ropers Syndrome (ASXL3).

Detailed Description
-----------------
Study participants will be asked to complete a series of brief surveys over time about their medical condition. The researchers will also attain primary medical records.The registry is based at UCLA as the IRB of record with collaborating sites at Boston Children's Hospital, Cincinnati Children's Hospital, and Duke University in a partnership with the Bohring-Opitz Syndrome (BOS) Foundation and ASXL-Rare Research Endowment (ARRE). The BOS Foundation and ARRE are non-profit organizations run by families of patients with ASXL-related disorders that are focused on supporting research. The data is co-managed by the researchers and the family groups. Aggregate data from the Registry will be shared with the participants as well as used for publication. The Registry is HIPPA compliant and follows all the IRB requirements regarding securing and managing patient data.

Official Title
-----------------
Clinical Registry for ASXL-Related Disorders and Disorders of Chromatin Remodeling

Conditions
-----------------
Bohring-Opitz Syndrome, ASXL1 Gene Mutation, Shashi-Pena Syndrome, ASXL2 Gene Mutation, Bainbridge-Ropers Syndrome, ASXL3 Gene Mutation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical or molecular diagnosis of an ASXL related disorder Exclusion Criteria: No clinical or molecular diagnosis of an ASXL related disorder
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 |
| --- | --- | --- |
| Natural history, treatment and management strategies of ASXL-related disorders | Use participant surveys including the GRDR CDE standard questions to collect data on disease history and management. Attain primary medical records with goal of publications to enhance treatment, management and understanding of the natural history of ASXL gene disorders. | 20 years |
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

Study Overview
=================
Brief Summary
-----------------
This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.

Detailed Description
-----------------
This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat or attempt to treat 20 patients. Patients for whom a POEM has been attempted but not completed (conversion to open or laparoscopic surgery, POEM surgery aborted and not re-attempted). Patients who proceed to study treatment will undergo ten years of follow-up as part of this study.

Official Title
-----------------
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Procedure: Peroral Endoscopic Myotomy (POEM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Achalasia Age 16-80 ASA Class 1-3 Exclusion Criteria: Pregnancy Any prior surgical or endoscopic treatment for achalasia -- first eight subjects. After eight subjects have been treated as part of this study, this exclusion criteria no longer applies Patients who are taking immunosuppressive medications or are immunocompromised Patients on anticoagulant medications or abnormal coagulation tests Patients with severe medical comorbidities, in the judgment of the treating surgeon

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>Peroral Endoscopic Myotomy (POEM) | Procedure: Peroral Endoscopic Myotomy (POEM)<br>* Endoscopy myotomy for treatment of achalasia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Efficacy of POEM Procedure | To assess adverse events related to POEM | Intraoperative to one year follow-up | 
| Long-term patient-reported quality of life | To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up. | Baseline to one year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
achalasia, POEM, peroral endoscopic myotomy, myotomy, Heller myotomy
The Duration of Humoral Immunity and the Memory Cell Function After Vaccination With 7-valent Pneumococcal Conjugate Vaccine in CLL

Study Overview
=================
Brief Summary
-----------------
Patients with chronic lymphocytic leukemia (CLL)have had very poor humoral responses to pneumococcal polysaccharide vaccine (PPV). The vaccine in which pneumococcal polysaccharide antigens are conjugated to protein (PCV) have been immunogenic in CLL patients in our previous studies. The purpose of this study is to evaluate the duration of these vaccine-induced antibodies and the function of memory cells by giving a one dose of PPV-vaccine after several years of PCV-vaccination.

Conditions
-----------------
Chronic Lymphocytic Leukemia (CLL)

Intervention / Treatment
-----------------
* Biological: Pneumococcal polysaccharide vaccine (PPV)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CLL patients and controls who have been vaccinated with PCV in our previous study Exclusion Criteria: Vaccinated with PPV-vaccine within the last 5 years, immunoglobulin substitution, corticosteroid treatment (equivalent of 20mg prednisolone per day)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PPV<br> | Biological: Pneumococcal polysaccharide vaccine (PPV)<br>* One intramuscular injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response |  | 1-3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL, PPV, PCV
Incidence, Risk Factors, Predictors and Survival for Neurological Complications After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Liver transplantation is the definitive treatment in patients with chronic liver disease. Neurological complications (NC) occur commonly after liver transplantation. The investigators aim to evaluate the incidence, risk factors and predictors of neurological complications in both living donor and deceased donor transplantation done in the hospital. Between January 2011 to December 2016, 253 liver transplant recipients were recruited for this study. The investigators recorded the incidence of neurological complications, their median time of onset, their relationship with etiology of chronic liver disease, and the risk factors for the complications. The investigators also studied the relationship of neurological complications with duration of hospital and ICU stay, and survival. Using multivariate forward regression analysis , the investigators developed a scoring system for prediction of neurological complications in liver transplantation.

Official Title
-----------------
Incidence, Risk Factors, Predictors and Survival for Neurological Complications After Liver Transplantation- A Retrospective Analysis

Conditions
-----------------
Liver Transplant; Complications, Neurologic Complication, Postoperative Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing liver transplant surgery 18-65 years Exclusion Criteria: pregnant patients Acute Liver Failure, Acute on Chronic Liver Failure

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological complications | type of neurological complication | 90 days | 
| Mortality | mortality due to any cause | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver transplantation, neurological complications, postoperative complications
Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.

Official Title
-----------------
A Single Masked, Randomized Controlled Study to Assess Efficacy of Ozurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Diabetic Macular Edema

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Drug: dexamethasone intravitreal implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female age 18 years or older Type 1 or type 2 diabetes BCVA score of >24 and <78 letters Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) >250microns Exclusion Criteria: Anti-VEGF intravitreal treatment in last 4 weeks Intravitreal steroid treatment in the last 8 weeks PRP or Focal laser in last 4 months Active iris neovascularization

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bevacizumab alone<br> | Drug: Bevacizumab<br>* intravitreal, 1.25mg., monthly<br>* Other names: Avastin;|
| Active Comparator: Combined group<br>Bevacizumab plus Ozurdex | Drug: Bevacizumab<br>* intravitreal, 1.25mg., monthly<br>* Other names: Avastin;Drug: dexamethasone intravitreal implant<br>* 0.7mg, intravitreal every 4 months<br>* Other names: Ozurdex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline | Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. | baseline to 12 month | 
| OCT CST | change in optical coherence tomography central subfield thickness | change in OCT CST from baseline to twelve months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic macular edema, DME
Study Evaluating The Effects Of Single Oral Doses Of NSA-789 On Auditory P50 Suppression In Schizophrenic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of single doses of NSA-789 on the P50 component of the auditory evoked potentials and to assess the safety, tolerability and the concentration of NSA-789 in the blood, in nonsmoking patients with schizophrenia.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effects of Single Oral Doses of NSA-789 on Auditory P50 Suppression in Nonsmoking Patients With Stabilized Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: NSA-789 at 2 different doses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Women of nonchildbearing potential, or men, aged 18 to 55 years inclusive on study day 1. Women of nonchildbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for â‰¥1 year (with a follicle-stimulating hormone [FSH] level of â‰¥38 mIU/mL). Women who are surgically sterile must provide documentation of the procedure by an operative report or ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration. Body mass index in the range of 18 to 32 kg/m2 and body weight â‰¥50 kg. Hemoglobin no lower than 0.4 g/dL, less than the lower limit of the normal range, and white blood cell count no lower than 0.5 103/mm3, less than the lower limit of the of the normal range at screening and day -1. Hematocrit and absolute neutrophil count within normal range at screening and on day -1. Exclusion criteria: Women of childbearing potential. Presence or history of any disorder that may prevent the successful completion of the study. Any unstable psychiatric condition, which may prevent the successful and safe completion of the study in the opinion of the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose 1 | Drug: NSA-789 at 2 different doses<br> <br> |
| Experimental: 2<br>Dose 2 | Drug: NSA-789 at 2 different doses<br> <br> |
| Placebo Comparator: 3<br> | Drug: NSA-789 at 2 different doses<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electroencephalogram |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood sample |  | 8 weeks |
Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: To compare prophylactic effect of ondansetron versus ramosetron on radiotherapy induced nausea and vomiting in the treatment of gastrointestinal cancer. To verify an improvement of 20% in complete response rate in term of radiotherapy induced nausea and vomiting (from 60% with ondansetron to 80% with ramosetron).

Official Title
-----------------
Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer

Conditions
-----------------
Radiotherapy Induced Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: ramosetron
* Drug: ondansetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AJCC 1-3 staged gastrointestinal cancer patient patient undergoing radiotherapy as treatment age 20 yr and higher ECOG 0-2 Exclusion Criteria: age < 20 ECOG 3-4 patient experiencing nausea or vomiting prior to accrual patient under antiemetic medication patient under steroid medication (topical or inhalant steroid application are exceptional) patient under opioid medication

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RMS<br>ramosetron 0.1mg q.d. SL on D1-5 | Drug: ramosetron<br>* ramosetron 0.1mg q.d. SL on D1-5<br>|
| Active Comparator: ODS<br>ondansetron 8mg, b.i.d SL on D1-5 | Drug: ondansetron<br>* ondansetron 8mg, b.i.d SL on D1-5<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response of RINV (no vomiting and no rescue medication) |  | 4 weeks after medication |
Low Dose Cyclosporin A in Primary Sjögren Syndrome

Study Overview
=================
Brief Summary
-----------------
Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome

Detailed Description
-----------------
NSAR are used currently for the treatment of musculoskeletal manifestations at Sjögren Syndrome for the symptomatic release of pain. For therapy-resistant cases drugs also used in Rheumatoid Arthritis are used. For these drugs there is no registration for the treatment of Sjögren Syndrome.

Official Title
-----------------
A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome

Conditions
-----------------
Sjögren´s Syndrome

Intervention / Treatment
-----------------
* Drug: Cyclosporine A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of a primary Sjögren´s Syndrome Liver values above 1,5 ULN uncontrolled arterial hypertension intraarticular or systemic use of Glucocorticoids in the last 4 weeks before begin with Study medication Exclusion Criteria: pre-treatment with Cyclosporine A Infection Neoplasia relevant cardiac, pulmonary, neurologic or psychiatric disease life-Vaccination within 4 weeks before begin with study medication pregnant or breast-feeding weight under 45kg or more than 110kg

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cyclosporine A<br>All patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks | Drug: Cyclosporine A<br>* Patients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period<br>* Other names: Sandimmun optoral;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examination of the therapeutic effects (improvement in number of tender, swolen joints, DAS 28) of low dose Cyclosporine A in patients with primary Sjögren Syndrome and articular involvement after a treatment-phase of 16 weeks. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the safety (type and number of adverse events and serious adverse events) of low-dose Cyclosporine A in patients with primary Sjögren Syndrome |  | 28 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary Sjogren´s Syndrome, Cyclosporine