linjc16/ctgov huggingface dataset:
Comparative Evaluation of Results of Allogeneic Hematopoietic Stem Cells Versus Ponatinib in CML Patients Carrying a Mutation T315I

Study Overview
=================
Brief Summary
-----------------
Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus allogeneic stem cell transplantation (allo-SCT).

Official Title
-----------------
Overall Survival With Ponatinib Versus Allogeneic Stem Cell Transplant in Philadelphia-positive Leukemias With the T315I Mutation

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Drug: Ponatinib (Iclusig®)
* Procedure: allogeneic stem cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CML any phase with T315I mutation Ph+ ALL with a T315I mutation Being treated in the PACE trial according to the criteria of this phase II trial Or being allogeneic stem cell transplanted with any source of allogeneic cells and after any conditioning regimen. Exclusion Criteria: Ph negative patients Patients under 18 years

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 |
| --- | --- |
| Ponatinib (PACE trial)<br>PACE trial : Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL), NCT01207440 | Drug: Ponatinib (Iclusig®)<br>* Novel tyrosine kinase inhibitor active in patients with an ABL T315I mutation compared to conventional or reduced intensity allogeneic stem cell transplantation.<br>|
| Allogenis stem cell transplantation (EBMT registry)<br>EBMT : European Group for Blood and Marrow Transplantation | Procedure: allogeneic stem cell transplantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months) |  | From date of inclusion until the date of death, assessed up to 180 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic myeloid leukemia (CML), Philadelphia-positive (Ph+), Acute Lymphoblastic Leukemia (ALL)
Measuring the Peripheral Optical Quality of The Eye

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to quantify wavefront aberration profiles of the eye with and without contact lens across the visual field. This will enable us to investigate the impact of the aberration on retinal image quality.

Detailed Description
-----------------
The goal of this study is to investigate the effects of monofocal and bifocal soft contact lenses in the changes of peripheral optical quality and through-focus visual performance on real eyes. The goal will be accomplished by performing optical measurements using Shack-Hartmann wavefront sensor with and without the use of single vision and bifocal soft contact lenses.

Official Title
-----------------
Measuring the Peripheral Optical Quality of The Eye

Conditions
-----------------
Nearsightedness

Intervention / Treatment
-----------------
* Device: Monofocal Contact Lens
* Device: Bifocal Contact Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria A person will be included in the study if he/she: Is 18 years or older and has full legal capacity to volunteer. Has no ocular condition or pathology, which may impact visual acuity e.g. keratoconus, amblyopia, cataract, macular degeneration; Has no active ocular disease or allergic conjunctivitis; Is not using any topical ocular medications; Is willing and able to follow instructions; Has voluntarily agreed to participate in the study by signing the statement of informed consent. Exclusion Criteria A person will be excluded from the study if he/she: Is under the age of 18 or over the age of 60 yrs. Correctable with high contrast logMAR acuity (EDTRS) testing to 20/20 or better; Pregnant at the time of enrolment in the study; Unable to handle, insert, remove or care for the study lenses; Considered by the Investigator to not be a suitable candidate for participation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental<br>Subjects will undergo three Wavefront measurements, once with no contact lens, once with a monofocal contact lens and once with a bifocal contact lens. | Device: Monofocal Contact Lens<br>* A monofocal contact lens will be used for this measurement.<br>Device: Bifocal Contact Lens<br>* A bifocal contact lens will be used for this measurement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Wavefront aberrations | The scanning wavefront sensor will be used to collect data. Mean Wavefront aberrations for each trail will be analyzed. | less than 2 hours |
Influence of Positive Margins on Tumour Recurrence and Overall Survival After Gastrectomy for Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Incidence of positive surgical margins after curative gastrectomy ranges from 1% to 20%. It has been suggested that positive surgical margins is an adverse prognosis factor, with a higher local recurrence and worse overall survival (OS). However, the management of these patients remains unclear.

Official Title
-----------------
Influence of Positive Margins on Tumour Recurrence and Overall Survival After Gastrectomy for Gastric Cancer

Conditions
-----------------
Stomach Neoplasms

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all consecutive patients who underwent an oncological gastrectomy due to gastric cancer, between January 2010 and December 2018 at Ramon y Cajal University Hospital. Exclusion Criteria: distant disease (including patients with positive cytology), early postoperative mortality (within 30 days after surgery) and follow-up data not available. Resections in patients with palliative intent were also excluded.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| R=0<br>Patients without positive margins after gastrectomy for gastric cancer | Other: Observation<br>* The primary aim of this study was to evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC. The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.<br>|
| R=1<br>Patients with positive margins after gastrectomy for gastric cancer | Other: Observation<br>* The primary aim of this study was to evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC. The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC |  | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy. |  | 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric cancer, gastrectomy, R1, positive margins, recurrence, overall survival, prognosis
Routine Bile Collection for Microbiological Analysis During Cholangiography

Study Overview
=================
Brief Summary
-----------------
Background: Antibiotic treatment of cholangitis often remains insufficient due to inappropriate antibiotic use or bacterial resistance. Objective: To evaluate the role of routine bile collection during endoscopic retrograde cholangiography (ERC) or percutaneous transhepatic cholangiography (PTC) for microbiological analysis in the antibiotic management of cholangitis and to identify risk factors of microbial growth. Design: Prospective, observational, diagnostic study. Setting: Hannover Medical School, Hannover, Germany. Patients and Interventions: Consecutive patients undergoing ERC/PTC for biliary complications after orthotopic liver transplantation , malignancy, primary sclerosing cholangitis, benign strictures and choledocholithiasis. Main outcome measurements: Microbiological examination of bile samples

Official Title
-----------------
Routine Bile Collection for Microbiological Analysis During Cholangiography and Its Impact on Management of Cholangitis: Results of a Prospective Study

Conditions
-----------------
Cholangitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 18 years written informed consent Exclusion Criteria: age under 18 years no written informed consent

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholangitis, antibiotic, bacteriobilia, bile, ERCP
Treatment of Posttraumatic Stress Disorder by Trained Lay Counsellors in an African Refugee Settlement

Study Overview
=================
Brief Summary
-----------------
The study is a pragmatic trial to study the efficacy of two active methods of psychotherapy for the treatment of posttraumatic stress disorder in a refugee camp in Africa. Treatment was administered by lay counsellors.

Detailed Description
-----------------
Traumatic stress due to conflict and war causes major mental health problems in many resource-poor countries, especially those coping with displaced populations. There is a lack of intervention research in these populations. Te purpose of this study was to examine whether trained lay counsellors can carry out effective treatment of PTSD in a refugee settlement.

Official Title
-----------------
Talking About Traumatic Events - A Randomized Controlled Dissemination Study of the Treatment of PTSD in an African Refugee Settlement

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Narrative Exposure Therapy
* Behavioral: Trauma Counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of posttraumatic stress disorder Exclusion Criteria: Drug abuse Psychosis Mental retardation

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 |
| --- | --- |
| Experimental: 1<br>NET | Behavioral: Narrative Exposure Therapy<br>* Six session of Narrative Exposure Therapy<br>|
| Experimental: 2<br>TC | Behavioral: Trauma Counselling<br>* Six sessions of Trauma Counselling, using a variety of skills incl. exposure methods following the skills of the therapist<br>|
| No Intervention: 3<br>Monitoring Group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expert diagnosis of PTSD established with CIDI interview |  | 9 months | 
| Physical health symptoms assessed with a checklist |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Posttraumatic Stress Disorder, refugees, war
The Role of Telemedical Monitoring in Diabetic Foot Ulcer Care

Study Overview
=================
Brief Summary
-----------------
The role of telemedical monitoring in diabetic foot care is still uncertain. The aim is to compare telemedical + standard and standard alone outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. The primary outcome of the overall study is the time of ulcer healing. The number of amputation, hospital admissions and surgical procedure will be also reported. Investigators hope to include 150 patients in this study.

Official Title
-----------------
The Role of Telemedical Monitoring in Diabetic Foot Ulcer Care

Conditions
-----------------
Diabetic Foot - Telemedical Monitoring

Intervention / Treatment
-----------------
* Device: telemedical monitoring ( T)
* Device: classic monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients treated in the diabetology department of CHU de Reims during the inclusion phase to a diabetic foot lesions ( infected or not). Patients with care of this lesion of diabetic foot externally. Patients who agreed to participate in or accepting ORNICARE network ( network for the transmission of information between health care professionals) (Appendix 3) . Patients aged over 18 years . Patients who agreed to participate in the study . The patients insured by a social security scheme . Exclusion Criteria: Patients requiring hospital care of the lesion of diabetic foot (infection requiring surgical intervention , ischemia requiring revascularization , ...). Patients are protected by law . Minor patients.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telemedical monitoring ( T)<br>Home care by a nurse trained in the management of diabetic foot lesions with transmission diabetologist doctor a photograph and a full description of the diabetic foot lesion every week | Device: telemedical monitoring ( T)<br> <br> Device: classic monitoring<br> <br> |
| Active Comparator: classic monitoring<br>Home care by a nurse trained in the management of diabetic foot lesions without transmission diabetologist doctor a photograph and a full description of the diabetic foot lesion | Device: classic monitoring<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of ulcer healing |  | 6 month after inclusion |
A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of 'Ursa Complex Soft Cap. (UDCA-004)' in Patients With Physical Fatigue.

Study Overview
=================
Brief Summary
-----------------
A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'Ursa Complex Soft Cap. (UDCA-004)' in patients with physical fatigue.

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Drug: Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CIS greater than or equal to 76, HADS less than or equal to 10 Exclusion Criteria: Subjects who have diseases that can cause fatigue Subjects who are taking medication that can cause fatigue

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UDCA004<br>UDCA004 | Drug: Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol<br> <br> |
| Placebo Comparator: Placebo of UDCA004<br>Placebo of UDCA004 | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of subjects whose CIS score has improved under 76 at week 4 |  | 4 weeks |
DEtermining Accuracy and TrEnding CharacTerization of AF

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).

Official Title
-----------------
DEtermining Accuracy and TrEnding CharacTerization of AF

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: SJM Confirm ICM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject has been implanted with a SJM Confirm ICM, DM2102. The subject has or is suspected to have paroxysmal AF. The subject is ≥ 18 years of age. The subject is willing and able to provide written Informed Consent (prior to any investigational related procedure). Exclusion Criteria: The subject has persistent (>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous AF >1 year) or permanent AF (not attempting to restore sinus rhythm). The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease). The subject has a contraindication to Holter recording. The subject has already received an active implantable medical device other than the SJM Confirm ICM, DM2102. The subject is unable to comply with the follow up schedule. The subject is participating in another investigational device or drug investigation. The subject is pregnant or is planning to become pregnant during the duration of the investigation.

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 |
| --- | --- |
| SJM Confirm ICM Observational Group<br> | Device: SJM Confirm ICM<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording. | Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM. Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor. | 4 days after Holter starts |
Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan

Study Overview
=================
Brief Summary
-----------------
This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable, recurrent or metastatic) Melanoma.

Official Title
-----------------
Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan

Conditions
-----------------
Advanced Melanoma, Hepatitis B, Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Age of 18 years or older on date of first dose of Ipilimumab Patients who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or Metastatic Melanoma in Taiwan Patients with advanced Melanoma and HBV or HCV who are initiating Ipilimumab under the discretion of their physician Exclusion Criteria: Patients who received Ipilimumab as part of a clinical trial Patients who are receiving Ipilimumab for any indication other than local approval (ie, unresectable or Metastatic Melanoma) Patients who are not infected with HBV or HCV

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 |
| --- | --- |
| Unresectable, recurrent or metastatic melanoma patients<br>All adult unresectable, recurrent, or metastatic melanoma patients with HBV or HCV treated with at least 1 dose of ipilimumab therapy in Taiwan | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load |  | During 6months after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBV, HBC