linjc16/ctgov huggingface dataset:
Long-Term Follow-Up Study of HIV-1 Infected Adults Who Received EBT-101

Study Overview
=================
Brief Summary
-----------------
Participants who receive EBT-101 in a parent protocol will be eligible to participate in this long-term follow-up (LTFU) study (EBT-101-002).

Detailed Description
-----------------
Participants who receive EBT-101 in a parent protocol will be eligible to participate in this LTFU study (EBT-101-002). All participants will have follow-up visits every six months until Year 5 post EBT-101. Thereafter, all participants will have follow-up visits annually on the anniversary of EBT-101 administration until study completion at Year 15.

Official Title
-----------------
Long-Term Follow-Up Study of HIV-1 Infected Adults Exiting a Parent Study Where EBT-101 Was Administered

Conditions
-----------------
HIV-1-infection

Intervention / Treatment
-----------------
* Biological: EBT-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide written, signed informed consent Participants who received the investigational study intervention EBT-101 in a parent study Exclusion Criteria: • Participants who did not receive EBT-101 in a parent study

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Long term follow up of participants who received EBT-101
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long Term Follow Up<br>Participants who received EBT-101 in a parent study will undergo long term follow up | Biological: EBT-101<br>* Long term follow up of participants who received EBT-101<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety of EBT-101 | Long-term safety of EBT-101 will be assessed based on incidence and severity of clinically significant adverse events (AEs) according to Division of AIDS (DAIDS) 2017 over 15 years | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRISPR, Gene Therapy, adeno-associated virus serotype 9 (AAV9)
Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.

Study Overview
=================
Brief Summary
-----------------
Despite good initial response, some patients with core binding factor and/or NPM1-mutated AML eventually relapse. Some of these patients can be identified earlier on, before overt cytological relapse, when followed for minimal residual disease. The outcome of patients treated when molecular relapse is confirmed, before overt cytological relapse, is not well known. This multi-center retrospective will therefore study the outcome of these patients and try to specify the role of allogeneic stem cell transplantation in this setting.

Official Title
-----------------
Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18 and 61 years Diagnosis between 2010 and 2019 Core binding factor and/or NPM1 acute myeloid leukemia First complete remission after induction therapy Measurable residual disease measurement after end of consolidation therapy Exclusion Criteria: Acute promyelocytic leukemia Allogeneic stem cell transplantation in CR1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 61 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Molecular relapse<br>Confirmed molecular relapse, without overt cytological relapse | Other: No intervention<br>* Retrospective analysis<br>|
| Cytological relapse<br>Overt cytological relapse, without prior molecular relapse | Other: No intervention<br>* Retrospective analysis<br>|
| Persistent responders<br>No molecular or cytological relapse during follow-up | Other: No intervention<br>* Retrospective analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Up to 5 years |
Vascular Healing After BVS-implantation

Study Overview
=================
Brief Summary
-----------------
Evaluation of coronary artery vessel wall healing at different time points in patients undergoing implantion of bioresorbable vascular scaffold by using intravascular imaging. In addition long-term clinical follow-ups are planned for all patients treated with Absorb in the institution

Detailed Description
-----------------
OCT-guided evalutation of the coronary vessel wall, endovascular healing and bioresorbable vascular scaffolds at different time points. These results will be analysed in terms of clinical presentation, gender and age.

Official Title
-----------------
Vascular Healing After Implantation of Bioresorbable Vascular Scaffold in Different Clinical Settings and Follow-up Time Points

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Device: Absorb-BVS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: optical coherence tomography examination after BVS-implantation Exclusion Criteria: None

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 |
| --- | --- |
| Absorb-BVS<br>Bioresorbable vascular scaffold implantation | Device: Absorb-BVS<br>* BVS patients undergoing optical coherence tomography examination at follow-up<br>* Other names: Absorb;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the amount of tissue coverage per strut level analysis at OCT | according to study protocol | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of diameter stenosis per strut in OCT examination | according to study protocol | 7 weeks | 
| amount of diameter stenosis per strut in OCT examination | according to study protocol | 24 months | 
| healing score in OCT examination | according to study protocol | 7 weeks | 
| healing score in OCT examination | according to study protocol | 24 months | 
| proportion of malapposed and protruding struts per stent in OCT examination | according to study protocol | 7 weeks | 
| proportion of malapposed and protruding struts per stent in OCT examination | according to study protocol | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioresorbable vascular scaffold, Optical coherence tomography, strut coverage, acute coronary syndrome
Rare Benign Lesion of Peins

Study Overview
=================
Brief Summary
-----------------
PEKMB was first named and described by Lortat-Jacob & Civatte in 1961 and by Bart & Kopf later. This rare condition is mostly reported in elderly males. The keratotic scales is usually micaceous and resembles psoriasis. Most patients are above 50 years of age and are circumcised later in life, but also reported in younger age group. This mica like scales contains keratin which gets dissolved in 10% potassium hydroxide solution. Disease progression may lead to phimosis. Differential diagnosis of this disease entity include moniliasis, wart, psoriasis ,penile horn, circinate balanitis, erythroplasia of Queyrat, squamous cell epithelioma and verrucous carcinoma. It is primarily a benign entity, it is capable of invasiveness. Bart and Kopf considered it to be in intermediate stage between benign hyperplasia and squamous cell carcinoma. However, the histological spectrum can range from hypertrophic-hyperplastic penile dystrophy to verrucous carcinoma. Fibro sarcoma has been reported developing in a same patient. Etiology is unclear. Despite search for a viral agent, Human Papilloma Virus (HPV) has not been demonstrated and its role in pathogenesis or its transformation to verrucous carcinoma has been proved. The treatment of PEKMB should be conservative when there is no histological evidence of malignancy. All such patients should be followed up. Treatment choices include potent topical steroids, topical 5% 5-flurouracil cream1, 2, cryotherapy, radiotherapy and shaving biopsy plus electro coagulation. When frank malignancy is observed, excision with wide margin is the rule.

Official Title
-----------------
Pseudoepitheliomatous Hyperplasia of the Penis a Very Rare Disease in Egypt

Conditions
-----------------
Skin Diseases, Penile Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40 years failed medical treatment Exclusion Criteria: psoriasis allergy trauma

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 50 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of the skin lesion | drugs will be given to patient then the effect ,either improvement or worsening will be noticied | 1 month after treatment | 
| improvement of associated lesion | patient complained of difficulty and burning micturition which will be seen after treatment | 1 month after drug given |
Assessment of the Accuracy of PET/MR in Detection and Monitoring Response of Bone Metastases

Study Overview
=================
Brief Summary
-----------------
The great promise of PET/MR for assessment of skeletal metastatic involvement is derived from the extensive experience with stand- alone MR, but initial data on the use of PET/MR for assessment of bone pathology indicate that PET/MR introduces unique issues that should be addressed when determining its role in this clinical scenario. In this study cohort includes 150 patients 18 years or older, having metastatic skeletal involvement on baseline PET/CT prior to treatment. Baseline studies and follow up studies of the patients referred post treatment, will be reviewed. The main goal of the study is to asses the accuracy of PET/MR in detection and monitoring response of bone metastases.

Official Title
-----------------
Assessment of the Accuracy of PET/MR in Detection and Monitoring Response of Bone Metastases

Conditions
-----------------
Bone Metastases

Intervention / Treatment
-----------------
* Diagnostic Test: PET/MR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 150 patients having metastatic skeletal involvement on baseline PET/CT prior to treatment Exclusion Criteria: Age <18. Pregnant or breast feeding patients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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: Bone Metastases Patients<br> | Diagnostic Test: PET/MR<br>* All patients will have a PET/CT and PET/MR study performed at the same clinical setting using a single dose of tracer administration. The study cohort includes 150 patients 18 years or older, having metastatic skeletal involvement on baseline PET/CT prior to treatment. Baseline studies and follow up studies of the patients referred post treatment, will be reviewed. The tracers will be FDG, labelled PSMA labelled Somatostatin and F-DOPA in order to assess skeletal lesions detection of all tumor types. Skeletal lesions will be divided into marrow-based lesions, lytic, blastic and scleroric lesions. Tracer uptake will be measured at baseline and after treatment. Metabolic PET parameters, CT appearance and MR parameters will be assessed. The best MR-based attenuation algorithm for detection of lesions and monitoring response will be derived.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The investigators will report about the number of patients who preformed PET/MR for assessment of skeletal involvement as well as activity after treatment, | and also preformed in routine PET/CT and to optimize the algorithm of MR-based attenuated PET images. | 1 year |
Clostridium Difficile Infection: the First Report in Southeast Asia by 2010 Nationwide Study

Study Overview
=================
Brief Summary
-----------------
The authors retrieved in-patient medical data, including the expense, from the 2010 Thailand Nationwide Hospital Admission Database, which is part of the National Health Security Office (NHSO). The diagnosis of digestive diseases with any form of colitis listed in the causes, either as principal diagnosis or co-morbidity, coding by the ICD-10 was recorded. The inclusion criteria were: 1) diagnosis of enterocolitis due to Clostridium difficile (ICD10-A07); and 2) age of more than 18 years. If the data was incomplete, the case was excluded. The baseline characteristics, including age, sex, co-morbidity disease and history of endoscopy or surgery, were recorded. The burden of CDI was evaluated by length of hospital stay (LOS), mortality rate, and hospital charge.

Official Title
-----------------
The Burden of Clostridium Difficile Infection in Thai Population: the First Report in Southeast Asia by 2010 Nationwide Study

Conditions
-----------------
Clostridium Difficile Infection

Intervention / Treatment
-----------------
* Other: Colitis with CDI treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with the diagnosis of Clostridium difficile (ICD10-A07) Age of more than 18 years. Exclusion Criteria: Data incompleted

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 |
| --- | --- |
| Colitis with CDI<br>Patients who diagnosed with CDI will be analysed | Other: Colitis with CDI treatment<br>* All patients will be treated with standard treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death rate and length of hospital stay in CDI during admission | Length of hospital stay(LOS), mortality rate and hospital charge were used as the indicators for evaluating the burden of CDI. | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Hospital charge of CDI | Length of hospital stay(LOS), mortality rate and hospital charge were used as the indicators for evaluating the burden of CDI. | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burden, Clostridium difficile infection, nationwide study, South East Asia, Thailand, Epidemiology, Outcome Assessment (Health Care) [N04.761.559.590]
Organ Failure After Advanced Endovascular Thoracoabdominal Aortic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the mortality and frequency of organ dysfunction in patients after endovascular thoracoabdominal aortic surgery, and to search for biomarkers of organ dysfunction, in particular the spinal cord, the kidneys and the gastrointestinal tract. All adult patients undergoing endovascular thoracoabdominal aortic surgery at Örebro University Hospital, Örebro, Sweden, are asked for participation in this study. All participating patients sign informed consent at the inclusion. During the operation and during the postoperative intensive care, the function of the spinal cord, the gastrointestinal tract and the kidneys are collected along with other clinical parameters. Plasma blood samples, urin samples and cerebrospinal fluid samples are collected from each patient during the operation and during the postoperative care at the intensive care unit. During the operation two microdialysis catheters are placed in the abdomen, and the samples are continuously collected and analyzed. The biomaterial samples are stored in a biobank for later determination of proteins and other molecules. Postoperative survival and the frequency of complications are analysed.

Official Title
-----------------
Kärlkirurgi Vid Komplicerade kroppspulsåderbråck - Utfall, Riskfaktorer Och sökande Efter biomarkörer för Organskada

Conditions
-----------------
Aortic Aneurysm, Spinal Ischaemia, Gastrointestinal Ischaemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Accepted for endovascular advanced thoracoabdominal aortic surgical procedure Adult Exclusion Criteria: Pregnant

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 |
| --- | --- | --- |
| Mortality | Overall and aortic-related mortality | 1 year postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ dysfunction and failure | Spinal cord, gastrointestinal tract, kidneys | Postoperative: 7 days, 30 days, 1 year follow-up |
Focal Brachytherapy in Patients With Selected Low-risk Prostate Cancer - a Phase-II-trial

Study Overview
=================
Brief Summary
-----------------
This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.

Detailed Description
-----------------
Patients with low-risk prostate cancer will receive HDR-Brachytherapy: 2 x 13,5 Gy.

Official Title
-----------------
Focal Brachytherapy in Patients With Selected Low-risk Prostate Cancer - a Phase-II-trial

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: HDR-Brachytherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Histologically confirmed prostate cancer Gleason Score of index lesion ≤ 6 (3+3) Tumor stage: cT1-2a cN0 cM0 Unilateral affection; index lesion ≤ 0.5ml with or without clinically non-significant lesion contralateral. No more than 25% of the punch should be affected. Therefore a 3D-TPM-biopsy is mandatory before treatment. PSA ≤ 10/ng/ml Prostate volume < 60 m^3 No distant metastasis Life expectancy > 10 years Informed consent Exclusion Criteria: Tumor stage ≥ T2b Known metastasis: N+ and/or M1 General anesthesia or peridural anesthesia is not possible Coagulation disorder

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

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

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 |
| --- | --- |
| Experimental: Focal Brachytherapy<br>HDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy | Radiation: HDR-Brachytherapy<br>* HDR-Brachytherapy 2x 13,5 Gy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity and frequency of adverse events |  | 6 weeks after therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor regression |  | 6 weeks up to 10 years after therapy | 
| Rate of recurrences measured by PSA |  | 10 years after therapy | 
| Correlation of Markers RTEN, ERG, APN, Ki67, KPNA1, PSMA, FGFR1, PMP22, CDKN1A/P16, PDCD4, KLF6, PITX with PSA free survival |  | 10 years after therapy | 
| Correlation of microRNA141 and -375 with outcome |  | 10 years after therapy | 
| Feasibility, as measured by NCI-CTCAE-scale, EORTC-QLQ, IIEF, IPSS, ICIQ |  | 6 weeks after therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, focal brachytherapy, PSA, Biological marker
Extracorporeal Shock Wave Treatment - Can the Pain be Reduced?

Study Overview
=================
Brief Summary
-----------------
Patients with Fascititis plantaris, Achillodynie, Periarthropathia humerosacpularis calcarea or Epikondylopathia humeri /radii get the shock wave therapy in our clinic as planned. During our study the investigators want to ask for pain, pain reduction and function.

Detailed Description
-----------------
Patients with either Fascititis plantaris, Achillodynie, Periarthropathia humerosacpularis calcarea or Epikondylopathia humeri /radii get a shock wave therapy in our clinic of rheumatology as planned. During our study the investigators ask for pain, pain reduction and function (all questionnaires).

Official Title
-----------------
Extracorporeal Shock Wave Treatment - Can the Pain be Reduced?

Conditions
-----------------
Fasciitis, Plantar, Achillodynia, Periarthritis Calcarea, Epikondylopathia Humeri /Radii

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: -Patients with: Fascititis plantaris, Achillodynie, Periarthropathia humerosacpularis calcarea or Epicondylopathia humeri /radii, who got the shock wave therapy. Exclusion criteria: Anticoagulation, Sepsis

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