linjc16/ctgov huggingface dataset:
Second Malignant Neoplasms After Childhood ALL Therapy

Study Overview
=================
Brief Summary
-----------------
Development of a second neoplasm (SMN) during or after therapy for childhood acute lymphoblastic leukemia (ALL) is a rare event generally associated with a poor prognosis. In this international study we analyze subtypes of SMN in relation to their initial leukemia characteristics and treatment, and their subsequent overall survival.

Detailed Description
-----------------
To explore epidemiology, potential risk factors and survival rates of second cancers occurring as the first event in childhood acute lymphoblastic leukemia the involved study groups will collect anonymous data on all such cases diagnosed within the last decades to form a common database with predefined variables comprising the clinical, biological, and cytogenetic characteristics (myeloid neoplasias only) as well as outcome. Furthermore, we will register the clinical, biological, and cytogenetic characteristics of the acute lymphoblastic leukemia as well as type of treatment given.

Official Title
-----------------
Second Malignant Neoplasms After Childhood ALL Therapy; An International Ponte di Legno Study

Conditions
-----------------
Acute Lymphoblastic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with childhood acute lymphoblastic leukemia Diagnosis of second cancer before December 31st 2007 Exclusion Criteria: Uncertainty if the second cancer has emerged from the same original leukemic clone

Ages Eligible for Study
-----------------
Maximum Age: 20 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 |
| --- | --- |
| ALL diagnosed 1980-2007<br>Cases of childhood acute lymphoblastic leukemia (ALL) diagnosed between 1980 and 2007 and included in the clinical trials of the participating ALL study groups | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of SMN subtypes | Pattern of the main groups of SMN and their clinical charactiristics | At 20 years from diagnosis | 
| Overall survival by subtype | Overall survival by the main SMN subtypes (myeloid malignancies, brain tumors, lymphomas, sarcomas, carcinomas, others) | At 10 years from diagnosis of SMN | 
| Risk factors for development of SMN | Identification of risk factors linked to the interval to SMN, the subtype of SMN, and the survival after. These risk factors are clinical characteristics of ALL or the anti-ALL therapy administered | At 20 years from ALL diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute lymphoblastic leukemia, Ponte-di-Legno consortium, Second cancer, Survival
Position Changes During Colonoscope Withdrawal and Polyp Detection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether position changes during colonoscope withdrawal affects polyp detection rate. We hypothesize that positions change during scope withdrawal will increase polyp detection rate.

Official Title
-----------------
Position Changes During Colonoscope Withdrawal to Increase Polyp Detection: a Prospective Randomized Trial

Conditions
-----------------
Colonic Polyp

Intervention / Treatment
-----------------
* Procedure: Position change
* Procedure: Standard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients undergoing colonoscopy Age 40 or greater Exclusion Criteria: Inpatient colonoscopy Unable to provide informed consent Unable to complete colonoscopy to cecum Previous bowel resection, inflammatory bowel disease, polyposis syndrome Musculoskeletal disorder or other mobility issue limiting effective patient position changes Inadequate bowel preparation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Subject will undergo standard colonoscopy. | Procedure: Standard<br>* Subjects will undergo standard colonoscopy without position changes during scope withdrawal.<br>|
| Active Comparator: Position change<br>Subject will under go standard colonoscopy, but also with position changes during colonoscope withdrawal. | Procedure: Position change<br>* Patients will be randomly assigned to two groups: Control group (those who will receive standard colonoscopy without position changes) and Position change group (those who will undergo position changes during colonoscope withdrawal during colonoscopy). Subjects in position change group will be asked to shift into three different positions during colonoscope withdrawal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate |  | 6 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
detection
A Study To Measure The Level Of Drug In Nasal Tissue And Blood After Taking A Single 2g Dose Or 500mg Tablets For Up To

Study Overview
=================
Brief Summary
-----------------
To measure the level of drug in nasal tissue and blood after taking a single 2g dose or 500mg tablets for up to 3 days.

Official Title
-----------------
An Open-Label Study Of Azithromycin Pharmacokinetics In Sinus Mucosal Tissue And Plasma In Subjects With Chronic Rhinosinusitis Following A Single 2g Dose Of Azithromycin Extended Release For Oral Suspension Or Azithromycin 500mg Tablet Formulation Once Daily For A Maximum Of Three Days

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Drug: Zithromax&#153; (azithromycin) 500mg tablets
* Procedure: Endoscopic Sinus Surgery
* Procedure: Blood sampling for hematology
* Procedure: Blood sampling for plasma chemistry profile
* Procedure: Serum pregnancy test (for women of child-bearing potential)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects considered by the Principal Investigator as an appropriate candidate for endoscopic sinus surgery, e.g., for the removal of the thickened and diseased mucosal tissue that blocks the ostiomeatal complex (OMC). Exclusion Criteria: Known or suspected hypersensitivity or intolerance to any macrolide-like compound, including erythromycin, clarithromycin, azithromycin or telithromycin.

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

| Intervention/Treatment |
| --- |
|Drug: Zithromax&#153; (azithromycin) 500mg tablets|nan|
|Procedure: Endoscopic Sinus Surgery|nan|
|Procedure: Blood sampling for hematology|nan|
|Procedure: Blood sampling for plasma chemistry profile|nan|
|Procedure: Serum pregnancy test (for women of child-bearing potential)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of azithromycin in sinus mucosal tissue and plasma in adult subjects after treatment with a single 2 g oral dose of azithromycin extended release for oral suspension or oral azithromycin 500 mg tablet |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets. |  |  |
An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.

Detailed Description
-----------------
The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study. This was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis. Eligible participants on hemodialysis were to remain in the Clinical Research Unit for 2 weeks (Day -7 to Day 8) and were required to consume a potassium, magnesium, calcium and sodium-controlled diet.

Official Title
-----------------
An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Hemodialysis Patients

Conditions
-----------------
Hyperkalemia

Intervention / Treatment
-----------------
* Drug: patiromer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants on hemodialysis between the ages of 18 and 70 years, with serum potassium levels of at least 5.5 mmol/L Adequately dialyzed (Kt/V ≥ 1.2) Exclusion Criteria: History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery. Severe constipation or irregular bowel habits. Unable to consume or tolerate the study-specific diet.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patiromer<br> | Drug: patiromer<br>* 15 grams/day (5 grams 3 times daily) administered orally<br>* Other names: Veltassa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Potassium (Day 1 to Day 8) |  | Day 1 and Day 8 | 
| Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7) |  | Day -7 Through Day -1 and Day 1 Through Day 7 |
Rapid Diagnosis of Patients With Chest Pain During the Covid-19 Outbreak (My-ABCDE)

Study Overview
=================
Brief Summary
-----------------
During the outbreak of COVID-19, among patients with chest tightness and chest pain as the main symptoms in major medical institutions in Shanghai, China, the past medical history and rapid testing were used to quickly identify the risk stratification of the patients.

Detailed Description
-----------------
During the outbreak of COVID-19, among patients with chest tightness and chest pain as the main symptoms in major medical institutions in Shanghai, China, the past medical history and rapid testing were used to quickly identify the risk stratification of the patients. Past medical history collection includes diabetes, hypertension, coronary atherosclerotic heart disease, percutaneous coronary stent implantation, etc. Rapid detection includes rapid myocardial markers, coagulation function, electrocardiogram, chest CT, etc. Risk stratification in the shortest possible time to reduce the time patients spend congregating in hospitals and reduce unnecessary contact to reduce the risk of Covid-19 infection.

Official Title
-----------------
Application of Rapid Risk Stratification for Patients Presenting With Chest Pain in the Emergency Department During the Covid-19 Outbreak in Shanghai, China.

Conditions
-----------------
Chest Pain

Intervention / Treatment
-----------------
* Other: None，observational study.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who came to the hospital with chest tightness and chest pain during Covid-19. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| CPC Cohort<br>A patient with chest tightness and pain during the Covid-19 outbreak. | Other: None，observational study.<br>* observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis time | The time from the first medical contact to the time of diagnosis. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | Preliminary and confirmed diagnoses were the same proportion of the total number of patients. | 1week |
Thrombolysis With Intra-arterial Urokinase

Study Overview
=================
Brief Summary
-----------------
Patients with acute superior mesenteric artery (SMA) occlusion were included in this study. The clinical presentation and effect of the recanalization of the SMA was analyzed on follow-up angiography.

Detailed Description
-----------------
Thirteen patients with acute SMA occlusion who underwent intra-arterial urokinase thrombolysis between 2008 and 2020 were retrospectively evaluated. Clinically, the abdominal pain and the effect of the SMA on angiography will be compared in response and non-response groups.

Official Title
-----------------
Thrombolysis With Intra-arterial Urokinase for Acute Superior Mesenteric Artery Occlusion: Outcome Analysis

Conditions
-----------------
Arterial Occlusion Mesenteric Artery Superior

Intervention / Treatment
-----------------
* Procedure: intra-arterial urokinase thrombolysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of SMA occlusion Exclusion Criteria: shock in the triage screening peritonitis 3. intramural gas, mesenteric or portal venous gas on contrast-enhanced abdominal CT
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| According to the degree of occlusion, 13 patients were divided into complete and incomplete groups.<br>Seven patients were complete occlusion and 6 patients were incomplete occlusion and all underwent thrombolysis with intra-arterial urokinase and the outcome was analysed.. | Procedure: intra-arterial urokinase thrombolysis<br>* Under local anaesthesia, the right femoral artery was punctured in accordance with the Seldinger technique, and a 6-Fr sheath, 10 cm in length, was implanted. Selective catheterization of the SMA was performed with 4-Fr catheter. The SMA angiography was performed to identify the filling defect. Thrombolysis was performed using a 5-Fr multiple-sideport infusion catheter (100cm with sideport of 7cm, 14 ports or 100cm with sideport of 15cm, 30 ports, Cook, Bloomington, IN, U.S.A). The tip of the microcatheter was embedded in the thromboembolism, which was fragmented at the time of thrombolysis. Thrombolysis was performed locally in the SMA with a bolus of urokinase<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombolysis with intra-arterial urokinase for acute superior mesenteric artery occlusion: Outcome analysis | Degree of patency and appearance of the SMA will be analyzed in the follow-up angiography. | Daily series follow-up angiography in the next 72 hours after thrombolysis with intra-arterial urokinase. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intra-arterial urokinase
Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

Study Overview
=================
Brief Summary
-----------------
The objectives of this study is to investigate if pre-treating the skin with an ablative fractional laser that creates small micropores in the skin: Increases the uptake of Methylaminolevulinat (MAL) in the skin. Decreases the required incubation time of MAL when performing photo dynamic therapy.

Detailed Description
-----------------
12 healthy male individuals were included. On the back, 25 areas measuring 2.8x2.8 cm were marked, plus one control area. We tested 2 variables. 1) Density of laser channels. 2) Methylaminolevulinat (MAL) concentration Laser - Each area was randomized to receiving: no treatment 1% laser channel density 2% laser channel density 5% laser channel density 10% laser channel density 15% laser channel density MAL - Each density was assigned to 4 areas. Within each density category, the four areas were randomized to receive: vehicle 4% MAL 8%MAL 16%MAL The uptake of MAL was evaluated by fluorescence intensity measured with a florescence camera at t= 0min 30min 1h 1.5h 2h 2.5h 3h

Conditions
-----------------
Photodynamic Therapy, Ablative Fractional Laser

Intervention / Treatment
-----------------
* Procedure: Laser+Methylaminolevulinat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male >18 years old Fitzpatrick skin type I-III No UV exposure thee months prior to study Signed study consent Exclusion Criteria: Known allergy to substances in MAL or Unguentum M cream. Previous keloid Use of topical or systemic photosensitizing drug Evaluated to not be able to follow treatment protocol

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser+Methylaminolevulinat<br>It's a single arm. Intervention as described in the detailed description. | Procedure: Laser+Methylaminolevulinat<br>* It's a single arm study. Intervention as described in detailed description.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescence Intensity | Fluorescence Intensity measured with a fluorescence camera. | up to 3 hours |
18776 - Human Photoallergy Test

Study Overview
=================
Brief Summary
-----------------
To evaluate the potential of a test material to produce a photoallergic response.

Official Title
-----------------
Human Photoallergy Test

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Other: BAY987516
* Other: Untreated skin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be male or female between the ages of 18 and 60 inclusive; be lightly pigmented (Fitzpatrick Skin Type I, II, III); have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164; be in general good health as determined by the subject's medical history and in the discretion of the investigator; Exclusion Criteria: have a visible sunburn; have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products. subjects who are employees of the CRO and/or Bayer or is a household member of an employee

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

Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>All subjects are patched with the same product | Other: BAY987516<br>* 50 μl/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.<br>Other: Untreated skin<br>* One site is patched without treatment as control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of skin reactions is evaluated by 5 point scale |  | Up to 72 hours |