linjc16/ctgov huggingface dataset:
Renal Function in Adults With Congenital Heart Disease.

Study Overview
=================
Brief Summary
-----------------
Impaired kidney function is associated with a poor outcome in patients with heart failure but it is not known of this is the case for patients who have been born with their heart condition (congenital heart disease). This study aims to investigate how frequently patients with congenital heart disease have kidney disease and whither this does have an impact on their outcome. The hypothesis is that kidney dysfunction will be common in these patients and may have an impact on long-term health and life-expectancy.

Detailed Description
-----------------
Renal dysfunction is a recognised independent prognosticator in patients with chronic heart failure. Indeed it has been suggested that the clinical impact of renal dysfunction may be greater than that of left ventricular ejection fraction per se. The role of renal function has also been investigated in small sub-groups of patients with adult congenital heart disease (ACHD) for example peri-operatively. It is not however known if renal dysfunction has the same prevalence and significance as when present to patient with acquired heart failure. The hypothesis of the study is that renal dysfunction, both overt and sub-clinical, will be commonly detected in patients with congenital heart disease. The study proposes that renal dysfunction will be associated with hospitalisation for heart failure and fluid overload and will also identify patients at an increased risk of worsening clinical status. Comparisons: Baseline renal function (creatinine, glomerular filtration rate by equation and clearance testing), quantification of urinalysis, baseline neurohormones. Follow-up data regarding clinical endpoints including new arrhythmia, functional deterioration, and hospitalisation.

Official Title
-----------------
Prospective Evaluation of Renal Function in Adults With Congenital Heart Disease.

Conditions
-----------------
Cardiovascular Abnormalities, Kidney Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The ability to give informed consent Age >18 years Congenital heart disease being treated as an outpatient Exclusion criteria: Pregnancy Renal failure requiring renal-replacement therapy Known diabetes Shellfish, iodine, or significant drug allergy (sub-study only).

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
-----------------
Proteinuria, Adult congenital heart disease, Heart failure, Renal failure
A Non Interventional Study With Irinotecan Onkovis (Irinotecan) Utilized for the Treatment of Cancer

Study Overview
=================
Brief Summary
-----------------
The main purpose of this observational study with Irinotecan onkovis is to determine the number of treatment cycles and the quantity of Irinotecan onkovis needed for this purpose under the special circumstances of ambulant chemotherapy. Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective. Secondary objective is the assessment of the side effects of Irinotecan onkovis. To this end, data regarding co-medication and adverse events are also collected.

Official Title
-----------------
Open, Multicenter Observational Study of Irinotecan Utilized in Mono- or Combination Therapy for the Treatment of Advanced Colorectal Carcinoma.

Conditions
-----------------
Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for Irinotecan according to the SmPC and treating physician Exclusion Criteria: according to the Irinotecan SmPC
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carcinoma, Irinotecan onkovis (Irinotecan)<br>Treatment in mono- or combination therapy with Irinotecan of advanced colorectal carcinoma. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Quantity of Irinotecan onkovis needed per treatment cycle | Determine the quantity of Irinotecan onkovis needed pro treatment cycle | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events during and after treatment | The number and kind of adverse events during and after the intra-venous application of Irinotecan will be assessed and documented. | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carcinoma, colorectal cancer, ambulant chemotherapy, treatment cycles, Irinotecan, Irinotecan onkovis, Quantity of Irinotecan, Packaging Sizes
COVID-19 and Rhino-orbital Mucormycosis

Study Overview
=================
Brief Summary
-----------------
Detect the clinical presentation and outcome of post covid-19 fungal mucormycosis in patients referred to Minia university Hospital.

Official Title
-----------------
Clinical Profile and Outcome of Post Covid-19 Rhino-orbital Fungal Mucormycosis in Minia Governorate

Conditions
-----------------
Mucormycosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had positive PCR test for Covid-19. Fungal rhino-orbital infection was confirmed. Exclusion Criteria: Suspected patient with COVID-19 not confirmed with PCR Incomplete data
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 |
| --- | --- | --- |
| Outcome of rhino-orbital mucormycosis in COVID-19 patients | Data of the patients who had post Covid-19 fungal mucormycosis in the last year will be revised to detect clinical presentation and final outcome | 9 months |
Reliability of the Melbourne Assessment

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the reliability of the Melbourne Assessment.

Detailed Description
-----------------
Children with central motor disorders will be tested twice within one week with the Melbourne Assessment. The assessments will be video scored. At a later time point, different raters will rate the same video for inter-rater reliability, the same rater will score the same video for intra-rater reliability, and the same rater will score the repeated assessment videos for test-retest reliability.

Official Title
-----------------
Reliability of the Melbourne Assessment

Conditions
-----------------
Cerebral Palsy, Stroke, Traumatic Brain Injury, Meningomyelocele, Central Nervous System Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: central motor disorders ambulant or stationary patients of the Rehabilitation Center Affoltern am Albis ability to understand test instructions ability to sit upright for 25 minutes minimal activity in the assessed upper limb Exclusion Criteria: severe visual and/or auditory problems acute lesion in the to assessed upper limb lack of compliance

Ages Eligible for Study
-----------------
Minimum Age: 30 Months
Maximum Age: 20 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 |
| --- | --- | --- |
| Melbourne Assessment 2 | Assessment to measure unilateral upper limb function | 2 assessments within 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Rehabilitation, Upper Limb, Assessments, Outcome Measures
Observational Study in Type 2 Diabetics Treated by an Intensive Insulin Treatment of Levemir®

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to gain practical experience with once daily Levemir® administration in type 2 diabetes patients who were previously treated with NPH insulins (e.g. Protaphane®) as basal insulin as part of their IIT under normal clinical practice conditions in Lithuania

Official Title
-----------------
Prospective, Multicentre, Open Label, Non-controlled, 24-week Observation in Type 2 Diabetics Using Once Daily Levemir® (Insulin Detemir) as Part of Their ITT Regimen

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic subjects on intensive insulin treatment (IIT) Eligibility for once daily insulin detemir administration Informed consent obtained before any observation-related activities Exclusion Criteria: Known or suspected allergy to insulin detemir Subjects previously enrolled in the observation Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months

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 |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.<br>* Other names: NN304;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline |  | at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | at 12 weeks/24weeks |
Computed Tomographic Angiography or Conventional Coronary Angiography in Clinical Decision Making

Study Overview
=================
Brief Summary
-----------------
Patients planned for elective conventional coronary angiography will undergo CT coronary angiography (Dual Source CT) in order to assess the correlation of stenosis detection and therapeutic advice between conventional and CT coronary angiography. We hypothesize that their is a good correlation between conventional and CT coronary angiography for stenosis detection and therapeutic advice.

Official Title
-----------------
Comparison Between Invasive Coronary Angiography and Dual-Source Computed Tomography

Conditions
-----------------
Coronary Artery Disease, Coronary Artery Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 50 years of age Scheduled for elective coronary angiography Exclusion Criteria: Patients with known iodine allergy Severe renal insufficiency (creatinine levels > 120 micromol/L) Hyperthyroidism Cardiac arrhythmias Unstable clinical condition Inability to follow breath-hold commands Previous PCI or CABG were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 50 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
-----------------
therapeutic advice
Vitiligo Skin Transplantation

Study Overview
=================
Brief Summary
-----------------
In vitiligo, the melanocytes are lost from the skin in certain areas. One treatment for vitiligo takes the melanocytes from areas of normal skin and places them on areas of that same person's body which have lost their color. This is called the melanocyte-keratinocyte transplantation procedure (MKTP). This procedure has been used successfully in over 3000 cases in India and Saudi Arabia. The purpose of this study is to see if it is effective when performed at the investigators' institution.

Official Title
-----------------
Safety and Efficacy of Melanocyte-keratinocyte Transplantation in the Treatment of Vitiligo

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Procedure: Melanocyte-keratinocyte transplantation procedure (MKTP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years old Have a diagnosis of vitiligo with no news lesions or growth of old lesions in the past 6 months Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form Agree to follow and undergo all study-related procedures Exclusion Criteria: Female patients who are breastfeeding, pregnant, or planning to become pregnant Patients with a history of developing vitiligo or keloids at sites of trauma Patients self-reported as having HIV or Hepatitis C Patients self-reported as having uncontrolled Diabetes Mellitus The investigator feels the patient should not participate in the study for any reason

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MKTP treatment<br>subject will undergo MKTP | Procedure: Melanocyte-keratinocyte transplantation procedure (MKTP)<br>* skin pigment cells are taken from areas of normal skin and placed on areas of that same person's body which have lost their color.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness of MKTP in treating vitiligo | Assessed by percent repigmentation (excellent= 100%-95%, good= 94%-65%, fair= 64%-25%, poor= 24%-0%). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of MKTP in treating vitiligo | Assessed by frequency of adverse events, including, scarring, infection, etc. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitiligo, skin transplantation, non-cultured, melanocyte, surgery
Early FDG PET/CT Imaging as a Measure of Response in Patients With Non-Hodgkin Lymphoma on Lenalidomide

Study Overview
=================
Brief Summary
-----------------
Adult patients with non-Hodgkin lymphoma who will be treated with lenalidomide will undergo FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG uptake will be correlated response and long term outcomes.

Official Title
-----------------
Early FDG PET/CT Imaging as a Measure of Response in Patients With Non-Hodgkin Lymphoma on Lenalidomide

Conditions
-----------------
Non-Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Diagnostic Test: 2-Deoxy-2-[18F]fluoro-D-glucose (FDG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, at least 18 years of age History of histologically confirmed NHL as assessed per medical record review. At least one site of measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT. Recommended to start lenalidomide. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria: Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit. Inability to tolerate imaging procedures in the opinion of the investigator or treating physician. Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 2-Deoxy-2-[18F]fluoro-D-glucose (FDG)|2-Deoxy-2-[18F]fluoro-D-glucose (FDG)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of FDGmax SUV % change in FDG SUVmax |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 2 years |
Neuroendocrine Brake for Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Evaluation to determine the safety of two laparoscopic procedures to control T2DM.

Official Title
-----------------
Phase IV Study of Neuroendocrine Brake Surgical Procedure for Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Procedure: ileal interposition with a sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Male and female between 18 and 65 years. BMI 25.1 - 34.9. Type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment. Diagnosis of T2DM for at least 3 years. Patient has been under routine care of hte study physician or another physician that can supply a reliable medical record for at least 3 years. HbA1c >/ 7.5 documented for at least 3 months. Stable weight (nor significant weight change (>3%) over the 3 months prior to enrollment. Stable medication for at least one month prior to enrollment except for diabetes medications which should be stable for at least 3 months prior to enrollment. Ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments. Exclusion Criteria: Prior abdominal surgery, except laparoscopic cholecystectomy. Taking appetite suppressant. Severe eating disorders. Severe pulmonary, renal or cardiac disease. Obese due to a clinically diagnosed endocrine disorder. Subjects with impaired liver function. History of peptic ulcer disease. History of malignant disease. Use of prescription, over the counter or herbal weight loss products. Pregnant or planning on pregnancy while enrolled in study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

| Intervention/Treatment |
| --- |
|Procedure: ileal interposition with a sleeve gastrectomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety and efficacy of the ileal interposition associated with a sleeve gastrectomy and the ileal interposition associated with a diverted sleeve gastrectomy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate neurohormonal effect in treating T2DM. |  |  | 
| Improvement or control of blood glucose levels. |  |  | 
| Improvement or control of comorbidities associated with T2DM. |  |  | 
| Hormonal effect and effect of the operations on diabetes related and total mortality. |  |  |
To Observe Ability of Fundamental Movement Skills in School Children of Age 5 to 10-year-old in Udupi District

Study Overview
=================
Brief Summary
-----------------
Fundamental movement skill is the precursor for physical activity in later life. Proficiency of Fundamental Movement Skills in Indian School Children is unknown. This observational trial shall tell us how proficient are our Udupi District Children.

Detailed Description
-----------------
After IRC and IEC approval and approval from district educational officers, proper assent and consent will be given to the principal of the respective school. 1-week prior to the study, parents will be explained about the study during parent meeting and even school leaving and opening times, a parent who visits the school to drop their children will be addressed. Children of age above 7 yr. will be explained the class about the study. Inform sheets will be distributed after conveying the information. Only the children who get an informed sheet signed will be included in the study.

Official Title
-----------------
Proficiency of Fundamental Movement Skills in 5 -10 Years Old School Children in Udupi District

Conditions
-----------------
Physical Activity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children in the age group 5 to 10 year old Exclusion Criteria: Cerebral palsy Attention deficit/hyperactivity disorder Autism

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 Years

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

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 |
| --- | --- | --- |
| Fundamental movement skill score | Satisfying the criterion of each skill such as run, jump, catch, throw | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FMS