linjc16/ctgov huggingface dataset:
A Study to Determine the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Caelyx (Study P05020)

Study Overview
=================
Brief Summary
-----------------
The objective of this trial is to study the management of PPE in participants with metastatic ovarian or breast cancer treated with Caelyx, and determine the frequency of use of pharmacological treatment (preventive or therapeutic) for PPE and compliance of educational recommendations for PPE.

Official Title
-----------------
Epidemiological Study to Assess the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Pegylated Liposomal Doxorubicin

Conditions
-----------------
Ovarian Neoplasms, Breast Neoplasms, Paresthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18 years of age or older. Participants with metastatic breast or ovarian cancer who are receiving treatment with pegylated liposomal doxorubicin. Participants who have given their written consent. Exclusion Criteria: Participants who are currently participating in a clinical trial.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Caelyx<br>Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment and according to data sheet approved indications. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE. Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it. | Participants will do a single visit, but cases will be collected during a period of 12 months. | 
| Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE | The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE. | Participants will do a single visit, but cases will be collected during a period of 12 months. |
Improvement of Physical Activity and Correction of Body Mass Index in School Children

Study Overview
=================
Brief Summary
-----------------
There is an increasing incidence of overweight children in Germany, due to a lack of physical activity. The aim of this study is to improve physical fitness and activity in school children. Two classes in different schools are provided with additional sport lessons over a period of one year.

Detailed Description
-----------------
The increasing incidence of overweight children in Germany is due to a lack of physical activity and intake of unhealthy food. The importance of physical activity for the prevention of cardiovascular diseases in adults was shown in several trials. Therefore we provide additional sport lessons over the period of one year in two defined schools in Leipzig with the aim to improve physical fitness in school children. Two other classes with the -in germany- usual quantity of sport classes served as control classes. In all classes at the beginning and at the end of the school year blood samples were taken, and a clinical investigation, a coordination test for children and a spiroergometer were performed. Additionally each child had to fill out a questionnaire. Endurance training is emphasized in the sport lessons.

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Behavioral: physical exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: School class Exclusion Criteria: Condition precluding exercise

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: physical exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of maximal oxygen uptake |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical fitness
PEG by Introducer Method Via EG Scan

Study Overview
=================
Brief Summary
-----------------
Percutaneous endoscopic gastrostomy(PEG) by introducer method has been proven to be safe and easy to perform. However, it is limited by its need to be performed in an endoscopy unit. E.G. ScanTM is an new portable ultrathin endoscope, capable of being performed in any hospital setting and introduced via nasal approach. Our aim is to prove that PEG by introducer method via E.G. ScanTM is feasible and safe. This will allow PEG to be done at hospitals and medical facilities without endoscopic units.

Official Title
-----------------
Percutaneous Endoscopic Gastrostomy by Introducer Method Via Visualization Through E.G. ScanTM

Conditions
-----------------
Dysphagia, Aspiration, Esophageal Stenosis

Intervention / Treatment
-----------------
* Procedure: Percutaneous Endoscopic Gastrostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Require percutaneous endoscopic gastrostomy placement due to inability to achieve oral feeding for at least one month Exclusion Criteria: Patients with esophageal ulcers or strictures Patients with prior esophageal/gastric surgery (excepting gastric wedge resection) Patients at high risk of gastric bleeding, mechanical ileus or gastrointestinal perforation Other patients in whom the study investigators consider unfit for inclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG insertion arm via EG Scan<br>Percutaneous endoscopic insertion of gastrostomy via visualization through E.G. ScanTM | Procedure: Percutaneous Endoscopic Gastrostomy<br>* Percutaneous Endoscopic Gastrostomy by introducer method via visualization through E.G. ScanTM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of PEG via introducer method by visualization through EG ScanTM | up to 1 year from PEG insertion or until patient death if within one year | up to 1 year from PEG insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Complication rate including bleeding, infection, gastric perforation and leakage of intragastric contents | up to one year from PEG insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
percutaneous endoscopic gastrostomy, Introducer method
Cancer in Infants: South Egypt Cancer Institute Experience

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the spectrum of various types of malignant neoplasms of infancy, according to the experience of South Egypt Cancer Institute, which represents the largest referral site in Upper Egypt.

Detailed Description
-----------------
Background: Cancer in the first year of life is relatively rare ; however, the age of peak cancer incidence among children occurs during the first year of life, representing 10% of all cancer that was diagnosed among children younger than 15 years of age. Female and male infants have essentially the same overall cancer incidence rates. Cancer occurring in infants often has a clinical and biological behavior that is different from cancers occurring in older children. The histologic distribution of cancers in infants and that in older children are also different. Patients & Methods: From January 2001 to December 2015, retrieval & analysis of the medical records of infant patients, diagnosed with any of malignant tumors, at the pediatric oncology department at South Egypt Cancer Institute will be done. Pathologic diagnoses & age of the patients will be verified for the enrollment in the study. The collected data will be analyzed to delineate the spectrum of these disease entities, their clinico-pathologic features, associated patients' demographics and characteristics, treatment modalities received, and outcomes of these treatments.

Official Title
-----------------
Cancer in Infants: South Egypt Cancer Institute Experience

Conditions
-----------------
Infantile Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whose age less than or equal to 1 year. Patients diagnosed with any of malignant neoplasms. Exclusion Criteria: • Patients whose age more than 1 year.

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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 |
| --- | --- | --- |
| Overall survival (OS) | Time from the date of initiation of treatment until death from any cause | Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years | 
| Event Free Survival (EFS) | Time from the date of initiation of treatment until disease progression, or death for any reason | Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childhood Cancer, Pediatric Oncology, Infant tumors
Risk Identification of the GlucoTab System in Routine Use

Study Overview
=================
Brief Summary
-----------------
Identification of risks of the GlucoTab system in routine use.

Detailed Description
-----------------
A study to identify risks in routine use of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.

Official Title
-----------------
A Study to Identify Risks in Routine Use of the GlucoTab System for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at General Wards

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent obtained after being advised of the nature of the study type 2 diabetes or new-onset hyperglycaemia which require s.c. insulin therapy during hospital stay diabetes therapy supported by GlucoTab system Exclusion Criteria: type 1 diabetes mellitus intravenous insulin therapy hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy gestational diabetes or pregnancy known or suspected allergy to certain insulin types, named in the user manual total parenteral nutrition (TPN) any mental condition rendering the patient incapable of giving his 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 |
| --- | --- | --- |
| Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week | efficacy: mean daily blood glucose during hospital stay, an expected average of 1 week | participants will be followed for the duration of hospital stay, an expected average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Blood Glucose During Hospital Stay | Efficacy: mean pre-breakfast blood glucose during hospital stay | participants will be followed for the duration of hospital stay, an expected average of 1 week | 
| Usability: Coverage of the GlucoTab | Usability: coverage of the GlucoTab treatment during hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
Paracetamol Metabolism in Post Operative Conditions

Study Overview
=================
Brief Summary
-----------------
Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)

Detailed Description
-----------------
D-15 to D0: selection patient information and non-opposition obtained inclusion and non inclusion criteria check clinical exam D-1 to D0 : 24 hours diuresis D0 : operation day Before anesthesia : urine collection (paracetamol metabolites dosage) blood sampling (glutathion and liver function test) Surgery: 1st paracetamol intake before closing Then administration every 6 hours D1 to D4 : 24 hours urine collection (metabolites dosage) blood sampling et D1 and D4(glutathion and liver function test) D5 : final clinical exam

Official Title
-----------------
Paracetamol Metabolism in Post Operative Conditions

Conditions
-----------------
Aortic Surgery and Treatment Post Operative With Paracetamol During 4 Days

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aortic surgery treatment with intraveinous paracetamol (4 grammes daily during 4 days) patient agrees to participate Exclusion Criteria: - patient disagrees paracetamol contra-indication paracetamol intake 5 days before surgery

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 |
| --- | --- | --- |
| Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day) |  | during 4 days therapeutic intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Follow-up of glutathion concentration during 4 post operative days |  | during 4 post operative days | 
| Monitoring of liver function |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post operative conditions, paracetamol metabolites
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Detailed Description
-----------------
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Official Title
-----------------
Comparison of Safety & Efficacy of a Unique Intravenous Iron (VIT45) Preparation vs Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Ferrous Sulfate tablets
* Drug: Ferric Carboxymaltose (FCM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females > or = 12 years of age NDD-CKD subjects Baseline hemoglobin < or = 11g/dl Stable erythropoietin (EPO) status Exclusion Criteria: Known hypersensitivity to ferrous sulfate or IV iron Unstable EPO status Anemia not related to CKD Chronic, serious infection Recent IV iron Recent blood transfusion Recent blood loss Need for surgery Received investigational drug within 30 days Female subjects who are pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 12 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferric Carboxymaltose (FCM)<br>A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values. | Drug: Ferric Carboxymaltose (FCM)<br>* A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.<br>|
| Active Comparator: Ferrous Sulfate tablets<br>325 mg/TID x 8 weeks | Drug: Ferrous Sulfate tablets<br>* 325 mg/TID x 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL |  | anytime during the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, Chronic Kidney Disease, Iron
Compassionate Use of Stanate (TM) [Stannsoporfin]

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] available to infants who meet the following criteria: the infant has a very high level of bilirubin without an adequate clinical response to phototherapy; the infant requires an exchange transfusion; and the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.

Official Title
-----------------
Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions

Conditions
-----------------
Neonatal Jaundice, Hyperbilirubinemia

Intervention / Treatment
-----------------
* Drug: Stanate (TM) [stannsoporfin, tin-mesoporphyrin]


Participation Criteria
=================
Eligibility Criteria
-----------------
Term or near term neonate Elevated serum bilirubin Failing phototherapy Requires exchange transfusion Family refuses exchange transfusion on religious grounds

Ages Eligible for Study
-----------------
Minimum Age: 12 Hours
Maximum Age: 1 Week

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Stanate (TM) [stannsoporfin, tin-mesoporphyrin]|Treatment with 4.5 mg/kg|

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
-----------------
hyperbilirubinemia, jaundice, tin-mesoporphyrin, stannsoporfin, exchange transfusion, neonatal hyperbilirubinemia
American Migraine Prevention Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of nutritional supplementation and dietary management for the reduction in frequency, duration, and intensity of migraine headache pain.

Detailed Description
-----------------
AMPS, the American Migraine Prevention Study Program is a home based nutritional study for migraine prevention. It is designed to evaluate a nutritional supplement along with proper diet, and trigger management that may prevent migraines or reduce the frequency, duration and intensity of migraine headache pain. The AMPS Program is availalbe nationwide. It is a home based study program. During the three month study period, participants will be asked to take a daily nutritional supplement and follow a recommended diet to avoid potential migraine triggers. Participants will be asked to maintain a headache log and submit headache questionnaires at the beginning and end of the study. Participants do not have to travel and can participate from their current location.

Official Title
-----------------
Nutritional Based Protocol to Balance Serotonin for the Prevention or Reduced Frequency/Duration/Intensity of Migraines

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Behavioral: Serotona Plus and dietary behavior management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of migraines Ages 18-72 Migraines more than once per month Diagnosed migraines for more than one year Exclusion Criteria: Pregnant/nursing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 72 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Serotona Plus and dietary behavior management|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine Impact and Disability Survey (MIDAS) - symptoms measured at study beginning and at 90 days |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutritional, C10.228.140.546.399.750