linjc16/ctgov huggingface dataset:
Metabolic Syndrome and Female Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The role among metabolic syndrome and breast cancer risk is not well understood and must be further explored. The objective of this study is to evaluate the association between metabolic syndrome and breast cancer in Southern Brazil. In this case-control study, breast cancer patients and controls without malignant disease, matched for age (±5 years) and menopausal status, were interviewed and asked to make a glucose, HDL-cholesterol and triglycerides test. Waist circumference and blood pressure were measured using standardized procedures. Metabolic Syndrome was considered by NCEP ATP III (2001) and IDF (2006) definitions. Cases and controls were compared in relation to the presence of diagnosed MetS (yes/no), number of metabolic abnormalities identified (1 to 5) for each definition, and according to each metabolic abnormality cutoff point.

Official Title
-----------------
Metabolic Syndrome and Female Breast Cancer: a Case-control Study in Southern Brazil

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Observation about the presence of metabolic syndrome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For cases: having newly diagnosed breast cancer without adjuvant or neoadjuvant treatment; For controls: having no evidence of cancer; be matched for age and menopausal status with controls Exclusion Criteria: Women with a recidivated tumor, HIV infection, renal, heart or liver disease, hypothyroidism or hyperthyroidism, mobility or neurological limitations, chronicle use of corticosteroids, pacemakers or identified with severe edema were excluded.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>newly diagnosed (within 6 months) breast cancer patients, before adjuvant or neoadjuvant treatment. | Other: Observation about the presence of metabolic syndrome<br> <br> |
| Controls<br>patients without any malignant disease, matched for age an menopausal status with cases. | Other: Observation about the presence of metabolic syndrome<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Odds Ratio for Breast Cancer according to the presence of Metabolic Syndrome and its components |  | Participants will be evaluated only once before the first appointment with the oncologist (cases with a biopsy) and gynecologist (controls). The blood test results for Metabolic Syndrome parameters were collected in an expected average of 30 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic syndrome, case-control study, Breast cancer
Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to determine if Topical Oral Wound Emulsion (TOWE) assists with dental wound healing and relieves pain from oral wounds.

Official Title
-----------------
Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing

Conditions
-----------------
Oral Surgical Procedures, Pain

Intervention / Treatment
-----------------
* Device: OroScience Topical Oral Wound Emulsion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned dental treatment includes intraoral surgery involving full thickness mucoperiosteal flaps with at least one vertical releasing incision Exclusion Criteria: Complicated medical history History of poor patient compliance Presence or placement of materials beneath the suture site

Ages Eligible for Study
-----------------
Minimum Age: 21 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: 1<br>Conventional postoperative care and instructions on dental hygiene will be provided along with the TOWE treatment which consists of the patient dispensing TOWE into a disposable dental tray and placing the dental tray over the dental arch and covering the surgical site 3 times daily for a period of 7 days. At three (3) days and seven (7) days postoperatively, photographs will be taken of all vertical releasing incisions (before suture removal). | Device: OroScience Topical Oral Wound Emulsion<br>* TOWE will be applied 3 times daily for a period of 7 days by the patient dispensing TOWE into a disposable dental tray and placing the dental tray over the dental arch and covering the surgical site.<br>|
| No Intervention: 2<br>Conventional postoperative care and instructions on dental hygiene. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visible signs of inflammation scored on a scale of 1 to 4 by three (3) blinded investigators. |  | Three (3) and seven (7) days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral periodontal gingival intraoral mucosal mucoperiosteal, Surgery, Oral
Efficay of Extended Peginterferon Alpha 2a Treatment in HBeAg Negative Chronic Hepatitis B Patients

Study Overview
=================
Brief Summary
-----------------
The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV defined as sustained viral response after treatment, however, most patients can't get this target after 48 weeks of interferon treatment, and some patients need extended treatment in clinical practice to enhance the rate of sustained viral response or HBsAg loss occurred during treatment. In this cohort study, the efficacy of extended therapy of interferon in HBeAg negative chronic hepatitis B patients will be evaluated.

Detailed Description
-----------------
In this cohort study, the HBeAg negative chronic hepatitis B patients would be treated with peginterferon alpha 2a(PEG-IFN a-2a) for 96 week and followed 24 weeks after treatment. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during treatment and follow period. Parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies were evaluated by the rate of HBsAg loss during treatment and the rate of sustained viral response after treatment and follow up.

Official Title
-----------------
Efficay of Extended Peginterferon Alpha 2a(PEG-IFN a-2a) Treatment in HBeAg Negative Chronic Hepatitis B Patients

Conditions
-----------------
Chronic Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBeAg negative chronic hepatitis B patients Exclusion Criteria: Active consumption of alcohol and/or drugs Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus History of autoimmune hepatitis Psychiatric disease Evidence of neoplastic diseases of the liver

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| rate of sustained viral response | Sutained viral response was defined as serum HBV DNA undetectable at the end of treatment and the end of 24 weeks follow up. | 120 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of HBsAg loss | HBsAg loss was defined as HBsAg level lower than 0.05 IU/ml. | 96 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic hepatitis B, interferon, peginterferon, HBsAg loss
Pain Measurement and Pain Management in the Intensive Care Unit(ICU)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of a pain training program and systematic measurement of pain scores on actual pain levels and the use of analgesics in critically ill patients.

Detailed Description
-----------------
Systematic evaluation of pain, though still not common practice in all ICUs, is recommended in clinical practice guidelines for optimal pain management. Pain is a frequently experienced problem in patients in the Intensive Care Unit(ICU). In search of literature to support the need for introduction of a pain management system and to train the entire health staff in our department little information was found concerning the effects of pain training and pain management systems in the ICU. The small number of available studies may be explained by the difficulty of systematic pain measurement in ICU patients, mainly due to the inability to communicate effectively with these patients.

Official Title
-----------------
Pain Measurement and Pain Management in the ICU

Conditions
-----------------
Critically Ill Patients

Intervention / Treatment
-----------------
* Other: A Pain training program and pain measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to the ICU of the St. Antonius hospital, >18 years old. Exclusion Criteria: Patients who are suspected to be brain-dead

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 |
| --- | --- |
| pain training program<br>ICU Patients treated with or without pain management protocol | Other: A Pain training program and pain measurement<br>* Comparing patients treated with and without analgesia and sedation protocol<br>* Other names: pain management;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores using the numerical rating scale, rated by the attending nurse and by the patient if possible. |  | 3 times a day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of all pain medication (morphine, paracetamol) per patient |  | 24 hr | 
| Length of stay in the ICU |  | ICU stay | 
| Pneumonia |  | ICU stay | 
| 30 day Mortality |  | within 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain scores, critically ill patients, ICU, pain management, pain measurement
A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea

Study Overview
=================
Brief Summary
-----------------
Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.

Official Title
-----------------
An Open-label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea

Conditions
-----------------
Enterocolitis, Pseudomembranous, Diarrhea, Clostridium Difficile

Intervention / Treatment
-----------------
* Drug: GT267-004 (tolevamer potassium sodium)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The presence of CDAD at the time of enrollment Negative serum pregnancy test (HCG) for women of childbearing potential. Exclusion Criteria: Any contraindication to oral / enteral therapy including fulminant C. difficile disease. Any acutely life-threatening medical conditions. Acute or chronic diarrhea of other cause.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GT267-004 (tolevamer potassium sodium)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success |  |  | 
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The extent of tolevamer absorption |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clostridium difficile Disease, Infectious diarrhea, C. difficile, CDAD, Clostridium difficile-associated diarrhea, Clostridium difficile diarrhea, Antibiotic-Associated Colitis, Clostridium Enterocolitis, Antibiotic-Associated Diarrhea, Pseudomembranous Colitis, Clostridium difficile
PCO2 ELSO (Extracorporeal Life Support Organization)

Study Overview
=================
Brief Summary
-----------------
Investigation of the association between PaCO2 change after extra corporeal membrane oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by ECMO for respiratory failure.

Detailed Description
-----------------
Retrospective analysis of the ELSO database investigating the association between the change of PCO2 value after ECMO start and the risk of acute neurological event under ECMO defined by the onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death.

Official Title
-----------------
Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Other: ECMO for neonates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Support by ECMO for respiratory indication Exclusion Criteria : None

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ECMO for neonates|Neonates (<28 j) supported by ECMO for severe respiratory failure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Neurological Event | Onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death. The outcome (ANE) was defined by the occurrence of almost one of the following item: Ischemic or hemmorrhagic stroke diagnosed by ultrasounds, CT or MRI Clinical or electrical seizures : diagnosed by ElectroEncepahloGraphy (EEG) Brain death clinically diagnosed | Up to 90 days after ECMO initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | Newborns died after 28 days despite ECMO assistance | 28 days after ECMO start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ecmo, Neonates
Exercise and Breast Cancer Related Lymphedema: Influence of Muscle Group and Sequence on Volume Change in Swollen and Normal Arms

Study Overview
=================
Brief Summary
-----------------
Arm exercise influences arm volume and symptoms in breast cancer related lymphedema.

Conditions
-----------------
Breast Cancer, Lymphedema

Intervention / Treatment
-----------------
* Other: Exercise
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral arm lymphedema as a result of breast cancer treatment completion of breast cancer treatments arm lymphedema onset 3 months or more after surgery and persistent for at least 6 months in the maintenance phase of lymphedema treatment Exclusion Criteria: women with recurrent cancer intercurrent diseases affecting the swollen arm lack of understanding of the Hebrew language

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Muscle Group<br>Exercise | Other: Exercise<br> <br> |
| Active Comparator: Sequence<br>Exercise | Other: Exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved arm volume measurement |  | Weekly for five weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | Weekly for 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arm, Lymphedema, Breast Cancer, Exercise, Breast Cancer related Lymphedema
Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization

Study Overview
=================
Brief Summary
-----------------
Axillary block is the good anesthetic technique for upper limb surgery without exceeding a certain total dose injected of Local Anesthetic (AL). The maximal recommended dose of Lidocaine adrenaline in the upper limb is 500 mg. The use of ultrasound helps guiding the locoregional anesthesia, and allows to decrease the AL concentration, thus decreasing the risks. No previous study estimated a concentration of lidocaine lower than 1,5 % to realize upper limb surgery by axillary block. The literature overestimating probably the rate of failure of the locoregional anesthesia under ultrasound-guidance, we suggest to estimate the rate of failure of the axillary block ultrasound-guided with the lidocaine 1 % adrenaline for realizing upper limb surgery in standard practice.

Official Title
-----------------
Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization

Conditions
-----------------
Axillary Block

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients operated for the upper limb under block axillaire Adult non-opposition Exclusion Criteria: medical advice to realize axillary block medical advice to local anaesthetic Allergy Pregnant ASA 3 or more

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 |
| --- | --- | --- |
| Resort to an anesthesia for help in case of ineffectiveness of the block | Yes or no Yes or No | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block depth | Bromage score | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Axillary Block, LidocaÏne 1% adrenaliné
Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion.

Detailed Description
-----------------
The purpose of this protocol is to provide a mechanism to collect Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion. Data on long-term impact of Stannsoporfin on the physical, neurological, neurodevelopmental, biochemical, metabolic and hematopoietic profiles of the children will be collected at 9 and 18 months, 3, 6 and 9 years after Stannsoporfin administration

Official Title
-----------------
Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)(WS)(ISNHP)

Conditions
-----------------
Hyperbilirubinemia

Intervention / Treatment
-----------------
* Other: Previous exposure to stannsoporfin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 60 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 0.75 mg/kg Previous exposure to stannsoporfin<br>Previous exposure 0.75 mg/kg | Other: Previous exposure to stannsoporfin<br>* No intervention in this protocol<br>|
| 1.5 mg/kg Previous exposure to stannsoporfin<br>Previous exposure 1.5 mg/kg | Other: Previous exposure to stannsoporfin<br>* No intervention in this protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEUROLOGICAL EXAMINATION; Child Behavior Check List | Child Behavior Check List is a standardized measure in child psychology for evaluating maladaptive behavioral and emotional problems in preschool patients | 10 years |