linjc16/ctgov huggingface dataset:
Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with advanced ovarian cancer, focusing on infusion reactions and palmar-plantar erythrodysesthesia.

Detailed Description
-----------------
This observational program is aimed at gaining tolerability and safety data with the routine use of Caelyx in its labelled indication in ovarian cancer, focusing on infusion reaction and PPE. Data will be raised about the premedication routinely used for the prevention of side effects caused by Caelyx. Premedications for infusion reactions include corticosteroids, serotonin 3 (5HT3) antagonists, histamine 1 (H1) blockers, and histamine 2 (H2) blockers. Premedications for PPE include oral dexamethasone and vitamin B6. The management of infusion reactions and PPE will be recorded. A detailed record of the medical history may reveal patient groups at a higher risk of experiencing these side effects.

Official Title
-----------------
Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (PPE).

Conditions
-----------------
Ovarian Neoplasms

Intervention / Treatment
-----------------
* Drug: Caelyx (Pegylated Lyposomal Doxorubicin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with advanced ovarian cancer with: previous platin/taxane therapy and documented measureable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al. Exclusion Criteria: Patients that are not treated according to the Austrian Summary of Product Characteristics (SPC)
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Women with advanced ovarian cancer | Drug: Caelyx (Pegylated Lyposomal Doxorubicin)<br>* Pegylated Lyposomal Doxorubicin, 50 mg/m2 every 4 weeks for 6 cycles.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) | Definitions in assessment of adverse event severity: Mild: awareness of sign, symptom, or event, but easily tolerated. Moderate: discomfort enough to cause interference with usual activity and may warrant intervention. Severe: incapacitating with inability to do usual activities or significantly affects clinical status, and warrants intervention. | The observational program was conducted over a period of 2 years |
A Study of LY3200327 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the safety and tolerability of single doses of LY3200327 when given to healthy male and female participants either by injection under the skin or by drip into a vein. The study will help determine how the drug behaves inside the body and how long it takes to disappear from the body. The study will also look for anti-drug antibodies and how these may affect how LY3200327 acts in your body. The study is expected to last approximately 12 weeks (with screening evaluations up to 4 weeks prior).

Official Title
-----------------
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3200327 in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Placebo (SC)
* Drug: LY3200327 (SC)
* Drug: LY3200327 (IV)
* Drug: Placebo (IV)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At the time of initial screening, in general good health First-generation healthy Japanese (age 20 to 65 years) will be included Exclusion Criteria: Pregnancy or breastfeeding during the study Chronic infection Treatment with prohibited medications

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (SC)<br>Single subcutaneous (SC) dose of placebo | Drug: Placebo (SC)<br>* Administered SC<br>|
| Experimental: LY3200327 (SC)<br>Single escalating subcutaneous (SC) dose of LY3200327 | Drug: LY3200327 (SC)<br>* Administered SC<br>|
| Experimental: LY3200327 (IV)<br>Single intravenous (IV) dose of LY3200327 | Drug: LY3200327 (IV)<br>* Administered IV<br>|
| Placebo Comparator: Placebo (IV)<br>Single intravenous (IV) dose of placebo | Drug: Placebo (IV)<br>* Administered IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |  | Baseline to study completion (approximately 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3200327 |  | Pre-dose up to 84 days post dose | 
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3200327 |  | Pre-dose up to 84 days post dose |
The Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane Block to Reduce the Narcotic Dosage and Pain After Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound guide can reduce narcotic dosage, side effects and pain after cesarean delivery.

Official Title
-----------------
the Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane (TAP) Block Under the Guide of Ultrasound to Reduce the Narcotic Dosage, Side Effects and Pain in the First 24 Hours After Cesarean Delivery

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Sufentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female 18 to 40 Years class ASA 1 and 2 candidates for elective cesarean section Exclusion Criteria: renal failure liver failure cardiac disorder coagulopathy hepatomegaly splenomegaly drug sensitivity and abuse morbid obesity smoking history of post operative nausea and vomiting motion sickness local hypoesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sufentanyl group<br>IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block | Drug: Sufentanyl<br>* As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block. As comparator 1cc normal saline is added to bupivacain in control group for Tap block.<br>|
| Placebo Comparator: Control group<br>In control group we add 1cc salin to 20cc bupivacain in TAP block | Drug: Sufentanyl<br>* As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block. As comparator 1cc normal saline is added to bupivacain in control group for Tap block.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic Dosage |  | 24 h | 
| Narcotic Dosage | The total dosage of morphin consumed by the patients in sufentanil or control group. | over 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | 24h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean Delivery, TAP block, sufentanyl, Narcotic dosages
Accelerated Corneal Cross-linking With Different Riboflavin Solutions

Study Overview
=================
Brief Summary
-----------------
Following the Bunsen-Roscoe law, accelerated cross-linking protocols with higher irradiation intensities and shorter irradiation times have been introduced. In addition, new riboflavin solutions with HPMC (hydroxylpropyl methylcellulose) instead of dextran found its way into CXL-treatment. The aim of this trial is to evaluate clinical outcomes in an accelerated corneal collagen cross-linking protocol with different riboflavin solutions.

Official Title
-----------------
Effect-evaluation of an Accelerated Corneal Cross-linking Protocol With Different Riboflavin Solutions

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Drug: Riboflavin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Progressive Keratoconus Indication for treatment Preoperative Pachymetry > 400 Exclusion Criteria: Pregnancy Re-CXL Keratitis Other visual acuity limiting eye diseases than corneal ectatic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Riboflavin with 20% Dextran<br>Riboflavin drops with Dextran | Drug: Riboflavin<br>* Riboflavin with 20% Dextran or HPMC will be admininstered every 2 minutes for overall 30 minuts (Dextran) or 10 minutes (HPMC), respectively<br>|
| Active Comparator: Riboflavin with HPMC<br>Riboflavin drops with HPMC | Drug: Riboflavin<br>* Riboflavin with 20% Dextran or HPMC will be admininstered every 2 minutes for overall 30 minuts (Dextran) or 10 minutes (HPMC), respectively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kmax | Steepest Keratometry | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative central stromal depth of the Demarcation Line | The depth of the Demarcation Line after CXL will be measured one month postoperatively with an AS-OCT | 1 month | 
| LogMAR | Visual Acuity | 12 months |
Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen

Study Overview
=================
Brief Summary
-----------------
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg, administered once daily during two consecutive days, on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.

Official Title
-----------------
Double-blind, 3 Parallel Randomized Groups, Therapeutic Confirmatory. Clinical Trial to Compare the Efficacy of Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects in an EEC.

Conditions
-----------------
Rhinitis, Allergic, Seasonal

Intervention / Treatment
-----------------
* Drug: Levocetirizine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years Subjects who obtain a minimum sum score, considering SAR related symptoms (mean value), as defined by the protocol Exclusion Criteria: Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety Have used forbidden concomitant medications as defined by the protocol

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levocetirizine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare efficacy of Levocetirizine 5 mg to montelukast 10 mg as measured by the mean change from baseline of major symptoms related to SAR in ragweed sensitive subjects. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in other SAR symptoms at different time points; Safety . |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
Validation of a Computerized Triage Algorithm for Ophthalmic Emergencies

Study Overview
=================
Brief Summary
-----------------
The investigators conceived a computerized interactive tool for Emergency Triage, based on a patient's symptoms, medical history and background. Using this tool, the patient (alone or helped by a nurse / supporting person) presenting to an ophthalmologic ER, should be able to detect and prioritize his most urgent symptoms (A,B), in opposition to less urgent (C) or non urgent symptoms (D). To test the validity of this tool, each patient presenting at the Rothschild Foundation ER (Paris, France) with an ophthalmological problem should be included and sorted by the algorithm before the medical consultation. Neither the patient nor the practitioner are aware of the scoring (A,B,C,D) defined by the algorithm. The practitioner should then give his own emergency scoring (A,B,C,D) after patient examination. A total of 1000 patients is expected.

Official Title
-----------------
Interactive Care Assessment of Risk Factors and Emergency Levels

Conditions
-----------------
Emergencies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending the Emergency Room for Ophthalmologic concerns Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Comparison between the emergency level defined by iCare and the emergency level decided by the physician at the end of his consultation (gold standard). |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Triage, Algorithms, Emergencies, Eyes emergencies, Ophtalmology
Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults

Study Overview
=================
Brief Summary
-----------------
Intervention study in malnourished adults to assess whether a nutritional supplement given for 8 weeks in addition to the subject's usual diet improves body weight, body composition, biochemical and immune parameters.

Detailed Description
-----------------
Criteria to be included in this study include: BMI (Body Mass Index) under 19 Free of cancer, HIV/AIDS, bulimia/anorexia and any malabsorption disorders Description: We are studying whether adding nutritional shakes will help participants gain weight and improve their health and immunity. This study lasts about 8 weeks and has a total of 7 visits.

Official Title
-----------------
Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Quaker Complete Nutrition Supplements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI (Body Mass Index) under 19 Adult Exclusion Criteria: HIV/AIDS Cancer malabsorption disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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: Experimental<br>Malnourished adults who will be given a dietary supplement. | Dietary Supplement: Quaker Complete Nutrition Supplements<br>* 3-6 250ml cans of Quaker Complete Nutrition Supplements per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess weight-gain efficacy following 8 weeks of dietary supplementation among malnourished adults. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare biochemical and immune markers before and following 8 weeks of treatment with dietary supplements. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malnutrition, underweight, low body weight, BMI under 19, under nourished, malnourished
Studying Tumor Tissue Samples and Blood Samples to Learn More About DNA Changes in Patients With Lung Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at tumor tissue samples and blood samples to learn more about DNA changes in patients with lung cancer.

Detailed Description
-----------------
OBJECTIVES: Examine the mutational status of the EGFR pathway in tumor and blood samples from patients with lung cancer. Correlate the EGFR pathway mutations in these samples with clinical outcomes of these patients. OUTLINE: Archived tumor tissue and blood samples are analyzed via PCR to detect EGFR pathway mutations in DNA.

Official Title
-----------------
EGFR Pathway Mutations in Lung Cancer Patient Tumors and Blood

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed lung cancer PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: May have received prior EGFR inhibitors

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 |
| --- | --- |
| Patients with lung cancer<br>Collection of archival tumor specimen at the beginning of the study and collection of blood samples at the beginning of the study and then at regular intervals | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mutational status of the EGFR pathway |  | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer
Clinical Effectiveness of(VistaProof)in Comparison With ICDAS-II & Histological Validation for Detecting Occlusal Caries

Study Overview
=================
Brief Summary
-----------------
a diagnostic accuracy study control trial is to be held to evaluate the Clinical performance of quantitative light fluorescence based device (Vistacam Proof) in comparison with the visual examination and histological validation in detection of initial pits and fissures caries

Official Title
-----------------
Clinical Effectiveness of Quantitative Light Fluorescence Based Device (Vistacam Proof) in Comparison With ICDAS-II and Histological Validation in Detection of Initial Pits and Fissures Caries:: Diagnostic Accuracy Study

Conditions
-----------------
Light Fluorescence Device

Intervention / Treatment
-----------------
* Device: vistacam proof
* Other: ICDASII
* Procedure: fissurotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged from 15 to 50 years. Patient at least has one posterior pits and fissure occlusal caries. No gender restriction Co-operative patients who signed the informed consent. Good general health Acceptable oral health Exclusion Criteria: Pregnancy. Disabilities. Systemic disease or severe medical complications. Allergic history concerning methacrylate. Rampant caries.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vistacam<br> | Device: vistacam proof<br>* Light fluorescence device<br>|
| ICDAS II<br> | Other: ICDASII<br>* visual examination<br>|
| Fissurotomy<br> | Device: vistacam proof<br>* Light fluorescence device<br>Other: ICDASII<br>* visual examination<br>Procedure: fissurotomy<br>* histological validation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pits and fissure caries | occlusal pits and fissure caries in posterior teeth non-cavitated | through study completion, an average of 1 year |