linjc16/ctgov huggingface dataset:
A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify approximately 100 - 150 patients who have received Vectibix (Panitumumab) in offices and clinics located in Tennessee, North Carolina, South Carolina, and North Georgia from February 2004 - April 2009. Information regarding the incidence and severity of hypersensitivity infusion reactions to Vectibix (Panitumumab)will be captured. In patients who experienced hypersensitivity reactions, the following information will also be collected: premedication, treatment cycle symptoms that were experienced during chemotherapy, changes required in subsequent Vectibix (Panitumumab) or chemotherapy treatment, and outcome of the hypersensitivity reaction.

Official Title
-----------------
A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

Conditions
-----------------
Infusion Reaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria All patients treated with at least one treatment of Vectibix(Panitumumab) from February 2004 -April 2009 are eligible for the study. Patients may or may not have had an infusion reaction to Vectibix (Panitumumab). Major infusion reactions are defined as rapid onset airway obstruction(bronchospasm, stridor, hoarseness), urticaria, erythema, and/or hypotension, anaphylaxis. Minor infusion reactions are defined as transient flushing or rash, urticaria, dyspnea, drug fever. Patients who have received treatment with an EGFR in the past are eligible. Exclusion Criteria There will be no exclusions based on age, sex, medical history, or use of concomitant therapies. All charts will be abstracted for the same information, through completion of the last chemotherapy cycle.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vectibix<br>patients who received at least one treatment of Vectibix | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Vectibix-related infusion reactions w/high rate of Erbitux-related infusion reactions | To determine the rate of Vectibix (Panitumumab)-related infusion reactions (CTCAE v3.0 grade I-IV) in geographic areas of the United States associated with a high rate of Erbitux-related infusion reactions | February 2004 -April 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vectibix
Observational Study of Effectiveness and Tolerability of Gliclazide MR 60mg in Diabetic Patients Fasting During RAMADAN

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to assess effectiveness and tolerability of gliclazide MR 60mg during RAMADAN in a real world setting in 9 countries from Asia Pacific and Middle East/North Africa

Official Title
-----------------
Observational Study Program Assessing Effectiveness and Tolerability of Gliclazide MR 60mg in Patients With Type 2 Diabetes Fasting During RAMADAN

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained before any trial-related activities Male or female type 2 diabetic patients aged >18 years Patients with controlled or suboptimal controlled type 2 diabetes Patients with experience in SMBG controlling using glucometer Patients who are willing to fast during Ramadan Patients already treated with Gliclazide MR 60mg Exclusion Criteria: Insulin therapy requirement Severe liver or renal failure HbA1c ≥ 9% Contraindication to gliclazide according to SmPC Pregnancy or breast feeding Previous experience of severe or repeated hypoglycemia events without triggered factor within the previous year

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 |
| --- | --- | --- |
| Proportion of patients with at least one Hypoglycemia event |  | up to 5 months |
Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of Cetaphil® Restoraderm® skin restoring moisturizer in reducing the signs and symptoms of very dry atopic skin in young children. Subjects with atopic dermatitis (AD) in remission phase will be randomized to receive either Cetaphil® Restoraderm® skin restoring body wash only, or the same body wash in association with Cetaphil® Restoraderm® skin restoring moisturizer.

Official Title
-----------------
Effect of Cetaphil® Restoraderm® Moisturizer on Very Dry Skin in Children With a Controlled Atopic Dermatitis:a Randomised, Parallel Group Study

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Other: Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash
* Other: Cetaphil® Restoraderm® body wash


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subject, aged 2 to 12 years inclusive Controlled mild to moderate atopic dermatitis with a Investigator Global Assessment score at 0 or 1, within one week after successful treatment with topical corticosteroid. Exclusion Criteria: Subject presenting bacterial, viral, fungal or parasite skin infection Subject with ulcerated lesions, acne or rosacea Immunosuppression Subject with a wash-out period from baseline for topical treatment less than 8 days for Calcineurin inhibitor Subject with a wash-out period from baseline for topical treatment more than 8 days for corticosteroid Subject with a wash-out period from baseline for systemic treatment less than 8 days for anti-histamines, less than 4 weeks for immunomodulators

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moisturizer + Body wash<br>Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day) | Other: Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash<br> <br> |
| Active Comparator: Body wash<br>Cetaphil® Restoraderm® body wash (1/day) | Other: Cetaphil® Restoraderm® body wash<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to relapse |  | The duration between Baseline and the first AD relapse occurs (from randomization to last visit at 12 weeks) |
Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer: Randomized Phase II Study of S-1/RT vs. S-1/Oxaliplatin/RT

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric cancer

Official Title
-----------------
A Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer

Conditions
-----------------
Phase I: To Determine the Maximum Tolerated Dose (MTD), Phase II: To Assess the Pathologic CR Rate and Feasibility Following Neoadjuvant Chemoradiation Therapy With S1/Oxaliplatin

Intervention / Treatment
-----------------
* Drug: Oxaliplatin, S-1, radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma ③ Localized gastric cancer of clinical stage (T2N(+), T3/T4) ECOG performance status of 0 to 1 ⑤ Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min ⑥ Written informed consent form Exclusion Criteria: T1 (regardless of N stage), T2N0 M1 ③ Peritoneal seeding ④ Uncontrolled medical condition

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-1/oxaliplatin/RT<br>Radiotherapy + 4 dose levels of oxaliplatin/S-1 | Drug: Oxaliplatin, S-1, radiotherapy<br>* Radiotherapy 4000cGy/20 fractions S-1 ( )mg/m2 po bid daily during radiotherapy Oxaliplatin at four dose levels (___mg/m2 iv weekly x 4 weeks)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTD/pathologic CR |  | at the time of surgery |
The Depth of Right Bronchial Blocker Placement in Taiwanese in Video-assisted Thoracoscopic Surgery(VATS)

Study Overview
=================
Brief Summary
-----------------
A retrospective study to demonstrate the optimal depth of right side bronchial blocker for complete right lung separation. Data were collected from all patients who completed right side VATS with right side BB from Jan 2010 through Nov 2010.

Detailed Description
-----------------
After general anesthesia, an 8.0 mm internal-diameter single-lumen endotracheal tube was inserted orally. An independent Coopdech bronchial blocker, which has a formed-curvature near the catheter tip, was directly inserted through the single-lumen endotracheal tube into right main bronchus. Chest inspection, auscultation, fiberoptic bronchoscopy confirmation, if necessary, by visualizing the blocker cuff located at right main bronchus just below the carina was performed firstly. After placing patients in left decubitus position, the position of BB was reconfirmed by auscultation firstly; then complete collapse of the right upper lobe was adjust, if necessary and reconfirmed on the video of thoracoscopy by both surgeon and anesthesiologists. The depth of BB and the need of fiberoptic bronchoscope were recorded. All the patients were extubated in operation room after completion of operation with optimal analgesia. Data collected included; age, sex, body height and weight and the depth of right-sided BB from incisor was then recorded.

Official Title
-----------------
Right Side Bronchial Blocker in Video-assisted Thoracoscopic Surgery

Conditions
-----------------
Lung Tumor, Pneumothorax

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving right side VATS( video-assisted thoracoscopic surgery) with right side bronchial blocker Exclusion Criteria: Patients receiving thoracic surgery with double lumen tubes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 77 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
-----------------
bronchial blocker, VATS
Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.

Study Overview
=================
Brief Summary
-----------------
The study investigates the possibility that levetiracetam may improve the symptoms of chronic post-stroke aphasia.

Detailed Description
-----------------
In the study, 50 post-stroke subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design.

Official Title
-----------------
Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.

Conditions
-----------------
Aphasia, Stroke

Intervention / Treatment
-----------------
* Drug: Wait first, then levetiracetam
* Drug: Levetiracetam first, then wait


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stroke Aphasia Can give consent Exclusion Criteria: Renal failure Pregnancy Other neurological condition

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wait control<br>Levitiracetam is started after a delay, with dosage and administration as described below. | Drug: Levetiracetam first, then wait<br>* subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design<br>* Other names: Keppra;|
| Experimental: Treatment first<br>Levitiracetam is started immediately after baseline data is collected; dosage and administration as described below. | Drug: Wait first, then levetiracetam<br>* Levetiracetam 250 mg orally twice daily for 7 days. This will increase to 500 mg oral twice daily for 7 days the following week. If this dose is tolerated, it will then be increased to 750 mg orally twice daily for another 7 days and then increased to 1000 mg orally twice daily for 7 days.<br>* Other names: Keppra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech and language assessment |  | 6 months - 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory assessment |  | 6 months to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aphasia, Stroke
High Resolution Micro OCT Imaging

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.

Detailed Description
-----------------
Lung Disease is the predominate cause of morbidity and mortality in patients with cystic fibrosis (CF). A better understanding of the primary pathogenesis of CF is essential in order to reveal the features that may lead to the onset of progressive lung disease. Discerning the nature of the CF defect could resolve longstanding controversy and result in a new therapeutic opportunity that may address pathophysiology. Recently the investigators have developed an innovative technology, termed 1-µm resolution optical coherence tomography (µOCT), which enables real-time cross-sectional microscopy of the functional epithelial surface of living airways.

Official Title
-----------------
Imaging of Human Epithelial Airway Using a High Resolution Micro OCT Catheter (Functional Anatomic Imaging of CF Patients With Early Lung Disease Using Micro OCT)

Conditions
-----------------
COPD, Cystic Fibrosis, PCD - Primary Ciliary Dyskinesia, Covid19, Sinusitis

Participation Criteria
=================
Eligibility Criteria
-----------------
THE INCLUSION CRITERIA: Patients diagnosed with CF or healthy normal controls with no respiratory disease Patients must be over the age of 14 Patient must be able to give informed consent THE EXCLUSION CRITERIA: Patients with recent respiratory infection requiring antibiotics or corticosteroids in the last 4 weeks (excluding routine perioperative antibiotics) Patients with major sinus surgery that will alter the nasal anatomy and preclude imaging of the nares Any condition that in the opinion of the investigator will alter the safety of pilot testing in the operating room Female subjects who are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Notmal<br>No lung Disease | |
| Cystic Fibrosis<br>cystic fibrosis Lung Disease | |
| PCD<br>Primary Ciliary Dyskinesia | |
| COPD<br>Chronic Obstructive Lung Disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of uOCT probe | to determine if a uOCT probe can image airway epithelial cells from the lung and the nares of adult patients | 1 year |
Vaginal Infection Study 2

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of a vaginal product compared with that of another vaginal product in the treatment of vaginal infections.

Conditions
-----------------
Vaginal Infection

Intervention / Treatment
-----------------
* Drug: clindamycin phosphate/butoconazole nitrate
* Drug: butoconazole nitrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a clinical diagnosis of vaginal infection. Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control. Exclusion Criteria: Patients must not have any other infections May not be pregnant or nursing May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>clindamycin phosphate/butoconazole nitrate | Drug: clindamycin phosphate/butoconazole nitrate<br>* semi-solid, single dose<br>|
| Active Comparator: 2<br>butoconazole nitrate | Drug: butoconazole nitrate<br>* semi-solid, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptom resolution |  | baseline, 7 to 10 days and 21 to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yeast Culture for Candida | Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response | baseline, 7 to 10 days and 21 to 30 days | 
| Gram Stain Nugent Score | Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution | baseline, 7 to 10 days and 21 to 30 days | 
| Saline wet mount for clue cells | Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution | baseline, 7 to 10 days and 21 to 30 days |
Daily Vitamin K in Patients on Warfarin With Unstable INRs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if daily Vitamin K supplementation stabilizes INRs in patients taking warfarin with a history of frequent dose changes or variable INRs.

Detailed Description
-----------------
Consistent daily Vitamin K intake may contribute to the stabilization of INR values in patients with unstable INRs on warfarin therapy. Subjects with unstable INRs will be identified from the existing patient records of the UNC Anticoagulation Clinics. Eligible subjects will sign an informed consent form and will receive a point-of-care (POC) INR monitoring device. They will undergo 9 weeks of home INR monitoring via the POC device (with monthly clinic follow-up). They will subsequently be provided with 500 mcg Vitamin K tablets to be taken once daily. Weekly POC INR monitoring with monthly clinic follow-up will continue for an additional 8 weeks.

Official Title
-----------------
Use of Daily Vitamin K Supplementation in Patients on Warfarin With a History of Frequent Dose Changes or Variable INRs

Conditions
-----------------
Anticoagulants, Warfarin

Intervention / Treatment
-----------------
* Drug: Vitamin K


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient of UNC Anticoagulation Clinic with INR target of 2.0-3.0 and at least 9 months on uninterrupted warfarin Unstable INRs for the past 6 months, defined as a minimum number of warfarin dose changes of 3 Patient demonstration of proper POC device technique on 2 measurements during one teaching session with investigator Age greater than or equal to 18 years Exclusion Criteria: Stroke or TIA within the previous 12 months VTE within the last 3 months Antiphospholipid antibody syndrome Pregnant patients, since warfarin is contraindicated during pregnancy

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: Vitamin K|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of warfarin adjustments required in each phase |  |  | 
| Time in therapeutic, sub-, and supra-therapeutic range |  |  | 
| Variance/SD of INRs for each patient |  |  | 
| Adherence assessed by pill counts and pharmacy record review |  |  | 
| Thrombotic/bleeding episodes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unstable INRs, Warfarin, Vitamin K