linjc16/ctgov huggingface dataset:
Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults

Study Overview
=================
Brief Summary
-----------------
It is planned to compare the efficacy and safety of cefdinir and cefdinir/clavulanic acide treatments in acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumoniae (CAP) patients.

Official Title
-----------------
Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Treatment of Acute Exacerbation of Chronic Bronchitis (AECB) and Community-acquired Pneumonia (CAP) in Adults

Conditions
-----------------
Acute Exacerbation of Chronic Bronchitis, Community-Acquired Pneumoniae

Intervention / Treatment
-----------------
* Combination Product: Cefdinir/clavulanic acide 300/125 mg film-coated tablets
* Drug: Cefdinir 300Mg Capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosis of chronic bronchitis The diagnosis of community-acquired pneumoniae FEV1 value = 30-80% The diagnosis of mild-severe acute exacerbation of chronic bronchitis (AECB) Oxygen saturation < 90% Exclusion Criteria: Pregnancy or breastfeeding Allergy against to penicillin or cephalosporins Renal impairment Active hepatic disease Antibiotic use except study drugs Immunosuppressive therapy before 6 months of study initiation Use of probenecid like drugs

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets<br> | Drug: Cefdinir 300Mg Capsule<br>* Cefdinir is used as comparator<br>|
| Active Comparator: Cefdinir 300 mg Capsules<br> | Combination Product: Cefdinir/clavulanic acide 300/125 mg film-coated tablets<br>* Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone.<br>* Other names: Fullcef Plus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The comparison of clinical success rates according to laboratory parameters |  | 7-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The comparison of remission or relief of inflammation according to laboratory parameters |  | 7-10 days | 
| The comparison of patient satisfaction according to satisfaction questionnaire |  | 7-10 days | 
| The comparison of adverse events |  | 7-10 days |
Observation Study of the Clinical Management of Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The objective of the ambispective cohort study is to describe clinical management and clinical outcomes related to bipolar disorder in China, and establish the factors associated with different management patterns and clinical outcomes, provide psychiatrists with reliable and up-to-date information on the disease.

Official Title
-----------------
Chinese Observation Study of the Clinical Management of Bipolar Disorder

Conditions
-----------------
Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of subject informed consent. Diagnosis of Bipolar Disorder I or II (DSM-IV TR) in any phase of the disorder. Patients who had at least one mood event( depression, mania, hypomania or mixed) according to DSM-IV TR definition during the 3 and 12 months prior to the beginning of the study. Exclusion Criteria: Inability to complete Patient Reported Outcomes (PROs) questionnaires. Participation in an interventional clinical study in last 12 months.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients diagnosed with bipolar disorder I or II<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes (depression, mania, hypomania or mixed). |  | Up to 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatments received for Bipolar Disorder: medication time. |  | Up to 21 months | 
| Treatments received for Bipolar Disorder: medication classes. |  | Up to 21 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar disorder, Clinical management, Clinical outcomes
Long Term Follow up for the Detection of Delayed Adverse Events in Cal-1 Recipients

Study Overview
=================
Brief Summary
-----------------
Long term safety follow-up of Cal-1 recipients

Detailed Description
-----------------
Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced with LVsh5/C46 (Cal-1), a Dual Anti-HIV Gene Transfer Construct

Official Title
-----------------
Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct

Conditions
-----------------
HIV-1 Infection, Receipt of Cal-1 Modified Hematopoietic Cellular Products

Intervention / Treatment
-----------------
* Genetic: Blood tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Previous treatment with the Cal-1 modified hematopoietic cellular products Exclusion Criteria: Inability to understand and provide informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single<br>Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses | Genetic: Blood tests<br>* Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures |  | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the long term survival and activity of Cal-1 modified hematopoietic cells through evaluation of Cal-1 marking and expression in peripheral blood |  | 15 yars |
Feasibility of Multi-gene Panel Testing at the Time of Diagnosis for Patients With Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the feasibility of routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or fallopian tube cancer.

Official Title
-----------------
Feasibility of Multi-gene Panel Testing at the Time of Diagnosis for Patients With Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects must have a new diagnosis of epithelial ovarian, primary peritoneal, fallopian tube or extra- uterine mullerian cancer. All subjects must have either undergone primary surgery or be planning neoadjuvant chemotherapy for the treatment of ovarian, primary peritoneal or fallopian tube cancer. All subjects must be able to comprehend and communicate in English. All subjects must agree to participate. A previous diagnosis of cancer is not an exclusion criterion. Previous genetic screening is not an exclusion criterion. Exclusion Criteria: Patients who do not meet the above inclusion criteria. Patients with a diagnosis of a low malignant potential mullerian tumor. Patients who are not proficient in English language because the survey aspect of this study is comprised of 4 validated surveys that are only available in English language.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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 |
| --- | --- | --- |
| Feasibility of timely routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or Fallopian tube cancer. |  | 9 Months |
Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of the combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

Official Title
-----------------
Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not previously treated with oral antidiabetic agents as defined by the protocol Blood glucose criteria must be met Body mass index (BMI) in the range 22-45 Exclusion Criteria: Pregnancy or lactation Type 1 diabetes Evidence of serious diabetic complications Evidence of serious cardiovascular complications Laboratory value abnormalities as defined by the protocol Known sensitivity to pioglitazone Other protocol-defined exclusion criteria may apply

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose at 24 weeks |  |  | 
| Adverse event profile after 24 weeks of treatment |  |  | 
| Patients with endpoint HbA1c <7% after 24 weeks |  |  | 
| Patients with endpoint HbA1C <6.5% after 24 weeks |  |  | 
| Patients with reduction in HbA1c >/= to 0.7% after 24 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, vildagliptin
Nutritional Practices and Outcomes in Non-Invasive Ventilation

Study Overview
=================
Brief Summary
-----------------
The Nutritional Practices and Outcomes in Non-Invasive Ventilation (NPO/NIV) study is a collaboration with lead sites from pediatric critical care units within US and Canada, and participating sites from multiple international regions. The goal of NPO/NIV is to understand how non-invasive ventilation (NIV) is used to treat critically ill children and, concurrently, how these children are fed while on NIV. Designed as a period prevalence study, NPO/NIV will collect observational, cross-sectional data over the course of five study weeks. Each study week will require two days of screening for eligible patients. On Mondays, study staff will screen for patients eligible in the previous 48 hours. On Tuesdays, study staff will screen for patients eligible in the previous 24 hours. Patients meeting study inclusion will be eligible to complete V0, V1, and V2. Included patients will be followed for 7 days after the initiation of NIV or until the patient is discharged from the pediatric intensive care unit. This study was granted exempt status by the University of Arizona Human Subjects Protection Program, including a waiver of informed consent. As no personal health information is transmitted during the course of the study, the University of Arizona does not require Data Use Agreements between sites to participate.

Official Title
-----------------
Nutritional Practices and Outcomes in Non-Invasive Ventilation

Conditions
-----------------
Non Invasive Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted to the Pediatric ICU in whom noninvasive ventilation (NIV) was initiated within previous 48 hours (NIV use includes any High Flow Nasal Canula > 2 lpm flow , continuous positive airway pressure or bilevel pressure or neurally adjusted ventilatory assist) Exclusion Criteria: Patients with: chronic home NIV use for >12 hours per day limitations of care decisions made Cardiac surgery during this admission Acute gastro intestinal bleeds Abdominal surgery in previous 48 hours Gut graft versus host disease Chronic parenteral nutrition Short Gut Syndrome

Ages Eligible for Study
-----------------
Minimum Age: 3 Days
Maximum 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 |
| --- | --- | --- |
| hospital mortality |  | 90 days |
MK0524 Seasonal Allergic Rhinitis Study (0524-005)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of MK0524 on seasonal allergies.

Conditions
-----------------
Seasonal Allergies

Intervention / Treatment
-----------------
* Drug: MK0524


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person has had at least 2 years of seasonal allergies Person has had a positive skin test to at least 1 of the allergens of the season Person is a non-smoker Exclusion Criteria: Person has been hospitalized within the last 4 weeks Person is a female who has had a baby within the last 8 weeks or is still breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0524|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular coherence tomography (OCT).

Official Title
-----------------
Randomized Clinical Trial Comparing Prophylactic Nepafenac 0.1% and Ketorolac 0.5% Versus Placebo in Preventing Postoperative Macular Edema After Uncomplicated Phacoemulsification Cataract Extraction (PNK)

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Drug: Nepafenac 0.1%
* Drug: Ketorolac 0.5%
* Other: Placebo (sterile saline drops)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to give informed consent Age 18 years and older Exclusion Criteria: Any pre-existing retinal disease (e.g., diabetic retinopathy, vein occlusion, exudative macular degeneration, etc.) Previous uveitis Previous intraocular surgery Allergy or hypersensitivity to NSAIDs Complicated cataract 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nepafenac 0.1%<br> | Drug: Nepafenac 0.1%<br>* 1 drop QID for 1 month<br>|
| Active Comparator: Ketorolac 0.5%<br> | Drug: Ketorolac 0.5%<br>* 1 drop QID for 1 month<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo (sterile saline drops)<br>* 1 drop QID for 1 month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in macular volume (as quantified by OCT) at one month (compared to baseline) |  | baseline and one month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMTOL health-related quality-of-life |  | one month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-cataract surgery, macular edema
Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center

Study Overview
=================
Brief Summary
-----------------
Aim. - To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics. Methods. - An observational study on all ADR notifications recorded in the French pharmaco-vigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics

Detailed Description
-----------------
Pediatry aged under 18 years accounted for around 22% of the French general population. Data regarding drug safety from clinical trials are insufficient in this population. Aim. - To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics. Methods. - An observational study on all ADR notifications recorded in the French pharmaco-vigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics.

Official Title
-----------------
Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center

Conditions
-----------------
Child With Adverse Drug Reactions

Intervention / Treatment
-----------------
* Other: Adverse drug reaction


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria: Children from 0 to 17 years inclusive Who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne exclusion criteria: none

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 |
| --- | --- |
| Adverse drug reaction<br>Children from 0 to 17 years inclusive with ADR notifications recorded in the French pharmaco-vigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 | Other: Adverse drug reaction<br>* description of the adverse drug reactions (ADR) and the drugs involved in pediatrics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the different type of ADR |  | 30 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatry; Adverse drug reactions; Pharmacovigilance