linjc16/ctgov huggingface dataset:
Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis

Study Overview
=================
Brief Summary
-----------------
Cefditoren pivoxil has been used in rhinosinusitis treatment. However, little is known about the efficacy of this drug at low and high doses.

Detailed Description
-----------------
The investigation was a randomized, investigator-blinded, and parallel study, conducted in patients (age 1-15 years) with acute rhinosinusitis. Two groups of patients were randomized received low (10 MKD) or high (20 MKD) of drug for 14 days. Changes in sinus symptoms scores, response rate and adverse effect were evaluated at days 7 and 14. Relapse rate was recorded at days 21 and 28. Recurrence of sinus symptoms at day 60 were assessed.

Official Title
-----------------
A Comparison of Cefditoren Pivoxil 10 mg/kg/Day and Cefditoren Pivoxil 20 mg/kg/Day in Treatment of Childhood With Acute Rhinosinusitis

Conditions
-----------------
Rhinosinusitis

Intervention / Treatment
-----------------
* Drug: cefditoren pivoxil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children age 1-15 years old diagnosed acute rhinosinusitis Exclusion Criteria: poor compliance other infections

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cefditoren pivoxil<br>cefditoren 10 mg/kg/day for 14 days | Drug: cefditoren pivoxil<br>* comparison of different dosages of cefditoren pivoxil<br>* Other names: Meiact;|
| Active Comparator: cefditoren pivoxil high dose<br>cefditoren 20 MKD were used to compare efficacy of treatment. | Drug: cefditoren pivoxil<br>* comparison of different dosages of cefditoren pivoxil<br>* Other names: Meiact;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sinus symptoms scores | Change of sinus sympotms scores from baseline in 2 weeks | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate | The relapse rate of sinus symptoms scores at day 28. | at day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rhinosinusitis, cefditoren pivoxil
Evaluation of Body Composition Improvement With Visceral Adiposity-Focused Anti-Obesity Telehealth Program

Study Overview
=================
Brief Summary
-----------------
A retrospective review of body composition changes in patients who participate in a 9-week non-invasive intensive health care provider supervised weight loss program as an overall cohort and in sub-cohorts of interest.

Official Title
-----------------
Evaluation of Body Composition Improvement With Visceral Adiposity-Focused Anti-Obesity Telehealth Program

Conditions
-----------------
Obesity, Cardiovascular Diseases, Metabolic Syndrome, Metabolic Disease

Intervention / Treatment
-----------------
* Other: 20Lighter Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 years of age and older, who enroll in the weight loss program are eligible for inclusion of the data review. Exclusion Criteria: Pregnancy or breastfeeding Current treatment of cancer Major organ transplant with immunosuppressant medication, Adult with a strict vegetarian diet, Certain psychiatric conditions (schizophrenia, bipolar disorder, manic depression) Adults with a BMI < 25.0 and no cardiovascular or metabolic comorbidities

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Program participants<br> | Other: 20Lighter Program<br>* Visceral Adiposity-Focused Anti-Obesity Telehealth Program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bodyweight Change | Change in bodyweight | Baseline to 90 days | 
| Body Mass Index (BMI) Change | Change in Body Mass Index (BMI) | Baseline to 90 days | 
| Visceral Adiposity Change | Change in Visceral Adiposity | Baseline to 90 days | 
| Body Fat % Change | Change in Body Fat % | Baseline to 90 days | 
| Lean Body Mass Change | Change in Lean Body Mass | Baseline to 90 days | 
| Intracellular Fluid % Change | Change in Intracellular Fluid % | Baseline to 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
visceral adiposity, BMI, body composition, obesity, cardiovascular disease, metabolic syndrome, metabolic disease
Comparative Evaluation of Stroke Triage Algorithms for Emergency Medical Dispatchers

Study Overview
=================
Brief Summary
-----------------
This study will compare the diagnostic accuracy of Card 28 stroke protocol to Card 28 and Cincinnati Stroke Scale, when used by emergency medical dispatchers to interrogate a 911 call suggestive of stroke. The authors hypothesize that a combination of Card 28 plus the Cincinnati Stroke Scale (CSS) will improve the diagnostic accuracy of emergency medical dispatchers for stroke.

Official Title
-----------------
Pilot Prospective Cohort to Determine the Comparative Diagnostic Accuracy of Card 28 to Card 28 and Cincinnati Stroke Scale.

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All 911 calls transferred by local Public Service Answering Points (PSAPs) to the County Communication center of Santa Clara County where the emergency medical dispatchers complete the interrogation using MPDS protocols. All 911 calls received directly at the County Communication center of Santa Clara County where emergency medical dispatchers complete the interrogation using the MPDS protocols. All 911 calls received from subjects (patient) aged > 18 years or second party calls (by-stander or family who are in close proximity to the patient and can administer the tool) by subjects > 18 years of age. Exclusion Criteria: All calls that require immediate response (ECHO level determinant for life threatening conditions) and emergency medical dispatchers cannot complete Card 28 Calls answered by emergency medical dispatchers who have not completed training on the use of Cincinnati Stroke Scale. Calls originating from the cities of Palo Alto, Mountain View, Sunnyvale, Santa Clara, and San Jose that are not interrogated by the County Communication Center for Santa Clara County. 911 calls with no available outcomes in the final discharge database. -

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebrovascular Accident, Stroke,Acute
Pringle Time Exceeding 120 Min in Liver Resection

Study Overview
=================
Brief Summary
-----------------
Intermittent Pringle's maneuver is widely used to limit blood loss during hepatectomy, without an established time-limit. However, many authors claims its danger for patients' outcome. The investigators check the short term outcome of a consecutive cohort of patients who underwent hepatectomy with intermittent clamping exceeding 120 minutes.

Official Title
-----------------
Safety of Intermittent Pringle Maneuver Cumulative Time Exceeding 120 Min in Liver Resection

Conditions
-----------------
Tolerance of the Liver

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in whom total cumulative clamping time exceeded 60 minutes. Exclusion Criteria: patients in whom total cumulative clamping time was less than 60 minutes

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 85 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 |
| --- | --- |
| Group 1<br>117 patients with cumulative clamping time between 60 and 120 minutes | |
| Group 2<br>72 patients with cumulative clamping time longer than 120 minutes | |

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
-----------------
Liver ischemia; Pringle time
Safety and Feasibility Study of XAF5 Gel for Reduction of Submental Fat

Study Overview
=================
Brief Summary
-----------------
This study will test the effects of XAF5 Gel (applied to skin each night for 6 weeks) on excess submental fat, also known as double chin. The study will also assess the safety and tolerability of XAF5 Gel.

Official Title
-----------------
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of XAF5 Gel for Reduction of Submental Fat

Conditions
-----------------
Excess Submental Fat (Double Chin)

Intervention / Treatment
-----------------
* Drug: XAF5 Gel
* Drug: Placebo Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (paraphrased): Adult men and women Must understand and provide informed consent Moderate submental fat (as determined by the clinician) No laxity (looseness) or minimal laxity of submental skin Healthy skin upon which a skin reaction would be visible Exclusion Criteria (paraphrased): A clinically significant health problem or recent illness A clinically significant abnormal result on physical exam or laboratory tests Neck or facial hair that would interfere with applying the study drug to submental skin Clinically significant skin disease Body Mass Index (BMI) >= 40 Plan to begin a diet or weight loss regimen during the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XAF5 Gel<br>The patient will apply XAF5 Gel to the skin of the submental area once a night. | Drug: XAF5 Gel<br> <br> |
| Placebo Comparator: Placebo Gel<br>The patient will apply a Placebo Gel to the skin of the submental area once a night. | Drug: Placebo Gel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events |  | From Day 1 to Day 57 |
General Anesthetic Mode and Postoperative Complications

Study Overview
=================
Brief Summary
-----------------
The relationship between anesthetic medication and postoperative major cardiac and cerebral complications will be studied using logistic regression model.

Detailed Description
-----------------
The study group try to find out if there is a connection between the use of different anesthetic methods with different narcotic drugs and postoperative major cardiac and cerebral complications.

Official Title
-----------------
Relationship Between General Anesthetic Mode and Postoperative Severe Cardiovascular and Cerebrovascular Complications: a Retrospective Cohort Study

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Combination Product: inhalation or propofol ,epidural or general anesthesia, remifentanil or sufentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-cardiac surgery, with age> = 18 years old, ASA grade I-IV, under general anesthesia Exclusion Criteria: non-general anesthesia, without the use of target-controlled infusion of remifentanil or sufentanil, absence of intraoperative or perioperative information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| non-MACE<br>patients without major postoperative cardiac or cerebral complications | Combination Product: inhalation or propofol ,epidural or general anesthesia, remifentanil or sufentanil<br>* Different combination of opioids and anesthetics<br>|
| MACE<br>patients with major postoperative cardiac or cerebral complications | Combination Product: inhalation or propofol ,epidural or general anesthesia, remifentanil or sufentanil<br>* Different combination of opioids and anesthetics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiac complication | major cardiac event | 90 days after surgery |
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Breeze.

Official Title
-----------------
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic acid (Dermacid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Integral skin test in the region; Exclusion Criteria: Lactation or gestational risk or gestation; Use of Anti-inflammatory or immunosuppression drugs 1 month before the study; Topical medication use at the region to be treated; Cutaneous disease or active gynecological disease which may interfere in study results; Personal history of allergic disease at the area to be treated; Allergic or atopic history; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Lactic acid (Dermacid)<br>* Liquid soup to be applied in the external genital area, in small quantity, with abundantly rinse after use, during 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and their intensity and their association with the treatment. |  | 21 days |
Construct Validity and Reliability SCUES

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to determine construct validity, discriminant validity and intra- and interrater reliability of the Selective Control of the Upper Extremity Scale (SCUES).

Detailed Description
-----------------
This study included children diagnosed with unilateral cerebral palsy. Children's upper extremity-selective motor controls were evaluated by video recording. Manual Ability Classification System and Taylor Hand Function Test were used to determine upper extremity functions

Official Title
-----------------
Construct Validity and Reliability of the Selective Control of the Upper Extremity Scale in Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy, Upper Extremity Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages between 3-18 years Diagnosed as Cerebral Palsy (Hemiplegia) Exclusion Criteria: Participants with an unstable situation regarding their tonus-regulating medications Participants had a botulinum toxin injection within the last 6 months, or any surgical correction within the last year

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selective Control of the Extremity Scale | SCUES administration required patients to perform specific isolated movement patterns at the shoulder (abduction/adduction), elbow (flexion/extension), forearm (supination/pronation), wrist (flexion/extension), and fingers/ thumb (grasp/release). Presence of mirror movements, movement of additional joints and motion less than available ROM are graded for movement at each joint level. Motion at each of the five joint levels is graded on a four-point scale: no SMC, moderately diminished SMC, mildly diminished SMC, and normal SMC. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jebsen Taylor Hand Function Test | The JTT measures movement, speed and manual dexterity. The subtests to assess hand function included turning over cards, simulated feeding, picking up small common objects, stacking checkers, picking up large objects, and picking up large heavy objects. Each task completion time was limited to 2 minutes. | 20 minutes |
Second-Line Irinotecan vs. ILF for AGC

Study Overview
=================
Brief Summary
-----------------
Patients with recurrent or metastatic gastric cancer can benefit from palliative chemotherapy. However, over half of patients with metastatic gastric cancer who received chemotherapy failed to achieve response and even in these responders, the duration of responses was as short as a few months. Patients with metastatic gastric cancer who fail to respond or have relapse after first line chemotherapy have a grim prognosis and a standard salvage treatment is not available. We designed this phase II trial to determine the efficacy and safety of irinotecan monotherapy or combination (ILF) as second-line therapy for advanced gastric cancer.

Official Title
-----------------
A Randomized Phase II Trial of Irinotecan Monotherapy Versus Irinotecan, Leucovorin and 5-FU (ILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer Failing Prior Chemotherapy

Conditions
-----------------
Stomach Neoplasm, Metastatic, Second-Line

Intervention / Treatment
-----------------
* Drug: irinotecan
* Drug: ILF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed gastric cancer inoperable, recurrent, or metastatic performance status 0 to 2 failed after one or more prior chemotherapy for advanced disease informed consent Exclusion Criteria: active infection severe co-morbidities previously treated with irinotecan or similar drugs

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks. | Drug: irinotecan<br>* Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.<br>|
| Active Comparator: 2<br>Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and infusional 5-fluorouracil, on day 1 every 2 weeks. | Drug: ILF<br>* Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and 5-fluorouracil, on day 1 every 2 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  |  |
Pediatric Sleep Questionnaire: Normalization and Validation Study

Study Overview
=================
Brief Summary
-----------------
The information gathered from normal pediatric patients seen at the Pediatric Neurology Clinic in the DCAM and LaRabida Children's Hospital will be used to standardize and validate the information gathered from pediatric patients with sleep disorders. This will serve as the information source for a pediatric sleep database.

Detailed Description
-----------------
A sleep questionnaire will be administered to patients who present to the Pediatric Neurology Clinic and LaRabida Children's Hospital. The questions asked are those routinely obtained in the clinical practice of sleep medicine. Medical students, residents and faculty as part of their normal clinical responsibilities will administer the questionnaire. The database will be maintained in Filemaker Pro program for future research purposes. Collection of the data will require approximately 15 minutes. A database file number not related to the patient medical record number will be assigned to each patient. The investigator will keep a separate log linking patient database number and patient medical record number. The logbook will be kept under lock and key by the investigator.

Official Title
-----------------
Pediatric Sleep Questionnaire: Normalization and Validation Study

Conditions
-----------------
Sleep Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients seen in the Pediatric Neurology Clinic and at LaRabida Children's Hospital Exclusion Criteria: Adults

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Sleep Questionnaire | This questionnaire is used to better understand the natural history of sleeping disorders in children. | When data from clinic patients becomes available | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Disorders