linjc16/ctgov huggingface dataset:
The Correlation Between Adenoid Hypertrophy and Body Temperature in Children Before and After Adenoidectomy

Study Overview
=================
Brief Summary
-----------------
Examination of the correlation between adenoid hypertrophy and body temperature in candidate children for adenoidectomy after exercise

Detailed Description
-----------------
Examination of the correlation between adenoid hypertrophy and body temperature in candidate children for adenoidectomy after exercise. Adenoid hypertrophy and adenoiditis are accompanied by chronic rhinitis with or without otitis media. It is very common phenomena at ages 2-6 years and those children are symptomatic with snoring, rhinitis, nasal obstruction. In healthy children with nasal obstruction, body temperature can be elevated following exercise. As adenoiditis and chronic rhinitis are accompanied by inflammatory process, we would like to examine body temperature of children with adenoid hypertrophy before after exercise.

Official Title
-----------------
The Correlation Between Adenoid Hypertrophy and Body Temperature in Children Before and After Adenoidectomy

Conditions
-----------------
Otolaryngological Diseases

Intervention / Treatment
-----------------
* Other: Temperature measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children with adenoid hypertrophy with or without OSA, SOM Parental concent. No other diseases Exclusion Criteria: Syndromatic children Other diseases If getting antibiotics or other medications

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temperature measurements<br> | Other: Temperature measurements<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in temperature |  | one week before the surgery and one week after the surgery |
Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic Pain After Hysterectomy

Study Overview
=================
Brief Summary
-----------------
The study is prospective and double blind. In the clinic, patients undergoing hysterectomy that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups.

Detailed Description
-----------------
The study is prospective and double blind. In the clinic, patients undergoing hysterectomy that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups. In the first group of patients will receive Nitrous Oxide and In the second group of patients will receive oxygen during the general anesthesia.

Official Title
-----------------
Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic

Conditions
-----------------
Abdominal Hysterectomy (& Wertheim), Nitrous Oxide, General Anesthesia

Intervention / Treatment
-----------------
* Drug: Nitrous oxide
* Other: General anesthesia with oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 65 years old at time of the first procedure Female American Society of Anesthesiologists physical status I or II Hysterectomy undergoing the general anesthesia Exclusion Criteria: Neuropathic disease Chronic opioid users Contraindication for Nitrous Oxide receive Consent will not be obtained patient Psychiatric disorders Current or recent drug abuse (within past 6 months).

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: General anesthesia with oxygen<br>General anesthesia and Air | Other: General anesthesia with oxygen<br>* General anesthesia with(Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.<br>|
| Experimental: nitrous oxide and general anesthesia<br>General anesthesia with Nitrous Oxide | Drug: Nitrous oxide<br>* General anesthesia with Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitrous oxide and chronic pain | The of the effect of 50% N20/50% O2 on post hysterectomy in prevention of chronic pain. | 30 days post operative | 
| Nitrous oxide and opioid consumption | The effect of 50% N20/50% O2 on post hysterectomy in decrease of opioid consumption. | 4 hours post operative |
ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease

Detailed Description
-----------------
Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease

Official Title
-----------------
A Phase 2b/3, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: ALY688 Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry eye disease for > 3 months meeting specific sign and symptom criteria Best corrected visual acuity of +0.6 logMAR or better Willing to sign informed consent and attend study visits Willing to comply with contraception requirements Exclusion Criteria: Unable to meet specific sign and symptom criteria Signs of ophthalmic allergic, inflammatory or infection conditions Use of contact lenses Anatomic abnormalities preventing accurate study assessments Use of medications that influence eye dryness Recent ophthalmic surgery Unwilling to suspend current treatments for dry eye disease

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle Ophthalmic Solution<br> | Drug: ALY688 Ophthalmic Solution<br>* Ophthalmic Solution<br>|
| Experimental: ALY688 Ophthalmic Solution Concentration 1<br> | Drug: ALY688 Ophthalmic Solution<br>* Ophthalmic Solution<br>|
| Experimental: ALY688 Ophthalmic Solution Concentration 2<br> | Drug: ALY688 Ophthalmic Solution<br>* Ophthalmic Solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal fluorescein staining | Difference between ALY688 Ophthalmic Solution 0.4% and vehicle | 8 weeks |
Cohort Study to Identify Cancer Patients at High Risk of Venous Thromboembolism

Study Overview
=================
Brief Summary
-----------------
Cancer patients are at increased risk of deep venous thrombosis and pulmonary embolism, collectively termed venous thromboembolism (VTE). Risk assessment scores for VTE in cancer patients have been previously developed by the groups of Khorana and Vienna CATS. However, routine thromboprophylaxis for ambulatory cancer patients based on these scores is currently not recommended. In the investigators prospective, observational cohort study, the investigators aim to identify cancer patients at high risk for VTE based on clinical characteristics, coagulation biomarkers and the coagulant activity of tissue factor bearing microparticles.

Official Title
-----------------
Microparticle's Procoagulant Activity to Identify Patients With Cancer and a High Risk for Venous Thrombosis

Conditions
-----------------
Cancer, Deep Venous Thrombosis, Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage III or IV esophageal carcinoma, gastric carcinoma, intestinal carcinoma, pancreatic carcinoma, ovarian cancer, breast carcinoma, prostate cancer, urothelial cell carcinoma or lung carcinoma (small cell or non-small cell) who have started chemotherapy no more than 3 months ago Chemotherapy started no more than 3 months ago or within 7 days after enrollment Aged 18 years or older Written informed consent Exclusion Criteria: Use of anticoagulants (heparin, vitamin K antagonists or direct oral anticoagulants) Adjuvant chemotherapy (i.e. after surgery with curative intent)

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 |
| --- | --- |
| cancer patients<br>Patients with stage III or IV esophageal carcinoma, gastric carcinoma, intestinal carcinoma, pancreatic carcinoma, ovarian cancer, breast carcinoma, prostate cancer, urothelial cell carcinoma or lung carcinoma (small cell or non-small cell) who have started chemotherapy no more than 3 months ago | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| venous thromboembolism | Objectively confirmed asymptomatic or symptomatic deep venous thrombosis or pulmonary embolism | 6 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality |  | 6 months after enrollment |
Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

Study Overview
=================
Brief Summary
-----------------
This is a single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY 14-2222).

Official Title
-----------------
Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A to Compare the Bioavailability of 2 Different Strengths of Kogenate FS (BAY14-2222)

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
* Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males, age 18 to 65 years Subjects with Severe hemophilia A with a documented plasma FVIII level of <1% >/= 150 ED (exposure days) with FVIII concentrates(s) as supported by medical records Exclusion Criteria: Evidence of current or past inhibitor antibody History of any congenital or acquired coagulation disorders other than hemophilia A Platelet count <75,000/mm3 Abnormal renal function (serum creatinine >2 times the upper limit of the normal range) Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x the upper limit of normal or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)<br>* 50 IU/kg single dose using the 3000 IU vial size (600 IU/ml)<br>|
| Experimental: Arm 2<br> | Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)<br>* 50 IU/kg single dose using the 2000 IU vial size (400 IU/ml)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of BAY14-2222 |  | Up to 48 hours | 
| Area under the plasma concentration vs time curve from time 0 to time of last measurable concentration AUC(0-tlast) of BAY14-2222 |  | Up to 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BAY14-2222, Pharmacokinetics
An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

Study Overview
=================
Brief Summary
-----------------
This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection

Detailed Description
-----------------
Subjects will be stratified by weight to receive one of two doses of study drug

Official Title
-----------------
A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

Conditions
-----------------
Candida

Intervention / Treatment
-----------------
* Drug: Micafungin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent and HIPAA authorization of the infant's parent or legally authorized representative must be obtained prior to study entry Infant has sufficient venous access to permit study drug dosing Infant is suspected to have a systemic Candida infection and appropriate cultures (blood with or without urine/CSF) are obtained at the time of study entry Exclusion Criteria: Infant has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals Infant has received an echinocandin within one month prior to study entry Infant has a concomitant medical condition which, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk Infant has a life expectancy of less than 96 hours

Ages Eligible for Study
-----------------
Minimum Age: 48 Hours
Maximum Age: 120 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. micafungin lower dose<br> | Drug: Micafungin<br>* IV Administration<br>* Other names: FK463;|
| Experimental: 2. micafungin higher dose<br> | Drug: Micafungin<br>* IV Administration<br>* Other names: FK463;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of micafungin plasma pharmacokinetic parameters |  | Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitor adverse events |  | 11 or 12 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Micafungin, Candida, Neonates, Mycamine, FK463
Test Catheter Pilot Study in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.

Official Title
-----------------
Test Catheter Pilot Study in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Device: SpeediCath Compact Male
* Device: Speedicath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Male Signed informed consent Negative urine multistix Exclusion Criteria: Abnormalities, diseases or surgical procedures performed in the lower urinary tract

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2 | Device: SpeediCath Compact Male<br>* CH 12 hydrophilic coated intermitten compact catheter<br>Device: Speedicath<br>* CH 12 hydrophilic coated intermittent coated catheter<br>|
| Other: Group B<br>SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2 | Device: SpeediCath Compact Male<br>* CH 12 hydrophilic coated intermitten compact catheter<br>Device: Speedicath<br>* CH 12 hydrophilic coated intermittent coated catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort | Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort) | After each catheterisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handling |  | After each catheterisation | 
| Preference |  | At study termination | 
| Haematuria |  | After each catheterisation |
Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Japan. The aim of this registry study is to observe the use of single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.

Official Title
-----------------
Special Survey of Production of Antibody Against Coagulation

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

Intervention / Treatment
-----------------
* Drug: eptacog alfa (activated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated with eptacog alpha (NovoSeven®) Exclusion Criteria: Investigator decision to measure for antibody as unnecessary medical testing
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| eptacog alpha users<br> | Drug: eptacog alfa (activated)<br>* Prescription of eptacog alpha at the discretion of the physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody production against eptacog alpha |  | Up to 10 years |
The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)

Study Overview
=================
Brief Summary
-----------------
Anidulafungin is an antifungal agent of the echinocandin class which is highly active in vitro against fluconazole resistant Candida species. The efficacy of anidulafungin has demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as, in Phase 2 Esophageal Candidiasis studies. This study is intended to offer patients with FRMC an alternate therapy with amphotericin B or with other agents whose efficacy and/or safety are inadequate in the treatment of this disease.

Official Title
-----------------
A Phase 2 Open-Label Study of the Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis.

Conditions
-----------------
Candidiasis

Intervention / Treatment
-----------------
* Drug: Anidulafungin, VER002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of definite azole-refractory mucosal candidiasis (oral or oropharyngeal candidiasis or esophageal candidiasis), i.e., patients who have not responded to a prior 14-day course of fluconazole at a dose of at least 200 mg daily or other azole (e.g. voriconazole) Grade 1 or higher mucosal disease and microscopic or culture confirmation of yeast Exclusion Criteria: Pregnant female Hypersensitivity to anidulafungin or echinocandin therapy Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid Abnormal blood chemistries: Bilirubin >2 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase) > 4 times the upper limit of normal Less than four weeks since prior participation in an investigational drug or device study with the exception of antiretroviral agents or licensed agents Patients taking other systemic antifungal therapies while on this study

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Anidulafungin, VER002|nan|

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
-----------------
Azole-Refractory Mucosal Candidiasis, Mucosal Candidiasis