linjc16/ctgov huggingface dataset:
Assessing the Effects of Air-cooling on Capillary Malformations

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to ascertain the effects of cutaneous air cooling on vessel diameter within Capillary Malformations (CM).

Detailed Description
-----------------
Capillary malformation (CM) is the most common vascular malformation occurring in approximately 0.3% of all newborn. The standard treatment for facial or aesthetically sensitive CM's is flashlamp Pulsed Dye Laser. Skin cooling prior to laser treatment of CMs is standard practice within our department. The effects of skin cooling on the vasculature within CMs are poorly understood. Previous studies by our department have shown that raising ambient temperature increases CM vessel size. It has been postulated that by increasing CM vessel size, it may also increase the effectiveness of treatment. We hypothesize that cooling the skin during laser treatment may cause vasconstriction of the superficial vessels within the CM. This may have an impact on treatment success.

Official Title
-----------------
An Observational Study as to the Effects of Cutaneous Air-cooling on Blood Vessel Diameter in Capillary Malformations

Conditions
-----------------
Capillary Malformation, Laser, Skin Cooling

Intervention / Treatment
-----------------
* Device: Air cooling to CM site


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult more than 16 years of age Patient diagnosed with Capillary Malformation Exclusion Criteria: Patients less than 16 years of age

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Capillary malformation<br> | Device: Air cooling to CM site<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation | In a temperature controlled room, the participant's capillary diameter/depth and skin/core temperatures will be taken from their CM prior to cooling the skin. The patients' CM will be cooled for a duration of 1 minute. The above measurements will be repeated immediately after 1 minute of cooling. | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin disease, Capillary Malformation, Laser therapy
Intrathecal Morphine in Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain relief and side effect profiles of same in the setting of Total Knee Replacement.We hypothesized that a dose greater than that used in Total Hip Replacement was needed and wished to find a dose which was effective but had a low side effect profile.

Official Title
-----------------
Determination of the Efficacy and Side-Effect Profile of Lower Doses of Intrathecal Morphine in Patients Undergoing Total Knee Arthroplasty

Conditions
-----------------
Pain, Postoperative, Arthroplasty, Replacement, Knee

Intervention / Treatment
-----------------
* Drug: intra thecal morphine
* Drug: intra thecal morphine
* Drug: intra thecal morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients for elective total knee arthroplasty Exclusion Criteria: No contraindication to spinal No allergy to morphine, rescue analgesia or anti-emesis treatment.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients in this group got 100mcg of intrathecal morphine. | Drug: intra thecal morphine<br>* 100 mcg intrathecal morphine given once .<br>* Other names: intraspinal morphine;|
| Experimental: 2<br>patients in this group got 200 mcg intrathecal morphine | Drug: intra thecal morphine<br>* 200 mcg intrathecal morphine given once<br>* Other names: intra spinal morphine;|
| Experimental: 3<br>patients in this group given 300 mcg intrathecal morphine. | Drug: intra thecal morphine<br>* 300 mcg intrathecal morphine given once<br>* Other names: intra spinal morphine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea and vomiting |  | 24 hours | 
| pruritus |  | 24 hours | 
| sedation |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Postoperative, Arthroplasty, Replacement, Knee, Morphine, Injections, Intrathecal
Epidemiological Study on Malignancy Complicated With Renal Injury

Study Overview
=================
Brief Summary
-----------------
The epidemiological study of tumor complicated with kidney disease can clarify the prevalence and risk factors of renal injury when malignant tumor is diagnosed, and understand the impact of malignant tumor complicated with renal injury on survival time. This study will bring enlightenment to clinicians, discover high-risk factors in time, and try to avoid renal damage factors in diagnosis and treatment. Early diagnosis and early treatment can partially terminate the progress of renal injury, avoid the suspension of treatment due to renal reasons, and avoid the occurrence of end-stage renal failure (ESRD).

Detailed Description
-----------------
To determine the prevalence of malignant tumor complicated with renal injury and analyze the related risk factors. To compare the survival time of malignant tumor with or without renal injury

Official Title
-----------------
Epidemiological Study on Malignancy Complicated With Renal Injury

Conditions
-----------------
Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignancy confirmed by pathology. Between 18-80 years old, regardless of gender; Patients initially diagnosed with malignant tumors in our hospital from July 2017 to June 2021; Waiver of informed consent. Exclusion Criteria: Patients with benign tumor diagnosed by pathology; The patient refused to participate; Patients judged by other researchers as unsuitable for inclusion in the study.

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 |
| --- | --- |
| Normal renal function group<br>Observe survival time | |
| Renal dysfunction group<br>Observe survival time | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | survival time | 3 years |
Incidence of Acute Lung Injury in Children

Study Overview
=================
Brief Summary
-----------------
Acute lung injury in children is a syndrome of rapid onset of acute respiratory failure and require admission into intensive care units (ICU) for advanced life support. There are almost no information on epidemiology of acute lung injury. Published studies do not have information for an entire year and none of them have evaluated the degree of oxygenation failure under standard ventilator settings. The investigators will perform a 1-year prospective audit of all patients admitted with acute lung injury in a network of pediatric ICUs in Spain.

Detailed Description
-----------------
We will evaluate oxygenation under standard ventilator settings (FiO2 0.5 and 1 on PEEP 5 or 10 cmH2O) in pediatric acute respiratory distress syndrome. Outcome measures will include: overall ICU mortality, number of patients meeting ARDS criteria at 24 hours, and stratification of patients depending on PaO2/FiO2 ratio at 24 h of meeting acute respiratory distress syndrome criteria.

Official Title
-----------------
Acute Lung Injury in Children: Epidemiology and Natural History: The Pediatric ALIEN Study

Conditions
-----------------
Acute Lung Injury, Children

Intervention / Treatment
-----------------
* Other: Evaluation oxygenation under standard ventilator settings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute onset of respiratory failure Age 1 month to 18 years old Bilateral pulmonary infiltrates on Chest X-ray Absence of left ventricular failure, PaO2/FiO2>300 mmHg Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- |
| Pediatric ALIEN<br>All children from 1 month to 18 years old meeting the American-European Consensus Conference definition of acute lung injury | Other: Evaluation oxygenation under standard ventilator settings<br>* Measure of PaO2 under standard FiO2-PEEP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases of acute lung injury per 100,000 population |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury |  | 1-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute lung injury, incidence, lung damage, PaO2/FiO2 ratio
Mastectomy in Ambulatory Breast Surgery

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational study, involving 550 mastectomies in Lorraine Institute of Oncology, to assess care patients management of ambulatory surgical compared to standard surgery procedure.

Official Title
-----------------
Mastectomy in Ambulatory Breast Surgery

Conditions
-----------------
Mastectomy

Intervention / Treatment
-----------------
* Other: Medical questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient managed for breast cancer surgery age >18 years old understand and comply with the requirements of the study patient must be affiliated to a social security system Exclusion Criteria: patient managed for a concomitant reconstructive surgery bilateral breast surgery patient already included in another clinical trial with an experimental molecule men patient deprived of liberty or under supervision neoadjuvant therapy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ambulatory surgery description<br> | Other: Medical questionnaire<br>* quality of life questionnaire (EORTC QLQ-C30 and QLQ-BR23) Hospital Anxiety and Depression scale satisfaction care questionnaire (IN-PATSAT32)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the type of hospitalization (ambulatory / conventional) according to the type of surgery (total / partial mastectomy) on quality of life 15 days after Intervention. | Quality of life is assessed by the EORTC QLQ-C30 questionnaire BR23 | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of type of hospitalization (ambulatory / conventional) depending on the type of surgery (total / partial mastectomy) on anxiety / depression of the patient 15 days after surgery. | Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale | 15 days | 
| Patient satisfaction by type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy) | Patient satisfaction is assessed by a satisfaction care questionnaire (PATSAT 32). | 15 days | 
| Complication rate within 15 days the intervention according to the type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy) | Postoperative complications will be classified according to Dindo- Clavien | 15 jours | 
| Estimate the conversion rate from ambulatory surgical to conventional surgery |  | 15 jours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, breast cancer, quality of life
Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea

Study Overview
=================
Brief Summary
-----------------
Aromatase(CYP19)inhibitor is one of the major antihormonal drug for breast cancer in postmenopausal women. The variation of CYP19 may affect the effect of aromatase inhibitor. However, the incidence of variation of CYP19 in Korea has not known. Therefore, the investigators want to know the incidence of variation of CYP19 and to assess the effect of these variations of CYP19 to aromatase inhibitor users.

Official Title
-----------------
Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea

Conditions
-----------------
Polymorphism, CYP19, Aromatase Inhibitor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hormone receptor positiveBreast cancer patient postmenopausal women first user of aromatase inhibitor Exclusion Criteria: premenopausal The patient who take the other antihormonal therapy osteoporosis patients

Ages Eligible for Study
-----------------
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SMAC (SMc AI user Cohort)<br>All patients who took the AI (Aromatase inhibitor)will be enrolled | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of CYP19 polymorphism |  | 12. 31. 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of CYP19 polymorphism to the prognosis of AI user |  | 12. 31. 2016 |
Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease

Study Overview
=================
Brief Summary
-----------------
Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of famotidine in subjects with non-erosive GERD.

Official Title
-----------------
YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-comparison Study in Patients With Non-erosive Gastroesophageal Reflux Disease

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: Famotidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have heartburn with non-erosive gastroesophageal reflux disease. Exclusion Criteria: Patients have diseases which interfere with evaluation of the efficacy and safety in this study. Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study. Patients have severe cardiovascular, hepatic, renal and hematological disorders. Patients are allergic to or have a history of drug allergy to H2RA. Patients have or have a history of malignant tumors. Patients are pregnant or a lactating mother. Patients have participated in other clinical studies less than 12 weeks prior to submitting the informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Famotidine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of days with no heart burn in the treatment period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disappearance of heart burn |  |  | 
| Severity of heart burn |  |  | 
| Frequency of heart burn |  |  | 
| Patient's final global improvement rating |  |  | 
| Other symptoms (e.g.,reflux sensation of gastric fluid, discomfort of pharynges) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment efficacy, Treatment effectiveness, Gastrointestinal Diseases, Reflux, Gastroesophageal, GERD
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of thin fluid with starch versus thin fluid without starch on coagulation in elective surgery when the patient is normovolæmic during operation.

Detailed Description
-----------------
The primary goal is to register coagulation on basis of blood samples inclusive thromboelastography results. The secondary goal is to register blood loss and use of blood products during operation. The trial concerns 40 patients.

Official Title
-----------------
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery. A Randomised Clinical Study

Conditions
-----------------
Disorders of Coagulation

Intervention / Treatment
-----------------
* Drug: Lactated Ringer
* Drug: Hydroxyethylstarch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18 years. Indication for elective surgery with removal of the urine bladder. Patient without anticoagulative, acethylsalisylsyre or NSAID medicine during the last 5 days,if using. Exclusion Criteria: Cerebral haemorrhage Renal insufficiency demanding dialysis Manifest cardiac and hepatic insufficiency Disturbance in coagulation Hypernatriæmi Hyperchloræmi Pregnant or nursing Allergic to hydroxyethylstarch Participating in another trial-if interferring the present trial Incapable of managing his own affairs.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ringer's lactate<br>Fluid therapy during operation | Drug: Lactated Ringer<br>* When normovolæmic status of the patient is secured, 35 ml/kg of the allocated fluid is infused during the operation (estimated time for this type of operation is 180 minutes), however max. 3500 ml.Lactated Ringer is the interventional medication.<br>Drug: Hydroxyethylstarch<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate coagulation on basis of bloodsamples |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate coagulation by bloodloss and need for transfusion |  | 6 months |
Does Elective Amniocentesis Change Vaginal Microbiome?

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to check if elective amniocentesis change vaginal microbiome

Official Title
-----------------
Does Elective Amniocentesis Change Vaginal Microbiome?

Conditions
-----------------
Vaginal Microbiome

Intervention / Treatment
-----------------
* Diagnostic Test: Vaginal Microbiome as result of aminocentesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women between 18-45 years old , pregnant week is 16-24 , and a signle pregnant. Exclusion Criteria: infection in the Uterus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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: Vaginal Microbiome as result of aminocentesis<br>aginal Microbiome as result of aminocentesis by a blood and a vaginal samples that will taken before and after the aminocentesis | Diagnostic Test: Vaginal Microbiome as result of aminocentesis<br>* we will take a blood samples and a vaginale samples after and before the aminicentesis and check if the sample that we took after is different and contain microrganisms , if we find a different o we can say that as result of the Elective Amniocentesis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Microbiome | through blood and vaginal samples we will check if there are a vaginale micobiome - the samples will collected after and before the elective aminocentesis , the samples will sent to the labour of dr. Omer in the university , it will be analaysed there | 1 year |