linjc16/ctgov huggingface dataset:
Complications in Parotid Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators conducted a prospective study of 132 patients undergoing benign parotid surgery at our department. Their primary objective was to analyze the incidence of and contributing factors associated with temporary and permanent postoperative facial palsy with strictly standardized methods in facial nerve function evaluation. Also other complications occurring within 12 months of operation were recorded.

Detailed Description
-----------------
Patients who underwent parotid surgery at the Department of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Hospital, Helsinki, Finland, between September 2011 and November 2012 were prospectively enrolled. Exclusion criteria were age under 18, suspicion of malignancy or facial schwannoma, a tumor extending into the parapharyngeal space, and previous parotid surgery exposing facial nerve.

Official Title
-----------------
Complications in Parotid Surgery - a Prospective Cohort Study

Conditions
-----------------
Facial Palsy

Intervention / Treatment
-----------------
* Procedure: Parotid surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parotid gland tumour surgery Exclusion Criteria: age under 18 suspicion of malignancy or facial schwannoma a tumor extending into the parapharyngeal space previous parotid surgery exposing facial nerve

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 |
| --- | --- |
| type of surgery<br>patients undergoing parotid surgery | Procedure: Parotid surgery<br>* Surgery of the parotid gland tumours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| facial palsy |  | post op 12 months |
Magnetic Resonance Imaging (MRI) Analysis of Coronary Artery Plaque Components

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze atherosclerotic vessel wall components with multidetector computed tomography (MDCT) and compare with MRI. The hypothesis is that MRI is comparable to computed tomography (CT) in showing plaque components of coronary plaques.

Conditions
-----------------
Coronary Artery Plaque Components

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males and females 18 - 65 who are scheduled to undergo a CT scan for evaluation of coronary artery plaque. Exclusion Criteria: Contraindications to having an MRI scan Pregnant women

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Acupuncture for Breast Engorgement During Lactation

Study Overview
=================
Brief Summary
-----------------
Breast engorgement which may manifest swell, throb, and cause mild to extreme pain is the common difficulty for breast feeding woman. It occurs in the mammary glands due to expansion and pressure exerted by the synthesis and storage of breast milk and it usually happens when the breasts switch from colostrums to mature milk. However, engorgement can also happen if lactating women miss several nursing and not enough milk is expressed from the breasts. It can be exacerbated by insufficient breastfeeding and/or blocked milk ducts. Engorgement may lead to mastitis and untreated engorgement puts pressure on the milk ducts, often causing a plugged duct. According the meridian theory, the investigators propose the acupuncture treatment for patients of breast engorgement. The investigators will include 60 patients and measure the acupuncture effect. The inclusion criteria are women with breast engorgement and 20 years old or older. Exclusion standards are patients with: 1. diabetes mellitus 2. Psychological disease or mental illness 3. Fever > 38 degrees Celsius 4. Mastitis 5.analgetics or anti - inflammatory agents used 6. ultrasound therapy applied

Official Title
-----------------
Acupuncture for Breast Engorgement During Lactation: a Pilot Study.

Conditions
-----------------
Breast Engorgement

Intervention / Treatment
-----------------
* Device: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with breast engorgement and 20 years old or older Exclusion Criteria: patients with: diabetes mellitus psychological disease or mental illness Fever > 38 degrees Celsius Mastitis analgesics or anti - inflammatory agents used ultrasound therapy applied

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br> | Device: acupuncture<br>* Device: acupuncture Acupuncture is the treatment which balances qi and blood by inserting needles into the acupoints of the meridians in human body.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breast engorgement | Six-point Engorgement Scale | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mastitis | The incidence of mastitis | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, breast engorgement, lactation
Efficacy and Safety of Xuesaitong Soft Capsule for Coronary Heart Disease Unstable Angina

Study Overview
=================
Brief Summary
-----------------
In this study, typical cases of coronary heart disease are selected. They will be intervened by Xuesaitong soft capsules to investigate efficacy and safety for Coronary Heart disease.

Official Title
-----------------
The Methylation Regulation Mechanism of Blood Stasis Relevant miRNA Expression on Coronary Heart Disease

Conditions
-----------------
Coronary Heart Disease, Unstable Angina

Intervention / Treatment
-----------------
* Drug: Xuesaitong soft capsule
* Drug: Placebo oral capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of coronary angiography unstable angina Clinical diagnosis of unstable angina Age of 30 to 75 years old Not use thrombolysis, dilate coronary drugs within two weeks Sign the consent Exclusion Criteria: Severe valvular heart disease Insulin-dependent diabetes mental disease Combined with severe liver, kidney, hematopoietic system disorder Patients with malignant tumors Pregnancy or breast-feeding women Recent history of trauma Drug allergy

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xuesaitong soft capsule group<br>Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and Xuesaitong soft capsule. | Drug: Xuesaitong soft capsule<br>* Panax Notoginseng Saponins, Specification:0.33 per bag, once take two pills and twice a day during a month.<br>|
| Placebo Comparator: Placebo Comparator<br>Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and placebo. | Drug: Placebo oral capsule<br>* Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiovascular events | death, myocardial infarction, hospitalization for unstable angina or stroke | 60 days | 
| Seattle Angina Questionnaire | to evaluate patients by Seattle Angina Questionnaire | 60 days | 
| blood stasis syndrome scale of Coronary heart disease angina pectoris | to evaluate patients by blood stasis syndrome scale of Coronary heart disease angina pectoris | 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid | Triacylglyceride,total cholesterol, low densith lipoprotein, high densith lipoprotein | 60 |
Finger Wearable Device to Monitor Heart Rate Variability and Oxygen Saturation

Study Overview
=================
Brief Summary
-----------------
Introduction: Chronic obstructive airway disease (COPD) is common condition in old age and the perception of hypoxia is often impaired in some COPD patients. Therefor it is need to monitor oxygen saturation in older people with COPD. A finger wearable device has been developed to measure oxygen saturation and heart rate variability. The investigators therefore will perform a cross sectional study to evaluate the clinical application of this finger wearable device in the detection and management of COPD in older people. Subject and method: 100 COPD subjects and 200 community dwelling older people without diagnosis of COPD will be recruited. Physical functioning and lung function test will be performed. Subjects will wear a finger wearable device to monitor heart rate variability and oxygen saturation and wear another wrist wearable device (Actigraph) to monitor physical activity and sleep for 6 days at the same time. Statistical analysis: Statistical analysis will be made to examine the potential association between oxygen saturation and physical activity and sleep, and the association between heart rate variability and physical activity and sleep.

Official Title
-----------------
Evaluation of Finger Wearable Device to Monitor Heart Rate Variability and Oxygen Saturation in Older People

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 60 years old or more with or without COPD Exclusion Criteria: Current smokers

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| COPD | COPD as defined by lung function | 6 days |
Sleep Apnea and Lung Cancer

Study Overview
=================
Brief Summary
-----------------
cases of locally advanced non small cell lung cancer (diagnosed by PET/CT scan and histopathological confirmation) will be screened for sleep disorders by Epworth sleepiness scale then confirmed by full night polysomnographic study. Blood sample to detect some genetic determinants will be withdrawn

Official Title
-----------------
Prognostic Significance of Sleep Apnea in Non Small Cell Lung Cancer

Conditions
-----------------
Locally Advanced Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: sleep study and blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with locally advanced non small cell lung cancer Exclusion Criteria: unable or refuse to perform sleep study metastatic cases
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: sleep study and blood sample|full night polysomnographic study and blood sample to detect some genetic issues|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment Response to treatment | CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria) | 6 weeks from ending therapy | 
| confirmed Response to treatment | CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria) | 4 weeks from assessment response | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria) | 3 months from confirmed response to treatment | 
| Progression Free Survival | CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria) | 6 months from confirmed response to treatment | 
| Progression Free Survival | CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria) | 9 months from confirmed response to treatment | 
| Progression Free Survival | CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria) | 12 months from confirmed response to treatment | 
| Overall survival | regular patient follow up visit | 3 months after enrollment | 
| Overall survival | regular patient follow up visit | 6 months after enrollment | 
| Overall survival | regular patient follow up visit | 9 months after enrollment | 
| Overall survival | regular patient follow up visit | 12 months after enrollment |
Post Marketing Surveillance Study of Dysport

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.

Official Title
-----------------
A Post Marketing Surveillance Study of Dysport Formulated With a Batch of Bulk Active Substance From a New Primary Manufacturing Facility at the Centre for Applied Microbiology & Research (CAMR)

Conditions
-----------------
Blepharospasm, Hemifacial Spasm, Cervical Dystonia, Spasmodic Torticollis, Cerebral Palsy, Muscle Spasticity, Cerebrovascular Accident, Equinus Deformity, Facial Hyperdynamic Lines

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult or child over the age of 2 years scheduled to receive Dysport as per their normal treatment practice, and in conformance with their country's Summary of Product Characteristics Exclusion Criteria: history of hypersensitivity to Dysport or drugs with a similar chemical structure treatment with any other investigational drug within the last 30 days before survey entry

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- | --- |
| - assessment of efficacy as assessed by treating physician at scheduled follow up visit |  |  | 
| - data on adverse events since treatment with Dysport |  |  |
Urinary Neurotrophin Levels in Healthy Children

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyse urinary neurotrophin levels in healthy children. Urine samples will be collected at 3 different times of day (morning, noon, and evening) at urge sensation from all age groups of children who gained bladder control, i.e. from 3-18 years of age. Urinary levels of nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) normalised to urinary creatinine will be analysed. Age and daytime related variations will be reported for both boys and girls. These results will contribute to understanding the role of neurotrophins in the physiology of lower urinary tract and pathophysiology of idiopathic and secondary hyperactive bladder in children.

Official Title
-----------------
Age and Daytime Variations in Urinary Neurotrophin Levels in Healthy Children Without Lower Urinary Tract Symptoms

Conditions
-----------------
Overactive Bladder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3-18 years of age a unremarkable clinical examination a normal voiding pattern a minimum of 3 micturitions per day informed oral and written consent from the child and both parents/legal guardian Exclusion Criteria: history of urinary tract infection diseases of central or peripheral nerve system anomalies of lumbosacral region chronic diseases operative procedures or anomalies of urinary or genital tract lower urinary tract symptoms constipation hypercalcuria urolithiasis, depression, eating disorders or cardio-metabolic diseases prior use of anticholinergic treatment

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 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 |
| --- | --- |
| Healthy children<br>Healthy children without lower urinary tract diseases, history of urinary tract infection, chronic diseases, anomalies of urinary or genital tract, and remarkable clinical examination. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of urinary nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) normalised to urinary creatinin | We will collect urine samples from healthy children without lower urinary tract symptoms and analyse urine concentrations of neurotrophins (NGF and BDNF) normalised to urinary creatinin in order to report its normal age- and daytime-related variations. | Collection of urine samples and analysis will take approximately 6 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nerve Growth Factor, Brain-Derived Neurotrophic Factor, Urinary Biomarkers, Children, Neurotrophins
A Phase II Study of AL-37807 to Treat Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether AL-37807 is safe and effective in treating patients with open-angle glaucoma or ocular hypertension

Official Title
-----------------
A Phase II Study of AL-37807 to Treat Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: AL-37807


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of either sex and any race with open-angle glaucoma or ocular hypertension; logMAR visual acuity not worse than 0.60; additionally clinically relevant ophthalmic or systemic conditions may be excluded Exclusion Criteria: Under 18

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

| Intervention/Treatment |
| --- |
|Drug: AL-37807|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP change from baseline |  |  |
Effects of PIOMI on Oral Feeding of the Premature Infants

Study Overview
=================
Brief Summary
-----------------
Randomized controlled clinical trial aimed at evaluating the effects of the Premature infant oral motor intervention method on the oral feeding skills of the premature infants.

Detailed Description
-----------------
Numerous evidences emerge from the literature review on the usefulness of the PIOMI method to improve food skills in the premature infant. The goal of this study is to evaluate the effects of the PIOMI method by adding the gustatory stimulation to the original protocol.

Official Title
-----------------
Effects of the Premature Infant Oral Motor Intervention on the Oral Feeding Skills of the Premature Infants: A Randomized Controlled Trial

Conditions
-----------------
Feeding Disorder Neonatal

Intervention / Treatment
-----------------
* Other: PIOMI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational age at birth between 25-33 weeks; clinical stability; possible presence of nasogastric or oro-gastric tube; non-invasive respiratory support (oxygen, high flows) Exclusion Criteria: gestational age <25 weeks or> 33 weeks absence of clinical stability invasive respiratory support (CPAP) previous surgical interventions ongoing infections congenital and / or chromosomal diseases brain, metabolic, cardiac, gastrointestinal diseases presence of bronchopulmonary dysplasia

Ages Eligible for Study
-----------------
Minimum Age: 25 Weeks
Maximum Age: 33 Weeks

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT characterized by the comparison between two groups (treated / untreated)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PIOMI Group<br>Patients in this group will receive the intraoral and extraoral stimulations provided by the PIOMI protocol. These stimulations will last 5 minutes and will be performed once a day for 7 consecutive days for each patient. | Other: PIOMI<br>* Intraoral and extraoral stimulation.<br>|
| No Intervention: Control Group<br>Patients in this group will receive classic care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean volume | Mean volume of oral intake | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feeding efficiency | oral intake at day one and at day three | 3 days | 
| achievement of full oral feeding | PMA on reaching full oral feeding | 6 moths | 
| hospital stay time | days spending to the hospital | 6 months | 
| transition time | transition times from the tube to full oral feeding | 6 months |