linjc16/ctgov huggingface dataset:
NovaTears® Eye Drops Observational Study NT-002

Study Overview
=================
Brief Summary
-----------------
This observational study is intended to collect outcome data from a cohort of 90 patients suffering from symptoms of dry eye disease due to meibomian gland dysfunction who are treated with the medical device NovaTears® eye drops for a duration of 6 to 8 weeks.

Official Title
-----------------
NovaTears® Observational Study NT-002

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

Intervention / Treatment
-----------------
* Device: NovaTears® Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to NovaTears® instruction for use ≥ 18 years Patients with dry eye disease due to meibomian gland dysfunction applying eye lid hygiene for at least 14 days Ability and willingness to provide written Informed Consent Ability and willingness to participate in all examinations Willingness and ability to return for follow up visit Exclusion Criteria: Patients with hypersensitivity to any of the components of NovaTears® Patients with contact lenses, pregnancies, or who are breast feeding Patients with dry eye disease not caused by meibomian gland dysfunction Patients taking lipid containing eye drops or requiring topical pharmacological treatment of 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NovaTears®<br> | Device: NovaTears® Eye Drops<br>* Topical eye drops for lubrication of the ocular surface<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective symptom severity | Change in subjective symptom severity score compared to Baseline | 6 to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear-Film Break-up Time | Change in Tear Film Break-up Time (measured in seconds) compared to Baseline | 6 to 8 weeks |
Moxibustion for Fetus in Breech Presentation

Study Overview
=================
Brief Summary
-----------------
Objective: To evaluate moxibustion of the BL67 acupoint between 34 and 38 weeks of gestation to facilitate cephalic version of breech presentation in a Western setting. The hypothesis is that moxibustion increase the likelihood of cephalic version. Design: Randomised controlled trial Setting: University hospital. Population: A total of 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation will be randomised to moxibustion (n=106) or expectant management (n=106). Main Outcome Measure: Cephalic presentation at delivery or before external cephalic version.

Official Title
-----------------
Moxibustion for Fetus in Breech Presentation

Conditions
-----------------
Breech Presentation

Intervention / Treatment
-----------------
* Procedure: Moxibustion of the BL67 acupoint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breech presentation 34 to 36 weeks of gestation Single fetus Exclusion Criteria: Uterine malformation Placenta praevia Transverse lie
Sexes Eligible for Study
-----------------
Female

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

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 |
| --- | --- |
| Experimental: Moxibustion<br> | Procedure: Moxibustion of the BL67 acupoint<br>* Moxibustion sessions every day (every other day in hospital, self-administration at home the other day) during a maximum of 14 days. Stopped if cephalic version.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cephalic presentation at delivery or before external cephalic version |  | end of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery |  | end of pregnancy | 
| Women's views on the intervention |  | end of pregnancy | 
| External cephalic version |  | end of pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breech presentation at 34 to 36 weeks of gestation
Growth-Health and Development in Children Exposed to Drugs During Pregnancy

Study Overview
=================
Brief Summary
-----------------
Children exposed to alcohol or drugs during pregnancy: Growth, health and development Background Children exposed to drugs during pregnancy are at risk of developmental disorders. The scope and size of this problem is poorly known in Norway. Alcohol has a known teratogenic effect on the fetus. How other drugs affect the fetus, is associated with more uncertainty. Withdrawal in the neonatal period has been perceived as the main problem. There is less knowledge about long-term outcome of exposure to drugs during pregnancy. Aim The aim of the study is to investigate the physical and mental health of children exposed to drugs during pregnancy. Identify the children's need for measures in the home and school, and how many of the children who are taken care of in fostercare. A sample of the children will be offered radiological examination of the brain (f-MRI). The purpose is to study the relationship between exposure to drugs, child development, environment and organic brain dysfunction. Design The project is a quantitative study. The relationship between exposure to drugs and development will be measured by questionnaires, clinical examination, neuropsychological tests and radiological examination (f-MRI). Children aged 2-15years who were referred, examined or treated for drug related problems at the Department of Pediatrics, Haukeland University Hospital will be invited to participate in the study. Information retrieval and examination of the children are expected to be completed during 2011. Data analysis and further processing of data are expected to be completed during 2013.

Official Title
-----------------
Growth-Health and Development in Children Exposed to Drugs During Pregnancy.

Conditions
-----------------
Growth Failure, Mental Health Disorder, Foetal Exposure During Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Foetal exposure of drugs during pregnancy. Exclusion Criteria: Non exposed children

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 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 |
| --- | --- |
| Control<br>Children born at term and not exposed to drugs during pregnancy | |
| Case<br>Case = Children exposed to drugs during pregnancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health Disorder | Questionaire regarding mental health: Strength and Difficulties Questionnaires | 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Foetal Exposure During Pregnancy, Health, Growth
Suicidal Poisoning in Emergency Units

Study Overview
=================
Brief Summary
-----------------
Poisoning is the deterioration of the body's functions by the ingestion of any substance being toxic to the body or by overdosing a nontoxic substance. Poisoning cases may vary according to the geographical and seasonal characteristics of the region, sociocultural structure of the population, life index and the age groups. Worldwide, intentional self-poisoning (ISP) is the most common form of suicide attempt and the most common method that results in medical hospitalization.

Detailed Description
-----------------
Questionnaire is prepared including the following items: Demographic data: Gender -age-marital status -occupation- socioeconomic state -special habit -history of psychiatric innless-history of chronic diseases-history of drug dependence -previous suicidal attempts-toxic substance used in suicide- time of poisoning, season and time of arrival . Data regarding poisoned substance: Dose, type of the substance used and rout of administration. Presenting symptoms of intoxication and management Complete clinical examination: General condition: conscious level and vital signs. Local examination: chest, heart, abdomen, etc. Investigation: (Arterial blood gases - ECG -otherwise according to case presentation) Prognosis: Complete recovery, complications, death.

Official Title
-----------------
Evaluation of Suicidal Poisoning Cases in Emergency Units of Assuit University Hospitals

Conditions
-----------------
Poisoning

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suicidal poisoning cases Exclusion Criteria: other causes of suicide
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Questionnaire including demographic data, data regarding poisoning substance and outcomes of suicidal attempts|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the prevalence of suicidal poisoning cases attending emergency units, Assuit university hospitals | Number of cases of all age group committing suicide by poisoning in a peroid of one year will be known. accidental poisoning will be detected to release the prevalence of suicidal poisoning | One year |
Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreaticoduodenectomy

Study Overview
=================
Brief Summary
-----------------
One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric emptying (DGE), otherwise known as gastroparesis, which is not fatal but results in prolonged hospital stay and increased hospital costs. Delayed gastric emptying is defined as nasogastric decompression after postoperative day (POD) 10 or a failure to tolerate a regular diet after POD 14. The incidence of DGE has been reported to range from 5% to 72%.

Detailed Description
-----------------
We hypothesized that the hand-sewn, two-layered, or continuous suture, could induce anastomotic edema to indeed the afferent peristalsis, which is one of the causes of DGE.

Official Title
-----------------
Benefit of R-Y Reconstruction After Pancreaticoduodenectomy

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: R-Y reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: These patients were to undergo elective pancreatic head resection for the treatment of periampullary mass Exclusion Criteria: A body weight loss greater than 10% during the six months prior to surgery The presence of distant metastases Seriously impaired function of vital organs due to respiratory, renal or heart disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-Y reconstruction<br>the reconstruction was performed by R-Y anastomosis | Procedure: R-Y reconstruction<br>* The reconstruction was performed by R-Y anastomosis.<br>* Other names: the cutting R-Y anastmosis;|
| No Intervention: conventional reconstruction<br>the anastomosis was performed by B-II | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of DGE |  | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of other complication associated with reconstruction |  | 3-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreaticoduodenectomy, reconstruction
Bile Leakage Test in Emergency Hydatid Liver Cyst Surgery Case Report

Study Overview
=================
Brief Summary
-----------------
In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Intraoperative bile leakage test has been shown to reduce postoperative biliary complications by revealing occult CBCs. However, bile leakage testing in emergency conditions such as hydatid cyst perforation has not been experienced so far.

Detailed Description
-----------------
In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Intraoperative bile leakage test has been shown to reduce postoperative biliary complications by revealing occult CBCs. However, bile leakage testing in emergency conditions such as hydatid cyst perforation has not been experienced so far. Here, a bile leakage test performed in a 23-year-old male patient undergoing emergency surgery due to the perforation of the hydatid liver cyst was presented. Following the treatment of perforated hydatid liver cyst and biliary peritonitis, a bile leakage test was performed. The common bile duct was cannulated with a 22 Gauge catheter, normal saline and parenteral lipid solution were given to demonstrate the CBCs, and leakage areas were suture ligated. The patient was discharged postoperatively without any problem. The investigators recommend detection and treatment of the CBCs even in emergency hydatid liver cyst surgery for prevention of postoperative biliary complications.

Official Title
-----------------
Bile Leakage Test in Emergency Hydatid Liver Cyst Surgery Case Report

Conditions
-----------------
Surgery--Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: this study is a case report Exclusion Criteria: this study is a case report
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| recurrent hydatid cyst | presence of recurrent hydatid cyst | 2 or 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydatidosis, complications, intra-biliary rupture, biliary duct, echinococcus, echinococcosis
Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia

Study Overview
=================
Brief Summary
-----------------
A history of preeclampsia is associated with a low plasma volume and higher sympathetic activity. Methyldopa will suppress sympathetic activity to normal values. In this study, the researchers will test that effect on the total cardiovascular balance.

Detailed Description
-----------------
This is a randomized double-blind placebo controlled cross-over study in formerly preeclamptic women with a contracted plasma volume. The researchers will test the effect of methyldopa on the cardiovascular balance and orthostatic tolerance in women with a history of preeclampsia and healthy controls.

Official Title
-----------------
Cardiovascular Performance and Autonomic Reactivity in Formerly Preeclamptic Women With a Contracted Plasma Volume (CAPACITY Trial)

Conditions
-----------------
Preeclampsia

Intervention / Treatment
-----------------
* Drug: alpha methyldopa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparous History of preeclampsia Low plasma volume Exclusion Criteria: Thrombophilia Hypertension Auto-immune disorder Insulin dependent diabetes mellitus
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: alpha methyldopa|500 mg twice a day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normalized plasma volume |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increased orthostatic tolerance |  | 1 month | 
| normalized cardiovascular balance |  | 1 month | 
| venous capacitance |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAPACITY trial, preeclampsia, plasma volume, sympathetic activity, hypertension, cardiovascular system
Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate Obesity

Study Overview
=================
Brief Summary
-----------------
This study is in patients with at least moderate obesity (Body Mass Index [BMI] > 30 kg/m2 or approximately 30 or more pounds overweight) and who also produce too much insulin (insulin stores sugar as fat). Sandostatin LAR® Depot suppresses insulin, and is being developed to help with weight loss in people who find it hard to lose weight on their own because they produce too much insulin. The main purpose of the study is to find the lowest dose of Sandostatin LAR® Depot that safely helps overweight people lose weight. The study will also compare weight loss in obese patients who receive one of three different dosages of Sandostatin LAR Depot or placebo.

Conditions
-----------------
Primary Insulin Hypersecretion, Obesity

Intervention / Treatment
-----------------
* Drug: Sandostatin LAR Depot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You may qualify for this study if you: are between the ages of 18-70 (male or female) are at least moderately obese (BMI > 30 kg/m2 or approximately 30 or more pounds overweight) and pass an oral glucose tolerance test (a 3 hour test to determine if your body produces too much insulin) Exclusion Criteria: You are not qualified for this study if you: have diabetes have been able to lose weight with diet and exercise alone have previously received Sandostatin LAR® Depot

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Sandostatin LAR Depot|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change at baseline compared to 6 months in body weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare changes from baseline and at 6 months in body mass index (BMI), percentage of total body fat percentage of abdominal fat, leptin, and waist-to-hip ratio |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PIH, Primary Insulin Hypersecretion, Obesity
Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study

Study Overview
=================
Brief Summary
-----------------
Background: Cholesteatoma is a potentially life-threatening inflammatory lesion that causes hearing loss, ear discharge, and ear pain, and serious complications. For the past several decades, most studies of cholesteatoma have been restricted to microscopic ear surgery. However, a growing body of evidence suggests endoscopic ear surgery is a safe, minimally invasive approach for cholesteatoma management. This thesis aim to investigate and compare the clinical effect between endoscopic and microscopic ear surgery of cholesteatoma. Materials and methods: The retrospective study included 186 patients with cholesteatoma who received endoscopic or microscopic ear surgery from 11 otorhinolaryngology centers between November 2016 and March 2021. Patients were followed-up for at least 1 year. Audiometry improvement, treatment cost, time, graft success rate and recurrence rate were assessed after surgery.

Official Title
-----------------
Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study

Conditions
-----------------
Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect

Intervention / Treatment
-----------------
* Procedure: endoscopic ear surgery
* Procedure: microscopic ear surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement the extent of disease was confirmed by preoperative HRCT temporal bone undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery Exclusion Criteria: were lacking in clinical characteristics had not preoperative audiometric data missed the follow-up data were lacking in surgical times were microscopic combined endoscopic ear surgery

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| endoscopic ear surgery group(EES)<br> | Procedure: endoscopic ear surgery<br>* a ear surgery via endoscopic<br>|
| microscopic ear surgery group(MES)<br> | Procedure: microscopic ear surgery<br>* a ear surgery via microscopic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pure Tone Average(PTA) | estimate the auditory acuity | at least 1 year | 
| Air-Bone Gap(A-B Gap) | estimate the auditory acuity | at least 1 year |