linjc16/ctgov huggingface dataset:
Non-Op Management of Ventral Hernia Patients

Study Overview
=================
Brief Summary
-----------------
Ventral hernias are among the most common surgical diseases among patients.The natural history of patients with ventral hernias who are managed non-operatively is unknown. The aim of this prospective trial is to document the natural history of patients who are undergoing initially non-operative management. The investigators hypothesize that 1) the risk of emergency ventral hernia repair is low, 2) the risk of elective ventral hernia repair is high, and 3) patients managed non-operatively will develop increasing hernia size and symptom progression. This is a prospective observational study of all patients undergoing non-operative management at LBJ General Hospital. Patients will be consented and then followed for 5 years. Phone interviews will be done with these patients yearly to assess surgical and medical history, information about their hernia, including pain level due to the hernia, as well as function and quality of life.

Official Title
-----------------
Prospective Observational Trial of Initial Non-operative Management of Ventral Hernia Repair

Conditions
-----------------
Hernia, Ventral

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing initial non-operative management as chosen by current practice patterns All patients who opt for non-operative management due to personal choice, lack of symptoms or concerns regarding surgical risks. Age 18 or older Exclusion Criteria: Patient meets surgery criteria but elects for surgery within 1 year due to personal scheduling Patient smokes < 1 pack per day, is actively quitting smoking, and desires to follow-up within 3 months upon smoking cessation Patient with BMI < 35 kg/m2, is actively losing weight, and desires to follow-up within 3 months upon weight loss goals being met Patient is unlikely to be able to follow-up due to no personal or home phone Patient is enrolled in another trial

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of surgical repair of the ventral hernias per patient year |  | Once a year for 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of emergency repair of ventral hernias per patient year |  | Once a year for 5 years | 
| Rate of elective repair of ventral hernias per patient year |  | Once a year for 5 years | 
| Rate of emergency room visits per patient year |  | Once a year for 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-operative management
Riskfactors of Post-operative Pain and Nausea After Ambulatory Gynaecological Laparocopy.

Study Overview
=================
Brief Summary
-----------------
Patient due for elective, ambulatory gynaecological laparoscopy will be screened peri-operatively for known and potential risk factors of postoperative pain and nausea/vomiting. The actual incidence and severity of pain and nausea/vomiting will be recorded during th 0-24 hr intervall after end of surgery, as well as the doses of all drugs, given for either prophylaxis or treatment

Official Title
-----------------
Risikofaktorer for Postoperativ Smerte og Kvalme Etter Dagkirurgisk Gynekologisk Laparoskopi

Conditions
-----------------
Postoperative Pain, Postoperative Nausea

Intervention / Treatment
-----------------
* Other: Patient interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective adult patients due for planned ambulatory gynaecological laparoscopy Must be able to speak and write in Norwegian language Exclusion Criteria: Patients who, for some reason, is transferred to non-ambulatory (same day discharge) care. Patients who, for some reason, have a change in surgical procedure from laparoscopy

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

| Intervention/Treatment |
| --- |
|Other: Patient interview|Patient will be interviewed pre-operatively and at 24 hrs post-opartively|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | Numerical Ratings Score (NRS) Scale 0-10, 10 is worst | 0-24 hours | 
| postoperative nausea | yes/no, Numerical Rating Score (NRS), Scale 0-10, 10 is worst | 0-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-operative nausea risk score | Apfel score, 0-4 (4 is maximal risk).Based on a number of registrations, such as: smoking status, postoperative opioid effects, smoking status, travel sickness, previous nause or vomiting after surgery/anaesthesia | preop, 0-24 hours post-operatively | 
| Peri-operative pain risk score | Based on a number of registrations, such as: age, sosio-economic status, pre-op pain, pre-op use of opioids, pre-op anxiety or depression, pre-op catastrophizing, pre-op expectations, type of surgery, type of anaesthesia, lenght/ivasive ness of surgery, peri-op drug consumtion | preop, 0-24 hours | 
| Post-op fatigue | Christensen score, 0-10, 10 is maximal fatigue | 0-24 hrs | 
| Post-op function | Everyday function | 0-24hr | 
| Post-op analgesia consumption | number of opioid equivalents consumed | 0-24hr | 
| Post-op anti-emetic drug consumption | type and dose of ante-emetic medication | 0-24hr |
Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective MAOI

Study Overview
=================
Brief Summary
-----------------
There are already recently published data on the tolerability and efficacy of the combination of ketamine and/or esketamine with MAOIs. However, these reports are few and far between, and to our knowledge, there are no data involving intranasal esketamine. Given the numerous interactions between MAOIs and other antidepressants, and the impossibility of combination, this pharmacological class is neglected. This is despite the fact that MAOIs are the only truly tri-aminergic drugs, that they have unparalleled efficacy in certain forms of resistant apathetic depression, and that new, more dietary permissive forms have appeared on the market. The arrival of antidepressants that can be combined with MAOIs, such as ketamine and esketamine, changes the situation and could offer a new treatment opportunity to many patients in a therapeutic impasse. For these opportunities to become a reality, sharing the clinical experience gained by specialized centers is essential.

Official Title
-----------------
Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective Monoamine Oxidase Inhibitors (MAOIs)

Conditions
-----------------
Depression Anxiety Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject. Having been treated with intranasal esketamine between 01/01/2018 and 01/03/2022. Not objecting to the reuse of their data for scientific research purposes. Exclusion Criteria: - Subject who has expressed opposition to the reuse of their data for scientific research purposes.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events for each patient |  | Files analysed retrospectively from January 01, 2018 to March 31, 2022 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression Disorder, Anxiety Disorder, intranasal esketamine, monoamine oxidase inhibitors (MAOIs), antidepressants, ketamine, MAOIs
Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.

Study Overview
=================
Brief Summary
-----------------
Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy on sleep apnea severity among patients with recent ischemic stroke. Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control night. Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with nasal EPAP therapy compared with a control night.

Official Title
-----------------
Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.

Conditions
-----------------
Ischemic Stroke, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: EPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with an ischemic stroke (including TIA with infarction) within the prior 14 days Exclusion Criteria: Current use of any transnasal tube (eg dobhoff tube) Current use of CPAP, mechanical ventilation, or supplemental oxygen Known severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum Severe heart disease (including severe heart failure) Pathologically low blood pressure An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum Sores, abrasions, or skin or mucosal irritation on or around the nose. Known pregnancy Inability to provide informed consent Use of alpha blockers or short acting nitrates Permanent pacemaker Sustained non-sinus cardiac arrhythmia

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPAP<br>Provent Sleep Apnea Therapy. | Device: EPAP<br> <br> * Other names: Provent Sleep Apnea Therapy.;|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea Index | Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model. | night 1 and night 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Sleep Apnea
Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study

Study Overview
=================
Brief Summary
-----------------
Smoking causes both smoking related lung disease (COPD) and ischaemic heart disease. These are very common conditions and many patients have both diseases. Beta-blocker drugs are extensively used in the treatment of angina, high blood pressure and after heart attacks to decrease symptoms and prolong life. Beta-agonists are used in COPD to decrease breathlessness and improve exercise tolerance. It used to be thought that beta-blockers cannot be used in COPD patients as they may make the breathlessness worse, but it has now been established that they can be used safely. Beta-blocker drugs and beta-agonists have 'opposite' effects on the body and the investigators do not know if they can work together or if they would cancel each other out. The investigators also do not know which of the different types of beta-blockers now available are better for COPD patients. This study will investigate what happens to the airways of people taking both of these drugs.

Official Title
-----------------
Do Beta-Blockers Affect the Use of Beta-Agonist Inhalers in COPD?

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: bronchodilator response


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of COPD > 40 years of age > 15 pack year smoking history Exclusion Criteria: Contra-indication to beta-blocker use Severe COPD FEV1 < 30% or 1 L Not responsive the methacholine

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: R302<br>Daily placebo capsules | Drug: bronchodilator response<br> <br> |
| Active Comparator: R303<br>Daily metoprolol 95mg capsules | Drug: bronchodilator response<br> <br> |
| Active Comparator: R304<br>Daily propranolol 80mg capsules | Drug: bronchodilator response<br> <br> |
| Active Comparator: Open Label<br>Daily Metoprolol 190mg capsules | Drug: bronchodilator response<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchodilator response to salbutamol after beta-blockers |  | 7-10 days | 
| Incremental Shuttle Walk Test Result after taking beta-blockers |  | 7-10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Betablockers, bronchodilator, exercise capacity, methacholine challenge
Effect of Percutaneous Botulinum Toxin A Injection on Natural Course of Upper Lid Retraction in Thyroid Eye Disease

Study Overview
=================
Brief Summary
-----------------
In active phase of thyroid eye disease some patients have obvious upper lid retraction , and sometimes exposure keratopathy .To date there is not any standard treatment for this situation . We are going to compare the natural course of the upper lid retraction with injection of botulinum toxin A injection to upper lid percutaneously.

Conditions
-----------------
Eye Diseases

Intervention / Treatment
-----------------
* Drug: Botulinum toxin A injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all the patients wiht oper lid retraction in active phase of thyroid ophthalmopathy Exclusion Criteria: patients in non active phase
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: Botulinum toxin A injection|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
-----------------
botulinum toxin, thyroid eye disease, lid retraction
Characterization and Epigenetics of Post-Partum Preeclampsia

Study Overview
=================
Brief Summary
-----------------
This study will recruit women with post partum pre-eclampsia and match them to controls without postpartum pre-eclampsia to identify an epigenetic signature that is specific to women with post partum pre-eclampsia to help characterize the underlying pathophysiology of post partum pre-eclampsia.

Detailed Description
-----------------
Preeclampsia (PEC) is a heterogeneous disease that complicates 5-8% of pregnancies. Approximately 10% of PEC patients will present with post-partum PEC without having developed the syndrome during the pregnancy (PP-PEC). Management of post-partum preeclampsia (PP-PEC) is challenging because many women do not seek care until neurologic symptoms result from severe-range elevated blood pressure. The pathogenesis and clinical characteristics of PP-PEC are understudied and poorly understood. Identifying clinical risk factors and biomarkers of PP-PEC would help to identify women at risk.

Official Title
-----------------
Characterization and Epigenetics of Post-Partum Preeclampsia

Conditions
-----------------
Post Partum Pre-eclampsia

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post partum pre-eclampsia Matching based on: maternal age (years +/-3) BMI (+/-5 points) Ethnicity Mode of delivery Gestational age at delivery (+/7 days) Smoking status Exclusion Criteria: Intrapartum pre-eclampsia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| post partum pre-eclampsia<br>women with normal deliveries followed by post partum pre-eclampsia within 1 month of delivery. | Other: no intervention<br>* database and epigenetic study<br>|
| controls<br>women with normal deliveries and normal post part courses who match the post partum pre-eclampsia women in age, BMI, smoking status, gestational age and race/ethnicity. | Other: no intervention<br>* database and epigenetic study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| methylation signature on circulating monocytes |  | 1 week post delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post Partum Pre-eclampsia
Micron Tracker: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to validate a simplified platform of a repositioning system in orthognathic surgery (a third generation optic repositioning system called MicronTracker) compared with the actual clinically validated one (Orthopilot system).

Detailed Description
-----------------
For the past 10 years, the use of computer-assisted surgery has expanded and is now widely spread in the orthopaedic domain, but not in maxillary-facial surgery. The main disadvantages of this technique are the necessity to fix a mark on the eyebrow with two transcutaneous pins, which is a long and invasive act, and to connect the infrared transmitter which is in contact with the patient with the computer in a limited surgery area. In this study, we want to show that the new repositioning optic systems are performing similarly to the actual validated one, that they permit to suppress the transcutaneous pins and the computer connection, and that it reduces the financial cost of this surgery. Neither the surgery technique, nor the pre-operative check-up will be modified in the study. The two repositioning systems will be used simultaneously during the mandibular osteotomy.

Official Title
-----------------
Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.

Conditions
-----------------
Computer-Assisted Surgery, Maxillofacial Surgery

Intervention / Treatment
-----------------
* Device: MicronTracker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mandibular orthognathic surgery Exclusion Criteria: Age <18 years

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

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MicronTracker|MicronTracker is a Third Generation Optic Repositioning System in orthognatic surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spatial coordinates of the target (3 translations and 3 rotations) |  | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to install the eyebrow mark with each technique. |  | during surgery | 
| adverse events due to the transcutaneous pins. |  | during surgery | 
| number of handling realized by the nurse for each technique. |  | during surgery | 
| evaluation of cost: number of cable versus number of marker. |  | during surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthognathic surgery., optic repositioning system.
Tolerability of Pentasa Sachet in Patients With Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Confirmation of safety profile

Official Title
-----------------
Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic

Conditions
-----------------
Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treatment of Ulcerative Colitis Exclusion Criteria: hypersensitivity to mesalazine severe liver or renal impairment

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| verify the safety profile: measured by number of AEs/SAEs |  | 12 months from patient recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dosage: evaluate dosage level |  | 12 months from patient recruitment |