linjc16/ctgov huggingface dataset:
Neuroendocrine and Adrenal Tumors

Study Overview
=================
Brief Summary
-----------------
This is a prospective study of rare neuroendocrine and adrenal tumors. Subjects will be enrolled via informed consent, and blood and/or saliva and tissue will be collected. This is designed to work in conjunction with IRB#831990 which is a retrospective protocol. The University of Pennsylvania will be a contributing site with the University of Michigan as the coordinating site for the A5 alliance, a multi-institutional collaborative designed to study neuroendocrine and adrenal tumors.

Official Title
-----------------
Neuroendocrine and Adrenal Tumors: Biochemical, Histopathologic and Genetic Studies

Conditions
-----------------
Neuroendocrine Tumors, Adrenal Tumor

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with neuroendocrine and/or an adrenal tumor Exclusion Criteria: pregnant women prisoners people under the age of 18

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neuroendocrine Tumor<br> | Other: No intervention<br>* There are no interventions<br>|
| Adrenal Tumor<br> | Other: No intervention<br>* There are no interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Recurrence | We want to record recurrences in our patient population | 10 years |
The Effect of Electrical Stimulation on Tear Production

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether electrical stimulation of the nerve innervating the tear gland results in tear production in subjects with severe Dry Eye.

Detailed Description
-----------------
A non-randomized, open-label study designed to investigate the feasibility of a novel treatment for severe Dry Eye Disease, which involves safe delivery of small electrical currents to the lacrimal nerve to induce tear production.

Official Title
-----------------
A Non-Randomized, Open-Label Study to Determine the Effect of Electrical Stimulation on Tear Production

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

Intervention / Treatment
-----------------
* Device: Electrode device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schirmer test with topical anesthesia of ≤ 5 mm/5 min in at least one eye Sum of corneal and interpalpebral conjunctival staining of > +5 in the same eye where corneal staining is > +2 using the CLEK criteria. Exclusion Criteria: Individuals with the presence or history of any ocular disorder or condition (including ocular surgery, trauma, and disease) that could possibly interfere with the interpretation of the study results. Individuals who have had LASIK or other refractive surgeries are eligible. Excluded conditions include: History of orbital trauma History of orbital surgery Orbital cancer History of orbital cancer Within the 3 months before the Screening Visit, known history of ocular infection (viral, bacterial, fungal), inflammation not associated with dry eye, or active ocular herpes

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical stimulation<br> | Device: Electrode device<br>* Lacrimal gland stimulation<br>* Other names: External Neurostimulator Trialing System (Medtronic);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schirmer Score |  | Up to 16 days |
Chronic Rhinosinusitis in a Danish Population: Evaluation of Causes of Disease, Progress and Treatment

Study Overview
=================
Brief Summary
-----------------
Introduction: Chronic Rhinosinusitis (CRS) is defined as inflammation of the nose and the paranasal sinuses. It is a very common disorder increasing in both incidence and prevalence with significant impact on quality of life and substantial health care costs. In this study we evaluate the prevalence of CRS in Denmark and there is a need for consensus about diagnosing this disease. Different questionnaires and different tests used for examination are evaluated together with the patients compliance and days lost through illness. Methods: As part of Ga2len (Global Asthma and Allergy European Network) a questionnaire on CRS was posted to 5000 residents on Funen. From the completed and returned questionnaires self reported CRS was evaluated. Respondents were invited for clinical examination including spirometry, skin prick test, bloodsample and an ENT examination including nasal endoscopy, acoustic rhinometry, peak nasal inspiratory flow and smell test. Questionnaire on quality of life (EQ-5D) and symptom severity (SNOT-22) was completed. Medical diagnosed CRS was diagnosed according to the definition on CRS stated by EPOS (European Position Paper on Rhinosinusitis and Nasal Polyps 2007). CRS is defined as inflammation in the nose and paranasal sinus and should be characterized by two or more symptoms one of which should be either nasal blockage/obstruction/congestion or nasal discharge, +/- facial pain/pressure, +/- reduction or loss of smell. Endoscopic signs should be present and symptoms must have been present > 12 weeks. Patients diagnosed with CRS were invited for a 1 year and 2 year follow up where examination and questionnaires were repeated and treatment compliance and days lost through illness were evaluated.

Official Title
-----------------
Chronic Rhinosinusitis in a Danish Population: Evaluation of Causes of Disease, Progress and Treatment

Conditions
-----------------
Chronic Rhinosinusitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: residents on Funen aged 18-75 years Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic rhinosinusitis, SNOT 22, Quality of life
Survival Analysis of Oral Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the survival rate of oral squamous cell carcinoma (OSCC) patients following immediate mandibular reconstruction with vascularized fibula flap (VFF) and to identify risk factors influencing the overall survival rate and postoperative outcomes.

Official Title
-----------------
Survival Analysis of Segmental Mandibulectomy With Immediate Vascularized Fibula Flap Reconstruction in Stage IV Oral Squamous Cell Carcinoma Patients

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Procedure: tumor resection and mandible reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of stage IV OSCC Follow-up period more than one year. Exclusion Criteria: Non-neoplastic diseases Two-staged reconstruction Presurgical distant metastasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: tumor resection and mandible reconstruction|The patients who underwent primary ablative tumor resection with segmental mandibulectomy and immediate VFF reconstruction were retrieved from the database|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall cumulative survival | The overall cumulative survival was recorded at the fifth-year. | 5th year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Squamous cell carcinoma, Free fibula flap, Prognosis, Survival, Mandibular reconstruction
Evaluation of the Reliability and Usability of the Reusable BrownieForSymphony Pump Set in Home Use

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this study is to evaluate the reliability and usability of the reusable BrownieForSymphony pump set in home use. The primary objectives of this study is to asses and compare the System Usability Scale (SUS) score of the BrownieForSymphony pump set and the current used Symphony pump set. Secondary Objectives The secondary objectives of this study are: to evaluate the rate of usability problems with the BrownieForSymphony pump set to evaluate the pragmatic quality (task/goal fulfilment) of the BrownieForSymphony pump set to evaluate perceived comfort during pumping with the BrownieForSymphony pump set Prospective Cohort Study (quasi Cross over design)

Official Title
-----------------
ESP II Evaluation of the Reliability and Usability of the Reusable BrownieForSymphony Pump Set in Home Use

Conditions
-----------------
Lactation

Intervention / Treatment
-----------------
* Device: Pumping CE-marked Symphony Pumpset
* Device: Pumping BrownieForSymphony Pumpset


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lactating woman >18 years who Have been pumping for at least 7 days with the Symphony pump and pump set prior to study participation Have been pumping at least 10 times in the week prior to study participation Consistently pump 10 ml of milk or more per breast, per pumping session prior to study participation Currently use a breast shield size of 24 mm Participant has agreed to pump at least 10 times a week over the next three weeks Exclusion Criteria: o Woman has a medical condition of the breast (eg. Mastitis)

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pumping<br>Each particpant will pump with the current pumpset one week and then two weeks with the pumpset | Device: Pumping CE-marked Symphony Pumpset<br>* Pumping with the CE-marked Symphony Pumpset<br>Device: Pumping BrownieForSymphony Pumpset<br>* Pumping with the the BrownieForSymphony Pumpset<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability Scale (SUS) Symphony Pumpset usability | Rating of the Usability of the Symphony Pumpset | after 7 days | 
| Usability Scale (SUS) BrownieForSymphony Pumpset usability | Rating of the Usability of the Symphony Pumpset | after 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User experience questionnaire (UEQ) |  | after 7 days, 14 days, 3 week |
Mindfulness and Neural Cardiovascular Control in Humans

Study Overview
=================
Brief Summary
-----------------
This study evaluates the impact of mindfulness-based stress reduction (MBSR) on sympathetic nerve activity and arterial stiffness. The investigator's central hypothesis is that MBSR will reduce sympathetic activity and arterial stiffness.

Detailed Description
-----------------
This study will recruit male and female subjects with elevated blood pressure who will participate in a randomized, active control study to examine the impact of mindfulness-based stress reduction (MBSR) on blood pressure, muscle sympathetic nerve activity and arterial stiffness. The study will utilize established techniques for assessing blood pressure patterns (24-hour ambulatory monitoring), peripheral sympathetic activity (microneurography) and vascular stiffness (applanation tonometry) in humans. This study includes a stress management education class for the active control.

Official Title
-----------------
Randomized, Active-Control Study to Determine the Effect of Mindfulness-Based Stress Reduction on Sympathetic Activity and Arterial Stiffness

Conditions
-----------------
Elevated Blood Pressure

Intervention / Treatment
-----------------
* Behavioral: Stress Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seated systolic blood pressure >119 mmHg and/or diastolic blood pressure >79 mmHg Body mass index <30 kg/m2 Exclusion Criteria: Smokers Diabetes Pregnant women History of autonomic dysfunction Cardiovascular medication

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Stress Reduction<br> | Behavioral: Stress Management<br>* An eight week stress reduction course.<br>|
| Active Comparator: Stress Management Education<br> | Behavioral: Stress Management<br>* An eight week stress reduction course.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sympathetic nerve activity | Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using microneurography. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial stiffness | Carotid-femoral pulse wave velocity using applanation tonometry. | 8 weeks |
Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss

Study Overview
=================
Brief Summary
-----------------
Assessing the efficiency of Prophylactic use of local tranexamic acid during vaginal hysterectomy to reduce blood loss during operation

Detailed Description
-----------------
This randomized control trial will investigate whether local tranexamic acid is efficient for decreasing bleeding during vaginal hysterectomy. The investigators will randomize local placebo (saline) vs. local 1 gr tranexamic acid; IV 1gr diluted in 100 ml saline and IV 100 ml saline at the beginning of surgery.

Official Title
-----------------
Local Tranexamic Acid During Vaginal Hysterectomy to Reduce Blood Loss

Conditions
-----------------
Blood Loss

Intervention / Treatment
-----------------
* Drug: local tranexamic acid injection
* Other: local normal saline injection to cervix
* Drug: IV 1 g tranexamic acid
* Other: IV 1 g normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-90 years old female patients going through vaginal hysterctomy Exclusion Criteria: massive bleeding during operation due to major vessles injury known coagulopathies sensitivity to tranexamic acid medical need in tranexamic acid administration during operation due to bleeding

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: local tranexamic acid injection to cervix<br>1 gr of Tranexamic acid diluted in 10 ml saline | Drug: local tranexamic acid injection<br>* local tranexamic acid injection to cervix- 1 g tranexamic acid diluted in 10 ml saline<br>* Other names: Hexakapron;|
| Placebo Comparator: local normal saline injection to cervix<br>20 ml of saline | Other: local normal saline injection to cervix<br>* local normal saline injection to the cervix- 20 ml saline<br>|
| Experimental: IV 1 g tranexamic acid<br>1 gr of Tranexamic acid diluted in 100 ml saline- IV | Drug: IV 1 g tranexamic acid<br>* IV 1 g tranexamic acid diluted in 100 ml saline<br>* Other names: Hexakapron;|
| Placebo Comparator: IV 1 g normal saline<br>100 ml saline- IV | Other: IV 1 g normal saline<br>* IV 100 ml normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss during operation - measure in ml | At the end of the surgery, surgeon will measure the blood in the suction can | End of surgery |
Insulin Detemir and Waist Circumference

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the weight-sparing effect of detemir and assess glycemic control and treatment satisfaction when switching from NPH to detemir, to improve metabolic control.

Official Title
-----------------
Waist Circumference Reduction After Insulin Detemir Treatment in Type 2 Diabetes Patients Previously Treated With NPH Insulin

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duration of type 2 diabetes for at least 12 months BMI <40 kg/m2 HbA1c >7.5% Requiring basal insulin replacement and previously treated with NPH insulin
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin therapy, insulin detemir, waist circumference
Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the effect of acetazolamide as a treatment for sleep related breathing disturbances in patients with the obstructive sleep apnea syndrome living at low altitude during a sojourn at moderate altitude

Official Title
-----------------
Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Drug: acetazolamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obstructive sleep apnea syndrome, successfully on CPAP therapy Residence at low altitude (<800m) Obstructive apnea/hypopnea index >20/h and a complaint of excessive daytime sleepiness before introduction of CPAP therapy. >15 oxygen desaturations/h (>3% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP Exclusion Criteria: Sleep disorders other than OSA. More than mild cardiovascular disease, unstable or recently diagnosed (within the last 6 months) cardiovascular disease such as arterial hypertension, coronary artery or cerebrovascular disease. Any lung disease, pulmonary hypertension. Chronic rhinitis. Treatment with drugs that affect respiratory center drive (benzodiazepines or other sedatives or sleep inducing drugs, morphine or codeine derivates), stimulants (modafinil, methylphenidate, theophylline) Internal, neurologic or psychiatric disease that interfere with sleep quality. Previous intolerance to moderate or low altitude (<2600m). Exposure to altitudes >1500m for >1 day within the last 4 weeks before the study

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: acetazolamide|acetazolamide 2 times 250mg per day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness |  | during treatment while at altitude | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure endothelial function |  | during treatment while at altitude | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
apnea, sleep, altitude, hypoxia
Classification of Adenocarcinoma of the Esophagogastric Junction

Study Overview
=================
Brief Summary
-----------------
The Siewert classification of oesophageal cancer is the standard approach in anatomically subdividing cancer of the lower oesohagus.

Detailed Description
-----------------
Retrospective review of tumour biology, pathological staging and outcomes in the participants based on Siewert classification. The investigators to scrutinise this scoring system to evaluate if it is indeed appropriate.

Official Title
-----------------
Biologic Classification of Adenocarinoma of the Esophagus and Esophagogastric Junction (AEG) Using a Novel Data-driven System: Should it Replace or Compliment the Siewert Classification?

Conditions
-----------------
Oesophagus Cancer, Barrett Esophagus, Siewert Type I Adenocarcinoma of Esophagogastric Junction, Siewert Type II Adenocarcinoma of Esophagogastric Junction, Siewert Type III Adenocarcinoma of Esophagogastric Junction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients Exclusion Criteria: -
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 |
| --- | --- | --- |
| Overall Survival |  | 2 years |