linjc16/ctgov huggingface dataset:
Change in Airway Responsiveness After Allergen Exposure

Study Overview
=================
Brief Summary
-----------------
Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The investigators will look at whether or not exposure to allergens changes the way the airway responds to a different stimuli (mannitol) and compare that with the known stimuli (methacholine).

Official Title
-----------------
Allergen Induced Increase in Indirect Non-allergic Bronchial Reactivity

Conditions
-----------------
Allergic Asthma

Intervention / Treatment
-----------------
* Drug: Mannitol
* Drug: Methacholine Chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild, allergic asthma FEV1 greater than 70% predicted methacholine PC20 less than or equal to 16mg/ml Exclusion Criteria: known sensitivity to mannitol or other excipient diagnosis of any other respiratory or non respiratory disease/disorder that would preclude the individual from participating recent thoracic, abdominal or eye surgery recent allergen exposure (4 weeks), respiratory infection (6 weeks) current immunotherapy pregnancy history of anaphylaxis use of asthma therapies other than short acting beta agonist

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mannitol<br>This arm will assess the allergen induced change in airway responsiveness to mannitol bronchoprovocation. | Drug: Mannitol<br>* Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)<br>* Other names: Aridol;|
| Active Comparator: Methacholine Chloride<br>This arm will assess the allergen induced change in airway responsiveness to methacholine bronchoprovocation. | Drug: Methacholine Chloride<br>* Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)<br>* Other names: Provocholine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in airway responsiveness three hours after allergen exposure |  | Change from Baseline at 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, allergies, mannitol, methacholine
Inflammatory Markers and Cognitive Function in Major Depression

Study Overview
=================
Brief Summary
-----------------
Major depression is accompanied by cognitive changes as well as alterations in multiple physical functions. The inflammatory system is altered generally toward a pro-inflammatory state. Antidepressants are associated with a decrease in this proinflammatory state. This study aims to generate pilot data concerning a possible link between cognition, inflammation and response to treatment. The cognitive function of subjects with major depression will be tested before and after treatment with duloxetine. Inflammatory markers will be measured at both time points.

Official Title
-----------------
Inflammatory Markers and Cognitive Function in Major Depression:a Pilot Study

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-50 Primary diagnosis of major depression Ability to give informed consent Exclusion Criteria: Neurologic disorders affecting cognition Unstable or untreated medical disorders Medical disorders associated with pain Recent pregnancy or delivery Psychiatric disorders other than MD which are the primary focus of treatment Treatment with antidepressants in the past 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine treatment<br>Subjects with major depression will be entered into the trial and treated with open label duloxetine | Drug: Duloxetine<br>* Subjects with major depression will be entered into the trial and treated with duloxetine 30 mg for one week, followed by 60 mg for 8 weeks. The option of increasing the dose as clinically indicated to 120mg is possible for the last 4 weeks of the study intervention<br>* Other names: Cymbalta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function measured by CANTAB | Correlation between cytokines and cognitive function | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain inhibition | Correlation between depression, antidepressant treatment status, inflammation and inhibition of perception of pain stimulus | 12 weeks | 
| Allostatic load | Correlation between depressive symptoms, antidepressant treatment status and allostatic load | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Inflammation, Cognition, Pain, Allostatic load
Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection

Study Overview
=================
Brief Summary
-----------------
Leakage is the most common complication after laparoscopic sleeve gastrectomy which may amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A) injection into the pyloric sphincter during the operation may decrease the risk of postoperative gastric leakage.

Detailed Description
-----------------
Laparoscopic sleeve gastrectomy (LSG) provides similar weight loss and resolution of obesity comorbidities to that of duodenal switch and Roux-en-Y gastric bypass. Inspite of its encouraging results, the pretended feasibility of the operative procedure can be associated with a remarkable operative morbidity. The main reason is gastric leakage from stable line which occurs in about 0-20% of the cases. The main accepted cause of leakage is formation of a high gastric tube pressure. Injection of BTX-A into the pyloric sphincter intraoperative will cause temporal paralysis of pyloric sphincter muscles postoperatively; so the pressure inside the gastric pouch will be decreased abolishing the formation of high pressure tube with subsequent leakage.

Official Title
-----------------
Laparoscopic Sleeve Gasterectomy With or Without Pyloric Sphincter Botulinum Neurotoxin Injection: a Comparative Study

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: laparoscopic sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index >40 or >35 with hypertension or DM Exclusion Criteria: Previous bariatric surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LSG<br>patients undergoing laparoscopic sleeve gastrectomy without BTX-A injection into the pyloric sphincter | Procedure: laparoscopic sleeve gastrectomy<br>* creation of a gastric tube of 100cc using a stapler.<br>|
| Active Comparator: BTX-LSG<br>patients undergoing laparoscopic sleeve gastrectomy with BTX-A injection into the pyloric sphincter | Procedure: laparoscopic sleeve gastrectomy<br>* creation of a gastric tube of 100cc using a stapler.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number pf patients developing postoperative gastric leakage |  | 0ne year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of patients with excess weight loss |  | one year |
Assessment of Sedation During Endoscopy

Study Overview
=================
Brief Summary
-----------------
Use of sedation is often required in endoscopic procedures such as ERCP (endoscopic retrograde cholangiopancreatography). However, assessment of the level of sedation during these procedures is not investigated in detail. The purpose of this study is to compare different sedation scales and bispectral index during sedation in endoscopic procedures in order to find the best suited assessment method for sedation under these conditions.

Official Title
-----------------
Assessment of Sedation During Endoscopy, a Prospective Validation Study

Conditions
-----------------
Sedation

Intervention / Treatment
-----------------
* Device: Bispectral Index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing endoscopic procedure in the endoscopy unit in HUCH Exclusion Criteria:
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopy patients<br>Patients undergoing endoscopy in the endoscopy unit in HUCH (Helsinki University Central Hospital). | Device: Bispectral Index<br>* use of BiS-monitor in the assessment of the level of sedation in patients receiving sedation in endoscopy procedures when compared to clinical sedation scales, such as the Richmond agitation-sedation score.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of sedation | Sedation measured by Bispectral Index (BiS) compared with RASS (Richmond Agitation-Sedation Score), MOAA/S (Modified Observer's Assessment of Alertness/Sedation) and Ramsay sedation score | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, PCS, Sedation, Bispectral index, Endoscopy
A Question Prompt Sheet for Depressive Outpatients

Study Overview
=================
Brief Summary
-----------------
question prompt sheet for outpatients suffering from depression. effects on patient-doctor-communication during the consultation.

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: question prompt sheet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years male and female patients outpatients informed consent Exclusion Criteria: poor German language skills

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?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>question prompt sheet | Behavioral: question prompt sheet<br> <br> |
| No Intervention: control<br>no question prompt sheet | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Tazocin Intervention Study

Study Overview
=================
Brief Summary
-----------------
To determine the value of using piperacillin/tazobactam in reducing the cases of extended spectrum beta lactamases (ESBL) producing E. coli or K. pneumoniae colonization and infection. To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both pre-and post-intervention in the selected medical centers.

Official Title
-----------------
Association of Antibiotic Utilization Measures and Control of ESBLs Producing Bacteria

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Tazocin (Piperacillin/Tazobactem)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted or transferred to the ICU/pulmonary/Infection units Patients of either sex, 18 years of age or older Patients who stay in units less than 48 hours will not be enrolled.

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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tazocin (Piperacillin/Tazobactem)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months; post-intervention) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The infection rate due to ESBL producing E. coli or K. pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months; post-intervention) |  |  |
Characterization of Breast Masses Incidentally Detected on Chest CT

Study Overview
=================
Brief Summary
-----------------
Although Computed tomography (CT) is not routinely used to evaluate beast masses, It is common to discover Incidental breast lesions on chest CT. The goal of this study is to investigate the incidence and appearance of incidentally discovered breast masses on chest CT.

Official Title
-----------------
Characterization of Breast Masses Incidentally Detected on Chest CT - a Prospective Study

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman with incidentally discovered breast masses on chest CT Exclusion Criteria: Male gender Known breast cancer

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient enrollment | Enrolling 100 patients with breast masses to study | One year |
Turmeric Effect on Reduction of Serum Prolactin and Related Hormonal Change and Adenoma Size in Prolactinoma Patients

Study Overview
=================
Brief Summary
-----------------
Prolactinoma is the most prevalent anterior hypophysis tumor. The principal treatment for this disorder is Dopamine agonist drugs including bromocriptin and Cabergoline. However, 50% of Bromocriptin treated and 17% of Cabergoline treated patients are resistant to these drugs. Curcumin is the main derivative of turmeric ,an old spice which is used frequently in Indian and Iranian cuisine. It has been proved that curcumin can reduce mammotrope cells proliferation and also intracellular hormone production. The purpose of this study is to evaluate the effect of turmeric on prolactinoma patients.

Conditions
-----------------
Hyperprolactinoma

Intervention / Treatment
-----------------
* Drug: Curcumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hyperprolactinemia microprolactinoma Exclusion Criteria: pregnancy macroadenoma neurologic signs due to tumor

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Curcumin|Curcumin is prescribed to new cases of hyperprolactinoma|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum prolactin level |  | 2weeks and one month after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in LH,FSH and estradiol from baseline |  | one month ofter treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyperprolactinoma, turmeric, amenorrhea
Nuchal Cord Detection in Sonographic Evaluation by a First Year Resident.

Study Overview
=================
Brief Summary
-----------------
The investigators aim to prove that minimal sonographic training for nuchal cord detection in an unexperienced first year medical resident is more than enough to detect the phenomenon. Patients undergoing elective cesarean section will undergo a routine ultrasound (that is performed to detect the fetal heart rate and the fetal presentation) during which the resident will attempt to detect nuchal cord. The resident will then attend the patient's surgery to verify the findings.

Detailed Description
-----------------
Patients undergoing elective cesarean section will undergo a routine ultrasound examination during which fetal heart rate, fetal presentation and nuchal cord presence will be documented. During surgery, after the fetus is delivered, presence or lack of nuchal cord will be documented. The aim of the study is to show that minimal sonographic training may assist even an unexperienced sonographist in detection of such a subtle yet important phenomenon. The study will be performed utilizing the newest resident in the OBGYN department.

Official Title
-----------------
The Efficiency in Nuchal Cord Detection in Sonographic Evaluation as Performed by an Unexperienced First Year Resident With Minimal Training.

Conditions
-----------------
Fetal Cord Entanglement

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any woman undergoing elective cesarean section. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elective cesarean section<br>Any patient undergoing elective cesarean section. Ultrasound | Diagnostic Test: Ultrasound<br>* Pre-operational ultrasound for the detection of fetal heart rate, fetal presentation and presence of nuchal cord.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate for nuchal cord. | Detection of nuchal cord in a pre-op ultrasound and verification of the sonographic findings during surgery. | up to 6 hours from admission for elective surgery. |
Duration Threstholds of Intraoperative Hypotension

Study Overview
=================
Brief Summary
-----------------
Intraoperative hypotension is common in non cardiac surgery. longer duration of intraoperative hypotension is related with postoperative morbidity and mortality. however, with the change of hypotension criteria, the duration threshold also change. the relationship of different hypotension criteria and its duration is unclear. This study is to explore the their relationship.

Detailed Description
-----------------
Intraoperative hypotension is common in non cardiac surgery. longer duration of intraoperative hypotension is related with postoperative morbidity and mortality. however, with the change of hypotension criteria, the duration threshold also change. the relationship of different hypotension criteria and its duration is unclear. This study is to explore the relationship between continous difference mean blood pressure criteria and its duration thresholds for postoperative major adverse events, which include acute cardiac infarction, heart failure, cardiac death, stroke and acute kidney injury.

Official Title
-----------------
Duration Threstholds of Intraoperative Hypotension for Postoperative Major Adverse Events

Conditions
-----------------
Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults underwent elective non-cardiac surgery Exclusion Criteria: cardiac surgeries; kidney surgeries; obstetric surgeries; local infiltration anesthesia; surgeries without arterial pressure monitoring; perioperative data missing; patients with more than one operation within a year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| major adverse events | including acute cardiac infarction, heart failure, cardiac death, stroke, kidney injury | 30 days postoperatively in hospital |