linjc16/ctgov huggingface dataset:
Procalcitonin as a Marker of Bacterial Pneumonia

Study Overview
=================
Brief Summary
-----------------
Objective: To evaluate PCT as a marker of bacterial community acquired pneumonia in a Danish Hospital setting. To test if it is possible to reduce the use of antibiotics and the length of stay in hospital, and the willingness of the clinicians to take this new marker under advisement in their choice of treatment. The study is a randomised, controlled intervention study. All adult patients admitted to the Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract infection (e.g. CAP, acute exacerbation of COPD and bronchitis) are eligible for inclusion. Patients are randomised to have either PCT guided treatment or standard care, in which case the doctor will not learn the PCT test result. In the PCT group the antibiotic treatment will be based on serum PCT as follows: If PCT is less than 0.25 µg/L antibiotic treatment is discouraged; if PCT is greater than 0.25 µg/L antibiotic treatment is encouraged and if PCT is greater than 0.5 µg/L antibiotic treatment is strongly encouraged. The treating doctor is allowed to overrule the treatment guidelines. The control group will receive antibiotics according to usual practice. The primary endpoints are antibiotic use and length of stay in hospital. Secondary endpoint is the proportion of patients where the treating doctor chooses to disregard the guidelines.

Conditions
-----------------
Pneumonia, Bronchitis, COPD

Intervention / Treatment
-----------------
* Behavioral: No antibiotics if se-procalcitonin is below stated limit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected lower respiratory tract infection must be able to give consent Exclusion Criteria: age under 18 years not able to give consent admitted not primarily because of the respiratory tract infection hospital acquired infections

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: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: No antibiotics if se-procalcitonin is below stated limit|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic use |  |  | 
| Length of stay in hospital |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients where the doctor chooses to disregard treatment guidelines |  |  |
Evaluate Breast Masses Using a New Method of Ultrasound Contrast to Detect Abnormal Blood Flow in Breasts

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if breast imaging with ultrasound can be improved by using 1) a ultrasound attachment with two transducers and 2) a contrast agent. These changes might allow smaller blood vessels to be seen than under the way breast ultrasound is usually performed.

Detailed Description
-----------------
The purpose of this study is to determine if performing ultrasound with an attachment made up of two transducers (rather than just a single transducer) will provide more information about the blood vessels in the breast than the current attachment. The study will also examine the question of whether use of an ultrasound contrast agent will the scanner to see smaller blood vessels than are detected without the agent.

Official Title
-----------------
Characterization of Breast Masses Using a New Method of Ultrasound Contrast Agent Imaging in 3D Mapping of Vascular Anomalies

Conditions
-----------------
Breast Cancer, Breast Abnormalities

Intervention / Treatment
-----------------
* Procedure: Ultrasound Imaging with Contrast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects who have breast masses and scheduled for core biopsy. Exclusion Criteria: Pregnant or lactating females. Females who have heart problems or sensitivity to contrast agents. Females who have had previous surgery for breast cancer.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Ultrasound Imaging<br>Ultrasound Imaging with Contrast | Procedure: Ultrasound Imaging with Contrast<br>* An ultrasound contrast agent, Definity, will be administered started through the IV line already in use. The imaging will be performed to map vascular flow. The breast will be scanned by a double ultrasound transducer system in a holder over the area of the breast to be biopsied. The machine will be set with different settings and the scan repeated, possibly multiple times.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ondansetron for the Treatment of Methamphetamine Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess ondansetron for the treatment of methamphetamine dependence.

Detailed Description
-----------------
This study was designed to be a preliminary assessment of the efficacy and safety of 3-wide range doses of ondansetron (0.25, 1.0 and 4.0 mg taken orally twice per day) to reduce methamphetamine use in subjects with methamphetamine dependence and to determine the optimal dose of ondansetron.

Official Title
-----------------
Double-Blind, Placebo-Controlled, Dose Response Trial of Ondansetron for the Treatment of Methamphetamine Dependence.

Conditions
-----------------
Amphetamine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Ondansetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age. Treatment seeking for meth dependence. Exclusion Criteria: Please contact site director for more details.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ondansetron|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinicial improvement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amphetamine dependence
Impact of CES1 Genotype on Metabolism of Methylphenidate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether differences in the gene coding for the liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of methylphenidate, a CES1 dependent drug.

Official Title
-----------------
Impact of CES1 Genotype on Metabolism of Methylphenidate

Conditions
-----------------
Carboxylesterase 1 (CES1) Genotype, CES1 Activity

Intervention / Treatment
-----------------
* Drug: Methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old Caucasian Exclusion Criteria: Chronic disease (except hay fever and eczema) Pregnancy Smoking High level of alcohol consumption (> 21 units per week for men and 14 for women) Known allergy towards methylphenidate Permanent use of medication (contraception ok)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylphenidate<br> | Drug: Methylphenidate<br>* 10 mg as a single dose followed by one blood sample 3 hours post-dose<br>* Other names: Ritalin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of methylphenidate and ritalinic acid | We are looking at the ratio of methylphenidate to ritalinic acid (metabolite) 3 hours post-dose as a measure of CES1 activity. | Predose and 3 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomic Profile | Three samples for each participant during the trials (as indicated above). Metabolomics will be assessed with focus on lipids (lipid platform) and with use of usual concentration measures (eg nanomolar (nM)) | Predose/pre-meal, predose/post-meal and 3 hours post-dose |
Cognitive-behavioral Therapy for Generalized Anxiety Disorder in Primary Care

Study Overview
=================
Brief Summary
-----------------
The feasibilty and preliminary comparative effectiveness of two methods of cognitive-behavioral therapy - metacognitive therapy and intolerance of uncertainty therapy - for primary care patients with generalized anxiety disorder is investigated in a pilot study using a randomized controlled design. Purpose of the study is to examine the feasibility of a full-scale randomized controlled trial. Research questions primarily concern recruitment, measurement, and adherence.

Official Title
-----------------
Metacognitive Therapy and Intolerance of Uncertainty Therapy for Generalized Anxiety Disorder in Primary Care: Randomized Controlled Pilot Study

Conditions
-----------------
Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Metacognitive therapy
* Behavioral: Intolerance of uncertainty therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of generalized anxiety disorder Age 18 years or above Being able to understand and speak Swedish without interpreter support Exclusion Criteria: Psychosis, bipolar disorder, severe depressive symptoms, risk of suicid, substance use disorder, intellectual disability Simultaneous psychological treatment If pharmacological treatment, it needs to be stable prior to and during treatment

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metacognitive therapy<br> | Behavioral: Metacognitive therapy<br>* Metacognitive therapy is a form av cognitive-behavioral therapy which aims to change cognitions about worry in patients with generalized anxiety disorder.<br>|
| Experimental: Intolerance of uncertainty therapy<br> | Behavioral: Intolerance of uncertainty therapy<br>* Intolerance of uncertainty therapy is a form av cognitive-behavioral therapy which aims to reduce cognitive and behavioral avoidance of uncertain situations or cognitions which lead to worry in patients with generalized anxiety disorder.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penn State Worry Questionnaire - measure of symptom change | A self-reported symptom measure of worry | Change from baseline symptoms at 12 weeks |
Impact of Total Thyroidectomy on Voice and Swallowing

Study Overview
=================
Brief Summary
-----------------
Purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and swallowing function.

Detailed Description
-----------------
Voice and swallowing alterations are frequently reported after thyroidectomy, even in the absence of nerve injury. These impair quality of life. Purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and swallowing function. Patients will be assessed using the Greek- version of Voice Handicap Index (VHI) and a questionnaire developed by the authors regarding swallowing symptoms. Furthermore they will undergo flexible laryngoscopy for evaluation of laryngeal mobility.

Official Title
-----------------
Study of Total Thyroidectomy Effect on Voice and Swallowing Function

Conditions
-----------------
Thyroidectomy, Voice Alteration, Swallowing Alteration

Intervention / Treatment
-----------------
* Other: Endoscopy of larynx
* Other: Voice Handicap Index
* Other: Swallowing Assesment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients submitted to total thyroidectomy during the study period Exclusion Criteria: Previous thyroid/ neck surgery Documented voice disorders
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients<br>patients undergoing total thyroidectomy | Other: Endoscopy of larynx<br>* Endoscopic Laryngeal mobility assessment<br>Other: Voice Handicap Index<br>* Subjective Evaluation of Voice disorders<br>Other: Swallowing Assesment<br>* Swallowing function questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective voice evaluation | Greek- version of Voice Handicap Index (VHI) | 1 Day preoperatively | 
| Subjective voice evaluation | Greek- version of Voice Handicap Index (VHI) | 1 week postoperatively | 
| Subjective Voice Evaluation | Greek- version of Voice Handicap Index (VHI) | 1 month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swallowing evaluation | questionnaire on swallowing symptoms | 1 day preoperatively | 
| Swallowing evaluation | questionnaire on swallowing symptoms | 1 week postoperatively | 
| Swallowing evaluation | questionnaire on swallowing symptoms | 1 month postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total thyroidectomy, voice handicap index, swallowing disorders, thyroid surgery, voice disorders
A Cohort Study on Thrombectomy for Stroke

Study Overview
=================
Brief Summary
-----------------
The cerebral collateral circulation refers to the subsidiary network of vascular channels that stabilize cerebral blood flow when principal conduits fail. Collateral status differs among patients with acute ischemic stroke. Relatively sparse attention has been devoted to the role of baseline collateral circulation in patients with acute ischemic stroke who are candidates for revascularization. This study aim to investigate the correlation between baseline collateral circulation and the likelihood of opening of an arterial occlusion, the extent of reperfusion, tissue injury and clinical impairment.

Official Title
-----------------
Registrated Cohort Study on Thrombectomy for Stroke

Conditions
-----------------
Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years. Mechanical thrombectomy initiated within 24 hours after onset CT perfusion can be performed before the initiation of thrombectomy and 24h after thrombectomy Exclusion Criteria: Contraindication to imaging with contrast agents Delay between imaging and beginning of thrombectomy > 90 minutes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Modified Rankin Scale | Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset | 3 month |
Clonal Evolution of B Cells in High-risk CLL After Idelalisib-rituximab

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the evolution of B cells at a genetic and surface-marker level in high-risk CLL after idelalisib-rituximab treatment. The targeted population includes 20 subjects ages 18 or older diagnosed with high-risk CLL. This will include patients with relapsed or refractory disease who require therapy with idelalisib and rituximab as per FDA label. This is an observational study for peripheral blood samples of these patients collected at pre-determined time points.

Official Title
-----------------
Clonal Evolution of B Cells in High-risk Chronic Lymphocytic Leukemia Patients After Idelalisib-rituximab Treatment

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Other: Biospecimen Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 Ability to provide informed consent Ability to provide peripheral blood samples Diagnosis of CLL Indication(s) for CLL therapy At least one criterion for high-risk disease Disease refractory (e.g., no response) to at least one round of chemotherapy Disease that has relapsed (i.e., returned) after at least one round of chemotherapy Proven presence of the 17p deletion within CLL cells Planned receipt of idelalisib-rituximab as per FDA guidelines and patient's oncologists Exclusion Criteria: Patients who do not meet the diagnostic criteria for CLL or at least one indication for treatment. Patients who are receiving idelalisib with an off-label indication Patients who do not or cannot provide informed consent to donate peripheral blood tumor samples to our stem cell core facility Patients who do not provide informed consent to collect clinical, prognostic, and outcomes data during the time period that they are treated with idelalisib-rituximab

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

| Intervention/Treatment |
| --- |
|Other: Biospecimen Collection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of somatic hypermutation |  | 12 months |
Study of Vitamin A and Carbomer in Comforting the Ocular Surface Irritations of Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
Most of the patients under long application of anti-glaucoma eyedrops endure severe ocular surface irritation, which interrupt their quality of life a lot. Lots of studies aimed to search for new drugs for therapy. The investigators hypothesized that the artificial tears containing vitamin A or carbomer may be a great substitute. Both of the two drugs were in common use and had already been tested in animals.

Conditions
-----------------
Primary Open-angle Glaucoma

Intervention / Treatment
-----------------
* Drug: Vitamin A
* Drug: carbomer eye gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - diagnosed primary open-angle glaucoma or normal tension glaucoma patients with prostaglandin analogs treatment for more than one year. Exclusion Criteria: any systemic diseases which may cause ocular damage; previous ocular trauma or surgery; contact lens wear history in previous 6 months; application of any artificial tears 3 months ago; allergic to any of the drugs we used during examination.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin A palmitate eye gel<br>0.1% vitamin A palmitate; Sinqi, Shenyang, China | Drug: Vitamin A<br>* use one drop in the eye<br>* Other names: vitamin A palmitate eye gel;|
| Experimental: carbomer eye gel<br>0.2% Carbomer 940; Bausch & Lomb, Aschheim, Germany | Drug: carbomer eye gel<br>* use one drop in the eye<br>* Other names: Carbomer Eye Drops;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of the density of conjunctival goblet cells |  | change from Baseline in goblet cell density at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tear film parameters changes in patients |  | change from baseline in TBUT and Schirmer test at 6 months | 
| changes of ocular irritation in patients |  | change from baseline in OSDI scores at 6 months |