linjc16/ctgov huggingface dataset:
MyVHL: Patient Natural History Study

Study Overview
=================
Brief Summary
-----------------
MyVHL is a multi-patient database which helps researchers identify patterns across VHL patients. MyVHL provides you -and researchers -with more complete information about VHL, like how your lifestyle, medications, and other factors impact the disease and quality of life. These insights help you better understand the condition and help researchers know where to focus their efforts. Due to its rarity, there is less understanding of VHL and the factors that may have an impact. The data individuals provide in MyVHL helps researchers identify and uncover factors that may increase risk, inhibit or slow tumor growth, or lead to an effective cure.

Official Title
-----------------
MyVHL: Patient Natural History Study

Conditions
-----------------
Von Hippel-Lindau Disease, Hereditary Leiomyomatosis and Renal Cell Cancer, Birt-Hogg-Dube Syndrome, SDHB Gene Mutation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with von Hippel-Lindau Disease (VHL) Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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 |
| --- | --- | --- |
| Number of patients with CNS, kidney, adrenal, retinal, thyroid, ear, and pancreatic tumors, along with cystadenomas and lesions in the lungs, liver and skin, as they relate to VHL, BHD, HLRCC, and SDHB and specific genetic mutation. | Data regarding changes in number of CNS, kidney, adrenal, retinal, ear, and pancreatic tumors, along with cystadenomas and lesions in the lungs, liver and skin, over a lifetime. | Through study completion, an average of 1 year. | 
| Size of tumors in patients with CNS, kidney, adrenal, retinal, thyroid, ear, and pancreatic tumors, along with cystadenomas and lesions in the lungs, liver and skin, as they relate to VHL, BHD, HLRCC, and SDHB and specific genetic mutation. | Data regarding changes in size of CNS, kidney, adrenal, retinal, ear, and pancreatic tumors, along with cystadenomas and lesions in the lungs, liver and skin, over a lifetime. | Through study completion, an average of 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VHL, BHD, HLRCC, SDHB, MyVHL
Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment initiation. To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7

Detailed Description
-----------------
The aim of the present study was to compare azithromycin tear and conjunctival ocular concentrations after one instillation of T1225 1.5% eye drops, twice a day during one day versus one instillation of T1225 1.5% eye drops, twice a day during 3 days versus an oral single dose of 1g azithromycin.

Official Title
-----------------
Comparison of Azithromycin Level in Tears and in Conjunctiva After Repeated Instillations of T1225 1.5% Eye Drops or After a Single Per Os Administration of Zithromax® (Azithromycin 1g), in 36 Healthy Volunteers

Conditions
-----------------
Eye Infections, Bacterial

Intervention / Treatment
-----------------
* Drug: Azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent; Healthy volunteers; Registered in the national register of healthy volunteers; Male or female aged from 18 to 45 years old; Able to understand the study instructions; Likely to comply with the study schedule and treatment; Normal subjective ocular symptoms, Schirmer test > 10 mm in 5 min and corrected visual acuity >= 6/10 in both eyes Exclusion Criteria: Ocular trauma, infection or inflammation within the last 3 months; Blepharitis; Conjunctival hyperaemia (score >= 2); Fluorescein-stained punctuations (score >= 1b); Hypersensitivity to one of the products used in the study; Clinically relevant allergy; Medical or surgical history incompatible with the study; Recent acute illness; Ocular surgery, including LASIK, LASEK and PRK within the last 12 months; Other ocular lasers or Zithromax® or Azadose® within the last 3 months; Systemic antibiotics and ocular medications within the last month; Contact lenses within the last week; Any medication on Day 0 and during the study (except paracetamol and contraceptives).

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14. |  |  | 
| Azithromycin Tear Concentrations on Day 7. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance |  |  |
The Butler-Program 2.0: An Internet Platform for Elderly

Study Overview
=================
Brief Summary
-----------------
In this study, effectiveness of an internet based intervention (Butler 2.0) for elderly is tested. Participants (n= 60) will be randomly assigned to two different groups (intervention vs. waitlist). Outcomes in terms of loneliness and quality of life will be assessed at pre-, post (6 weeks) and follow-up (3 months).

Detailed Description
-----------------
Elderly people (age 65+ ) in Zurich will have access to the Butler program 2.0. Butler 2.0 has been designed for elderly with little experience in the use of computers. Several means of communication such as e-mail, video conferencing, chat and a blog are united on this platform. Furthermore, relaxation exercises are offered in the form of virtual walks.

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Other: Butler-Program 2.0


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 65 years or older comprehension of German language access to Internet Exclusion Criteria: suicidality poor eyesight which makes use of intervention impossible

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Access to Butler-Program 2.0 | Other: Butler-Program 2.0<br>* Internet based intervention for elderly, in which they learn how to use e-mail, video conferencing and a blog, in addition to virtual relaxation exercises.<br>|
| No Intervention: Waitlist<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Quality of Life (WHOQL)-BREF | Quality of life | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geriatric Depression Scale | Depression | 3 months | 
| State-Scale of the State-Trait Anxiety Inventory (STAI-S) | Anxiety | 3 months |
Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency

Study Overview
=================
Brief Summary
-----------------
The etiology of immune-mediated diabetes mellitus (IMD) remains unclear. However, previous studies indicate that autoimmunity may be a result of dysfunction of natural killer T cells (NK-T cells). Newly diagnoses patients with IMD have been shown in our laboratory to have significantly lower NK-T cells than normal controls. Other studies have shown that oral administration of lactobacillus can boost NK-T cell activity in children with HIV without side effects. Our objective is to evaluate the effect of lactobacillus administration on NK-T cell activity in patients with IMD

Official Title
-----------------
Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Oral lactobacillus administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Recently diagnosed (within the last 6 months) patients with immune-mediated (type 1) diabetes

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 95 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral lactobacillus administration|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
-----------------
Immune-mediated diabetes mellitus
Patient Experiences in Rheumatology

Study Overview
=================
Brief Summary
-----------------
Information was entered by mistake by a Research Assistant. Study never went beyond the initial discussion phase.

Official Title
-----------------
Communication Skills in Rheumatology Fellows

Conditions
-----------------
Rheumatic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
All adult patients who have an appointment scheduled at the Rheumatology Clinic at Good Samaritan Hospital, can speak and read English and are willing and capable of providing informed consent are eligible to participate. All fellows in the Rheumatology Fellowship training program will participate.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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 |
| --- | --- | --- |
| Changes in patient and provider satisfaction scores will be measured at baseline and 6 months using self-report. |  | Baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
communication, patient experience, fellowship training
Anesthesia With Endotracheal Laser Tube

Study Overview
=================
Brief Summary
-----------------
The study examines the special endotracheal laser tube during anesthesia of endolaryngeal laser surgery.

Detailed Description
-----------------
The special endotracheal tube is covered by a special aluminum tape.

Official Title
-----------------
Anesthesia of Endolaryngeal Surgery With a Special Endotracheal Laser Tube

Conditions
-----------------
Anesthesia, Anesthesia Morbidity

Intervention / Treatment
-----------------
* Other: Application of ET laser tube in propofol anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laser surgery Exclusion Criteria: allergy of propofol

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| anesthesia with laser tube<br>The special endotracheal (ET) laser tube is tested during endolaryngeal laser surgery. Anesthesia type is the total intravenous anesthesia with propofol. We tested the application of ET laser tube in propofol anesthesia. | Other: Application of ET laser tube in propofol anesthesia<br>* The special ET laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Side Effects | problem with airway or special laser tube | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laser, endotracheal tube, total intravenous anesthesia, side effect, endolaryngeal surgery
Comparison Between Different Doses of Steroids in COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
aim of this study is to compare between standard dose methyl prednisolone and mega dose methyl prednisolone as regards outcome reflected by mortality rate, percentage of mechanically ventilated patients and icu length of stay of covid 19 patients admitted in intensive care unit.

Detailed Description
-----------------
Retrospective study for comparison between standard dose methyl prednisolone and mega dose methyl prednisolone as regards outcome reflected by mortality rate ,percentage of mechanically ventilated patients and icu length of stay of covid 19 patients admitted in intensive care unit. Previous studies suggested that cytokine release syndrome could be involved in the pathophysiology of critical SARS.COV.2 resulting in death so early suppression of cytokine storm may be lifesaving in critical patients.

Official Title
-----------------
Comparison Between Standard Dose Methyl Prednisolone and Megadose Methyl Prednisolone as Regards Outcome in SARS.COV.2 Patients in Intensive Care Unit : Retrospective Study

Conditions
-----------------
Critical Illness, Pneumonia, Viral

Intervention / Treatment
-----------------
* Other: observation for outcome of methylprednisolone dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All icu admitted covid 19 patients with positive PCR, diagnosed by CT chest and needing oxygen therapy Exclusion Criteria: Not requiring oxygen therapy Negative PCR Uncontrolled blood sugar or DKA Patients on long term steroids therapy
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group treated with standard dose methyl prednisolone<br>patients with positive PCR and requiring oxygen therapy | Other: observation for outcome of methylprednisolone dose<br>* no intervention as it is retrospective study for outcome<br>|
| group treated with mega dose methyl prednisolone<br>patients with positive PCR and requiring oxygen therapy | Other: observation for outcome of methylprednisolone dose<br>* no intervention as it is retrospective study for outcome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 days mortality rate | observation for mortality rate in both groups | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mechanical ventilation and icu length of stay | observation for percentage of mechanically ventilated patients and length of stay | up to 3 months |
Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.

Official Title
-----------------
A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Safety of Extended Treatment With Brexpiprazole (OPC-34712) to Patients With Agitation Associated With Dementia of the Alzheimer's Type

Conditions
-----------------
Agitation Associated With Dementia of the Alzheimer's Type

Intervention / Treatment
-----------------
* Drug: Brexpiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial. Patients whose caregiver can properly collect the necessary information. Exclusion Criteria: Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial. Patients who had delirium during the double-blind trial.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 89 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: Brexpiprazole<br> | Drug: Brexpiprazole<br>* Brexpiprazole 1mg or 2mg will be orally once daily for 14 weeks<br>* Other names: OPC-34712;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of Adverse events |  | From baseline to week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Cohen-Mansfield Agitation Inventory (CMAI) score at 14 weeks after dosing |  | Baseline and 14 weeks after dosing | 
| Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 14 weeks after dosing |  | Baseline and 14 weeks after dosing | 
| Mean change from baseline in Clinical Global Impression of Improvement (CGI-I) score at 14 weeks after dosing |  | Baseline and 14 weeks after dosing |
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, the project focuses on the importance of dopamine signaling in the process. Participants will have two different brain scans (MRI and PET scan). They will also have treatment for your depression with an FDA approved medication, lurasidone (Latuda). The study is funded by the Columbia University Irving Institute to improve the treatment of bipolar disorder.

Official Title
-----------------
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder

Conditions
-----------------
Bipolar Depression

Intervention / Treatment
-----------------
* Drug: Lurasidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bipolar I disorder, bipolar II disorder or other specified bipolar disorder Currently in a major depressive episode and moderately depressed Age 18-50 years old Patients on psychiatric medications will not be benefitting from those medications Females of childbearing potential must be willing to use an acceptable form of birth control throughout the study Exclusion Criteria: Diagnosis of schizophrenia or other psychotic disorders, recent alcohol or substance use disorder, recent anorexia or bulimia nervosa Previous failed trial of lurasidone, or had intolerable side effects of lurasidone Significant active physical illness Actively suicidal ECT within the past 6 months Recent pregnancy, abortion or miscarriage or plans to conceive during the study; currently lactating Metal in the body that is not MRI compatible Current, past or anticipated exposure to radiation Currently taking an anticoagulant medication

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lurasidone<br>Open-label treatment with lurasidone within the dose range of 20-60 mg daily | Drug: Lurasidone<br>* Participant will have an open label trial of lurasidone for eight weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale | Measures severity of depression symptoms; Scale from 0 to 54; higher numbers mean greater depression severity, so a decrease in score is a better outcome. | 15 minutes |