linjc16/ctgov huggingface dataset:
Mobile Sensing and Support for Depression

Study Overview
=================
Brief Summary
-----------------
The objective of this study is two fold, first to explore the potential of context sensitive intervention delivery to provide in-situ support for people with depressive symptoms, second to explore the detection of daily-life behavior based on smart phone sensor information to identify subjects with a clinically meaningful depression level.

Detailed Description
-----------------
To conduct a very first pilot trial, a monocentric, single-arm clinical study is conducted. The study is approved by the local ethics committee of the Canton of Zurich in Switzerland and the Swiss Agency for Therapeutic Products. It is conducted in full accordance with the Declaration of Helsinki, with all subjects providing their electronic informed consent prior to participation. As the main interest lies in a proof of concept of the proposed MOSS app, emphasis is put on real life conditions. A range of different recruitment channels is used to attract subjects from the general public; they include physical flyers, online posts on relevant online bulletin boards and the Google Play Store.

Official Title
-----------------
Monocentric Study for Development of a Smartphone Application for Patients With Depressive

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

Intervention / Treatment
-----------------
* Device: Mobile sensing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self-declaration of depressive symptoms app runs on Android 4.0 and higher germen speaking Exclusion Criteria: psychotic symptoms bipolar symptoms drug or alcohol dependency dementia

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

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

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

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 |
| --- | --- |
| Other: Mobile Sensing<br>This phase of the study is designed to develop the app. due to algorithms the app should lern to detect depressive symptoms | Device: Mobile sensing<br> <br> * Other names: Mobile app;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire - for depression (PHQ-9) | subjective depressive symptoms to compare the detected symptoms measured by the app This outcome is needed for the sensing part of the study | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client Satisfaction Questionnaire (ZUF-8)- measures client satisfaction with the app | Client satisfaction with the app is assessed | at post (at least 6 weeks after baseline) however some participants will use the app longer than 6 weeks, maximum 6 months |
Newborn Screening for Severe Combined Immunodeficiency (SCID) in a High-Risk Population

Study Overview
=================
Brief Summary
-----------------
The goal of the proposed research is to establish the validity of a newborn screening method for severe combined immunodeficiency (SCID). The assay to be used is developed on the basis of PCR quantification of T-cell receptor excision circles (TRECs) that is absent in SCID patients, thus correlating with the disease

Detailed Description
-----------------
To show that early diagnosis of SCID with a TREC screening assay can warrant timely treatment of the disease and avoid life-threatening infections on patients. Babies with SCID are unable to fight infections. They become severely ill in their first months of life and do not survive unless their immune systems can be restored. SCID can be treated by bone marrow transplant if recognized early. The newborn screening test to be employed in this study is designed to diagnose SCID before infections occur. By conducting a pilot testing program in a high-risk population on the Navajo Indian Reservation, where one in 2,000 infants is born with SCID, we hope to confirm the benefits of newborn screening for early diagnosis of SCID

Official Title
-----------------
Newborn Screening for SCID in a High-Risk Population

Conditions
-----------------
Severe Combined Immunodeficiency, T Cell Lymphocytopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth in a study hospital on the Navajo Reservation Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 30 Days

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
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TREC, T cell, Primary Immunodeficiency, PID, Navajo, SCID
Feasibility Study of Blood Glucose Monitoring With the Non-invasive Medical Device D-Base

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the feasibility of monitoring the blood glucose values by measuring the glucose in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus type 1 and 2.

Detailed Description
-----------------
The investigation is designed as an open, monocentric, non-randomized, single-arm, explorative study in adult subjects with type 1 or 2 diabetes mellitus (any therapy form). The clinical investigation will be performed in an outpatient setting on up to two study days with up to 100 subjects. A nearly equal number of subjects with diabetes type 1 and 2 shall participate in the study.

Official Title
-----------------
Feasibility of Predicting Blood Glucose Values by Measuring in the Interstitial Fluid of the Skin on the Wrist With the Non-invasive Medical Device D-Base

Conditions
-----------------
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of type 1 or type 2 diabetes HbA1c <10% An understanding of and willingness to follow the protocol Signed informed consent Exclusion Criteria: Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment Hypoglycemia unawareness Have extensive skin changes/diseases at the proposed measurement site (wrist) that could interfere with the accuracy of glucose measurements. Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy) Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection Severe diabetes related complications (i.e. severe macro angiopathy, severe micro angiopathy, severe neuro-, retino- or nephropathy) when unstable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, tremor, language barriers, alcohol or drug misuse Not able to understand, write or read German Dependency from the sponsor or the clinical investigator

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 |
| --- | --- | --- |
| System Performance | Accuracy of glucose values determined with the device in comparison with values from a standard glucometer | 1 week per subject |
A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response. Secondary goals are to describe the safety and tolerability at this dose and schedule, to determine the time to sustained biochemical response, to determine the duration of biochemical response, to determine the time to disease progression.

Official Title
-----------------
A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Oral Triamcinalone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older Histologically documented adenocarcinoma of prostate Currently receiving LHRH agonists with castrate levels of testosterone or who have had an orchiectomy Must have had a rise in PSA despite anti androgen withdrawal Exhibit 2 consecutive rise in PSA after the last hormonal manipulation Minimum PSA of greater than 5 KPS greater than 80% Normal cortisol level at entry Life expectancy greater than 6 months Provide written consent pursuant to regulatory requirements prior to initiation of study procedure Exclusion criteria: Younger than 18 years Patients without prostate cancer

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

Sexes Eligible for Study
-----------------
Male

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: Oral Triamcinalone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response. |  | Following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability at this dose and schedule, time to sustained biochemical response, duration of biochemical response, time to disease progression |  | Following treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral Triamcinalone, Prostate Cancer
Does Azithromycin Cause QT Prolongation in Hospitalized Patients With Severe Community Acquired Pneumonia?

Study Overview
=================
Brief Summary
-----------------
The macrolide group of antibiotics can cause QT prolongation, and endanger the patient with life threatening arrythmias. QT prolongation caused by Azythromycin, a relatively new macrolide, is extremely rare, and was not reported in clinical trials. Our hypothesis is that patients hospitalized with severe community acquired pneumonia, usually with multiple comorbid conditions will have a higher rate of QT prolongation, compared to the clinical trials published

Detailed Description
-----------------
Patients hospitalized with community aquired pneumonia will have their corrected QT measured daily during antibiotic therapy. Concomittant medications and electrolyte abnormalities that cause prolonged QT will be recorded

Official Title
-----------------
Does Azithromycin Cause QT Prolongation in Hospitalized Patients With Severe Community Acquired Pneumonia?

Conditions
-----------------
Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe community acquired pneumonia treated with azithromycin age over 18 years Exclusion Criteria: Azithromycin initiated before hospitalization technically undecipherable ECG Permanent pacemaker

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 |
| --- | --- | --- |
| Corrected QT segment of ECG |  | Daily, at estimated peak antibiotic level, during index hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QT prolongation, Azithromycin, macrolide, pneumonia, ECG changes
MRI Perfusion Curves Typology and Orbital Tumors (PERFORM)

Study Overview
=================
Brief Summary
-----------------
Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation. Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers. The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients. For salivary glands, MRI allows to identify 4 different types of MRI characteristics, one (type C) being related to malignant tumors. In this study, the investigators will try to see if extrapolation of those data to orbiltal tumors is feasible.

Official Title
-----------------
Validation, for Orbital Tumors, of the MRI Perfusion Curves Typology Established for Salivary Tumors

Conditions
-----------------
Orbital Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 years or more with orbital mass for which a biopsy and/or a surgical removal is planned undergoing an MRI before surgery Exclusion Criteria: contra-indication to MRI intolerance to constrast agent pregnancy breast feeding patient under a legal protection procedure patient denying to participate to the study lack of affiliation to a social security system

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 |
| --- | --- | --- |
| Concordance of the MRI type and the pathological findings as assessed by the kappa coefficient |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Orbital neoplasm
QuantiFERON Change During Anti-tuberculosis Medication

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the change of QuantiFERON-TB gold in tube assay (QFT) during the treatment of active tuberculosis.

Detailed Description
-----------------
Patients with active pulmonary tuberculosis are enrolled and, QFTs are performed for each subjects before treatment and 1, 3, 6 months after treatment. Investigators check the level of interferon-gamma, and reversion and conversion of this test.

Official Title
-----------------
The Change in Level of Interferon-gamma Assay in Active Tuberculosis Patients During Treatment

Conditions
-----------------
Tuberculosis, Interferon-gamma Release Assay

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects with active tuberculosis Exclusion Criteria: Subjects who cannot complete study Subjects who have taken anti-tuberculosis medication for more than a month before visit of our hospital
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 |
| --- | --- | --- |
Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the long-term effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).

Official Title
-----------------
The Long-Term Safety and Tolerability of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD): An Open-Label Extension Study for Subjects Completing Study M10-346

Conditions
-----------------
Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: ABT-089


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject was randomized into Study M10-346 and completed the study. Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements. Male subjects must agree to comply with applicable contraceptive requirements. The subject is judged to be in generally good health. Exclusion Criteria: The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 and the first dose of study drug in the current study. The subject anticipates a move outside the geographic area.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ABT-089<br>* Subjects will take up to 80 mg daily for 24 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAARS:Inv |  | Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 | 
| CGI-ADHD-S |  | Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAARS:Self |  | Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 | 
| BRIEF-A |  | Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 | 
| AAQOL |  | Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 | 
| WPAI |  | Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 | 
| FTND |  | Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Attention-Deficit/Hyperactivity Disorder
Goal-directed and Cue-dependent Behavior in Severe Obesity

Study Overview
=================
Brief Summary
-----------------
The current proposal aims to investigate implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior in participants with severe obesity before and after bariatric surgery as well as in a control group with normal weight.

Detailed Description
-----------------
Food choice and intake is a daily and throughout normal subject. However, for more and more people eating habits and the question of food choice are of increasing interest and in several cases even a problem. The prevalence of obesity has tripled in the last decades and it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail on the long run, also because people fall back into former unhealthy eating habits. Bariatric surgery is a very effective procedure to reduce weight fundamentally. Various factors influence our daily food choice, not all of which are apparent to ourselves. Thus, food choice might be goal-directed and therefore conscious and reflective, yet in other circumstances the choice to eat something specific might be based on cue dependent processes which are automatic and thus difficult to control. The aim of the current study is to investigate cue-dependent and goal-directed nutritional behavior as well as the effect of a health mindset induction in severe obesity as well as changes in such behaviors due to bariatric surgery.

Official Title
-----------------
Goal-directed and Cue-dependent Behavior in Severe Obesity

Conditions
-----------------
Eating Behavior, Habits, Obesity

Intervention / Treatment
-----------------
* Behavioral: mindset induction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: experimental: severe obesity control: normal weight Exclusion Criteria: impaired cognitive functions, which might conflict with the task appropriate German

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese<br>severe obesity | Behavioral: mindset induction<br>* induction of a health mindset to measure changes in cue-dependent and goal-directed behavior<br>|
| Control<br>Control group with normal weight | Behavioral: mindset induction<br>* induction of a health mindset to measure changes in cue-dependent and goal-directed behavior<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in food choice behavior due to substantial weight loss by bariatric surgery | changes in cue-dependent and goal-directed food choices assessed by the Pavlovian-to-instrumental transfer task | pre bariatric surgery, 1 month after bariatric surgery, 6 months after bariatric surgery |