linjc16/ctgov huggingface dataset:
Effects of Using E-Cigarettes on Lungs in People With HIV (HBS Ancillary)

Study Overview
=================
Brief Summary
-----------------
This is an ancillary study, thus participants will be recruited from participants in the HBS Study. This project acutely assesses the role of the e-cigarettes and vaping on lung health. The proposed work will inform the design of future studies to better understand vaping's health consequences and to test novel interventions to mitigate vaping's contribution to acute and/or chronic lung injury.

Official Title
-----------------
Effects of E-Cigarettes on the Lung Metabolome in People Living With HIV

Conditions
-----------------
Hiv, Lung Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
This project is an ancillary study to the HBS Study. Inclusion Criteria for that IRB approved study are: documented HIV-infection in care at an HIV specialty clinic age ≥ 18 years. Exclusion criteria for the HBS Study are: a pacemaker or other implanted electronic device pregnant women, prisoners, cognitively-impaired subjects. For this ancillary, the experimental group must actively use at least one of the following: e-cigarettes, e-liquid vapes, burning leaf tobacco cigarettes, or inhaled burning leaf marijuana (cannabis). The control group will have no use of e-cigarettes or vape or active smoking in the past year. Participants must be willing to archive data and biological samples for future use. Exclusion from the ancillary are: overt respiratory or oral cavity disease acute illness in the past 4 weeks active cancer active weight loss program any other medical, psychiatric or behavioral factors that, in the judgment of the PI may interfere with study participation or ability to follow the protocol

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 |
| --- | --- |
| e-cigarettes and/or e-liquid vaping smokers<br>actively use e-cigarettes or e-liquid vaping | |
| cigarette smokers<br>actively use burning leaf tobacco cigarettes or inhaled burning leaf marijuana (cannabis) | |
| Non-smokers<br>no use of e-cigarettes or vape or active smoking in the past 5 years (and less than a total of 10 pack-years lifetime use) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in respiratory tract metabolite profiles in PLWH | Metabolomic analyses of exhaled breath condensate and gas. | Baseline only (at Visit 1) |
Pain Perception in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine response to pain in Alzheimer's disease.We plan to study the effect of diffuse noxious inhibitory controls(counterirritation phenomenon)and the autonomic nervous system reaction(reflected by the heart rate) in Alzheimer's disease. The study's hypothesis is that pain perception and autonomic nervous system reaction are altered in Alzheimer's disease.

Official Title
-----------------
Pain Perception in Alzheimer's Disease

Conditions
-----------------
Dementia Alzheimer Type

Intervention / Treatment
-----------------
* Behavioral: reaction to pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Clinical diagnosis of Alzheimer's disease Must be able to understand a simple pain scale Exclusion Criteria: Neuropathy Psychotropic drugs use -

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: reaction to pain|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008

Study Overview
=================
Brief Summary
-----------------
Annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and elderly subjects

Official Title
-----------------
A Phase III, Multicenter, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2007/2008 When Administered to Adult and Elderly Subjects

Conditions
-----------------
Seasonal Influenza, Vaccine

Intervention / Treatment
-----------------
* Biological: trivalent split influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry available for all the visits scheduled in the study and able to comply with all study requirements in good health as determined by: medical history, physical examination, clinical judgment of the investigator Exclusion Criteria: n/a

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: trivalent split influenza vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21 |  |  | 
| evaluate safety of trivalent split influenza vaccine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza vaccine
Duration of Untreated Psychosis (DUP) and Pathways to Care in Nordland

Study Overview
=================
Brief Summary
-----------------
During the 1990s, evidence began to emerge of the long duration of untreated illness prior to receiving treatment for patients with psychotic disorders. Studies across the world on first episode psychosis have consistently found an average of 1 - 2 years between the onset of psychotic symptoms and the start of treatment. Lengthy treatment delay has immediate implications such as unnecessary distress for patients and families, and may also compromise potential recovery when treatment is initiated.By understanding how and why substantial delays occur the investigators may be able to better design interventions to facilitate better earlier treatment. The components of DUP can be conceptualised as comprising 3 distinct intervals: help-seeking delay, referral delay and delay in mental health services. In this study the primary aim is to establish the level of DUP in nordland, and explore the components of this variable. Help-seeking delay will be investigated by interviewing patients presenting at the central mental health hospital in Nordland about their psychosis onset and pathways to care. Referral delay will be investigated by a questionnaire about the referral pratices among GPs in Nordland. Delays in mental health services will be investigated by focus group interviews with leaders and professionals at the 7 community mental health centers in Nordland. This knowledge is believed to be crucial for developing services that can reduce DUP and give this patient population earlier access to adequate treatment.

Official Title
-----------------
Duration of Untreated Psychosis (DUP) and Pathways to Care in Patients With First- and Multiple Episodes of Psychosis in Nordland - a Study of the Components of DUP in a Rural Mental Health System

Conditions
-----------------
Schizophrenia and Disorders With Psychotic Features, Affective Psychosis, Bipolar, Psychoses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient presenting with a possible psychotic illness (including schizophrenia, affective psychosis and drug-related psychosis, but excluding organic psychosis). Understands and speaks norwegian Exclusion Criteria: Severe learning disability

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 35 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 |
| --- | --- | --- |
| Duration of untreated psychosis | Nottingham Onset Schedule | retrospective, lifetime |
Evaluation of Inter-patient Variability Size of the Nasal Cavity, Based on CT Scans

Study Overview
=================
Brief Summary
-----------------
This study is part of the french research program ANR NEMRO MICROROBOTIC NASAL ENDOSCOPY BY OPTICAL COHERENCE TOMOGRAPHY: IMPACT OF SMELL DEFICIENCY ON NEURODEGENERATIVE DISEASES. Recent studies have shown a strong correlation between the decrease in olfactory faculties of patients and the presence of neurodegenerative diseases. This possible relationship has created a need to inspect in detail the area of the nasal cavity that houses the olfactory function. Thus, the purpose of NEMRO project is developing a robot to explore olfactory slots of patients, with a view to extract images through non invasive imaging probe, and hoping to identify early signs of degeneration the olfactory tissue. The robot developed will thus be able to navigate in the nasal cavity of patients, and to break into the olfactory slots, which will host the imaging phase. The purpose of this study is therefore to collect data on the usual path of instruments (endoscope, for example) in this area, and future potential pathway of the robot. This collection made from Computed Tomography (CT) scans will define the clinical geometry of the target area and provide precisely the dimensional constraints needed to build the NEMRO robot .

Official Title
-----------------
Evaluation of Inter-patient Variability Size of the Nasal Cavity, Based on CT Scans

Conditions
-----------------
Nasal Cavity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men or women aged >18 Exclusion Criteria: any pathology observed on the scan (sinusitis, cancer, previous surgery ...), that could interfere with the evaluated parameters, according to the medical expert

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Width of the nasal cavity and olfactory slots | Distance measurements to evaluate the width of the nasal cavity and olfactory slots, on previous available imaging. Composite primary outcome. | at enrollment | 
| Geometry of the nasal cavity and olfactory slots | Assesment of the geometry of the nasal cavity and olfactory slots, on previous available imaging. Composite primary outcome. | at enrollment |
Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.

Official Title
-----------------
A Phase 2 Study of the Efficacy and Safety of Irinotecan (Campto®) in Combination With Capecitabine (Xeloda®) as First-Line Chemotherapy in Asian Subjects With Inoperable Hepatocellular Carcinoma

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Drug: Irinotecan plus capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asian subjects with histologically or cytologically confirmed hepatocellular carcinoma Inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement) Eastern Cooperative Oncology Group performance status of ?2 Exclusion Criteria: Decompensated cirrhosis or stage C (Index>10) according to the Child-Pugh Classification Current history of chronic diarrhoea Reproductive potential not using adequate contraceptive measures

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Irinotecan plus capecitabine<br>* Irinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | Weeks 6, 12, 18, 24, 36, and 1 year | 
| Duration of overall response |  | Weeks 6, 12, 18, 24, 36, and 1 year | 
| Overall tumour growth control rate |  | Weeks 6, 12, 18, 24, 36, and 1 year | 
| Overall survival |  | Weeks 6, 12, 18, 24, 36, and 1 year | 
| Adverse events |  | Weeks 6, 12, 18, 24, 36, and 1 year | 
| Physical exam |  | Weeks 6, 12, 18, 24, 36, and 1 year | 
| Laboratory tests |  | Weeks 6, 12, 18, 24, 36, and 1 year |
YAZ Post-marketing Surveillance in Japan

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received YAZ for dysmenorrhea. The objective of this study is to assess safety and efficacy of using YAZ in clinical practice. A total 3,000 patients will be recruited and followed 3 years since starting YAZ administration.

Official Title
-----------------
Drug Use Investigation of YAZ

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Drug: EE20/DRSP(YAZ, BAY86-5300)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received YAZ for dysmenorrhea Additional criteria for QOL questionnaire Patient informed consent Exclusion Criteria: Patients who are contraindicated based on the product label Additional criteria for QOL questionnaire Six months or less after treatment of estrogen or estrogen combination drug
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: EE20/DRSP(YAZ, BAY86-5300)<br>* Patients in daily life treatment receiving YAZ for dysmenorrhea.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions and sever adverse events |  | During YAZ administration, up to 3 years | 
| Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle) |  | Baseline and during YAZ administration, up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | During YAZ administration, up to 3 years | 
| Unpleasant physical symptoms collection |  | Baseline and during YAZ administration, up to 3 years | 
| Unpleasant psychological symptoms collection |  | Baseline and during YAZ administration, up to 3 years | 
| Analgesic drug for dysmenorrhea |  | During YAZ administration, up to 3 years | 
| QOL survey using Short-Form 36-Item Health Survey (SF-36) |  | Baseline and at 6th - 8th cycles (28 datys per cycle) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YAZ, Dysmenorrhea
Perthes Disease in Norway

Study Overview
=================
Brief Summary
-----------------
Calvé-Legg-Perthes disease (CLP) is a hip disease in children whose femoral head becomes completely or partially necrotic. The disease is most common in five-six years of age. The femoral head is gradually deformed during the active stages of the disease (5-7 years). By healing, the hip joint shape will vary from an approximately normal joint to pronounced changes, the hip joint will be irregular. Such a hip joint is available for osteoarthritis. The purpose of this study is to map the function of the hip, the patient's quality of life and especially the risk factors that affect the outcome of the previous CLP. A nationwide prospective study of CLP was conducted between 1996 and 2000. All children with newly diagnosed Perthes disease (425) were registered. The current study will follow up all these patients with an average follow-up of 20 years. Radiological endpoints are evidence of hip osteoarthritis. Patient-reported outcomes (PROMS) should illuminate the function of the hip and quality of life.

Official Title
-----------------
A Prospective Nationwide Study of Perthes' Disease in Norway: Functional and Radiographic Outcomes at a Mean Follow-up of Twenty Years

Conditions
-----------------
Legg Calve Perthes Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - Subject was diagnosed with Perthes disease between 1996 and 2000 in Norway Exclusion Criteria: Death upon follow up Other skeletal dysplasia Patient not able to give consent,

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- | --- |
| Hip osteoarthritis | radiographic measurement of weight bearing zone | an average of 20 years follow-up | 
| Hip function | PROMS HOOS | an average of 20 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip ROM | functional test of range of motion of the hip | an average of 20 years follow-up | 
| Gluteal muscle strength | Trendelenburg test | an average of 20 years follow-up | 
| Hip strength | single leg hop test - 6 meters | an average of 20 years follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip, function, quality of life, osteoarthritis, Perthes, LCPD
A Study of MabThera/Rituxan (Rituximab) in Patients With Non-Bulky Follicular Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in treatment-naive patients with non-bulky follicular non-Hodgkin's lymphoma. The anticipated time on study treatment is 3 months.

Official Title
-----------------
An Open-label Study of MabThera on Objective Overall Tumor Response in Treatment-naïve Patients With Non-bulky Follicular Non-Hodgkin's Lymphoma

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: rituximab [MabThera/Rituxan]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients 18-75 years of age Newly diagnosed non-bulky follicular non-Hodgkin's lymphoma >/=1 measurable lesion No prior treatment (no corticosteroids or radiotherapy) Exclusion Criteria: Transformed follicular lymphoma Cerebral or meningeal lymphomaotus localization Uncontrolled concurrent infection

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

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: Single arm<br> | Drug: rituximab [MabThera/Rituxan]<br>* 375 mg/m2 intravenously once a week for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall objective complete response rate |  | Day 50 | 
| Overall objective partial response rate |  | Day 50 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 7 years | 
| Overall survival |  | 7 years | 
| Duration of response |  | 7 years | 
| Safety: Incidence of adverse events |  | 7 years | 
| Level of biological marker bcl2 in peripheral blood and bone marrow |  | 7 years |