linjc16/ctgov huggingface dataset:
A Web App for Patients With Alcohol and Drug Use Problems in Primary Care

Study Overview
=================
Brief Summary
-----------------
The objective of this pilot study is to evaluate the feasibility and technical merit of a web application for patients in primary care called Check-up and Choices (CC).

Detailed Description
-----------------
The overall objective of this project is to develop, evaluate, and disseminate a web application called Check-up and Choices (CC). CC will be developed for use in primary care. It would tightly integrate screening for heavy drinking and drug use, a brief motivational intervention for hazardous or heavy drinkers, a moderation training protocol for less dependent problem drinkers, and an abstinence-oriented protocol for more dependent drinkers and drug abusers. The brief motivational intervention will be tailored to the patient's age. Its purpose will be to motivate problem drinkers to change their drinking. The action-oriented moderation and abstinence protocols are cognitive-behavioral interventions (CBIs) that provide patients with the skills to maximize their chances of success with changing their drinking and/or drug use. The investigators have already developed these elements but they are not integrated into a single program with appropriate branching between them. Nor has the content been tailored for use in primary care.

Official Title
-----------------
A Web App for Patients With Alcohol and Drug Use Problems in Primary Care

Conditions
-----------------
Alcohol Abuse, Drug Abuse

Intervention / Treatment
-----------------
* Behavioral: Web app


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physicians, nurses, nurse practitioners, physician's assistants, psychologists embedded in primary care settings, and other mental health counselors embedded in primary care settings.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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: Web app evaluation group<br> | Behavioral: Web app<br>* The Checkup and Choices web application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility Questionnaire | A 17 item questionnaire that asks about the feasibility of using the web app with patients in primary care and the app's technical merit. | Within 1 month of enrollment with an expected average of 1 week.. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol abuse, drug abuse, hazardous alcohol use, hazardous drug use
Breast Augmentation Rehabilitation Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether implementing a rehabilitation program can improve the post-operative time to pain free living after breast augmentation.

Official Title
-----------------
How Rehabilitation Affects the Time to Pain-free Living After Endoscopic Transaxillary Subpectoral Breast Augmentation

Conditions
-----------------
Breast Implants, Surgery, Plastic

Intervention / Treatment
-----------------
* Behavioral: Rehabilitation
* Behavioral: Follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women who undergo endoscopic transaxillary subpectoral breast augmentation women above the age of 18 years women with a BMI 18-27 Exclusion Criteria: women who underwent previous breast reconstruction (cosmetic or therapeutic) women who underwent previous chest surgery women with previous chest trauma women who underwent previous shoulder/arm surgery women with previous shoulder/arm injury women who smoke women who are Immunocompromised

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br> | Behavioral: Follow-up<br>* Follow-up with surgeon's clinic<br>|
| Experimental: Rehabilitation<br> | Behavioral: Rehabilitation<br>* Range of motion stretching exercises<br>Behavioral: Follow-up<br>* Follow-up with surgeon's clinic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return to baseline as measured on Visual Analogue Scale for pain |  | Baseline, six months, and one year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return to bilateral shoulder baseline range of motion |  | Baseline, six months, and one year after surgery | 
| Change in psychosocial outcomes as measured by the BREAST-Q questionnaire |  | Baseline, six months, and one year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation, reconstructive surgery
fNIRs, Listening Effort, and Speech Intelligibility

Study Overview
=================
Brief Summary
-----------------
The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Adults with hearing loss will be asked to repeat the final word from low-context sentences in noise at two SNRs; a hard SNR (individually-measured SNR-50), and an easy SNR (SNR-50 + 10 dB) both without and with hearing aids set to a directional mode. The procedure will be a within-subject repeated measures. Stimuli will be randomized.

Detailed Description
-----------------
See above.

Official Title
-----------------
Functional Near-infrared Spectroscopy (fNIRS) as a Measure of Listening Effort and Speech Intelligibility in Adults With Hearing Loss

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: Hearing aids
* Other: Unaided


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18-99 years) with ≥3 months hearing aid experience binaural, symmetric, sensorineural N2 (mild) to N6 (severe) hearing loss fluent in English Exclusion Criteria: children/teenagers normal hearing or hearing loss exceeding N6 (severe) by 10 dB

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with hearing loss.<br>Participants with hearing loss. | Device: Hearing aids<br>* Participants will listen to stimuli in the environment while wearing hearing aids which should make the stimuli more audible. Speech in noise performance is expected to improve and PFC oxygenation is expected to be reduced in this condition.<br>* Other names: Investigational;Other: Unaided<br>* Participants will listen to stimuli in the environment with their hearing loss. Speech in noise performance is expected to decline and PFC oxygenation is expected to be increased in this condition.<br>* Other names: Control;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Listening effort | Listening effort inferred from infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. A higher concentration is indicative of more listening effort. | Up to 2 hours during 1 session | 
| Speech-in-noise performance | Number of words repeatedly correctly for a given listening condition. | Up to 2 hours during 1 session |
Phase I Pilot Study of Ad5-CB-CFTR, an Adenovirus Vector Containing the Cystic Fibrosis Transmembrane Conductance Regulator Gene, in Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the safety and efficacy of gene transfer into the nasal epithelium using Ad5-CB-CFTR, an E1-deleted adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, in patients with cystic fibrosis (CF). II. Determine whether ion transport abnormalities in CF airway cells can be corrected.

Detailed Description
-----------------
PROTOCOL OUTLINE: Groups of 3 patients receive 1 of 4 doses of Ad5-CB-CFTR, a recombinant E1-deleted adenovirus serotype 5 vector containing the cystic fibrosis transmembrane conductance regulator gene. Ad5-CB-CFTR is administered to 1 nasal cavity and the vehicle alone is administered to the opposite nasal cavity as the control.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Genetic: Ad5-CB-CFTR


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Cystic fibrosis No mild genetic mutations, i.e., normal nasal chloride ion permeability At least 2 weeks since decrease in pulmonary function --Prior/Concurrent Therapy-- At least 3 months since systemic cortisone At least 1 month since other therapeutic research study, e.g., DNAse --Patient Characteristics-- Other: Adequate endocrine, liver, kidney, and cardiac function Adenovirus antibody seropositive No pregnant or nursing women Negative pregnancy test required of fertile women Adequate contraception required of fertile patients

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Ad5-CB-CFTR|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
-----------------
cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy

Official Title
-----------------
A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer Without Progression After First Line Concurrent Chemoradiotherapy Treatment

Conditions
-----------------
Limited-stage Small Cell Lung Cancer, LS-SCLC

Intervention / Treatment
-----------------
* Drug: SHR-1316


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age is 18-75 years old (including both ends), regardless of gender; Histologically confirmed limited stage small cell lung cancer ; ECOG PS 0   1; Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication. The last chemotherapy must be finished before or at the same time of radiotherapy. The disease did not progress after concurrent chemoradiotherapy; The expected survival time was more than 3 months; Pulmonary function: FEV1 > 70%; Exclusion Criteria: The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up. Mixed SCLC or NSCLC confirmed by histology; Locally advanced small cell lung cancer receiving sequential chemoradiotherapy; Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC; Extensive SCLC; Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery); Interstitial pneumonia History of active, known or suspected autoimmune diseases and autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. HIV, active Hepatitis B or Hepatitis C 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1316<br> | Drug: SHR-1316<br>* Anti-PD-L1 antibody，Maintenance therapy, The drug was administered every three weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-free survival | Up to approximately 24 months |
The Role of the Coagulation Pathways in Recurrent Angioedema

Study Overview
=================
Brief Summary
-----------------
Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways.

Detailed Description
-----------------
Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways. the main objective is to highlight a difference between the rates of different coagulation factors in the 3 groups presenting different categories of angiodemes patients with a group of patients with isolated superficial chronic urticaria

Official Title
-----------------
The Role of the Coagulation Pathways in Recurrent Angioedema

Conditions
-----------------
Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor Deficiency

Intervention / Treatment
-----------------
* Other: BLOOD TEST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent angioderma Exclusion Criteria: anticoagulant therapy, diseases of hemostasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1 AE-Bk<br>Arm of the recurring angiodeme medié by the bradykinine: blood test | Other: BLOOD TEST<br> <br> |
| Other: Arm 2 AE-Mast<br>Superficial nettle rash group recurring angiodemes associated with superficial nettle rash: blood test | Other: BLOOD TEST<br> <br> |
| Other: ARM 3 AEI<br>Arm recurring angiodemes isolate idiopathique not hostaminergique: blood test | Other: BLOOD TEST<br> <br> |
| Other: ARM 4 US<br>Arm of superficial nettle rashes: blood test | Other: BLOOD TEST<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of several coagulation pathway markers in each group |  | 24 Months |
Biomarkers for Intestinal Permeability

Study Overview
=================
Brief Summary
-----------------
This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful gold standard methods.

Detailed Description
-----------------
This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful gold standard methods. In healthy volunteers potential biomarkers for intestinal permeability as well as an established gold standard method for intestinal permeability (urinary lactulose/mannitol excretion) will be measured at one time point. Using correlation analyses, potential associations will be assessed and potential biomarkers will be addressed and discussed.

Official Title
-----------------
Pilot Study: Validation of Easy-to-measure Biomarkers for Intestinal Permeability in Human Trials

Conditions
-----------------
Focus: Simplified Method to Assess Intestinal Permeability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Written informed consent Exclusion Criteria: Underweight (BMI <18 kg / m2) and obesity from grade II (BMI ≥ 30 kg / m2) Acute or chronic gastrointestinal diseases Chronically consuming diseases (e.g. chronic tumor disease, florid infections, etc.) Smokers (12 hours before the test and during the test it is not allowed to smoke) Ingestion of intestinal therapeutics, antibiotics, immunosuppressants or similar within the last 3 months Simultaneous participation in another clinical study Pregnancy / breastfeeding Intolerance to the sugar solution Occurrence of relevant diseases Revocation of consent

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactulose / mannitol ratio | Urinary excretion of lactulose and mannitol | 1 day (Single measurement) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal albumin [ng/mg] | Potential easy-to-measure biomarker #1 | 1 day (Single measurement) | 
| Fecal calprotectin [ng/mg] | Potential easy-to-measure biomarker #2 | 1 day (Single measurement) | 
| Fecal zonulin [ng/mg] | Potential easy-to-measure biomarker #3 | 1 day (Single measurement) | 
| Plasma lipopolysaccharide binding protein [µg/ml] | Potential easy-to-measure biomarker #4 | 1 day (Single measurement) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroenterology, Gut barrier, Intestinal permeability
Glucose Regulation During Risperidone and Olanzapine Treatment

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this research is to look at how two of the most commonly prescribed newer antipsychotic medications, risperidone and olanzapine, affect substances in the body such as glucose and insulin. Undesirable changes in blood sugar control, or glucose regulation, and type 2 diabetes can occur more commonly in individuals with schizophrenia compared to healthy subjects and subjects with other psychiatric conditions. While abnormalities in glucose regulation were first reported in schizophrenia before the introduction of antipsychotic medications, antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Attention to the way that antipsychotic medications may affect glucose regulation has increased as doctors have become more concerned in general about disease- and drug-related medical complications, including weight gain during antipsychotic treatment.

Detailed Description
-----------------
This study will include 70 patients diagnosed with schizophrenia, taking either risperidone, olanzapine or haloperidol, and 20 healthy control subjects. Each subject will undergo a 4 hour glucose tolerance test. In addition, there will be a small project within the overall study to measure the effects of risperidone and olanzapine on glucose regulation as the individuals switch from their prior treatment with a conventional antipsychotic medication to either risperidone or olanzapine. Ten subjects will be studied on a typical neuroleptic at baseline then switched over a one week period to risperidone or olanzapine. The participants will be evaluated at 1 week, 4 weeks, and 12 weeks, prospectively. Each evaluation will consist of a 4 hour glucose tolerance test.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: risperidone
* Drug: olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: meet DSM-IV criteria for schizophrenia, any type, or schizoaffective disorder; able to give informed consent; no medication changes for 2 weeks prior to and during the period of study; currently taking olanzapine, risperidone, haloperidol or another typical antipsychotic

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: risperidone|nan|
|Drug: olanzapine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |