linjc16/ctgov huggingface dataset:
Fluorine F 18 FEQA in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer and in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Fluorine F 18 FEQA may be an effective radioactive drug to use with positron emission tomography (PET) scans. PURPOSE: This clinical trial is studying the use of fluorine F 18 FEQA in patients with stage III or stage IV non-small cell lung cancer and in healthy participants.

Detailed Description
-----------------
OBJECTIVES: Determine the biodistribution of fluorine F 18 FEQA in patients with stage III or IV non-small cell lung cancer (NSCLC) and in healthy participants. Determine whether fluorine F 18 FEQA can be used as an imaging agent with positron emission tomography in patients with stage III or IV NSCLC. OUTLINE: This is a pilot study. Patients and healthy participants receive fluorine F 18 FEQA IV and then undergo whole-body dynamic scans comprising positron emission tomography. Blood is collected during and after imaging to measure radioactivity. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Official Title
-----------------
The Biodistribution of N-{4-[3'-[F-18] Fluoroethylphenyl)Amino]-6-quinazolinyl}-Acrylamide ([F-F18]FEQA) in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC) and in Healthy Subjects: A Pilot Study

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: fluorine F 18 FEQA + positron emission tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must meet 1 of the following criteria: Diagnosis of non-small cell lung cancer by CT scan, bone scan, or biopsy Stage III or IV disease Clinically assessed with Healthy participant Exclusion Criteria:

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 |
| --- | --- |
| Experimental: fluorine F 18 FEQA + positron emission tomography<br> | Procedure: fluorine F 18 FEQA + positron emission tomography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biodistribution of fluorine F 18 FEQA |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
A Qualitative Study About Smoking Practices

Study Overview
=================
Brief Summary
-----------------
This study involves in-depth interviews with parents of urban children with asthma and focus groups with additional parents in order to understand their attitudes and beliefs about smoking.

Official Title
-----------------
Smoking Practices Among Parents of Urban Children With Asthma: A Qualitative Study

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child with asthma Parents being current smokers, ex-smokers, or non-smokers Exclusion Criteria: Non-English speaking families

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Dialectical Cognitive Traumatherapy (DCT) on Patients With Severe PTSD Following Sexual Abuse

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Dialectical Cognitive Traumatherapy is effective in the treatment of severe and chronic Posttraumatic Stress Disorder (PTSD) following childhood sexual abuse.

Detailed Description
-----------------
Most studies on psychological treatments for PTSD exclude patients with severe, co-occurring psychopathology. We designed a new treatment (Dialectical Cognitive Trauma Therapy, or DCT) specifically to treat these patients. DCT includes elements of emotion regulation, mindfulness exercises, cognitive and exposure treatment, as well as new elements. This randomized controlled study evaluates the effect of inpatient DCT on these patients.

Official Title
-----------------
Dialectical Cognitive Traumatherapy (DCT) on Patients With Severe Posttraumatic Stress Disorder Following Sexual Abuse - A Randomised Controlled Trial

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Dialectical Cognitive Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Minimum age of 17 Childhood sexual abuse Posttraumatic Stress Disorder (criteria of SCID) At least one of the following diagnoses: Anorexia Nervosa, or Bulimia Nervosa, or substance abuse, or substance dependence, or major depression or at least 4 out of 9 criteria for Borderline Personality Disorder Exclusion Criteria: Diagnosis of schizophrenia Mental retardation Body Mass Index lower than 16.5 Acute delirium Perilous selfharming behaviour during the last 4 month Suicide attempt with the distinct intention to die during the last 4 month Unstability (e.g. homelessness, acute victimisation by offender) Pretreatment by DCT

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| No Intervention: 1<br>Waitlist; Treatment as usual | Behavioral: Dialectical Cognitive Therapy<br>* Dialectical Behavior Therapy in Combination with Traumafocused CBT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptoms (CAPS, SCID, PDS, IESR) |  | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| general psychopathology |  | 1.5 years | 
| change of pain threshold |  | 1.5 years | 
| fMRI: activity of the amygdala |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dialectical Cognitive Therapy, Clinical Psychology
Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

Study Overview
=================
Brief Summary
-----------------
This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.

Official Title
-----------------
Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

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

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood glucose criteria must be met Not currently on drug therapy for type 2 diabetes Body mass index (BMI) in the range 22-45 Exclusion Criteria: Pregnancy or lactation Type 1 diabetes Evidence of serious diabetic complications Evidence of serious cardiovascular conditions Laboratory value abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile after 12 weeks of treatment |  |  | 
| Patients with reduction in HbA1c >/= 0.7% after 12 weeks |  |  | 
| Change from baseline in fasting plasma glucose at 12 weeks |  |  | 
| Change from baseline in HOMA-B at 12 weeks |  |  | 
| Change from baseline in body weight at 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, vildagliptin
Buprenorphine Dosing Interval - 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the feasibility of extending the dosing interval of well maintained buprenorphine patients to 48 and 72 hours, leading to eventual 3 times/week dosing.

Official Title
-----------------
Buprenorphine Dosing Interval

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 21-50. Opiate dependence according to DSM-IV critera. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Treatment
Masking: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Withdrawal symptoms |  |  | 
| Opiate and cocaine craving |  |  |
A Study of MCAF5352A in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This single-center, randomized, placebo-controlled, double-blind, multiple ascending dose study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy volunteers. Subjects will be randomized to receive either MCAF5352A or placebo on Days 1, 15 and 29.

Official Title
-----------------
A Phase Ib, Single-Center, Randomized, Placebo-Controlled, Double-Blind Multiple Ascending-Dose Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of Subcutaneous MCAF5352A in Healthy Volunteers

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: MCAF5352A
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females, 18 - 55 years of age Subjects in good health as determined by screening medical history, physical examination, vital signs, 12-lead ECG and laboratory tests Body weight between 45 kg and 110 kg Female subjects must be willing to use two effective methods of contraception from screening to a minimum of 4 months after the last dose of study drug Exclusion Criteria: Pregnant or lactating women Positive for hepatitis B, hepatitis C or HIV infection History of significant chronic or recurrent infections History of clinically significant drug allergy and/or a known hypersensitivity to protein therapeutics or formulation components or a related drug History of alcohol or drug abuse within 12 months prior to Day 1, or evidence of such abuse Subjects who have previously received the study drug Participation in a clinical trial within 4 weeks prior to Day 1 or use of any experimental or biologic therapy within 12 weeks prior to Day 1 or within 5 half-lives of the product, whichever is greater

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCAF5352A<br> | Drug: MCAF5352A<br>* Multiple ascending doses<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching MCAF5352A, multiple doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the concentration-time curve |  | Pre-dose and 5 time points up to 14 days post-dose | 
| Immunogenicity: Serum MCAF5252A antibodies |  | Days 1, 29, 50, 78, 106 and 134 |
Safety and Performance Assessment of Drug-Eluting Stent CRE8 in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The study is a 'real-world' study which evaluates the safety and performance of the coronary DES-CRE8 in diabetic patients. As routine care, each patient will be followed until 12 months after stent implantation.

Official Title
-----------------
Safety and Performance Assessment of Coronary Drug-Eluting Stent CRE8 : Post-market Observationnal Study

Conditions
-----------------
Diabetes, Coronaropathy

Intervention / Treatment
-----------------
* Device: DES-CRE8


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years old, patient informed and agreed to participate, patient with one or more lesions treated with one or more coronary stent CRE8, patient with a diabete insulin dependent or non-insulin dependant. Exclusion Criteria: pregnant or breast-feading women, patient who refused to participate, patient with another lesion treated during the same intervention with a balloon alone or with another stent

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 |
| --- |
|Device: DES-CRE8|Polymer-free Amphilimus™ (Sirolimus + Fatty Acid) eluting coronary stent. The absence of the polymer minimizes the risk of inflammation/thrombosis, while the propriety formulation enhances drug absorption.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is Target Lesion Failure (TLF) rate at 1 year | The TLF is defined as cardiac deaths, heart attack in relation with the target vessel or revascularization of the target lesion. If a patient has at least one of these events, he will be considered as TLF. | 1 year post implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) at 1 year | MACE are defined as: revascularization of the target lesion, heart attack or cardiac deaths. | 1 year | 
| Non cardiac deaths at 1 year | Non cardiac deaths at 1 year | 1 year | 
| Stent thrombosis at 1 year | Certain or probable stent thrombosis | 1 year | 
| Major Adverse Cardiac Events (MACE) at 1 year in the sub-group of patients with a short planned dual-therapy | MACE are defined as: revascularization of the target lesion, heart attack or cardiac deaths. | 1 year | 
| Non cardiac deaths at 1 year in the sub-group of patients with a short planned dual-therapy | Non cardiac deaths at 1 year | 1 year | 
| Stent thrombosis at 1 year in the sub-group of patients with a short planned dual-therapy | Certain or probable stent thrombosis | 1 year |
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Study Overview
=================
Brief Summary
-----------------
Tree nut immunotherapy Route Assessment and DEvelopment (TRADE) is a randomized controlled trial that evaluates the efficacy and safety of sublingual immunotherapy and lower, more tolerable, doses of oral immunotherapy than currently in use.

Official Title
-----------------
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Conditions
-----------------
Tree Nut Allergy, Food Allergy

Intervention / Treatment
-----------------
* Other: Food


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent. Exclusion Criteria: History of anaphylaxis to tree nut severe enough to cause shock, syncope, or intubation Eosinophilic or other inflammatory gastrointestinal disease within the past 2 years Severe (GINA severity class 5) or uncontrolled asthma including exacerbation within past 6 months Use of biologics, other food immunotherapy or experimental treatment in past 6 months. Ongoing other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits Pregnancy or significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease; allergy to the oat-based placebo) which would put the participant at excessive risk for food allergic reactions as judged by local investigator

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 16 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active low dose oral immunotherapy and Placebo sublingual immunotherapy<br> | Other: Food<br>* Commercially available powders or liquids<br>|
| Experimental: Placebo low dose oral immunotherapy and Active sublingual immunotherapy<br> | Other: Food<br>* Commercially available powders or liquids<br>|
| Experimental: Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy<br> | Other: Food<br>* Commercially available powders or liquids<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eliciting dose thresholds to food challenge |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Food allergy quality of life questionnaire | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunotherapy, Randomized Controlled Trial (RCT)
Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy

Study Overview
=================
Brief Summary
-----------------
On joint orthopaedic hardware infections are one of the most frequently encountered complications in orthopaedic surgery. However 6% of the cultures remain sterile, etiological diagnosis cannot be established despite obvious signs of infection. As part of this research project, we have developed a new strategy diagnosis including directly the use of PCR to reduce the number of negative results. This should have a major therapeutic impact in terms of timeliness and specificity of antibiotic. Primary: Evaluate the effectiveness of the new diagnostic strategy on etiological identification of prosthesis infections. Hypothesis: Minimum 6 percent increase in the number of patients with an etiological diagnosis of infection on prosthesis.

Official Title
-----------------
Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy

Conditions
-----------------
Prosthetic Joint Infections

Intervention / Treatment
-----------------
* Procedure: bone biopsies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is more than 18 years old. Patient with a prescription of a microbiologic diagnostic of Prosthetic joint infection Patient who do not declined to have his medical records reviewed for research Patient with health insurance Exclusion Criteria: Patient minor (<18 years). Pregnant or lactating woman. Major under guardianship Patient. Patient deprived of liberty or under court order

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bone biopsies<br> | Procedure: bone biopsies<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone biopsies multisite | Increase of at least 6% of patients with an etiologic diagnosis of prosthesis infection established. | 4 years |