linjc16/ctgov huggingface dataset:
Clinical Benefit of Genetic Biomarkers for Guiding Treatment Decisions in Oncology Drugs

Study Overview
=================
Brief Summary
-----------------
This study is a meta-epidemiological study which aim is to quantify the clinical benefit of the biomarker-based strategy compared to conventional strategy across all drugs with such a strategy.

Detailed Description
-----------------
Personalized medicine consist to differentially treat patients based on their individual characteristics (mainly genetics). It is of the most promising area of cancer research and cancer care. The label of more than 140 FDA- approved drugs mention a biomarker, the majority being indicated in oncology. However, it has also been suggested that the hopes of personalized medicine were not matched by evidence. Indeed, there is a threat that genetic biomarkers are used without evidence that this use translates in improved outcomes for patients, and the use of biomarkers is in need for thorough validation. In a previous work the investigators showed that the mention of a pharmacogenomic biomarker in a drug label can have different meanings depending on the drug, and that oncology had higher proportion of required or recommended genetic testing compared to other therapeutic areas. Hence, the investigators will include only the drug-biomarker pairs with (i) required or recommended genetic testing, or (ii) with biomarker-based indication and (iii) with at least one indication in oncology.

Official Title
-----------------
Clinical Benefit of Genetic Biomarkers for Guiding Treatment Decisions in Oncology Drugs

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: Drug selected in the study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: phase II or III randomized clinical trials including patients with one of the drug-biomarker-indication triplet studied evaluating treatment effect in biomarker-defined strata (either in biomarker-positive patients, in biomarker-negative patients or in both strata). reporting OS or PFS or DFS Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biomarker-positive patients<br> | Drug: Drug selected in the study<br> <br> |
| Biomarker-negative patients<br> | Drug: Drug selected in the study<br> <br> |
| All patients<br> | Drug: Drug selected in the study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) |  | Up to 5 years |
Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia

Study Overview
=================
Brief Summary
-----------------
Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia

Official Title
-----------------
Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia

Conditions
-----------------
Aplastic Anemia

Intervention / Treatment
-----------------
* Drug: Iticitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Fasting Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose administered under fasting conditions.

Official Title
-----------------
Single-Dose Fasting Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Topiramate Sprinkle Capsules 25 mg
* Drug: Topamax® Sprinkle Capsule 25 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Topiramate Sprinkle Capsules 25 mg | Drug: Topiramate Sprinkle Capsules 25 mg<br>* 25mg, single dose fasting<br>|
| Active Comparator: 2<br>Topamax® Sprinkle Capsule 25 mg | Drug: Topamax® Sprinkle Capsule 25 mg<br>* 25mg, single dose fasting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | blood collections through 144 hours |
Study Evaluating Venlafaxine ER in Patients With Panic Disorder

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine the efficacy, safety, and tolerability of venlafaxine extended release (ER) capsules in the treatment of outpatients with panic disorder (PD) in comparison to those of placebo.

Official Title
-----------------
A Double-blind, Placebo-controlled, Parallel-group Comparison of Venlafaxine Extended-release Capsules and Paroxetine in Outpatients With Panic Disorder

Conditions
-----------------
Panic Disorder

Intervention / Treatment
-----------------
* Drug: Venlafaxine ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet DSM-IV criteria for PD (with or without agoraphobia) for at least 3 months before study day 1 Have sufficient symptoms to require anxiolytic drug therapy Have a score ≥4 on the Clinical Global Impressions Scale (CGI) severity of illness item at screening and baseline Exclusion Criteria: Known hypersensitivity to venlafaxine (IR or ER), related compounds, or paroxetine History or presence of any clinically important hepatic, renal, or other medical disease that might compromise the study or be detrimental to the patient (eg, clinically important cardiac arrhythmia, unstable diabetes, carcinoma [except basal cell epithelioma], uncontrolled hypertension) Clinically important abnormality on screening physical examination, vital signs, electrocardiogram (ECG), laboratory tests or urine drug screen

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Venlafaxine ER|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
-----------------
Panic, Disorder
Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and Kidney Uptake

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to make a comparison between 11C-acetate and 11C-Acetoacetate heart and kidney metabolism

Detailed Description
-----------------
Healthy people will have two positron emission tomography scan to perform. One, with a 11C-Acetate Tracer and the other with 11C-Acetoacetate. The results will allow to determine if both tracers are used in a similar way but the organs and see if the investigators can use the already validated analyse method for acetate to make acetoacetate analysis

Official Title
-----------------
Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and

Conditions
-----------------
Ketoses, Metabolic

Intervention / Treatment
-----------------
* Radiation: Observational heart and kidney on siemens TEP scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18 and 55 BMI between 18,5 and 28 Healthy Normal value for blood pressure Exclusion Criteria: Taking drugs that could influence metabolism Diabetes or prediabetes Pregnancy or lactation Participation in a intensive sport program Being on a ketogenic diet Any clinical abnomally in prescreen blood sample

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

Primary Purpose: Health Services Research
Intervention Model: Sequential Assignment
Interventional Model Description: Participants will have to perform 2 scans one after the other
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Observational heart and kidney metabolism<br>Participants will have a PET scan with 11C-Acetate followed by a TEP Scan with 11C-Acetoacetate all in the same day. | Radiation: Observational heart and kidney on siemens TEP scan<br>* Same as arm description<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean in left ventricule myocradial blood flow | Heart acetate metabolism measured by TEP scan | 30 minutes | 
| Mean in left ventricule myocardial blood flow | Heart acetoacetate metabolism measured by TEP scan | 30 minutes | 
| Mean in Kidney acetate uptake | Kidney acetate uptake measured by TEP scan | 30 minutes | 
| Mean in Kidney acetoacetate uptake | Kidney acetoacetate uptake measured by TEP scan. | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ketones, heart metabolism, kidney metabolism
Efficacy of Hypnotherapy in Children With Dental Anxiety

Study Overview
=================
Brief Summary
-----------------
Dental anxiety is a common problem among the children. The aim of this study is to evaluate the efficacy of hypnotherapy in children with dental anxiety. The participants will be randomized in a 1:1 ratio to hypnotherapy or control group. The outcome measures will be Modified Children Dental Anxiety Scale-faces version(MCDAS(f)) and Visual Analogue Scale(VAS).

Official Title
-----------------
Efficacy of Hypnotherapy in Children Aged 8-12 Years Old With Dental Anxiety: A Randomized Clinical Trial

Conditions
-----------------
Dental Anxiety

Intervention / Treatment
-----------------
* Behavioral: Hypnotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: initial MCDAS(f) total score > 19 ICDAS II (international caries detection and assessment score)= 5 for at least one tooth Exclusion Criteria: presence of dental pain complaint non-obtaining the informed consent form

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnotherapy<br> | Behavioral: Hypnotherapy<br>* Hypnotherapy<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Children Dental Anxiety Scale Faces version MCDAS(f) | Modified Children Dental Anxiety Scale is a self-reported measurement and consists of 8 questions with 5 pictorial answers for each question. Total score ranges from 8 to 40, with higher scores higher dental anxiety. | maximum 1 week after hypnotherapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | Visual Analog Scale was used to evaluate the dental anxiety in six stages of dental treatment. The scores range from 0 to 10, with higher scores higher dental anxiety. | during dental treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental anxiety, hypnotherapy, pediatric dentistry
Non-invasive Haemodynamic Monitoring in Pregnancy

Study Overview
=================
Brief Summary
-----------------
This prospective and observational trial over 55 pregnant women (third trimester) compares non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic

Official Title
-----------------
Non-invasive Haemodynamic Monitoring in Pregnancy : Comparison Between Ultrasound and Nexfin Technology

Conditions
-----------------
Pregnancy Related, Cardiac Output, High, Haemodynamic Instability

Intervention / Treatment
-----------------
* Other: haemodynamic evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: third trimester of pregnancy Non-labouring pregnant women accepting study Exclusion Criteria: refusal of study first or second trimester of pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women in third trimester<br>Non-labouring pregnant women hospitalised during their third trimester of pregnancy has an haemodynamic evaluation with Nexfin technology and transthoracic cardiac ultrasonography. Evaluation is performed in two positions : dorsal decubitus and left lateral decubitus. | Other: haemodynamic evaluation<br>* continous haemodynamic monitoring is performed with digital Nexfin captor in two positions. in the same time transthoracic cardiac ultrasonography is performed to calculate cardiac output using velocity time index of aortic outflow chamber.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output measure | Cardiac output is measured with non-invasive digital Nexfin technology (ml/min) and compared with transthoracic echocardiographic measure of cardiac output (ml/min) used as reference. Echographic cardiac output (ml/min) is measured as the produce of cross sectional aera of left ventricular outflow track (cm²) multiplied by velocity time index (cm) multiplied by heart rate (beat/min) | 30 minutes |
Endometrial Ablation With Non-hysteroscopic Methods

Study Overview
=================
Brief Summary
-----------------
Endometrial ablation in women with dysfunctional uterine bleeding using second generation ablation devices is a common widespread therapeutic approach. This study aims to prove that amenorrhoea rates using Novasure are higher than those observed in microwave endometrial ablation, one year following intervention.

Official Title
-----------------
Treatment of Dysfunctional Uterine Bleeding With Second Generation Ablation Devices: Microwaves (MEA®) vs Bipolar Impedance Control System (Novasure®)

Conditions
-----------------
Dysfunctional Uterine Bleeding

Intervention / Treatment
-----------------
* Device: MEA
* Device: Novasure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women presenting with dysfunctional uterine bleeding having completed their family planning(no wish for further childbearing) Exclusion Criteria: Endometrial pathology FSH > 20 day 2 -day 3 of the cycle Clotting Disorders Thyroid Dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 49 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 |
| --- | --- |
| Active Comparator: Endometrial ablation with microwaves<br>Endometrial ablation with the use of MEA(microwaves endometrial ablation device) | Device: MEA<br>* Microwave endometrial ablation device<br>* Other names: Microwaves (MEA®);|
| Active Comparator: Endometrial ablation with bipolar diathermy<br>Endometrial ablation with Novasure(bipolar impedence control system) | Device: Novasure<br>* Bipolar impedence control system<br>* Other names: Bipolar Impedance Control System (Novasure®);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amenorrhoea rates one year after intervention |  |  |
Copeptin After Arginine Infusion in Polyuria-Polydipsia Syndrome

Study Overview
=================
Brief Summary
-----------------
the purpose of the study is to investigate whether arginine infusion is a new tool to differentiate patients with diabetes insipidus, primary polydipsia and healthy subjects.

Official Title
-----------------
Copeptin After Arginine Infusion for the Differential Diagnosis of the Polyuria-Polydipsia Syndrome ''The CARGO-Study''

Conditions
-----------------
Healthy, Polyuria-polydipsia Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years No medication except hormonal contraception Exclusion Criteria: Evidence of any acute illness Subjects refusing or unable to give written informed consent Pregnancy Any evidence of disordered drinking habits and diuresis

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy adults<br> | |
| Patients with a polyuria-polydipsia syndrome<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discriminative value of copeptin after arginine infusion in the differential diagnosis of polyuria-polydipsia syndrome. |  | up to 120 minutes after the Arginine infusion. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Copeptin, Arginin stimulation test
NCCLS Interpretive Criteria for Salmonella

Study Overview
=================
Brief Summary
-----------------
To determine the clinical significance of gene mutations encoding antibiotic resistance, but not expressed as clinical resistance, in Salmonella bacteria

Detailed Description
-----------------
Observational study. Physicians in foreign countries caring for patients with Salmonella meningitis or bloodstream infections will collect data on the patients they care for and send this data and an isolate of the organism causing the infection to the University of Pittsburgh.

Official Title
-----------------
NCCLS Interpretive Criteria for Salmonella

Conditions
-----------------
Salmonella Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: salmonella positive isolate

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Salmonella
The London COPD Exacerbation Cohort

Study Overview
=================
Brief Summary
-----------------
The London COPD exacerbation (EXCEL) cohort builds on an established cohort started in 1995 and designed to study COPD exacerbations and their impact on health-status and disease progression.

Detailed Description
-----------------
Our intentions are to phenotype Chronic Obstructive Pulmonary Disease (COPD) patients on the basis of factors that a related to (a) exacerbation frequency which will include (b) lung function to assess disease severity, (c) baseline therapy, (d) airway and systemic inflammatory markers, (e) health status, (f) gene expression, (g) airway bacterial and viral load and (h) co-morbidity including cardiovascular disease, diabetes and psychological disease, (i) psychological factors,(j) mortality, (k) nasal susceptibility to rhinovirus infection, (l) heart rate variability (m) exhaled hydrogen sulphide.

Official Title
-----------------
Relationship Between Patient Phenotypes and Exacerbations in Chronic Obstructive Pulmonary Disease.

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Forced Expiratory Volume in 1 sec (FEV1)/Forced Vital Capacity (FVC) ratio of <0.70 Able and willing to give informed and written consent Exclusion Criteria: Patients with a history of asthma, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease were excluded. Patients on Immunosuppressive medications or with active cancer Long term steroid therapy Age <40 years at recruitment

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Annual exacerbation rate (number of exacerbations over a 12 month period) | Definition of an exacerbation The presence of 2 new symptoms (one of which must be major) for 2 consecutive days Major symptoms: increased breathlessness (A), increased sputum colour (B1) or increased sputum amount (B2) Minor symptoms: a cold (C), increased wheeze or chest tightness (D), Sore throat (E1), Increased cough (E2), Fever (F) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease