linjc16/ctgov huggingface dataset:
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XX

Study Overview
=================
Brief Summary
-----------------
To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 163538 XX within a predefined dose range

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled Trial in Healthy Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 2.5 mg to 160 mg of BI 163538 XX

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

Intervention / Treatment
-----------------
* Drug: Placebo to BI 163538 XX
* Drug: BI 163538 XX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy male subjects overweight or obese Exclusion criteria: 1. Any relevant deviation from healthy conditions

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

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 163538 XX<br>1 single dose per subject as oral solution | Drug: BI 163538 XX<br>* 1 single dose per subject as oral solution<br>|
| Placebo Comparator: Placebo to BI 163538 XX<br>1 single dose per subject as oral solution | Drug: Placebo to BI 163538 XX<br>* 1 single dose per subject as oral solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  | up to 15 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of the analyte in plasma) |  | up to 96 hours postdose | 
| AUC0-∞ (area under the concentration-time curve of the in plasma over the time interval from 0 extrapolated to infinity) |  | up to 96 hours postdose | 
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) |  | up to 96 hours postdose |
Does Visceral Manipulation Works in Treating Functional Dyspepsia?

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine if Visceral Manipulation (VM) is effective in treating Functional Dyspepsia in addition to drug therapy. Null hypothesis is that VM does not influence FD symptoms.

Detailed Description
-----------------
50 patients with Functional Dyspepsia (FD) diagnosed by General Practitioners are randomized in two therapy group: 1) drug only group and 2) drug + Visceral Manipulation group. Group 1 receive drug therapy for 4 weeks, Group 2 receive drug therapy for 4 weeks and 4 Visceral Manipulation visits with weekly frequency (visit 1 at day 1 of drug therapy). FD symptoms are recorded with VAS at baseline and after 1 and 4 weeks of therapy, and after 8 weeks (4 weeks after the finish of all therapies).

Official Title
-----------------
Does Visceral Manipulation Works in Treating Functional Dyspepsia? A Randomized Study

Conditions
-----------------
Functional Dyspepsia

Intervention / Treatment
-----------------
* Procedure: Visceral Manipulation
* Drug: PPIs and/or Domperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Functional Dyspepsia Exclusion Criteria: Diabetes Mellitus Mental disturbance Thyroid gland dysfunction Intestinal, liver and biliary tract disease Concurrent medications that could interact with GI function Positive Helicobacter Pylori status

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual drug FD therapy + Visceral Manipulation<br> | Procedure: Visceral Manipulation<br>* Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks and 4 VM visits with weekly frequency with first VM visit at day 1 of drug therapy.<br>|
| Active Comparator: Usual drug FD therapy<br> | Drug: PPIs and/or Domperidone<br>* Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning |  | baseline, 1, 4 and 8 weeks after therapy start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional Dyspepsia, Visceral Manipulation
How to Improve Diagnosis in Infective Endocarditis

Study Overview
=================
Brief Summary
-----------------
The purpose is to exam prospective if simple clinical information in combination with a normal s-procalcitonin are sufficient for exclusion of infective endocarditis (IE).

Detailed Description
-----------------
Despite progress in surgical and medical treatment, infective endocarditis is still associated with high morbidity and mortality. The variable clinical presentation of IE makes the diagnosis a clinical challenge. Procalcitonin is a precursor from the hormone calcitonin and also a marker of systemic bacterial infections. The purpose of this study is: to investigate the diagnostic value of serum procalcitonin (PCT), C-reactive protein (CRP) and sedimentation rate (SR) when IE is suspected. to investigate if a retrospectively generated clinical model suitable for exclusion of IE can be confirmed prospectively.

Official Title
-----------------
Ph. D Student, Jane Byriel Knudsen, Aarhus University

Conditions
-----------------
Endocarditis, Bacterial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > or = 18 year with suspected or verified Infective Endocarditis By word of mouth or in writing consent Exclusion Criteria: Incapacity

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 |
| --- | --- |
| IE confirmed IE rejected<br>Prospective, controlled, blinded study of clinical/TEE criteria of IE compare to clinical/blood test criteria of IE. | |
| IE confirmed IE rejected<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Validation of InferRead Lung CT.AI

Study Overview
=================
Brief Summary
-----------------
Lung cancer is the second most common cause of cancer-related death in men and women. Early pulmonary nodule screening is an effective means to prevent lung cancer, which is no less important than the diagnosis and treatment of lung cancer. Early lung cancer screening has been investigated and applied as a medical practice. InferRead Lung CT.AI by Infervision is a dedicated post processing application that generates CADe marks as an overlay on the original CT series intended to aid the radiologist in the detection of pulmonary nodules. This study was designed to evaluate radiologists' performance in detecting actionable nodules on chest CT when aided by InferRead.

Official Title
-----------------
Clinical Validation of InferRead Lung CT.AI

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

Intervention / Treatment
-----------------
* Device: Aided read with InferRead Lung CT.AI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung cancer screening eligible patients Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Aided read with InferRead Lung CT.AI|Radiologists read chest CT scans with the aid of InferRead Lung CT.AI|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection accuracy | The primary objective of this clinical study is to demonstrate that a radiologist review of a CT scan aided with InferRead Lung CT.AI significantly improves detection of actionable lung nodules. Area under the ROC curve, Sensitivity, specificity, PPV, NPV will be reported, compared between unaided and aided reads. | 20 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reading time change | The secondary objective of this clinical study is to demonstrate that the radiologist's review time is not significantly increased when aided with InferRead Lung CT.AI. The reading time for each case will be recorded in both aided and unaided reads. The reading times will be compared using a paired T test. | 20 hours |
Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of MT921 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To determine the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability of MT921 in Healthy Subjects

Official Title
-----------------
A Randomized, Double-blinded, Placebo-controlled, Single Center, Dose Escalation, Phase I Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of MT921 in Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: MT921
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged between 20 and 65 years Exclusion Criteria: Subject not appropriate for participating in this study according to the investigator's opinion

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT921 60mg Group<br>MT921 60 mg | Drug: MT921<br>* Formulated as an injectable solution<br>|
| Experimental: MT921 120mg Group<br>MT921 120 mg | Drug: MT921<br>* Formulated as an injectable solution<br>|
| Experimental: MT921 150mg Group<br>MT921 150 mg | Drug: MT921<br>* Formulated as an injectable solution<br>|
| Placebo Comparator: Placebo Group<br>Placebo | Drug: Placebo<br>* normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Concentration (Cmax) measured by Liquid Chromatography-mass spectrometry (LC/MS) | Peak plasma concentration measured by Liquid Chromatography-mass spectrometry (LC/MS) achieving in the test area of the body after administration. | Up to 24 hours | 
| AUC0-24 | Area under the plasma concentration versus time curve from time 0 to 24 hours measured by Liquid Chromatography-mass spectrometry (LC/MS) after administration | Up to 24 hours | 
| Maximum Time (Tmax) measured by Liquid Chromatography-mass spectrometry (LC/MS) | The time at which the Cmax is observed measured by Liquid Chromatography-mass spectrometry (LC/MS). | Up to 24 hours | 
| Half-life (t1/2) measured by Liquid Chromatography-mass spectrometry (LC/MS) | The time it takes for the concentration of the drug in the plasma or the total amount in the body to be reduced by 50% measured by Liquid Chromatography-mass spectrometry (LC/MS). | Up to 24 hours |
Common Recreational Diving Practices: A Randomized Control Trial Using Pre-Dive Checklist

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of using a pre-dive checklist to prevent the incidence of diving mishaps in recreational divers.

Official Title
-----------------
A Group Randomized Trial to Evaluate the Efficacy of Using Pre-dive Checklist to Prevent the Incidence of Recreational Scuba Diving Mishaps

Conditions
-----------------
Injuries

Intervention / Treatment
-----------------
* Other: A pre-dive checklist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age Having a valid Diver Certification Deemed fit by the Dive operator to dive on the day of participation Planning to dive on the day of participation Have basic knowledge of English Exclusion Criteria: Anyone not meeting all of the inclusion criteria A diver who did not answer the outcomes questionnaire was later excluded

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention group received a pre-dive checklist and a post-dive log | Other: A pre-dive checklist<br>* The pre-dive checklist included a checklist of tasks to be undertaken before the dive, a dive-plan that asked the diver to plan the depth, and amount of gas kept at different levels of diving, and 4 dive tips.<br>|
| No Intervention: Control<br>The control group received the post-dive log only. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mishaps | Mishaps were reported by scuba divers themselves, at the end of their diving day (the day they were enrolled). Mishaps are precursors of injuries. Injuries are less common outcomes (in fact, nobody got injured), hence we used mishaps - which allowed us to test the efficacy of pre-dive checklists, and do so with limited resources. | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major mishaps | Major mishaps are a type of mishaps | One day | 
| Minor Mishaps | Minor mishaps are a type of mishaps | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diving, Water, Recreation, Precursor
Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day initial treatment period with quetiapine. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate
* Drug: sodium valproate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from a manic or mixed episode. Exclusion Criteria: Patients who have not provided personal informed consent, Known intolerance, hypersensitivity or lack of antimanic response to sodium valproate or quetiapine fumarate, Involuntary admittance/detainment.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>quetiapine fumarate monotherapy | Drug: Quetiapine fumarate<br>* oral variable dose<br>* Other names: Seroquel;|
| Experimental: 2<br>Quetiapine + sodium valproate | Drug: Quetiapine fumarate<br>* oral variable dose<br>* Other names: Seroquel;Drug: sodium valproate<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate) |  | after 2 weeks treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)
Study of Microbiota in Bile From Patients With Common Bile Duct Stone During ERCP

Study Overview
=================
Brief Summary
-----------------
In this study, investigators will investigate the microbiota of bile in common bile duct stone participants. Three key questions are of concern. The first one is whether there is bacteriria in bile in participants without common bile duct stone. The second one is whether the microbiota of bile is similar with that of gut mucosa in common bile duct stone participants. The third one is whether the bacteria in bile of common bile participants with intact papillar is the same as that of participants underwent sphinctomy.

Official Title
-----------------
ERCP Based Study of Microbiota in Bile From Patients With Common Bile Duct Stone

Conditions
-----------------
Cholangiopancreatography, Endoscopic Retrograde, Common Bile Duct Calculi, Microbial Colonization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CBD tumor or CBD calculi Exclusion Criteria: contraindication for ERCP
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients without CBD calculi<br>patients without CBD calculi | |
| CBD calculi without ERCP history<br>patients with CBD calculi without ERCP history | |
| CBD calculi with ERCP history<br>patients with CBD calculi and ERCP history | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiota in bile | 16s RNA | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, CBD stone, Microbial Colonization
Atrial Fibrillation in Patients Receiving Ibrutinib

Study Overview
=================
Brief Summary
-----------------
Ibrutinib (a tyrosine kinase inhibitor targeting Bruton) is a standard of treatment in haematology. According to retrospective data, atrial fibrillation and systemic hypertension are common ibrutinib-related advserse events. The investigators aim at prospectively establishing the incidence of thesedrug related advsere events through clinical monitoring and attempt at identifying populations at risk.

Official Title
-----------------
Etude de l'Incidence et Des Facteurs prédictifs de la Survenue de Fibrillation Atriale Sous Ibrutinib

Conditions
-----------------
Leukemia, Chronic Lymphatic, Mantle Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients deem to start ibrutinib therapy Exclusion Criteria: Past history of ibrutinib therapy

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 |
| --- | --- | --- |
| Incidence of cardiovascular events on ibrutinib | Evaluate the incidence of cardiotoxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of ibrutinib. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of supra-ventricular arrythmias | Number of patients with supra-ventricular arrythmias | 6 months | 
| Incidence of systemic hypertension | Number of patients with systemic hypertension | 6 months | 
| Incidence of arterial embolism | Number of patients with systemic hypertension | 6 months | 
| Incidence of hemorraghe | Number of patients with hemorraghe | 6 months | 
| Safety mesures | Compare advsere events in patients with supr-ventricular arrhythmias according to the continuation or discontinuation of ibrutinib | 1 year | 
| Anticoagulants | Correlation between anti thrombotic strategies and cardiovascular outcomes | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, haematology, systemic hypertension, prognosis, heart