linjc16/ctgov huggingface dataset:
Drug-Drug Interaction Study in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of rifampin on the pharmacokinetics of K-877 in healthy adult volunteers.

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

Intervention / Treatment
-----------------
* Drug: K-877
* Drug: Rifampin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening. Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening. Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening. Exclusion Criteria: Subject has clinically relevant abnormalities in the screening or check in assessments. Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females). Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-877<br>K-877 | Drug: K-877<br> <br> |
| Experimental: K-877 with Rifampin<br>K-877 with Rifampin | Drug: K-877<br> <br> Drug: Rifampin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under concentration curve (AUC) |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult Volunteers
A Trial of Pre-Operative Chemoradiotherapy Using Capecitabine, Radiation & Cetuximab, in Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer

Detailed Description
-----------------
Its a pilot study of pre-op chemotherapy and RT utilizing CAPECITABINE, XRT and CETUXIMAB in pts with locally advanced rectal carcinoma.

Official Title
-----------------
A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer

Conditions
-----------------
Colon Rectal Cancer Duke Stage Stageval

Intervention / Treatment
-----------------
* Drug: Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Localized Non-Metastatic Rectal Cancer Exclusion Criteria: Patients with diagnosis other than Localized Non-Metastatic Rectal Cancer

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)|Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of pre-operative concurrent chemotherapy with capacitabine (Xeloda), weekly cetuximab (Erbitux), and external beam radiation. |  | For the duration of the experiment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate efficacy of sphincter preserving surgery rate, local recurrence rate and the disease free and overall survival in patients. |  | For the duration of the experiment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rectal Cancer
Study to Investigate ADME of 14C Labeled SLV334 After an i.v. Infusion

Study Overview
=================
Brief Summary
-----------------
This study will investigate the absorption, distribution, metabolism and excretion after giving 2000 mg 14C-SLV334 via a 1-hour infusion. The absolute bioavailability will also be determined.

Official Title
-----------------
An Open Label Study to Determine ADME of 14C Labeled SLV334 and Its Metabolites After Single Intravenous Dose Infusion

Conditions
-----------------
Pharmacology, Clinical

Intervention / Treatment
-----------------
* Radiation: SLV 334


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria healthy non-smoking subjects Exclusion Criteria QTc > 430 ms; positive drug screen

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SLV 334 | Radiation: SLV 334<br>* 2000 mg via i.v. solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage excreted in urine and feces |  | 16 days | 
| metabolic profile SLV334 |  | 16 days | 
| AUC, CL, lambda z, Cmax, t1/2, tmax and Vss |  | 16 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | 16 days | 
| vital signs |  | 16 days | 
| ECG |  | 16 days | 
| Laboratory safety variables |  | 16 days | 
| Physical examination |  | 16 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
14C labeled ADME (Aborption Distribution Metabolism and Elimination) study, Phase I
Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments

Study Overview
=================
Brief Summary
-----------------
Meningitis is the development of an inflammatory reaction in the meningeal space, most often of infectious origin. Many pathogens can cause meningitis, the severity of which varies greatly. Patients presenting with a febrile meningeal syndrome are most often managed in the emergency room, where the challenge for physicians is to quickly differentiate bacterial and viral meningitis. Viral meningitis is the most common, with enterovirus meningitis having a classically excellent prognosis. Bacterial meningitis is less frequent but more serious.The current public health objective is to save antibiotics. Investigator hypothesizes that the BMS score can be used to exclude bacterial meningitis in the emergency department in an adult European population of patients with suspected bacterial meningitis.

Official Title
-----------------
Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments

Conditions
-----------------
Meningitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted to the Adult Emergency Department of CH Le Mans,CHU Angers, CHU Nantes or Beaujon Hospital. Over 18 years old Having had a lumbar puncture during their stay in the Adult Emergency Department Having had a diagnosis of meningitis defined as a pleocytosis ≥ 5leukocytes/mm3 after correction with CSF red blood cells at a standardized ratio of 500/1. Exclusion Criteria: Antibiotic therapy within 72 hours of inclusion Immunosuppression from any cause Presence of petechiae or purpura History of recent neurosurgery or head trauma Other associated bacterial infection Inability to collect information for the BMS score calculation or primary endpoint (e.g., transfer to another facility) Minor or adult patient under guardianship or protection

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 |
| --- | --- | --- |
| External validation of the BMS score in a European adult population to exclude bacterial meningitis | Validation was measured by comparaison between BMS score and the diagnosis retained from the data collected in the file | 1 month after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMS score, Meningitis
Convalescent Plasma in Hospitalized COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
The study assesses the efficacy and safety of administration of hyperimmune plasma in hospitalized COVID-19 patients. Efficacy was measured as 28-day mortality following convalescent plasma transfusion. Safety was measured as the rate of adverse reactions. to plasma infusion.

Detailed Description
-----------------
Inclusion criteria: Adult inpatients with a severe form of COVID-19 have been enrolled, with at least one of the following inclusion criteria: 1) tachypnea with respiratory rate (RR) > 30 breaths/min; 2) oxygen saturation (SpO2) ≤ 93% at rest and in room air; 3) partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤ 200 mmHg, 4) radiological picture and/or chest CT scan showing signs of interstitial disease and/or rapid progression of lung involvement. Primary outcome: Overall mortality at 28 days after hospitalization Secondary outcome: Adverse reaction to plasma transfusion.

Official Title
-----------------
Convalescent Plasma in Hospitalized COVID-19 Patients: a Single Center Experience

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: Convalescent plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients admitted for severe COVID-19 Exclusion Criteria: < 18 years participation in any other clinical trial of an experimental treatment for COVID-19

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Convalescent plasma|Hyperimmune plasma from convalescent COVID-19 donors with titre 1:80 or more|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
An Epidemiological Study Aimed to Record Standard Daily Practice in Managing Patients With Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
This study is aimed to collect the following Serbia-specific epidemiology data on hypercholesterolemia: patents characteristics, patients' management/treatment and physicians' standard practice. In addition, the aim is to determine the proportion of patients on lipid-lowering pharmacological treatment who have reached the LDL-C and HDL-C treatment goals.

Official Title
-----------------
An Epidemiological Study Aimed to Record Standard Daily Practice in Managing Patients With Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hypercholesterolemia currently receiving a lipid lowering agent Exclusion Criteria: Pregnancy and lactation.

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 |
| --- | --- |
| 1<br>Patients with hypercholesterolemia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on lipid-lowering pharmacological treatment reaching the non HDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines; |  | 24 weeks | 
| Physicians' standard practice in managing patients with hypercholesterolemia (by using physicians' questionnaire); |  | 24 weeks | 
| Local epidemiological date on patients with hypercholesterolemia (Demographic Data; Hypercholesterolemia management data: treatment, treatment changes) |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Standard daily practice in managing patients with hypercholesterolemia
ANalyzing Olfactory Dysfunction Mechanisms In COVID-19

Study Overview
=================
Brief Summary
-----------------
We aim to understand the mechanism of olfactory dysfunction in COVID-19.

Detailed Description
-----------------
In December 2019, a new coronavirus causing severe acute respiratory syndrome was described in Wuhan, China. This virus, later named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), spread worldwide and has been designated a pandemic by the World Health Organization. By the beginning of March 2020, several Ear, Nose, Throat societies raised awareness of a frequent association between coronavirus disease 2019 (COVID-19) and smell disorders. In the present study, the investigators wish to begin to understand the pathogenesis of olfactory dysfunction in COVID-19.

Official Title
-----------------
ANalyzing Olfactory Dysfunction Mechanisms In COVID-19

Conditions
-----------------
SARS-CoV-2

Intervention / Treatment
-----------------
* Other: Sampling of tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Deceased hospitalised patients, tested positive or negative for SARS-CoV-2 for patient or control group respectively Exclusion Criteria: none
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 |
| --- | --- |
| Other: COVID-19 positive or negative patients<br>Hospitalised patients with or without COVID-19 (with or without olfactory dysfunctions) | Other: Sampling of tissue<br>* In all groups of participants, tissue from the nasal cavity and olfactory system will be surgically removed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of SARS-CoV-2 in the sampled tissue | In the sampled tissues, the investigators will determine presence of SARS-CoV-2 by means of immunohistochemistry, RNA-scope and spatial transcriptomics | Immediately after death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyposmia, Anosmia, Olfactory Dysfunction, COVID-19, SARS-CoV-2
Dexmedetomidine and Bupivacaine With Bupivacaine in Ultrasonography Guided Fascia Iliaca Compartment Block in Adults

Study Overview
=================
Brief Summary
-----------------
Few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia illiaca compartment black. Comparison of dexmedetomidine and bupivacaine with bupivacaine alone on the quality of ultrasonography guided fascia iliaca compartment block in adults undergoing femur fracture fixation surgery at 2014.

Official Title
-----------------
Comparison of Dexmedetomidine and Bupivacaine With Bupivacaine Alone on the Quality of Ultrasonography Guided Fascia Iliaca Compartment Block in Adults Undergoing Femur Fracture Fixation Surgery

Conditions
-----------------
Femoral Fractures

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with femural fracture Exclusion Criteria: Hypersensitivity to drugs Neurological diseases Coagulation abnormalities Infection at the site of block

Ages Eligible for Study
-----------------
Minimum Age: 14 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: Bupivacaine<br>30cc of 0.25% bupivacaine | Drug: Bupivacaine<br>* dexmedetomidine and Bupivacaine<br>|
| Active Comparator: Dexmedetomidine and bupivacaine<br>30cc of 0.25% bupivacaine and 2mg/kg dexmedetomidine | Drug: Dexmedetomidine<br>* dexmedetomidine plus placebo<br>Drug: Bupivacaine<br>* dexmedetomidine and Bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | A point between 0 and 10 based on patient report | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory depression | respiratory rate < 12/min | 24 hours | 
| Hypotension | Systolic blood pressure < 90 mmHg | 24 hours | 
| Baradycardia | Heart rate < 60/min | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femoral Fractures
To Evaluate the Safety and Efficacy of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of pregabalin in patients with painful diabetic peripheral neuropathy.

Official Title
-----------------
An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.

Conditions
-----------------
Diabetic Neuropathy, Painful

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have met the inclusion criteria for the preceding double-blind BID study in painful diabetic peripheral neuropathy Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks. Exclusion Criteria: Patients may not participate if they experienced a serious adverse event during the preceding double-blind BID study which was determined to be related to the study medication.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Efficacy |  |  |
An Evaluation of Motivational Interviewing to Increase Compliance in a Probation Setting

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of Motivational Interviewing (MI) on probationer progress over a 6-month period, using probation officers as the MI providers.

Official Title
-----------------
An Evaluation of Motivational Interviewing to Increase Compliance in a Probation Setting (Enhancing Communication and Officer Responsivity; ENCORE)

Conditions
-----------------
Compliance With Terms of Probation Sentence

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be on felony probation. Participants must be English speaking. Participants must be classified as medium or high-risk. Participants must be placed on a non-specialized caseload. Participants must be at least 18 years of age. Exclusion Criteria: Does not speak English. Is less than 18 years old. Is not on felony probation. Is not classified as medium or high-risk. Is placed on a specialized caseload.

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Probation officers trained to use Motivational Interviewing while conducting meetings with probationers. | Behavioral: Motivational Interviewing<br>* Probation officers trained to use Motivational Interviewing while conducting meetings with probationers.<br>|
| No Intervention: 2<br>Probation officers who are interested in Motivational Interviewing, but have not yet been trained to use it while conducting meetings with probationers. | |
| No Intervention: 3<br>Treatment as usual. Regular probation officers conduct standard meetings with probationers. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revocations |  | 6 months | 
| Absconder Status |  | 6 months | 
| Urinalysis (UA) Data |  | 6 months | 
| Arrest Data |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Officer Responses Questionnaire |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probation, Motivational