linjc16/ctgov huggingface dataset:
Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community-Healthcare Workers

Study Overview
=================
Brief Summary
-----------------
Medical staff will be screened for MRSA and ESBL (including: doctors, nurses, nurse aids, physical therapists, dietitians, Janitors and other medical staff). PURPOSE: To define the carriage of, and risk factors for carriage of resistant organisms among healthcare employees of carriers of resistant bacteria. To define activities of healthcare employees who likely to lead to dissemination of resistant bacteria in rehabilitation centers.

Detailed Description
-----------------
Detailed activity: Medical staff will be screened for MRSA and ESBL (including: doctors, nurses, nurse aids, physical therapists, dietitians, Janitors and other medical staff). Screening will be performed by obtaining nares and perirectal cultures. Nares cultures will be obtained by ward staff or research personnel who are experienced in performing this activity: a moisture swab will be applied gently to the distal part of both nares. Perirectal cultures, will be taken by swab, who will be applied to the perirectal area, either by staff as mentioned above, or will be given to the healthcare workers to perform by himself (with explanation on how to perform it).

Official Title
-----------------
Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community- the Role of Healthcare Workers

Conditions
-----------------
Methicillin-Resistant Staphylococcus Aureus, ESBL

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health care employees Exclusion Criteria: Age 18 years or less

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 |
| --- | --- | --- |
| Healthcare employees) including: doctors, nurses, nurse aids, physical therapists, dietitians, Janitors and other medical staff) who work in the rehabilitation center |  | 1 YEAR | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthcare employees who work in the rehabilitation center
Efficacy and Safety of SQV in Patients Who Have Chronic IDV Nephrotoxicity

Study Overview
=================
Brief Summary
-----------------
Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who have chronic indinavir (IDV) associated nephrotoxicity.

Detailed Description
-----------------
Primary objective: To determine whether a switch to a SQV can cause improvements in renal function in patients with chronic IDV associated nephrotoxicity without improvement after IDV dose reduction. Secondary objective: To describe the pathophysiology of chronic IDV associated renal impairment through renal biopsies at baseline and week 48 To describe the pathophysiology of chronic IDV associated renal impairment through renal tubular function at baseline and week 48 To determine whether a switch to an SQV can cause improvements in renal pathophysiology in patients with chronic IDV associated nephrotoxicity through renal biopsies performed at baseline and at weeks 48 To determine whether a switch to an SQV results in improvements in hypertension, lipid profiles and cutaneous side effects

Official Title
-----------------
Efficacy and Safety of a Saquinavir Based Regimen in HIV-1 Infected Thai Patients Who Have Chronic IDV Associated Nephrotoxicity.

Conditions
-----------------
IDV Associated Nephrotoxicity

Intervention / Treatment
-----------------
* Drug: Saquinavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IDV containing regimen for more than 1 year and have creatinine more than 1.4 at least 6 months/abnormal renal imaging/abnormal urinary examinations Viral load less than 50 copies Exclusion Criteria: Saquinavir intolerance

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Replace Indinavir with SQV in patients with indinavir toxicity | Drug: Saquinavir<br>* SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load less than 50 copies/ml Improvement of renal functions and renal imaging |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic and cutaneous profile |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IDV nephrotoxicity
A Blinded Study Comparing the Safety and Efficacy of a Fully Human Anti-IL8 Monoclonal Antibody (ABX-IL8) to Placebo in Patients With Chronic Bronchitis and COPD

Study Overview
=================
Brief Summary
-----------------
To determine if ABX-IL8 will improve shortness of breath.

Detailed Description
-----------------
Chronic Obstructive Pulmonary Disease (COPD) is defined as a disease state characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema. The airflow obstruction is generally progressive, may be accompanied by airway hyper-reactivity, and may be partially reversible. Inflammation in the lungs is triggered by exposure to inhaled toxic substances that can lead to tissue damage, mucous secretion, airways narrowing and tissue destruction. Interleukin-8 (IL-8) plays a major role in elevating sputum in patients with COPD and may contribute to tissue destruction. Therefore, the highly specific antibody to IL-8 (such as ABX-IL8) may help to reduce mucous production and tissue destruction.

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

Intervention / Treatment
-----------------
* Drug: ABX-IL8


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 50 years old > 20 pack-year of smoking Diagnosed with COPD and chronic bronchitis Exclusion Criteria: Patients with bronchiectasis, cystic fibrosis, tuberculosis, asthma, alpha-1 antitrypsin deficiency, CHF Require oxygen therapy Uncontrolled hypertension HIV or Hepatitis Recent history of COPD exacerbation Patients with cancer Recent history of infection

Ages Eligible for Study
-----------------
Minimum Age: 50 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: ABX-IL8|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
-----------------
COPD, Chronic bronchitis, Chronic obstructive pulmonary disease, Shortness of breath, Dyspnea, Bronchitis
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 for Phase 2 studies

Official Title
-----------------
A Phase I Multiple Ascending Dose Study of BMS-754807 in Subjects With Advanced or Metastatic Solid Tumors

Conditions
-----------------
Neoplasms, Solid Tumors, Metastases

Intervention / Treatment
-----------------
* Drug: BMS-754807


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate ECOG performance status 0-1 at least 4 weeks between surgery or last dose prior anti-cancer therapy Exclusion Criteria: symptomatic brain metastases any disorder or dysregulation of glucose homeostasis {e.g. diabetes) uncontrolled or significant cardiovascular disease inadequate bone marrow, liver or kidney function

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-754807<br>Single arm, multiple-ascending dose escalation study | Drug: BMS-754807<br>* Tablets, Oral, Dose Cohorts: 4mg, 10mg, 20mg, 30mg, 50mg, 70mg, 100mg, 130mg, 160mg, 200mg, Once Daily, Until disease progression, unacceptable toxicity or at the subject's request<br>* Other names: IGF-IR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3 |  | Continuous assessment throughout the duration of the trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | assessed during the first 4 weeks of the study | 
| Pharmacodynamics |  | assessed during the first 4 weeks of the study | 
| Metabolic measures |  | assessed during the first 4 weeks of the study | 
| ECG |  | assessed during the first 4 weeks of the study | 
| Efficacy Measures |  | assessed every 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced or Metastatic Solid Tumors or Neoplasms
Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency.

Official Title
-----------------
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Congenital FVII Deficiency - Registry for All Treated Patients

Conditions
-----------------
Congenital Bleeding Disorder, Congenital FVII Deficiency

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congenital FVII deficiency Never been treated with NovoSeven® before Patients already in treatment with NovoSeven® Exclusion Criteria: History of hypersensitivity to any of the components in NovoSeven®
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: activated recombinant human factor VII<br>* Data will be collected at the baseline visit and approximately once a year until end of study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions |  | once a year in years 1-4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the treatment evaluation for bleeding episodes |  | year 1, year 4 | 
| To assess the course and outcome of pregnancy in women treated with novoseven |  | until 1 month after giving birth |
Biomarkers in Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in patients with acute myeloid leukemia.

Detailed Description
-----------------
OBJECTIVES: To determine whether clonally expanded somatic mitochondrial DNA mutations are associated with acute myeloid leukemia. OUTLINE: Genomic DNA from blood samples obtained at diagnosis, remission, and relapse are analyzed for mitochondrial DNA mutations via PCR.

Official Title
-----------------
Mitochondrial Mutations and AML

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: DNA analysis
* Genetic: mutation analysis
* Genetic: polymerase chain reaction
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia Available blood samples from diagnosis, remission, and relapse PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA analysis|nan|
|Genetic: mutation analysis|nan|
|Genetic: polymerase chain reaction|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between clonally expanded somatic mitochondrial DNA mutations and acute myeloid leukemia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult acute myeloid leukemia, childhood acute myeloid leukemia/other myeloid malignancies
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins

Study Overview
=================
Brief Summary
-----------------
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with twins and a short cervical length at 18-22 weeks scan.

Detailed Description
-----------------
This trial includes pregnant women with twins undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Official Title
-----------------
Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Device: Silicon ring (Arabin Cervical Pessary)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Twins Minimal age of 18 years Exclusion Criteria: Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap) Spontaneous rupture of membranes at the time of randomization Cervical cerclage in situ Active vaginal bleeding Placenta previa

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Expectant Management<br> | |
| Experimental: Placement of cervical pessary since 23 weeks until 37 weeks<br> | Device: Silicon ring (Arabin Cervical Pessary)<br>* Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous delivery before 34 completed weeks |  | Each 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth weight |  | Each 6 months | 
| Fetal-Neonatal Death |  | Each 6 months | 
| Neonatal morbidity |  | Each 6 months | 
| Maternal adverse effects |  | Each 6 months | 
| Preterm birth before 37 weeks or 28 weeks |  | Each 6 months | 
| Rupture of membranes before 34 weeks |  | Each 6 months | 
| Hospitalisation for threatened preterm labour |  | Each 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Short cervix, Preterm birth, Cervical pessary, Twins
A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy

Study Overview
=================
Brief Summary
-----------------
To observe the decreased levels of low-density lipoprotein from baseline in patients with obesity-related glomerulopathy (ORG) after 12 weeks of Sevelamer Carbonate treatment.

Conditions
-----------------
Obesity and Glomerulopathy

Intervention / Treatment
-----------------
* Drug: High dosage Sevelamer Carbonate + Irbesartan
* Drug: Low dosage Sevelamer Carbonate + Irbesartan
* Drug: Irbesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of obesity diagnosed ORG by renal biopsy LDL>3.37mmol/L Proteinuria 0.5-3.5g/d eGFR (CKD-EPI formula) > 30ml/min Exclusion Criteria: Other concomitant renal diseases Endocrine or drug-induced obesity; Type 2 diabetes eyes or obvious microscopic hematuria; Swallowing difficulty / severe gastrointestinal dysfunction intestinal obstruction; severe arrhythmia; Hypophosphatemia (<0.7mmol/L); allergic to Sevelamer Carbonate unable to well cooperate Females who are in the period of gestation or lactation, or refuse to use contraception; participated in other clinical trial of drug within three months

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A Group<br> | Drug: High dosage Sevelamer Carbonate + Irbesartan<br>* Sevelamer Carbonate 4.8g/d+Irbesartan 300mg/d<br>|
| Experimental: B Group<br> | Drug: Low dosage Sevelamer Carbonate + Irbesartan<br>* Sevelamer Carbonate 2.4g/d+Irbesartan 300mg/d<br>|
| Active Comparator: C Group<br> | Drug: Irbesartan<br>* Irbesartan 300mg/d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| low-density lipoprotein | decreased levels of low-density lipoprotein from baseline | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uric acid | Changes of uric acid from baseline after 12 weeks of treatment | 12 weeks | 
| blood lipids parameters (CHO, TG, HDL) | Changes of blood lipids parameters from baseline after 12 weeks of treatment | 12 weeks | 
| proteinuria | Changes of proteinuria from baseline after 12 weeks of treatment | 12 weeks | 
| blood glucose | Changes of blood glucose from baseline after 12 weeks of treatment | 12 weeks | 
| glycated hemoglobin | Changes of glycated hemoglobin from baseline after 12 weeks of treatment | 12 weeks |
Dabigatran in an Interaction Probe Drug Cocktail

Study Overview
=================
Brief Summary
-----------------
Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods. Adverse events, haematology and clinical chemistry recorded.

Official Title
-----------------
An Open-label Crossover Trial Assessing the Value of Dabigatran in a Drug Interaction Cocktail in Healthy Young Volunteers

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

Intervention / Treatment
-----------------
* Drug: Caffeine
* Drug: Diclofenac
* Drug: Esomeprazole
* Drug: Metoprolol
* Drug: Midazolam
* Drug: Dabigatran
* Drug: Clarithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Weight at least 50 kg and body mass index 19 - 30 kg m-2 Normal clinical laboratory profiles No childbearing potential or use of adequate contraceptive measures Exclusion Criteria: Blood loss >300 ml within 2 months prior to the first dosing day Pregnancy, breastfeeding Allergy or hypersensitivity to caffeine, diclofenac, esomeprazole, metoprolol, midazolam, dabigatran or clarithromycin or to excipients in the pharmaceutical products Infection with HIV, HBV or HCV Participation in the preceding 3 months or concomitantly in any clinical drug study Suspected current drug or alcohol abuse History of drug or alcohol abuse. Concomitant medication with the exception of hormonal contraception. Positive result in urine test for drug abuse. Nicotine consumption equivalent to >5 cigarettes per day

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Caffeine<br>* probe<br>Drug: Diclofenac<br>* probe<br>Drug: Esomeprazole<br>* probe<br>Drug: Metoprolol<br>* probe<br>Drug: Midazolam<br>* probe<br>Drug: Dabigatran<br>* probe<br>Drug: Clarithromycin<br>* perpetrator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of dabigatran in plasma | Exposure ratio for dabigatran in combination and dabigatran alone | 24 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | 23 days |