linjc16/ctgov huggingface dataset:
An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how safe and tolerable Brincidofovir (BCV) is when given for post exposure prophylaxis of Ebola virus disease.

Detailed Description
-----------------
The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD

Official Title
-----------------
An Open-Label, Multicenter Study of the Safety and Tolerability of Brincidofovir (CMX001) for Post-Exposure Prophylaxis of Ebola Virus Disease

Conditions
-----------------
Ebola Virus Disease

Intervention / Treatment
-----------------
* Drug: Brincidofovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals have high-risk exposure to Ebola Virus based on CDC definitions Must be able to ingest, absorb and tolerate oral medication As appropriate, must be willing to use adequate methods of contraception during the study and at least 6 months after their last dose of BCV Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: CMX001<br>Initial dose of 200mg followed by 4 doses of 100mg | Drug: Brincidofovir<br> <br> * Other names: CMX001;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of BCV treatment on development of EVD in subjects through 21 days post-initiation of BCV therapy |  | 8 weeks |
Effect of Probiotics on Oral Candida Among Denture Wearers

Study Overview
=================
Brief Summary
-----------------
Forty-eight denture wearers with detectable levels of candida colonization without clinical symptoms will be randomly allocated into two groups: probiotics and placebo. All patients will take a daily dose of chewable tablets (probiotics or placebo according to the assigned group) for 8 weeks. Samples of mouth rinse will be collected from patients at baseline, 4 weeks from the beginning of the intervention, 8 weeks (the end of intervention), and after another 4 weeks for post-intervention follow up. Samples will be tested for both candida count and candida species identification

Official Title
-----------------
Effect of Probiotics on Oral Candida Colonization Level in Complete Denture Wearers (Randomized Controlled Clinical Trial)

Conditions
-----------------
Oral Candida Albicans Infection

Intervention / Treatment
-----------------
* Other: Probiotic group
* Other: Placebo group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Detectable levels of Candida in palatal mucosa without clinical symptoms of active candidiasis. Completely edentulous arches with newly formed denture . Patients with controlled hypertension, and diabetes will be included in this study as they are considered very common problems in the targeted population. Exclusion Criteria: Inability to understand/ follow the experimental procedures, Administration of topic or systemic antifungal or antibacterial agents in the previous 60 days. Consumption of probiotics. GITdisorders. Heartdisease. Diseases that significantly influence immunity such as; kidney problems, head and neck cancer, or radiotherapy, AIDS, or immunosuppressive therapy. Clinical manifestations of oral candidiasis.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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: Probiotic group<br> | Other: Probiotic group<br>* Participants will use the probiotic product once daily (1 tablet/day) for 8 weeks<br>|
| Placebo Comparator: Control group<br> | Other: Placebo group<br>* Patients will chew placebo products (blueberry tablets) once daily (1 tablet/day) for 8 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in candida count | Quantitative culture will be performed from mouth-rinse samples by inoculation onto the surface of Sabouraud dextrose agar plates with chloramphenicol, and subsequent aerobic incubation for 24 to 48 hours at 37°C. | Baseline, 4 weeks, 8 weeks, 12 weeks |
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets

Study Overview
=================
Brief Summary
-----------------
To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg medication for 12 weeks in smokers

Detailed Description
-----------------
No sampling method will be applied to this study.

Official Title
-----------------
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: varenicline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects selected for this study are those who would have been prescribed Champix tablets by the physician according to the subject's condition in usual clinical practice. Exclusion Criteria: None

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 |
| --- | --- |
| Healthy smokers<br> | Drug: varenicline<br>* As prescribed by physician in usual clinical practice.<br>* Other names: Champix, Chantix, CP-526,555;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7 | Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No). | Week 3 through Week 7 | 
| Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11 | Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No). | Week 7 through Week 11 | 
| Percentage of Participants With 7-day Point Prevalence for at Least Week 11 | Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No). | At least Week 11 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
A prospective and observational program to monitor use in real practice including efficacy of Varenicline in Korea.
Comparison of the Effects of TIVA vs VIMA on Content of GSK-3beta in Leucocytes in On-pump Patients

Study Overview
=================
Brief Summary
-----------------
Assessment of GSK-3beta contents in leukocytes in on-pump cardiosurgical patients receiving either volatile or intravenous anesthesia

Official Title
-----------------
Comparison of the Effects of TIVA vs VIMA on Content of GSK-3beta in Leucocytes in On-pump Patients: a Randomized Clinical Trial

Conditions
-----------------
Glycogen Synthase Kinase 3

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective on-pump CABG Exclusion Criteria: re-operation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VIMA<br>Patiens receiving volatile induction and maitenance of anesthesia | Drug: Sevoflurane<br> <br> |
| Active Comparator: TIVA<br>Patiens receiving total intravenous anesthesia based on propofol | Drug: Propofol<br> <br> |
| Active Comparator: Combi<br>Patiens receiving total intravenous induction and volatile anesthesia | Drug: Sevoflurane<br> <br> Drug: Propofol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gsk-3beta base line content |  | base line | 
| Gsk-3beta content after induction |  | 20 minutes after tracheal intubation | 
| Gsk-3beta content after surgery |  | immediately after surgery |
Study of the Nervous Control of the Anal Sphincter

Study Overview
=================
Brief Summary
-----------------
Anal incontinence and constipation are frequently observed in patients with neurological disease. The purpose of this study is to evaluate the neurological control of the anal sphincter in healthy subjects, patients with neurological disease by a new electrophysiological technique. This technique consists in recordings of anal sphincter responses after magnetic stimulations of the cortex and the sacral nerves.

Official Title
-----------------
Evoked Responses of External Anal Sphincter After Cortical and Lombo-sacral Magnetic Stimulations

Conditions
-----------------
Spinal Cord Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers patients with spinal lesion patients with cauda equina syndrome Exclusion Criteria: pregnant women pacemaker or other metallic material implanted epileptic patients organic colorectal disease obese patients previous neurological surgery

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?
-----------------
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
-----------------
spinal cord injuries - anal sphincter - evoked potentials
The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density

Study Overview
=================
Brief Summary
-----------------
Hemodialysis patients with low bone density (total hip T-score <-2.5) will be assigned to receive teriparatide (those with histologic confirmation of adynamic bone disease) or ibandronate (subjects with increased osteoclast number on bone biopsy). Follow-up period: one year. A second bone biopsy at the end of the study.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: ibandronate
* Drug: teriparatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bone mineral density (T-score<-2.5) Adynamic bone disease for the teriparatide group Increased osteoclast number on bone biopsy (high turnover) for the ibandronate group Calcium greater than 8.1 mg/dl Exclusion Criteria: Suspected carcinoma Unstable clinical setting

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: F<br>HD pts suffering from osteoporosis and adynamic bone disease who received teriparatide | Drug: teriparatide<br>* sc injection using a pen like device during every hemodialysis session (thrice a week)<br>|
| Experimental: I<br>Hemodialysis pts suffering from osteoporosis who received iv ibandronate | Drug: ibandronate<br>* iv 1mg ibandronate monthly for one year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of ibandronate and teriparatide on other bone disease markers |  | one year |
Natriuretic Peptides - Predictors of In-hospital and Long-term Major Adverse Cardiac Events After Emergency Surgery?

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that the level of perioperative natriuretic peptides is associated with in-hospital and long term major adverse cardiac events.

Detailed Description
-----------------
The purpose of the study is to measure levels of brain natriuretic peptides before and after urgent non-cardiac surgery and to evaluate their predictive value for adverse long-term outcome.

Official Title
-----------------
Prospective Study to Evaluate the Predictive Value of Brain Natriuretic Peptides for Adverse Long-term Cardiac Outcome

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Emergency surgery: Vascular Intra-abdominal Orthopedic Exclusion Criteria: Patients unable to provide informed consent Thoracic surgery Trauma surgery

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| No treatment<br>Consecutive patients undergoing emergency surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of Adverse Cardiac Events | Occurence of major adverse cardiac events (composite of nonfatal myocardial infarction, acute heart failure or death). Non-fatal Myocardial infarction was defined as a typical increase and decrease of troponin together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes indicative of ischemia or new Q waves, or imaging evidence of new regional wall motion abnormality. Acute heart failure was defined as clinical signs and symptoms of heart failure with echocardiographic evidence of cardiac dysfunction and clinical response to treatment directed towards heart failure. | postoperatively (index surgery) until a median follow-up of 34 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
natriuretic peptides, emergency non-cardiac surgery
Study of Nutritional Suitability of a New Infant Formula for Term Infants

Study Overview
=================
Brief Summary
-----------------
This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.

Official Title
-----------------
Study of Nutritional Suitability of a New Infant Formula for Term Infants

Conditions
-----------------
Growth

Intervention / Treatment
-----------------
* Other: Investigational infant formula
* Other: Active Comparator: Commercially available Infant formula
* Other: Active Comparator: Human milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy full term infant (37-42 weeks of gestational age) Birth weight 2,500 to 4,500 g Infant's mother willing and able to exclusively breast feed or infant's parent(s)/caregiver(s) willing to exclusively use randomized infant formula during study participation Parent(s)/caregiver(s) able to attend visits and willing to complete the subject diary Informed consent signed by parent(s)/caregiver(s) Exclusion Criteria: Congenital illness or malformation that may affect infant feeding or normal growth Gastrointestinal disorders Suspected or known allergy to milk protein for formula groups Known food allergies in parents or siblings for formula groups Multiples Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrollment Infant participating in another clinical study Infant's family unable to comply with the protocol according to the investigators's assessment

Ages Eligible for Study
-----------------
Maximum Age: 13 Days

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Infant formula<br>Healthy term infants fed exclusively the investigational Infant Formula | Other: Investigational infant formula<br>* fed ad libitum<br>|
| Active Comparator: Commercially available Infant formula<br>Healthy term infants fed exclusively a commercially available Infant Formula | Other: Active Comparator: Commercially available Infant formula<br>* fed ad libitum<br>|
| Active Comparator: Human milk<br>Healthy term infants fed exclusively human milk | Other: Active Comparator: Human milk<br>* fed ad libitum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 16 weeks |
Tall Stature Women Fetal Weight Estimation

Study Overview
=================
Brief Summary
-----------------
To investigate the difference of clinical VS sonographic fetal weight estimation of tall women stature (above 10t percentile)

Detailed Description
-----------------
Women undergoing delivery after week 39 will be estimated of their fetal wight with clinical estimation and then sonographic estimation. each women will be case control 1:1 for the actual fetal weight of the delivery. the fetal weight will be blinded for each estimation. Primary outcome is the actual fetal weight Secondary outcomes will be mode of delivery, fetal complication as APGAR score and fetal hypoxia and maternal complication as perineal laceration

Official Title
-----------------
Tall Stature Women Fetal Weight Estimation,Clinical Versus Sonographic Estimation

Conditions
-----------------
Ultrasonography, Prenatal

Intervention / Treatment
-----------------
* Diagnostic Test: Fetal wight estimation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women above 172 cm height above 39 weeks of gestation Exclusion Criteria: contraindication for vaginal delivery Intrauterus growth restriction

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical fetal weight estimation<br>The fetal weight estimation will be taken by professional obstetrician durin her 39 week | Diagnostic Test: Fetal wight estimation<br>* We will estimate the fetal weight by sonographic and clinical estimation<br>|
| Sonographic fetal weight estimation<br>The fetal weight estimation will be taken by professional Sonographic obstetrician durin her 39 week | Diagnostic Test: Fetal wight estimation<br>* We will estimate the fetal weight by sonographic and clinical estimation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of fetal weight estimation | Comparing the sonographic and clinical fetal weight estimation to the actual fetal weight | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery and fetal complication | Vaginal Versus cesarian section delivery | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical weight estimation