linjc16/ctgov huggingface dataset:
TTP and aHUS in Complicated Pregnancies

Study Overview
=================
Brief Summary
-----------------
A single site observational study aiming to: (i) Identify cases of previously undiagnosed thrombotic thrombocytopenic purpura (TTP) and atypical haemolytic syndrome (aHUS) in a cohort of women with complicated pregnancies (ii) Characterise the clinical features of these cases and (ii) Identify clinical features or biomarkers which may help distinguish TTP/aHUS from other complications of pregnancy such as preeclampsia

Official Title
-----------------
A Observational Study to Determine the Prevalence of Pregnancy-related Thrombotic Thrombocytopenic Purpura and Atypical Haemolytic Uraemic Syndrome in Women Affected by Specific Obstetric Complications

Conditions
-----------------
IUGR, Thrombotic Thrombocytopenic Purpura, Atypical Hemolytic Uremic Syndrome, Pre-Eclampsia, HELLP Syndrome, Thrombocytopenia, Stillbirth, Thrombotic Microangiopathies

Intervention / Treatment
-----------------
* Diagnostic Test: ADAMTS 13, complement and angiogenic biomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Women, either currently pregnant or recently postpartum, and affected by one or more of the following complications in the index pregnancy: (i) Preeclampsia with evidence of end organ damage (renal/ liver/ haematological/ neurological) or uteroplacental dysfunction (FGR/IUFD) (ii) HELLP syndrome (iii) Fetal growth restriction (FGR) (growth <10th centile) that is unexplained (ie not due to infection, fetal structural anomaly, fetal chromosomal or pre-existing maternal medical problem) (iv) Intrauterine fetal demise (IUFD) after 20 weeks' gestation that is unexplained (v) Unexplained new onset renal impairment (defined by serum creatinine >85umol/L 1st trimester, or >80umol/L 2nd trimester, or >90 umol/L 3rd trimester[32]; OR an increase in serum creatinine by (i) at least 1.5 times the baseline or (ii) of equal or greater than 26.5umol/L (as per KDIGO criteria) (vi) Unexplained new onset thrombocytopenia (platelets <75x10^9/L) Exclusion Criteria: Previous diagnosis of TTP or aHUS Known disorder of complement dysregulation Patients not wishing to participate Patients aged less than 16 Patients lacking capacity to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ADAMTS 13, complement and angiogenic biomarkers|ADAMTS 13, complement and angiogenic biomarkers|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of TTP and aHUS in the cohort | Number of new cases identified as a percentage of sample size | At study completion, approximately 18 months after recruitment of first patient |
Early Pregnancy Failure: Factors Affecting Successful Medical Termination Treatment

Study Overview
=================
Brief Summary
-----------------
The main purpose of our study was to which determine factors, those measured by ultrasound and also demographic and clinical factors (age, number of previous pregnancies, abortions and deliveries) predict outcome of medical treatment for early pregnancy failure. Our hypothesis was that gestational sac volume predicts outcome of medical treatment for early pregnancy failure.

Conditions
-----------------
Early Pregnancy Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Crown rump length (CRL) is appropriate to less than 12 weeks.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| unsuccessful termination<br>unsuccessful termination of early pregnancy failure with Misoprostol | |
| successful termination<br>successful termination of early pregnancy failure with Misoprostol | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An empty uterus or an endometrial lining with thickness of less than 30mm. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early pregnancy failure, Misoprostol, Gestational sac volume
Pharmacologic Study of Oseltamivir in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Pharmacologic Study of Oseltamivir in Healthy Volunteers is a Phase I study in which 8 to 32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens within each of 4 visits. The study is being conducted at the Bangkok Hospital of Tropical Diseases Research Unit, Faculty of Tropical Medicine, and commenced enrolling healthy volunteers on 23 November 2006. The duration of the study is expected to be approximately four months. The goals of this study are to assess the use of loading dose oseltamivir and the concomitant use of probenecid and to characterize the pharmacokinetic properties of oseltamivir in Thai subjects.

Official Title
-----------------
Pharmacologic Study of Oseltamivir in Healthy Volunteers

Conditions
-----------------
Avian Influenza A Virus

Intervention / Treatment
-----------------
* Drug: oseltamivir
* Drug: probenecid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy with no underlying chronic disease normal baseline laboratory screening no regular prescribed medication used in the past 30 days and no over-the-counter medication in the past week agree to abstain from self-medication during the study negative urine pregnancy test for females and agreement that they will not try to become pregnant until 1 month after the study is completed only use non-hormonal methods of contraception for females non-smoker for the last 30 days and for duration of the study no consumption of alcohol for the last 30 days and for duration of the study no use of recreational drugs for the last 30 days and for duration of the study Exclusion Criteria: known hypersensitivity to oseltamivir and/or probenecid Hepatitis B virus surface antigen positive presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study

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

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oseltamivir|nan|
|Drug: probenecid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 0-12 hrs. |  | 12 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 12-24 hrs. |  | 24 hrs | 
| C max |  | 24 hrs | 
| t max |  | 24 hrs | 
| t 1/2 |  | 24 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oseltamivir, pharmacokinetics, probenecid, avian influenza
Rate of Force Development vs Isometric Strength of Quadriceps

Study Overview
=================
Brief Summary
-----------------
Peak isometric strength of quadriceps (QI) has been used to help determine an athletes ability to safely return back to sport following an anterior cruciate ligament (ACL) reconstruction surgery. However, rate of force development (RFD) of the quadriceps, or how fast the quadriceps are able to reach their peak strength, is rarely used as part of this decision despite the role it plays in protecting the knee. This retrospective data only study will look back at the limb symmetry index (LSI) of patients post ACL reconstruction for the Noyes Hop Test, QI, and RFD. The hypothesis is that RFD does not recover at the same rate as Noyes Hop Test and QI.

Official Title
-----------------
Is Rate of Force Development (RFD) Superior to Isometric Strength (QS) of the Quadriceps as a Predictor of Functional Performance After Anterior Cruciate Ligament Reconstruction

Conditions
-----------------
Post ACL Reconstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No pain (at baseline) or edema/effusion Full knee range of motion Post Op: 20 weeks - 2 years Non antalgic gait Exclusion Criteria: History of low back pain or other lower extremity injury within 1 year, skeletal immature, pregnant, concomitant ligament injury

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb Symmetry (Noyes hop testing, Isokinetic testing-rate of force development, Isokinetic testing-quadriceps index) | Limb symmetry was calculated comparing surgical leg over non-surgical leg giving a percentage. A percentage will be calculated for each one of the 3 observations allowing easy comparison with same unit of measure. | March - June 2019 |
Safety and Performance Study of the Nyxoah SAT System for Treating OSA

Study Overview
=================
Brief Summary
-----------------
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea

Official Title
-----------------
Safety and Performance Study of the Use of the Nyxoah SAT System for the Treatment of Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Nyxoah SAT system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with moderate to severe Obstructive Sleep Apnea Have failed or have not tolerated CPAP treatment Willing and capable of providing informed consent Willing and capable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires Exclusion Criteria: BMI limits Subjects with complete concentric collapse at the soft palate level per endoscopy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 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: Nyxoah SAT therapy<br> | Device: Nyxoah SAT system<br>* The Nyxoah SAT system is comprised of an implantable nerve stimulator implanted over one of the tongue muscles via a minimally invasive procedure. Stimulation of the Hypoglossal nerves causes the tongue muscles to contract, thus maintaining an open airway during sleep.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious device related adverse events |  | 6-months post-implantation | 
| Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation |  | 6-months post-implantation |
Cognitive Changes in Mild Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
Background: In recent years, the changes of cognitive function in mild cognitive impairment have attracted attention. Methods/design: We will follow up at 3. The primary outcome will be the measurement of cognitive function using neuropsychological assessment scales such as MOCA, MMSE, etc... Minor variables will be included plasma biomarkers (Aβ, Tau, GFAP, etc.), multimodal brain electrophysiology (P300, VP300, heart rate variability, etc.), and neuroimaging indicators (NODDI).

Official Title
-----------------
Cognitive Changes in Mild Cognitive Impairment Without Orthostatic Hypotension

Conditions
-----------------
Healthy Controls Without Orthostatic Hypotension

Intervention / Treatment
-----------------
* Other: observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed mild cognitive impairment Exclusion Criteria: Patients with orthostatic hypotension Patients with other neurological disorders. Pregnant or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 controls without orthostatic hypotension<br> | Other: observational study<br>* observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Montreal Cognitive Assessment (MoCA) scores after 3 months. | The MOCA scale scores range from 0 to 30, with higher scores indicating better cognition | Participants will be followed up for 3 months after baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Plasma amyloid protein levels after 3 months. | Plasma amyloid protein(ug/ml) is an important indicator of cognitive function. | Participants will be followed up for 3 months after baseline. | 
| Changes in Plasma tau levels after 3 months. | Plasma tau(ug/ml) is an important indicator of cognitive function | Participants will be followed up for 3 months after baseline. | 
| Changes in Blood pressure (mmHg) after 3 months. | An experienced physician will measure blood pressure on the right upper arm after the subject rest for 5 min, taking the average of the two measurements as the final result. | Participants will be followed up for 3 months after baseline. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognition
Long Term Outcomes Following Hernia Repair With Mesh

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to establish the extent to which mesh improves quality of life and surgical outcomes following hernia repair.

Detailed Description
-----------------
This is a large scale registry of prospectively collected medical record data and self-reported outcomes for those patients undergoing abdominal hernia repair with mesh.

Official Title
-----------------
Long Term Outcomes Following Hernia Repair With Mesh

Conditions
-----------------
Abdominal Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abdominal hernia repair using mesh Exclusion Criteria: less than 18 years old

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 |
| --- | --- | --- |
| Hernia recurrence rate | Should the hernia repair fail and the hernia reappears, this is counted as a recurrent hernia. | Within 5 years of initial hernia repair | 
| Patient quality of life | Quality of life before and after surgery will be compared using various self-reported assessment tools/questionnaires. | Up to 5 years postopertively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative infection rate | Infection related to hernia repair or mesh use will be reported. | Up to 5 years postoperatively |
Effect of Bacterial Translocation on Haemodynamic and Coagulation Parameters During Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The present study is to demonstrate the effect of the presence of bacterial translocation detected by bacterial deoxyribonucleic acid (bactDNA) in blood and ascites using the polymerase chain reaction (PCR) on some haemodynamic and coagulation parameters during a liver transplant procedure.

Official Title
-----------------
Effect of Bacterial Translocation on Haemodynamic and Coagulation Parameters During a Liver Transplantation

Conditions
-----------------
Effect of Bacterial Translocation

Intervention / Treatment
-----------------
* Diagnostic Test: PCR for bacterial translocation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • patients with liver failure undergoing liver transplantation Exclusion Criteria: Age less than 18 years; Active overt infection; Patients on oral or systemic anticoagulation or with known coagulopathic disorders apart from those caused by liver failure (eg.: Protein C or S deficiency, congenital platelet disorders and congenital coagulation disorders…etc); Patients undergoing re-transplantation.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DNA positive patients<br>patients who have bacterial DNA in their samples | Diagnostic Test: PCR for bacterial translocation<br>* samples taken from the blood and ascites of patients to search for bacterial DNA<br>|
| DNA negative patients<br>patients who do not have bacterial DNA in their samples | Diagnostic Test: PCR for bacterial translocation<br>* samples taken from the blood and ascites of patients to search for bacterial DNA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the mean arterial blood pressure |  | at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase | 
| antifactor X activity |  | at the beginning of surgery | 
| change in the heart rate |  | at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase | 
| change in the cardiac output |  | at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase |
Renal Arterial Resistive Index for Differential Diagnosis of Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
early differential diagnosis of anticipated acute kidney injury via ultrasound renal resistive index calculation

Detailed Description
-----------------
acute kidney injury is a common clinical syndrome introducing to emergency services with varying symptoms. acute kidney injury is divided into 3 subgroups: prerenal, renal and postrenal. there is not any certain laboratory or imaging modality for early detection of injury's type. calculation of renal resistive index with doppler ultrasound at emergency setting can be helpful for early detection of etiology of acute kidney injury subgroup.patient will be selected according to clinical status and detailed history and laboratory parameters.renal resistive index will we calculated with doppler ultrasound of arcuate and interlober arteries of kidneys. resistive index values of acute kidney injury patients will be compared depending on further tests and resistive indexes of suggestive etiologies will be compared according to final diagnosis.

Official Title
-----------------
Value of Renal Resistive Arterial Index for Differential Diagnosis of Patient With Anticipated Acute Kidney Injury Administered to Emergency Department

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 patient with acute kidney injury diagnosed according to KDIGO, AKIN or RIFLE criteria Exclusion Criteria: end stage kidney disease patients receiving renal replacement treatment

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 |
| --- | --- | --- |
| increased resistive index | differential diagnosis of acute kidney injury using renal doppler ultrasound and resistive index and comparison of subgroups | time spent at emergency service until renal doppler is done and resisitive index is calculated (6 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | mortality | mortality at 7 days | 
| mortality | mortality | mortality at 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute kidney injury, renal resistive index, doppler ultrasound