linjc16/ctgov huggingface dataset:
Bioequivalence Study Of Verapamil

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate bioequivalence of single doses of two verapamil formulations

Official Title
-----------------
Bioequivalence Study Of Verapamil (Covera HS) 240 Mg Extended Release Tablets Produced By Alza Corporation, Vacaville And Pfizer Inc, Puerto Rico: A Two Sequence, Four-Way Crossover Design, Single Dose, Open-Label, Randomized Study In Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: verapamil
* Drug: verapamil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects Mass Index (BMI) of approximately 18 to 30 kg/m2 Exclusion Criteria: Any condition possibly affecting drug absorption A positive urine drug screen

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Reference<br>marketed extended release verapamil tablet | Drug: verapamil<br>* 240 mg extended release tablets once daily at bedtime for 28 days<br>* Other names: Covera HS;|
| Other: Test<br>reformulated extended release verapamil tablet | Drug: verapamil<br>* 240 mg extended release tablets once daily at bedtime for 28 days<br>* Other names: Covera HS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary study endpoints will be AUClast, AUCinf and Cmax of R- and S-verapamil. |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints will include Tmax and t1/2 of R- and S-verapamil and S- and R- norverapamil, as data permit. AUClast, AUCinf and Cmax of R- and S-norverapamil as data permit. |  | 5 months | 
| Safety and tolerability as assessed by reported adverse events, safety lab test and vital signs |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular Diseases, Hypertension
Aetiology of Asymmetrical Hearing Loss: A Retro-spective Study Thesis Submitted for Partial Fulfillment of Master Degree in Audio-Vestibular Medicine

Study Overview
=================
Brief Summary
-----------------
Hearing loss maybe: -Symmetrical: in which the severity and pattern of hearing loss are the same in each ear. Or -Asymmetrical: is defined as binaural difference in bone conduction thresholds of >10 dB at two consecutive frequencies or >20 dB at one frequency (0.25-8.0 kHz), Poorer speech perception will often accompany poorer hearing and may be the reason for the patient's presentation .Unilateral or asymmetrical sensorineural hearing loss is important to discern, as it is an important risk factor for auditory nerve tumors (i.e. vestibular schwannoma) which is a life threatening condition, and in such cases further investigation is required (i.e. MRI scan) unless there is a known reason for the asymmetry, Several reports have recommended that further evaluation, especially expensive imaging studies, be conducted to rule out acoustic tumors when AHL is present

Official Title
-----------------
Aetiology of Asymmetrical Hearing Loss: A Retro-spective Study Thesis Submitted for Partial Fulfillment of Master Degree in Audio-Vestibular Medicine

Conditions
-----------------
Asymmetrical Hearing Loss

Intervention / Treatment
-----------------
* Diagnostic Test: basic audiological evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 6 years old and more. Sex: male and female. Exclusion Criteria: Age: less than 6 years old. Patients with symmetrical hearing loss.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cases<br>patients with asymmetrical hearing loss | Diagnostic Test: basic audiological evaluation<br>* pure tone audiometry&immitancemetry<br>* Other names: CT&MRI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asymmetrical hearing loss | asymmetrical hearing loss using basic audiological evalution &imaging | 1 year |
Blood Coagulation Abnormalities in COVID-19 (Corona Virus Disease-19) Patients

Study Overview
=================
Brief Summary
-----------------
The role of the coagulation parameters in predicting the severity of COVID-19 disease will be assessed

Detailed Description
-----------------
In COVID-19 patients the coagulation parameters Prothrombin concentration (PC), Activated Partial Thromboplastin Time (aPTT), D Dimer, Antithrombin III (ATIII) and Fibrinogen are measured and correlation with disease severity is to be investigated

Official Title
-----------------
Blood Coagulation Abnormalities in COVID-19 Patients and Correlation With Severity

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Blood coagulation profile


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ● Confirmed cases with COVID 19 Exclusion Criteria: ● Known history of blood coagulopathy disorder

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 |
| --- | --- |
| Mild cases<br>Patients with confirmed COVID-19 and with mild disease | Diagnostic Test: Blood coagulation profile<br>* Venous blood sample for measurement of blood coagulation profile<br>|
| Severe cases<br>Patients with confirmed COVID-19 and with severe disease | Diagnostic Test: Blood coagulation profile<br>* Venous blood sample for measurement of blood coagulation profile<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of disease severity with results of laboratory test | The results of blood coagulation profile will be correlated with degree of severity of illness | Baseline results of coagulation profile and baseline disease severity assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of abnormalities in coagulation profile with measured inflammatory markers | The inflammatory markers will be measured and correlation with abnormalities in coagulation profile will be assessed | baseline measurement of inflammatory markers |
IgY Efficacy on Periodontitis Patients

Study Overview
=================
Brief Summary
-----------------
Patients visiting National Hospital of Odonto-Stomatology for treating periodontitis used a food supplement (lozenge) containing chicken egg antibody (IgY) against Porphyromonas gingivalis gingipains as an adjunct to conventional scaling and root planing (SRP). After 8 weeks the patients were examined against. Parameters including probing depth (PD), bleeding on probing (BOP), number of P. gingivalis in periodontal pockets were evaluated and compared to the control group that had used placebo lozenges.

Official Title
-----------------
Evaluation of IgY Antibody Effectiveness in Supportive Therapy of Periodontitis Patients

Conditions
-----------------
Chronic Periodontitis

Intervention / Treatment
-----------------
* Dietary Supplement: lozenges containing IgY
* Dietary Supplement: Placebo IgY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with chronic periodontitis had at least 2 interproximal site with pocket depth between 3 mm to 5 mm nonsmokers with at least 20 natural teeth bone loss and bleeding on probing had not undergone periodontal treatments within 6 weeks before the study Exclusion Criteria: patients received medication such as antibiotics or anti-inflammatory drugs within the previous 3 months had allergy to egg proteins
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gingipain IgY<br>Participants consume lozenges containing IgY against gingipains of Porphyromonas gingivalis | Dietary Supplement: lozenges containing IgY<br>* Patients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy<br>|
| Placebo Comparator: Placebo IgY<br>Participants consume lozenges containing placebo IgY | Dietary Supplement: Placebo IgY<br>* Placebo IgY<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis | Outcome measurement is probing pocket depth (PD) | 8 weeks | 
| Effect of anti-gingipain IgY on bleeding on probing of subjects with chronic periodontitis | Outcome measurement is bleeding on probing (BOP) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of anti-gingipain IgY on Porphyromonas gingivalis level of subjects with chronic periodontitis | Outcome measurement is P. gingivalis level in periodontal pockets | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IgY, Periodontitis, Porphyromonas gingivalis, gingipains, Efficacy
Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia, Europe, and Middle East. Adult patients with chronic kidney disease are treated with growth hormone to assess effect on nutritional status.

Official Title
-----------------
The Effect of Norditropin® on Nutritional Status in Adult Patients in Chronic Haemodialysis

Conditions
-----------------
Chronic Kidney Disease, End-Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ESRD patients Exclusion Criteria: Diabetes Mellitus Severe and Malignant diseases Patients in Intensive Care Units

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: somatropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in surrogate markers of nutrition |  | After 6 months treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  |  | 
| Other markers of nutrition |  |  |
Comparison of Pulse Hemoglobin and Pleth Variability Index

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether a validated sensor that is able to measure how much oxygen-carrying molecules called hemoglobin using pulse hemoglobin and Pleth Variability Index (PVI)] are in your blood during surgery can help your doctors manage how much fluid and possibly blood you need to get during your surgery. The hope of the study is that the device may provide an early indication you are having bleeding and this may mean you need to be treated with a transfusion. Our current method of checking this is by getting a blood sample for analysis. The investigators hope is that this device may be able to alert the clinician of the need for blood or fluids without a blood draw being needed.

Official Title
-----------------
Comparison of Pulse Hemoglobin and Pleth Variability Index to Standard Methods of Guiding Intraoperative Fluid and Transfusion Management During Major Surgical Procedures.

Conditions
-----------------
Anemia, Fluid Management

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be >18 years old; must be having a major surgical procedure; The pre-operative estimation of blood loss must be at least 15% of the total blood volume Exclusion Criteria: Does subject have hemoglobinopathy; cardiac arrhythmias producing irregular rhythms; severe pulmonary disease; procedures where loss of more that 10 to 15% of total blood volume is unlikely; subject refusal

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 |
| --- | --- | --- |
| The difference between hemoglobin values from the two monitors. | The primary outcome measure is the difference between hemoglobin values from the pulse oximetry device and from the arterial blood gas co-oximeter. | Pulse hemoglobin will be monitored during the surgery from the first arterial blood gas drawn to the last ABG drawn. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between measures compared to patient characteristics | Secondary outcome measures are the size of difference between measures compared to patient characteristics. | Start of surgery to end of surgery |
EP Device Registry

Study Overview
=================
Brief Summary
-----------------
This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting.

Official Title
-----------------
EP Device Registry

Conditions
-----------------
Cardiac Rhythm Disorder

Intervention / Treatment
-----------------
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject underwent an electrophysiology imaging (diagnostic procedure) and/or ablation procedure that used one or more Abbott devices covered by this Registry. Subject is willing and able to comply with the site's standard of care follow-up schedule. Exclusion Criteria: Subject is currently participating in another clinical investigation that may confound the results of this Registry.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Standard of Care|Standard of care mapping and/or ablation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with a device- and/or procedure-related Serious Adverse Event | that occurred within 7-days of the procedure. | 7-days | 
| The proportion of procedures that achieved acute success. |  | Baseline |
Myotonic Dystrophy Family Registry

Study Overview
=================
Brief Summary
-----------------
The Myotonic Dystrophy Family Registry (MDFR) is an online, patient-entered database that collects information on myotonic dystrophy (DM) to aid researchers in developing new, effective treatments and help identify participants for research studies and clinical trials.

Detailed Description
-----------------
The Myotonic Dystrophy Family Registry (MDFR) is an online, patient-entered database that collects information on myotonic dystrophy (DM) such as disease symptoms and demographic information to aid researchers in developing new, effective treatments and help identify participants for research studies and clinical trials. The Registry supports trials and studies, making it easier for researchers to explore data and identify possible trial and study participants. It is the first DM registry that gives community members the opportunity to explore anonymous Registry data, to see what the DM community looks like and what others with DM experience. It also provides information on the community of people living with DM, giving researchers and other medical professionals the opportunity to improve how they treat those affected with DM and learn more about how and why certain treatments work and don't work.

Official Title
-----------------
Myotonic Dystrophy Family Registry

Conditions
-----------------
Myotonic Dystrophy, Congenital Myotonic Dystrophy, Myotonic Dystrophy 1, Myotonic Dystrophy 2, Dystrophia Myotonica, Dystrophia Myotonica 1, Dystrophia Myotonica 2, Myotonia Dystrophica, Myotonic Dystrophy, Congenital, Myotonic Myopathy, Proximal, PROMM (Proximal Myotonic Myopathy), Proximal Myotonic Myopathy, Steinert Disease, Steinert Myotonic Dystrophy, Steinert's Disease, Myotonia Atrophica

Intervention / Treatment
-----------------
* Other: Patient-entered data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with congenital, juvenile-onset or adult onset DM1 or DM2 (confirmed by clinical exam or genetic test) Exclusion Criteria: Not diagnosed with DM, unaffected family members
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Patient-entered data|This registry provides patient-entered data for future clinical trial and study use.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes | Number of patients reporting specific symptoms and symptom severity, as well as impacts to quality of life and overall burden of disease in order to inform clinical trial development, understanding of disease for academic, industry and federal agency stakeholders and overall policy decisions. Results will be analyzed in comparison to other registry data and surveys to characterize this disease population cohort and to further define the population. | 36 months |
Urinary Excretion of Enteroviruses From Children With a Presumed Enteroviral Infection

Study Overview
=================
Brief Summary
-----------------
Enteroviruses can infect most human organ systems, especially the heart, nervous system and pancreas. Whether Enteroviruses can also affect the kidneys is not known yet. Therefore we will analyze urine of children with a suspected enteroviral infection for enteroviruses and signs of kidney infection.

Detailed Description
-----------------
Enteroviruses have been shown to cause mesangioproliferation and glomerulonephritis in mice (especially coxsackievirus B4). In some cases, large amounts of IgA are deposited in the mesangium, resembling human IgA-nephropathy. In humans, case reports indicate the propensity of certain enteroviruses to cause kidney infections. Our project aims to analyze urine of children with suspected enteroviral infections (e.g. meningitis, myocarditis, sepsis of the newborn etc.) to identify cases suspicious of concomitant enteroviral kidney affection. To achieve this aim, enterovirus-PCRs will be performed and microhematuria searched for.

Conditions
-----------------
Enterovirus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children, suspected of suffering from an enteroviral infection

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
enterovirus, meningitis, sepsis, myocarditis, kidney, urine, glomerulonephritis
ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Short-term relapse and poor survival are prevalent in patients with pancreatic adenocarcinoma (PAAD) after surgeries. Despite the importance of adjuvant treatments for resected PAAD patients, there is currently no suitable biomarker to identify those individuals with high risk of recurrence and inform therapeutic decision making. In this study, we aim to examine whether postoperative circulating tumor DNA (ctDNA) could be used as a biomarker for early detection of minimal residual disease (MRD) and predicting relapse in resected PAAD through high-depth targeted next-generation sequencing.

Official Title
-----------------
Postoperative ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma: A Prospective Observational Cohort Study

Conditions
-----------------
Pancreatic Cancer Resectable

Intervention / Treatment
-----------------
* Device: ctDNA-based MRD detection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically diagnosed pancreatic adenocarcinoma (stage I-III) KRAS mutations identified in resected tumor tissues Margin negative (R0) or no imaging recurrence/metastasis and CA 19-9<37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy) Receiving adjuvant chemotherapy ECOG 0-2 Signed informed consent Exclusion Criteria: With serious internal medicine diseases, infectious diseases, other solid tumors (except PAAD) or hematologic disorders Distant organ metastasis or malignant ascites Receiving neo-adjuvant therapy before surgery Imaging recurrence/metastasis or CA 19-9>37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy) Pregnant or breastfeeding at time of enrollment Prior transplantation of bone marrow, stem cell or organ

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ctDNA-based MRD detection|Postoperative circulating tumor DNA (ctDNA)-based minimal residual disease (MRD) detection for predicting relapse and survival benefit|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death and overall survival | Overall survival difference between MRD-positive and MRD-negative patients | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
circulating tumor DNA, minimal residual disease