linjc16/ctgov huggingface dataset:
Risk Factors for Anal Sphincter Damage During Vaginal Delivery

Study Overview
=================
Brief Summary
-----------------
Vaginal delivery may cause various levels of damage to the anal sphincter. According to the literature, one third - two third of women diagnosed with 3rd degree rupture during vaginal delivery suffer from fecal incontinence. This has an adverse effect on the quality of life. Different risk factors such as: first births, instrumental delivery, high birth weight, prolonged second stage, epidural anesthesia etc. were assessed and found to be associated with anal sphincter disruption. The purpose of this study is to assess risk factors for anal sphincter disruption by new methods such as three-Dimensional transperineal ultrasound (3D transperineal US).

Official Title
-----------------
Risk Factors for Anal Sphincter Damage During Vaginal Delivery

Conditions
-----------------
Anal Sphincter Injury, Fecal Incontinence

Intervention / Treatment
-----------------
* Other: 3D transperineal Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First Delivery Vaginal Delivery Birthweight > 3000 Singleton pregnancy Exclusion Criteria: Anal sphincter disruption before birth

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 42 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 |
| --- | --- |
| anal sphincter damage<br>After assessing women after vaginal delivery, a comparison will be made between those with anal sphincter damage and those women without. | Other: 3D transperineal Ultrasound<br>* 3D transperineal Ultrasound after vaginal delivery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal sphincter damage | Anal Sphincter Damage wil be assessed by usin 3D transperineal US in women after vaginal delivery | up to one year after vaginal birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anal Sphincter injury, Fecal Incontinence
Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating chronic kidney disease in large scale samples with long time take.

Detailed Description
-----------------
The test has not been completed.

Official Title
-----------------
Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease：a Multicentre Open Study

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Abelmoschus manihot (AM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosed as non-ESRD chronic kidney disease (stage I-IV) Blood pressure of ≤140/90mmHg Obtaining the signed informed consent from patients Exclusion Criteria: Be allergic to Huangkui Capsule Combined with severe primary diseases of heart, brain, liver and hematopoietic system and so on, or other serious diseases which can affect the patient's life Lactation, pregnancy or plans pregnancy during the study period Participating in another clinical study in the same period
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: Abelmoschus manihot (AM)<br>age above 12 years old (including 12)：huangkui capsule are given orally at 2.5 g three times per day age between 6-12 years old(including 6):huangkui capsule are given orally at 1.5 g three times per day age under 6 years old：huangkui capsule are given orally at 1.0 g three times per day | Drug: Abelmoschus manihot (AM)<br>* Abelmoschus manihot (AM): Huanghui capsule (Jiangsu Suzhong Pharmaceutical Group Co., Ltd.), 0.5 g × 30 capsules/box. A huangkui capsule is a single plant drug extract of Flos Abelmoschus manihot.<br>* Other names: Huanghui capsule;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-h proteinuria from baseline after treatment |  | Baseline(week 0), week 12, week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the serum creatinine level from baseline after treatment |  | Baseline(week 0), week 12, week 24 | 
| change in the estimated glomerular filtration rate (eGFR) from baseline after treatment |  | Baseline(week 0), week 12, week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abelmoschus manihot, Chronic Kidney Disease, proteinuria, efficacy, safety
Usefulness of Non EPI-DWI-MRI / CT 3D Static Co-registration Prior to Surgery of Cholesteatomas

Study Overview
=================
Brief Summary
-----------------
Cholesteatoma is a destructive and expanding pathologic condition consisting of keratin pearl arising from a squamous epithelium in the middle ear and/or mastoid process. Evolution consists in a destruction of the ossicles as well as their possible spread through the base of the skull into the brain. Surgical treatment is required to prevent infectious or functional complications. A recurrence after surgery occurs in approximately 10% of patients and rarely affects initial site. Surgical treatment is the only care option for recurrent cholesteatoma. Various locations such as surgical approach cavity, mastoid, hypotympanum are seen. Temporal bone CT is performed prior to surgery for added information on bone erosions especially of ossicules, tegmen tympani, facial nerve canal of internal ear. Due high anatomical resolution and complex anatomy, temporal bone CT is usually displayed with Magnetic Resonance Imaging (MRI) in operating room to help surgical guidance . Imaging especially using MRI is the cornerstone for diagnosis in asymptomatic patients. Since 2006, non echo planar imaging (EPI) Diffusion weighted imaging (DWI) Magnetic resonance imaging (MRI) (sequences has shown high accuracy to depict recurrent cholesteatoma. If EPI sequences had a high rate of diffeomorphic atefacts whereas non EPI sequences using either HAlf-Fourier acquisition Single-shot Turbo spin-Echo (HASTE) or Fast-spin-echo demonstrates less magnetic susceptibility artifacts. Multimodality fusion between NonEPI-DWI-MRI and computerized tomography (CT) is a rational promising tool to rise the performance for cholesteatomas delineation. The performances of NonEPI-DWI-MRI in assessing lesion spread and volume are still unknown and needs further investigations. The aim of the study is to assess the DWI-MRI/CT fusion feasibility, reproducibility and the accuracy prior to surgery propectively compared to surgical findings.

Official Title
-----------------
Usefulness of Non EPI-DWI-MRI / CT 3D Static Co-registration Prior to Surgery of Cholesteatomas

Conditions
-----------------
Cholesteatoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adult woman or man who had surgery and suspicion of cholesteatoma recurrence Exclusion Criteria: Chronic renal failure Contraindications to MRI
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 |
| --- | --- | --- |
| Determination of the lesion on the scanner with the help of MRI, but without having merged both methods |  | UP to 18 months | 
| Measure of the lesion volume in mm3 |  | Up to 18 months |
The Association Between Advancing Age and Mortality at 30 Days in Patients With Bacteremia E. Coli Beta-lactamase Phenotype Extended Spectrum RC15_0421

Study Overview
=================
Brief Summary
-----------------
In the US and Europe, bacteremia are ranked the 7th leading cause of death from all causes. E. coli is one of the main microorganism involved, responsible for 30% to 45% of bacteremia. In Europe, bacteremia E. coli, including BLSE phenotype, have a strong impact on public health, causing increased mortality, particularly in the elderly, and an increase in the average hospital stay. However, few studies have specifically concerned with the criteria associated with mortality of elderly patients with BLSE E. coli bacteremia. Finally, improving epidemiological knowledge of the elderly patients with bacteremia due to BLSE E. coli has importance in terms of public health and is a prerequisite to the development of preventive strategies and to improve the short-term prognosis.

Official Title
-----------------
Study Single-center, Uncontrolled, Retrospective, the Association Between Advancing Age and Mortality at 30 Days in Patients With Bacteremia E. Coli Beta-lactamase Phenotype Extended Spectrum

Conditions
-----------------
Beta-lactamase Extended Spectrum, E. Coli, Elderly, Mortality, Risk Factor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with positive blood culture E. coli BLSE will be included in the study. Bacteremia E. coli BLSE will be defined as the identification of one or more blood cultures positive for E. coli BLSE in patients with clinical criteria of systemic inflammatory response, at least two of the following 4 criteria: temperature> 38 ° C or < 36 ° C; heart rate> 90 beat / min; respiratory rate > 20 c / min or PaCO2 < 32 mmHg; WBC > 12,000 / microL or < 4000 / microL or 10% immature forms Exclusion Criteria: For each patient included, only the first episode of bacteremia will be included in the study

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 105 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 |
| --- | --- | --- |
| Association between advancing age and mortality at 30 days in patients with bacteremia E. coli beta-lactamase phenotype extended spectrum. |  | 30 days |
Occupational Exposure to Dust and the Relationship With the Respiratory Symptoms, Lung Function Among Construction Workers of the University of Malaysia Sabah (UMS)

Study Overview
=================
Brief Summary
-----------------
Background The respiratory tract often becomes the site of injury from occupational exposure. All construction sites generate high levels of dust, typically from concrete, silica, asbestos, cement, wood, stone, sand and therefore, the workers are exposed to this airborne dust and increased their risk of developing respiratory disorders. Limited studies have been conducted to assess the relationship between respiratory symptoms, lung function and occupational dust exposure among construction workers in Sabah. The objectives of this study are to determine the occupational exposure to dust and the relationship with the respiratory symptoms as well as lung function among construction workers in UMS Teaching Hospital. Materials and methods This cross-sectional study consisted of construction workers working in all sections in the development of UMS Teaching Hospital. A standard respiratory questionnaire was distributed to construction workers and lung function measurement was performed using Spirometry and the results of their respiratory status were compared between workers who were exposed and unexposed to dust. Occupational dust exposure was determined by the gravimetric method using an air sampler. The total duration of the collection was 8 hours and the filters with the dust samples were analyzed in the laboratory.

Official Title
-----------------
Occupational Exposure to Dust and the Relationship With the Respiratory Symptoms, Lung Function Among Construction Workers of the University of Malaysia Sabah (UMS)

Conditions
-----------------
Occupational Exposure

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all construction worker Exclusion Criteria: has chronic lung impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Occupational exposure to dust | Number of participants with Occupational exposure to dust and having respiratory symptoms | 2019-2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Occupational exposure, Air pollution, Lung function
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in IBS

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to IBS.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel, Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome Mixed, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome Without Diarrhea, Irritable Bowel Syndrome Aggravated, Irritable Bowel Syndrome Characterized by Constipation, Irritable Bowel Syndrome Characterised by Alternating Bowel Habit

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent Male or female of all ages Diagnosis of IBS Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Irritable Bowel Syndrome Patients<br>Patients with IBS. | Other: No intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with diabetes mellitus | Three years |
89Zr-labeled NY008 PET Imaging in Patients

Study Overview
=================
Brief Summary
-----------------
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY008 PET Imaging in patients with multiple myeloma

Official Title
-----------------
89Zr-labeled NY008 PET Imaging in Patients

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: 89Zr-NY008


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years old, male or female; Patients diagnosed with relapsing or refractory multiple myeloma； LVEF≥50%； ECOG score 0 2； Exclusion Criteria: Life expectancy of less than 3 months; Participated in other clinical research within 1 month; Recovery from major trauma (including surgery) within 28 days prior to study treatment; Patients with systemic or locally severe infections, or other serious coexisting diseases; Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines; Patients with autoimmune diseases, including rheumatoid arthritis; Inadequate control of arrhythmias, including atrial fibrillation; Uncontrolled hypertension; Patients with allergies or allergies to any component of the imaging agent or antibody; Patients who cannot undergo PET/CT imaging scan; Syphilis, HBV, HCV, or HIV positive subjects; Male and female subjects of reproductive age cannot take effective contraceptive measures; Pregnant or lactating women; Patients with a history of mental illness or related conditions; Other subjects considered unsuitable by researchers.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 89Zr-NY008<br> | Drug: 89Zr-NY008<br>* Patients will receive a tracer (5-10mg, IV) dose of 89Zr (2-3mCi) labelled NY008<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of tissue distribution of 89Zr-NY008 | Biodistribution of 89Zr-NY008 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs will be reported. | 7 days |
Portal Blood Flushes in the Peri-Reperfusion Stage of Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
By showing that increased levels of acidotic metabolites and electrolytes in the systemic blood of patients who do not receive portal blood flush prior to reperfusion compared to patients who do receive portal blood flush, and that these increased levels correlate with cardiac depression as seen on TEE, the investigators hope to find a superior technique for liver reperfusion.

Official Title
-----------------
Are Portal Blood Flushes Useful in Maintaining Hemodynamic Stability in the Peri-Reperfusion Stage of Orthotopic Liver Transplantation

Conditions
-----------------
Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver Transplantation 18 years old or older 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 |
| --- | --- |
| Portal Blood Flush<br>participants that receive the portal blood flush | |
| No Portal Blood Flush<br>participants that don't receive the portal blood flush | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic Stability | The primary objective of this study is to determine whether or not a portal blood flush is useful for maintaining hemodynamic stability in the peri-reperfusion stage of Orthotopic Liver Transplantation as evidence by TEE. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between the cardiac dysfunction and the degree of hyperkalemia seen after reperfusion. | The secondary objective is to determine if there is a correlation between cardiac dysfunction as measured by a qualitative analysis of TEE and the degree of hyperkalemia measured by a post reperfusion blood sample. | 5 days |