linjc16/ctgov huggingface dataset:
Idiopathic Pulmonary Fibrosis: a Case-control Study

Study Overview
=================
Brief Summary
-----------------
To determine risk factors for idiopathic pulmonary fibrosis.

Detailed Description
-----------------
BACKGROUND: Idiopathic pulmonary fibrosis is a progressive and generally fatal disease that causes fibrosis of the pulmonary interstitium. While many environmental agents cause diseases clinically similar, the etiology of idiopathic pulmonary fibrosis suggests that environmental agents could incite the tissue injury that results in the disease; furthermore, host characteristics could have an important role in determining the magnitude of the host response to the agent initiating injury. DESIGN NARRATIVE: In this case control study, cases were ascertained at the multiple collaborating centers and controls were identified by telephone screening. A telephone interview was conducted to collect information needed to test hypotheses concerning cigarette smoking, occupational exposure, indoor exposures, other environmental factors, and host factors. To limit disease misclassification, two pathologists experienced with interstitial diseases of the lung reviewed histopathological material from all cases to exclude entities other than interstitial lung fibrosis and to fully characterize the cases clinically. The mortality of this large series of cases was also described.

Conditions
-----------------
Lung Diseases, Pulmonary Fibrosis, Lung Diseases, Interstitial

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery

Study Overview
=================
Brief Summary
-----------------
To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.

Detailed Description
-----------------
The effect of liberal vs restrictive transfusion regimens after hip fracture surgery is unresolved. Liberal transfusion regimens (transfusion trigger hgb. 6.25 mmol/l) leads to an increased use of blood products but may impact positively on rehabilitation outcome, a restrictive transfusion trigger (hbg. 5.0 mmol/l) saves blood products but may also impair postoperative rehabilitation and outcome. the study randomizes 120 elderly patients with hip fractures to either a restrictive or a liberal perioperative transfusion therapy and measures postoperative rehabilitation outcomes within a well defined multimodal rehabilitation regimen.

Official Title
-----------------
The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery

Conditions
-----------------
Hip Fracture

Intervention / Treatment
-----------------
* Drug: Red blood cell transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary hip fracture capable of informed consent independently dwelling able to ambulate independent of human assistance no active heart condition defined as no AMI within 3 months, no unstable angina or present incompensation/pulmonary oedema no regular transfusion demand or terminal disease. Exclusion Criteria: Multiple fractures postop. immobilization due to to surgical reasons patient refusal to participate in relevant rehabilitation reoperation within 4. postoperative day.

Ages Eligible for Study
-----------------
Minimum 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Red blood cell transfusion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Functional mobility |  |  | 
| Restricting factors for functional mobility |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  |  | 
| Complications |  |  | 
| Dizziness |  |  | 
| Exhaustion |  |  | 
| Haematoma (leg swelling) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip fracture, Rehabilitation, Transfusion, Outcome
Report of a New Method Used to Identify the Bacteria Present in a Human Colon Biopsy Sample

Study Overview
=================
Brief Summary
-----------------
The method used for the biopsy analysis may be able to provide important insights into the complex microbial communities found in the human colon or in complex human infections. Therefore, this methodology may prove useful to other researchers or physicians.

Detailed Description
-----------------
The method used to identify the microbes in the sample was chosen because it had the potential to provide more exhaustive identification of the bacteria present in the sample as compared to culturing methodology. The molecular method worked well, so it is appropriate to share the method with the medical and scientific communities.

Official Title
-----------------
Retrospective Study Protocol: Report of a New Method Used to Identify the Bacteria Present in a Human Colon Biopsy

Conditions
-----------------
Molecular Analysis

Intervention / Treatment
-----------------
* Procedure: molecular analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ulcerative colitis Age >= 18 years old Female Exclusion Criteria: Anyone not meeting inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Ulcerative colitius<br>The method used to identify the microbes in the sample was chosen because it had the potential to provide more exhaustive identification of the bacteria present in the sample as compared to culturing methodology. | Procedure: molecular analysis<br>* bowel disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The method used for the biopsy analysis may be able to provide important insights into the complex microbial communities found in the human colon or in complex human infections. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative Colitis (UC)
Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.

Official Title
-----------------
A Randomized, Double-blind, Multi-center, Vehicle-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Once or Twice Daily in Patients With Acute Ankle Sprain

Conditions
-----------------
Ankle Sprain

Intervention / Treatment
-----------------
* Drug: Diclofenac diethylamine 2.32% gel
* Drug: Placebo
* Drug: Diclofenac diethylamine 2.32% gel / Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute sprain of the ankle Injury within past 48 hours. Exclusion Criteria: Pain medication taken since the injury Pain or instability in the same ankle due to previous ankle sprain or any other trauma. Ankle sprain due to a known disease affecting the ligaments Other protocol-defined inclusion/exclusion criteria may apply

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Diclofenac diethylamine 2.32% gel<br>* Diclofenac diethylamine 2.32% gel twice daily<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Vehicle 2 times daily<br>|
| Active Comparator: 3<br> | Drug: Diclofenac diethylamine 2.32% gel / Placebo<br>* Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. | Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain) | change from baseline (on day 1) to day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankle, sprain, diclofenac diethylamine
Sun Protection Factor Assay (319/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987521
* Drug: SPF Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose). Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987521<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z09-180)<br>Drug: SPF Control<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Serum Magnesium and Vascular Calcification

Study Overview
=================
Brief Summary
-----------------
Both Kidney transplantation (KT) and Chronic Kidney Disease (CKD) patients have reduced kidney function. Low serum magnesium is more prevalent in KT recipients. The present study examines the difference in vascular calcification between KT and CKD and its association with serum magnesium.

Detailed Description
-----------------
Kidney transplantation (KT) improved quality of life and longevity of CKD patients. Nevertheless, kidney function deteriorates overtime in a manner not different from CKD counterparts. Hypomagnesemia is prevalent in KT recipients secondary to immunosuppressive therapy. In addition to serum calcium, phosphate and elemental calcium intake, the relationship between low serum magnesium and vascular calcification (VC) has been observed in small studies in CKD. Whether low serum magnesium associates with VC in KT has never been elucidated. The present study compares vascular calcification between KT and CKD and its association with serum magnesium.

Official Title
-----------------
Comparison of Vascular Calcification Between Kidney Transplant Recipients and Predialysis Chronic Kidney Disease and Its Association With Serum Magnesium

Conditions
-----------------
Vascular Calcification, Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: kidney transplant recipients at least 1 year post surgery predialysis chronic kidney disease with serum creatinine > 1.1 mg/dL in female and 1.3 mg/dL in male Exclusion Criteria: acute kidney injury parathyroidectomy

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 |
| --- | --- |
| Kidney transplant recipients<br> | |
| Chronic kidney disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in vascular calcification score between KT and CKD |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association of serum magnesium with vascular calcification in KT |  | Baseline | 
| The association of serum magnesium with vascular calcification in CKD |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
magnesium, kidney transplantation, hypomagnesemia
Bladder Wall Blood Perfusion Pattern and Sexual Dysfunction in Female Patients With Lower Urinary Tract Symptoms, and the Association of That Perfusion Pattern and Therapeutic Efficacy of Antimuscarincs for Female Overactive Bladder Syndrome.

Study Overview
=================
Brief Summary
-----------------
Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the etiology of OAB is complicated and unclear in many aspects. Bladder wall thickness had been reported to be strongly associated with OAB, but its use as a screening tool remains controversial. Besides, few studies reported patterns of sexual dysfunction in female patients with lower urinary tract symptoms (LUTS). Therefore the aims of our study were to analyze the bladder wall blood perfusion pattern in female LUTS patients, the association of between the bladder wall blood perfusion pattern and the efficacy of anti-muscarinic treatment for female OAB, and the patterns of sexual dysfunction in the female LUTS patients.

Conditions
-----------------
Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Drug: Tolterodine SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cases are female patients with lower urinary tract symptoms Exclusion Criteria: nil

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 Years

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

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

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: Bladder wall blood perfusion pattern<br> | Drug: Tolterodine SR<br>* Tolterodine SR 4 mg qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow pattern after antimuscarinics |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow patterns between different LUTS subgroups |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LUTS
The Effect of the Modified Perineal Protection Device During Delivery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.

Detailed Description
-----------------
RCT investigation using a modified device during delivery of the baby's head (an earlier model has proved successful) and assess whether the use can decrease delivery tears as measured in length.

Official Title
-----------------
Randomized Controlled Trial (RCT) of Primiparous Women Using the Modified Perineal Protection Device

Conditions
-----------------
Perineal Tears.

Intervention / Treatment
-----------------
* Device: Perineal protection device.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vaginal delivery at term (week 36 - 41) Exclusion Criteria: Age below 18 Breech delivery Not understanding written and oral information

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Perineal device during delivery<br>Delivery should be managed by using the perineal protection device when the head was crowning and 5-6 cm of it was visible. One part the tongue was inserted between the head and the posterior vaginal wall and the two wings were held against the perineum and kept in place by the delivery attendant's hand. | Device: Perineal protection device.<br>* A device used to reduce perineal tears during delivery of the baby.<br>* Other names: The perineal protection device have no brand name.;|
| Other: Standard care<br>Standard care at delivery: Manual support of the perineum | Device: Perineal protection device.<br>* A device used to reduce perineal tears during delivery of the baby.<br>* Other names: The perineal protection device have no brand name.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of delivery tear measured in cm with ruler | The outcome measured is the occurrence of first and second degree vaginal and perineal tears during delivery. | at delivery - Participants will be followed for the duration of the first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects of the device on mother and child | Measure eventual adverse effects on mother and child. | at delivery-Participants will be followed for the duration of the first 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delivery tears, Birth injuries, Perineal protection device
Influence of Fluid Challenge on End-Expiratory Lung Impedance in Mechanically Ventilated Patients Monitored With Electrical Impedance Tomography

Study Overview
=================
Brief Summary
-----------------
The study investigates the influence of a clinically indicated fluid challenge on end-expiratory lung impedance, assessed by electrical impedance tomography (EIT). EIT data will be collected before, during and after infusion of 500 ml of crystalloid solution in mechanically ventilated patients on an operative intensive care unit.

Official Title
-----------------
Influence of Fluid Challenge on End-Expiratory Lung Impedance in Mechanically Ventilated Patients Monitored With Electrical Impedance Tomography

Conditions
-----------------
Respiratory Failure, Circulatory Failure, Fluid Responsiveness, Fluid Overload

Intervention / Treatment
-----------------
* Other: Fluid Challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients on mechanical ventilation clincial decision to monitor regional ventilation with electrical impedance tomography clinical indication for fluid challenge established cardiac output monitoring with transpulmonary thermodilution Exclusion Criteria: age < 18 years open lung injuries instable injury of spine or cranium thoracic metal implants body mass index > 35

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

| Intervention/Treatment |
| --- |
|Other: Fluid Challenge|Infusion of a standardized amount of crystalloid solution (500 ml) to assess fluid responsiveness by means of changes in cardiac output, assessed by transpulmonary thermodilution.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in end-expiratory lung impedance (EELI) | To assess the effect of fluid challenge on EELI, the change in EELI during the fluid challenge will be measured by electrical impedance tomography and will be compared to the change in EELI during the last 15 minutes before start of the fluid challenge. | 15-30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between change in end-expiratory lung impedance and change in intrathoracic blood volume | We will assess the correlation between the change in end-expiratory lung impedance during infusion of 500 ml of crystalloid solution and the change in intrathoracic blood volume (assessed by transpulmonary thermodilution) during the same time period. | 15-30 minutes | 
| Fluid responsiveness | We will investigate whether the ratio of cardiac-related impedance changes to ventilation-related impedance changes, measured by EIT at baseline (i.e. before start of fluid challenge), can predict fluid responsiveness, defined as an increase in stroke volume of greater or equal to 15% compared to baseline. | 15-30 minutes |