linjc16/ctgov huggingface dataset:
Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: Influence of Component Design

Study Overview
=================
Brief Summary
-----------------
The investigators want to examine if specific acetabular liner designs can be a contributing factor to audible squeaking associated with CoC bearings. The aim of the present study is to compare two different designed and well documented acetabular component systems with reference to squeaking and other noises from the hip.

Official Title
-----------------
Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: A Prospective, Blinded, Randomized Clinical Trial of Influence of Component Design

Conditions
-----------------
Hip Arthrosis

Intervention / Treatment
-----------------
* Device: THA with ABG II / Trident
* Device: THA with CLS / Trilogy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients scheduled for uncemented THA under the age of 65 years. Exclusion Criteria: Patients with the following diagnoses of the hip: Recent femoral fracture, sequelae from older femoral fracture, acetabular fracture, and traumatic dislocation of the hip. Patients without ability to give informed consent and/or willingness to participate in the follow-up protocol. Severely impaired level of function due to other physical deficiencies than the hip. Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection. Earlier primary THA or revision THA in the contralateral hip. Pathology requiring another prosthesis concept than the below mentioned. Body mass index greater than 35.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ABG II / Trident<br> | Device: THA with ABG II / Trident<br>* Surgery with total hip arthroplasty in the form of ABG II / Trident<br>|
| Active Comparator: CLS / Trilogy<br> | Device: THA with CLS / Trilogy<br>* Surgery with total hip arthroplasty in the form of CLS / Trilogy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All noises from THA |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life quality |  | One year |
Infections in Pediatric Cancer Patients

Study Overview
=================
Brief Summary
-----------------
A prospective epidemiological study conducted in pediatric hematology oncology center in Hadassah medical center. The study will include all newly diagnosed pediatric cancer patients age 0-18 years admitted with fever during chemotherapy. In each event of febrile episode during chemotherapy, the following data will be collected using a patient data form and computerized software. Demographic data: age, gender, ethnicity. Clinical data: Underlying disease, immunizations, prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy, duration of fever, duration and severity of neutropenia, diagnosis of present event. Imaging data Microbiological data Outcome The statistical analysis will be performed by an epidemiologist and statistician using the SPSS 12.0 software.

Official Title
-----------------
Epidemiology and Etiology of Infections in Pediatric Cancer Patients: A Prospective Study

Conditions
-----------------
Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric cancer patients age 0-18 years admitted with fever during or following chemotherapy Exclusion Criteria: No exclusions

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fever, children, cancer, leukemia, stem cell transplantation, infections in pediatric cancer patients presenting with fever during or following chemotherapy.
Safety and Efficacy of Laser Therapy in Gynaecology

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to retrospectively evaluate the effectiveness and safety of Er:YAG laser for treatment of different gynecological indication, e.g. genital lesions, Bartholin's cyst, condyloma, episiotomy scars, lesions of hydradenitis suppurativa and use of laser in genital surgery used in private practice.

Official Title
-----------------
Safety and Efficacy of Er:YAG and Nd:YAG Laser Therapy in Gynecology: A Retrospective Case Series.

Conditions
-----------------
Herpes Genitalis, Genital Wart, Lichen Sclerosus, Cervical Intraepithelial Neoplasia, Labial Reduction Surgery, Episiotomy Scar, Bartholin Cyst, Hidradenitis Suppurativa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with any of the selected gynecology indications, treated with laser in the period 2013-2018 signed informed consent Exclusion Criteria: N/A

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - occurence of adverse effects. | Recording if any adverse effects occur. | [1 year] | 
| Efficacy - number of laser treatments. | Number of laser treatments needed for lesion clearance. | [1 year] |
Effect of Regulated Oxygen-Enriched Negative Pressure Therapy (RO-NPT) On Soft Tissue Wound Repair

Study Overview
=================
Brief Summary
-----------------
The investigators believe that regulated oxygen-enriched negative Pressure Therapy (RO-NPT) will be beneficial in the reduction or elimination of anaerobic infection in hard-to-heal soft tissue wounds.

Conditions
-----------------
Wounds and Injuries

Intervention / Treatment
-----------------
* Device: Wound treatment with RO-NPT
* Device: Wound Irrigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hard-to-heal wounds Exclusion Criteria: Everyone else
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Research Group I<br>Wound treatment with RO-NPT 40% | Device: Wound treatment with RO-NPT<br> <br> * Other names: Oxygen-enriched vacuum therapy;|
| Research Group II<br>Wound treatment with RO-NPT 60% | Device: Wound treatment with RO-NPT<br> <br> * Other names: Oxygen-enriched vacuum therapy;|
| Research Group III<br>Wound treatment with RO-NPT 40% and irrigation | Device: Wound treatment with RO-NPT<br> <br> * Other names: Oxygen-enriched vacuum therapy;Device: Wound Irrigation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Closure | Before treatment and after treatment wound area measurements will indicate percentage of closure | One Month |
Inventory of the Management of Acute Community-acquired Pneumonia in Strasbourg University Hospitals

Study Overview
=================
Brief Summary
-----------------
Acute community-acquired pneumonia (CAP) refers to an acute infection of the lung parenchyma, occurring within the first 48 hours of hospitalization. It is a frequent, serious pathology with a strong economic impact. Viruses (rhinovirus, respiratory syncitial virus, influenza virus for the most common) and Streptococcus pneumoniae are the most frequently encountered pathogens. However, more than half of the PACs have no microbiological documentation. The management of CAPs is based on national and international recommendations. Several studies have shown imperfect compliance by clinicians with recommendations with a prognostic impact. The various published studies insist on the variability of the incidence, the type of pathogen, the severity and the economic impact, depending on the series. They also insist on the need to know the local epidemiology, in particular microbiological, in order to adapt the recommendations.

Detailed Description
-----------------
The objective of the study is to determine the epidemiological, clinical, biological and imaging characteristics of people admitted for acute community-acquired pneumonia.

Official Title
-----------------
Inventory of the Management of Acute Community-acquired Pneumonia in the Pneumology Department of the Strasbourg University Hospitals

Conditions
-----------------
Infection, Lung Parenchyma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult subject (≥ 18 years old), acute community-acquired pneumonia (< 48 hours after admission), admitted from the Emergency Department, consultation or home. Subject not objecting to the reuse of their data for scientific research purposes Exclusion criteria: Expressed refusal to reuse data for scientific research purposes. bronchitis, acute nosocomial pneumopathy, secondary infection due to bronchial dilation.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Retrospectively determine the epidemiological, clinical, biological and imaging characteristics of people admitted for acute community-acquired pneumonia | Retrospective analysis of health data from patients' medical records | Files analysed retrospectively from January 01, 2015 to December 31, 2019 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Community-acquired Pneumonia, Infection, Lung parenchyma, Rhinovirus, Respiratory syncitial virus, Influenza virus, Streptococcus pneumoniae
The Rates of Overtreatment and Deintensification in Patients With Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study evaluates the overtreatment and deintensification rates of antidiabetic and antihypertensive medications in patients with diabetes mellitus in Turkey.

Detailed Description
-----------------
Diabetes mellitus is one of the most common chronic diseases which lead to serious public health problems and a significant economic burden worldwide. The prevalence of diabetes in elderly patients is very high and is predicted to increase dramatically. Prior studies have generally been concerned with the inadequate treatment of diabetes however, over the last few years the overtreatment of diabetes has also come to the fore. Unfortunately, there are very few data worldwide and no data in Turkey about the overtreatment of patients with type 2 diabetes. This study aimed to assess the rates and predictors of overtreatment and undertreatment of glycemia and blood pressure in older adults with T2DM. Treatment deintensification or intensification by the physicians were also investigated.

Official Title
-----------------
The Rates of Overtreatment and Deintensification of Antidiabetic and Antihypertensive Medications in Patients With Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Diabetes Mellitus type I or II Age 65 years or older To be under follow-up in the same center for at least one year. Exclusion Criteria: Younger than 65 years old having decompensated liver disease psychiatric disorders interfering cognition or compliance having bariatric surgery or on renal replacement therapy

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Overtreatment for glycemia | HbA1c<6.5% plus use of ≥2 oral hypoglycemics or insulin, except metformine. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undertreatment for glycemia | HbA1c>9% | 7 days | 
| Overtreatment for blood pressure | systolic blood pressure < 120 mmHg or diastolic blood pressure < 65 mmHg and use of at least one drug additional to ACE inhibitors | 7 days | 
| Undertreatment for blood pressure | SBP≥140 mmHg or DPB ≥ 90 mmHg and use of two or less drugs | 7 days | 
| Deintensification of treatment | discontinuation or dosage decrease within 6 months after the index measurement. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Polypharmacy, Overtreatment, Undertreatment
The Efficacy and Safety of Dexibuprofen Syrup

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and efficacy of dexibuprofen syrup and ibuprofen syrup in patients with fever due to common cold.

Official Title
-----------------
Multi-center, Randomized, Double Blinded (Double-dummy), Active-Controlled Parallel-group Comparative, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Dexibuprofen Syrup Compared to Ibuprofen Syrup in Patients With Fever of Common Cold (Acute Upper Respiratory Infection)

Conditions
-----------------
Fever, Respiratory Tract Infection

Intervention / Treatment
-----------------
* Drug: Dexibuprofen
* Drug: Dexibuprofen
* Drug: Ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Common cold with fever Age 6 months to 14 years Exclusion Criteria: Gastric ulcer Bleeding tendency Liver disease Kidney disease Hypertension Hypersensitivity to the drug

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 14 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 |
| --- | --- |
| Experimental: Dexibuprofen 1<br>Dexibuprofen 2.5 or 5 mg/kg | Drug: Dexibuprofen<br>* one dose of Dexibuprofen 2.5 or 5 mg/kg<br>|
| Experimental: Dexibuprofen 2<br>Dexibuprofen 3.5 or 7 mg/kg | Drug: Dexibuprofen<br>* one dose of Dexibuprofen 3.5 or 7 mg/kg<br>|
| Active Comparator: Ibuprofen<br>Ibuprofen 5 or 10 mg/kg | Drug: Ibuprofen<br>* one dose of Ibuprofen 5 or 10 mg/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure reduction in fever |  | measure temperature every hour for 3 hours then once again 3 days later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine safety of dexibuprofen by unwanted reaction, clinical laboratory test and physical examination. |  | every hour for 3 hours (unwanted reaction). 3 days later (clinical laboratory test and physical examination). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fever due to acute upper respiratory tract infection
VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to evaluate the feasibility, acceptability, and initial efficacy of the VOCALE LBD+ intervention in caregivers of persons living with Lewy Body Dementia. The main question[s] it aims to answer are: What is the extent to which the VOCALE LBD+ intervention affects caregiving mastery scores at the end of the eight-week intervention What is the extent to which a change in caregiving mastery scores is retained four weeks after the end of the VOCALE LBD+ intervention Participants will be asked to participate in a fully online asynchronous VOCALE LBD+ intervention that involves a moderated web-based discussion platform, peer-to-peer support, didactic training, and problem-solving skill enactment.

Official Title
-----------------
VOCALE LBD+ Leveraging Social Technologies and Problem-Solving Skills to Enhance Mastery Among Caregivers of Persons With Lewy Body Dementia

Conditions
-----------------
Caregiver Burden, Lewy Body Disease, Stress, Skill, Coping

Intervention / Treatment
-----------------
* Behavioral: VOCALE LBD+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informal and/or lay caregiver of a patient with LBD Can read, write, and speak English Has access to a device that can be used for videoconferencing and/or phone calls 18 years or older Exclusion Criteria: Not an informal and/or lay caregiver Cannot read and write in English No access to a device that can be used for videoconferencing and/or phone calls Younger than 18 years old

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VOCALE LBD+<br> | Behavioral: VOCALE LBD+<br>* Intervention employs a web-based platform that allows participants to engage asynchronously in an eight-week online intervention involving didactic training, peer-to-peer support, and moderated problem-solving skill enactment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Change From Baseline Caregiving Mastery at 4 and 8 weeks | Change in Pearlin's Caregiver Competence Scale Over Time, scale ranges from 7 to 35 with lower score indicating better mastery | Baseline; 4 weeks, 8 weeks |
A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Dutasteride will perform better than finasteride in decreasing prostate volume, improving symptoms based on International Prostate Symptom score,and lower pvr based on the scientific information that dutasteride inhibits both Type I and II 5-alpha-reducatase vs. finasteride which only inhibits the Type II enzyme

Official Title
-----------------
Switch Study: Are There Any Measurable Differences When Switching Patients on Finasteride Therapy to Dutasteride?

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Dutasteride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age 50-80 On finasteride for no less than 12 months Willing to undergo all necessary test in the 12 month evaluation Exclusion Criteria: History of medication non-compliance Unwillingness to undergo/tolerate 2 blood draws Unwillingness to tolerate/undergo 2 TRUSP

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dutasteride|0.5mg capsule, taken once daily for 12 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory parameters: including serum testosterone, DHT level and PSA |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume measurements of TRUSP and PVR |  | 12 months | 
| A decrease in the AUASI |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BPH
The Effect of Terlipressin on Intesitnal Function in Septic Shock Patients

Study Overview
=================
Brief Summary
-----------------
Terlipressin becomes a vasopressin for septic shock. But some studies found it may lead to severe intesitnal complications such as intestinal ischemia. The investigators study was designed to find the effect of terlipressin on intestinal function in septic shock patients.

Official Title
-----------------
the Surgical Intensive Care Unit

Conditions
-----------------
Terlipressin, Septic Shock

Intervention / Treatment
-----------------
* Drug: Terlipressin
* Drug: Norepinephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: septic shock Exclusion Criteria: shock due to other reasons diagnosited intesitinal ischemia

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: norepinephrine<br>patients received norepinephrine | Drug: Norepinephrine<br> <br> |
| Experimental: terlipressin<br>patients received terlipressin | Drug: Terlipressin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intestinal function assessed by abdominal distension, intestinal bleeding, peritonitis, plasma DAO level, enteral nutrition |  | 7 days |