linjc16/ctgov huggingface dataset:
Epidemiology of Bacteremia at Two Tertiary ICUs in Switzerland

Study Overview
=================
Brief Summary
-----------------
The objectives of the retrospective cohort study is to describe the actual current practice of antibiotic treatment duration for bloodstream infections in critically ill patients at two tertiary hospitals (ICU Inselspital Bern and ICU CHUV Lausanne), to examine patient, pathogen and infectious syndrome factors associated with selection of shortened treatment duration, and to describe the expected time course of clinical resolution among bacteremic patients.

Official Title
-----------------
Duration of Antimicrobial Treatment for Bloodstream Infections in Swiss Critically Ill Patients - Retrospective Double Center Study

Conditions
-----------------
Bacteremia

Intervention / Treatment
-----------------
* Diagnostic Test: Blood Culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a positive blood culture with a pathogenic organism Patient is critically ill at the time the blood culture was collected as defined by the following: was treated at the ICU/IMC at the time of blood culture collection; or has been admitted to ICU/IMC in the 48 hours after blood culture collection Exclusion Criteria: Patient has a single positive blood culture with a common contaminant organism: coagulase negative staphylococci; Bacillus spp.; Corynebacterium spp.; Propionibacterium spp.; Aerococcus spp.; Micrococcus spp. Explicit documentation that the patient does not want to participate in any study

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 |
| --- | --- |
| Bern ICU<br> | Diagnostic Test: Blood Culture<br>* Blood Culture<br>|
| Lausanne ICU<br> | Diagnostic Test: Blood Culture<br>* Blood Culture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic Treatment Duration | Days of adequate antibiotic treatment in Patients with Bacteremia | Hospital discharge, expected to be on average ca. 15-20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of ICU stay | Days of ICU Stay in Patients with Bacteremia | ICU discharge, expected to be on average ca. 5-15 days | 
| Days of hospital stay | Days of Inhospital Stay in Patients with Bacteremia | Hospital discharge, expected to be on average ca. 15-25 days |
Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars

Study Overview
=================
Brief Summary
-----------------
This study aim to assess the efficacy of Er-YAG laser 2940nm and PRP as a single line of treatment in comparison with combined treatment in atrophic post acne scars.

Official Title
-----------------
Fractional Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars: A Randomized Clinical Trial

Conditions
-----------------
Acne Vulgaris, Scars

Intervention / Treatment
-----------------
* Device: Fractional Erbium Yağ Laser
* Procedure: Platelet Rich Plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with atrophic post acne scars classified on the basis of Goodman and Baron's Qualitative classification, no active acne lesions and patients with atrophic scars only Exclusion Criteria: patients with positive history of keloidal tendency, positive history of bleeding tendency, platelet disorder, patients with any acute infection on face like, herpes, folliculitis, patients with HIV, HBsAg, patients with a history of autoimmune diseases or patients on immunosuppressive drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 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: Group A<br>treated with platelet rich plasma | Procedure: Platelet Rich Plasma<br>* Multiple injections of Platelet Rich Plasma<br>|
| Active Comparator: Group B<br>treated with Erbium Yag Laser | Device: Fractional Erbium Yağ Laser<br>* Multiple sessions of Fractional Erbium Yağ Laser<br>|
| Active Comparator: Group C<br>treated with both line of treatments | Device: Fractional Erbium Yağ Laser<br>* Multiple sessions of Fractional Erbium Yağ Laser<br>Procedure: Platelet Rich Plasma<br>* Multiple injections of Platelet Rich Plasma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in grade of acne scares according toQualitative scarring grading system of Goodman and Baron | Grade of acne scares improvement after treatment | 6 months | 
| Change in clinical appearance of acne scare accordinga four-point scale for assessment of clinical improvement of skin smoothness | improvement of acne scares as evaluated by sequential photos | 6 month | 
| Change in patient satisfaction usinga four-point scale; Grade 4 highly satisfied, Grade 3 satisfied, Grade 2 neutral and Grade 1 dissatisfied | increase in patient satisfaction after treatment | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne scars, Erbium-YAG laser, platelet-rich plasma
Determine the Effect of Multiple Doses of AZD7325, CYP Study

Study Overview
=================
Brief Summary
-----------------
To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).

Official Title
-----------------
A Phase I Open-Labeled, Fixed Sequence Study to Determine the Effect of Multiple Doses of AZD7325 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: AZD7325
* Drug: Midazolam
* Drug: Caffeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor. Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD7325<br>* Oral, day 1-12<br>Drug: Midazolam<br>* single dose, twice during treatment<br>Drug: Caffeine<br>* single dose, twice during treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite). |  | Blood samples will be taken during the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of repeated doses of AZD7325 in combination with midazolam and caffeine. |  | Blood samples will be taken during the study. | 
| Evaluation of the pharmacodynamic effects of AZD7325 |  | Test batteries will be performed at specified times both before and following study drug administration. | 
| To evaluate the pharmacokinetics of AZD7325 |  | Blood samples will be taken on Days 1, 11 and 12. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I
The Anatomic Determinants of Perforation Induced Hearing Loss

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify factors that may contribute to conductive hearing loss. Conductive hearing loss is a type that is due to a problem with the outer or middle ear. Because of this, sound does not travel through the ear normally. Perforated tympanic membranes of study patients will be photographed during the patient's routine visit using a digital otoscope. These pictures will be used to analyze perforation size as an absolute value as well as a percentage of the tympanic membrane. Audiometric results and CT scans of temporal bone (reports and images) collected as standard of care will be evaluated. Images of CT scans will be imported into a medical imaging software for creation of anatomically realistic 3D models of the middle ear and mastoid air space. Structural analysis on each 3D model will be conducted and analyzed, the volume of middle ear and mastoid air spaces will be recorded, and data points will be correlated with perforation size and location to audiogram results.

Official Title
-----------------
The Anatomic Determinants of Perforation Induced Hearing Loss

Conditions
-----------------
Conductive Hearing Loss, Perforated Tympanic Membrane

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18 and 89 years of age Confirmed diagnosis of conductive hearing loss secondary to tympanic membrane perforation Treated for the above condition by a Duke physician Received both a CT temporal bone scan interpreted by a Duke radiologist and audiometry at a Duke-based facility (both tests performed within four weeks of each other), as part of standard pre-operative workup Exclusion Criteria: Temporal CT scan with inadequate resolution as per determination of study staff Unable to provide written informed consent Unable to read and understand English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Patients with conductive hearing loss<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of perforation | Number of patients with perforations | Day 1 | 
| absence of perforation | number of patients without perforations | Day 1 | 
| change in audiometric measurements | looking at difference between baseline and last observation | Baseline, up to 16 weeks |
An Explorative Prospective Observational Study to Describe Morphokinetic De-selection Parameters in Human Embryos

Study Overview
=================
Brief Summary
-----------------
This post-marketing, multi-center prospective study will be conducted in a open-label, non-interventional setting, for women seeking fertility treatment and will describe morphokinetic de-selection parameters in human embryos.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: menotropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21-45 years In Vitro Fertilisation/Intra Cytoplasmic Sperm Injection treatment in long or short protocol Receiving follicle stimulation with Menopur 600/1200 IU

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women treated with Menopur<br>Women treated with Menopur can participate with more than one cycle. 700 cycles will be enrolled. | Drug: menotropin<br> <br> * Other names: Menopur;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells |  | 1 week after oocyte retrieval | 
| Incidence of uneven blastomeres at the 2 and 4 cell stage |  | 1 week after oocyte retrieval | 
| Incidence of bi- and multinucleation at 2 cell and 4 cell stage |  | 1 week after oocyte retrieval | 
| Incidence of Smooth Endoplasmatic Reticulum at the Metaphase II stage, the Pro Nuclei stage and the 2, 3 and 4 cell stage |  | 1 week after oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive serum human Chorion Gonadotrophin (hCG) rate |  | 13-15 days after transfer | 
| Implantation rate |  | 5 weeks after transfer | 
| Clinical pregnancy rate |  | 7 weeks after transfer | 
| Ongoing pregnancy rate |  | 10 weeks after transfer | 
| Live birth rate |  | 9 months |
Comparison of Two Methods for Treatment of Colles´s Fracture

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two different fixationmethods for fractures of the wrist(distal radius fractures). We are comparing an external fixation (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail). Primary endpoint is patient satisfaction as scored by the DASH-questionnaire.Secondary followup is X-rays, strength, PRWE-questionnaire.

Official Title
-----------------
Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study.

Conditions
-----------------
Distal Radius Fracture, Colle´s Fracture

Intervention / Treatment
-----------------
* Procedure: Osteosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fracture Older type 2. Fracture Older type 3. Exclusion Criteria: Fractures older than 3 weeks. Pregnancy. Seq. after previous fracture. Distal fragments volar cortex < 10 mm. Open fracture larger than Gustillo 1. Disability due to other illness. Congenital abnormity or injury/disease in the affected extremity. Not capable of mentally/physically to cooperate. Not able to go to followup on the operating hospital.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Internal fixation with Micronail. 41 patients. | Procedure: Osteosynthesis<br>* Micronail osteosynthesis. A cast for the first 14 days, thereafter starting physiotherapy. Control at weeks 1,2,5,12. Hoffmann-II-non-bridging osteosynthesis. Removal of device after 5 weeks. physiotherapy starts at 14 days. Control at weeks 1,2,5,12.<br>|
| Experimental: 2<br>External fixation with Hoffmann-II-non-bridging. 41 patients. | Procedure: Osteosynthesis<br>* Micronail osteosynthesis. A cast for the first 14 days, thereafter starting physiotherapy. Control at weeks 1,2,5,12. Hoffmann-II-non-bridging osteosynthesis. Removal of device after 5 weeks. physiotherapy starts at 14 days. Control at weeks 1,2,5,12.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASH-questionnaire |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRWE-questionnaire |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Distal radius fracture, Colle´s fracture, Internal fixation, External fixation, DASH, PRWE
Prospective Registration and Assessment of Serious Adverse Events Within the AFNET

Study Overview
=================
Brief Summary
-----------------
Prospective registration and independent assessment of SAE associated with atrial fibrillation such as thromboembolic events, and other cardiac and noncardiac complications by a Critical Event Committee.

Detailed Description
-----------------
Atrial fibrillation (AF), the most common sustained rhythm disturbance, is associated with a significantly enhanced mortality and morbidity due to thromboembolic events, and other cardiac and noncardiac complications. Therefore the Network of Competence on Atrial Fibrillation (AFNET) supported by the German Ministry for Education and Research (BMBF) was established in order to collect clinical data on patients (pts) with AF (paroxysmal, persistent, permanent) over a study period of 6 years with an expected sample size of 12,000 pts. Incidence, clinical relevance and outcome after SAE is recorded and assessed by a Critical Event Committee (CEC). The CEC-members (experts in cardiology and neurology) defined as SAE any death with or without relationship to AF, cardio-embolic events (stroke, peripheral arterial embolism), bleeding complications due to antithrombotic therapy, acute heart failure, syncope, resuscitation; additionally, the complication of interventional strategies for AF-treatment and other AF-independent SAEs. Over a 3-year follow-up period, during 6-monthly and unscheduled visits, the SAEs are systematically documented, blinded and their relationship to AF will be interpreted in detail by the CEC.

Official Title
-----------------
Prospective Registration and Independent Assessment of Incidence, Clinical Relevance and Outcome of Serious Adverse Events (SAE) Registered in the German Competence Network on Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation, Assessment of Serious Advers Events, Thromboembolic and Bleeding Complications, Complications of Antiarrhythmic Drugs or Invasive Procedures, Assessment by a Critical Event Committee

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrial fibrillation documented by ECG not older then one year Age > 18 years Informed consent 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?
-----------------
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
-----------------
Atrial Fibrillation, Critical Event Committee, Serious adverse events, Thromboembolic complications, Cardiac and noncardiac complications, Bleeding complications, Acute heart failure, Syncope, Resuscitation
Validation of a Nutrition Screening Tool

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the sensitivity and specificity of two nutrition screening tools to identify inpatients with malnutrition or at risk of malnutrition. The two tools are the Royal Marsden Abridged Adult Nutrition Screening Tool (AANST) and the Malnutrition Screening Tool (MST)[10] The tools will be compared with the currently accepted gold standard, Patient Generated Subjective Global Assessment (PG-SGA). Both screening tools are in the form of scored questionnaires and are suitable for electronic input. The ultimate objective is to select an adult inpatient nutrition screening tool with the highest sensitivity for future use in the oncology inpatient setting in order to allow prompt commencement of an appropriate nutrition care plan.

Official Title
-----------------
The Validation of Two Inpatient Adult Nutrition Screening Tools in Cancer Care - a Prospective Study

Conditions
-----------------
Ovarian Cancer, Sarcoma, Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Fallopian Tube Cancer, Gastric Cancer, Vaginal Cancer, Vulvar Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult inpatients, over the age of 18, admitted to RMH for whom a measured weight and height can be obtained Exclusion Criteria Patients for whom it is not possible to obtain a measured height and weight People with a definitive diagnosis of dementia People who lack capacity to understand the purpose of the study and to consent Patients who are unable to understand and speak English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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 |
| --- | --- | --- |
| Sensitivity of Screening Tool | The primary endpoint of the study is the sensitivity of each screening tool as compared to the gold standard of PG-SGA when completed by a trained dietitian. | 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of the Tool | Secondary endpoints are as follows: specificity of the screening tool proportion of inpatients with malnutrition on admission | 24 hrs |