linjc16/ctgov huggingface dataset:
Cologne Placenta Cohort (CPC)

Study Overview
=================
Brief Summary
-----------------
Aim of the study was to determine if signaling pathways in placentas of mothers affected by overweight/obesity or by gestational diabetes are altered compared to placentas of a control group (normal weight, no gestational diabetes). Moreover, maternal blood and umbilical cord blood were analysed.

Official Title
-----------------
Study to Investigate Signaling Pathways in Placentas of Overweight or Obese Patients and Patients With Gestational Diabetes Mellitus

Conditions
-----------------
Obesity, Maternal, Gestational Diabetes Mellitus in Pregnancy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy BMI before pregnancy >= 18 with & without gestational diabetes c-section at gestational week 35+0 until 41+6 Exclusion Criteria: multiple pregnancy maternal serious internal disease infections before pregnancy (e.g. HIV, hepatitis B) pregnancy-associates diseases (e.g. gestoses, androgen insensitivity syndrome)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal weight without gestational diabetes<br>BMI < 25; normal glucose tolerance | Other: no intervention<br>* no intervention<br>|
| normal weight with gestational diabetes<br>BMI < 25; impaired oral glucose tolerance | Other: no intervention<br>* no intervention<br>|
| overweight without gestational diabetes<br>BMI 25 - 29.9; normal glucose tolerance | Other: no intervention<br>* no intervention<br>|
| overweight with gestational diabetes<br>BMI 25 - 29.9; impaired glucose tolerance | Other: no intervention<br>* no intervention<br>|
| obese without gestational diabetes<br>BMI >= 30; normal glucose tolerance | Other: no intervention<br>* no intervention<br>|
| obese with gestational diabetes<br>BMI >= 30; impaired glucose tolerance | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity of Wnt signaling pathway in placental tissue | Analysis of components of the Wnt signaling pathway; like LRP6 receptor, beta-Catenin, GSK3beta, Wnt ligands (=proteins of interest) and an appropriate protein for normalization. Total protein lysates of placental tissue will be used. Analysis will be performed by western blotting and subsequent densitometric analysis. Outcome measure will be [relative protein level of protein or interest/relative protein level of normalization protein]. | through study completion, about 4 years in total |
Study Evaluating the Efficacy and Safety of Etanercept

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of etanercept 25 mg administered subcutaneously twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.

Official Title
-----------------
Open-Label Evaluation Of The Efficacy And Safety Of Etanercept In Patients With Active Rheumatoid Arthritis (RA)

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A negative serum or urine pregnancy test at screening and a medically acceptable form of contraception starting at screening and continuing throughout the study is required for all females of childbearing potential (defined as an oral, injectable, or implantable contraceptive, intrauterine device, or barrier method combined with a spermicide). Failed therapy with at least one DMARD (DMARD failure is defined as a discontinuation because of lack of clinical efficacy). Meet the 1987 American Rheumatism Association (ARA) revised criteria for rheumatoid arthritis. Exclusion Criteria: Uncooperative patients with a history of poor compliance. Known hypersensitivity to etanercept or any of its components. Known significant concurrent medical disease
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Etanercept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the clinical efficacy of etanercept 25 mg administered twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate. |  |  |
Development of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery Room

Study Overview
=================
Brief Summary
-----------------
Apgar scoring system has been widely used for the evaluation of the infant's postnatal condition. As conventional Apgar scoring system is affected by gestational age and resuscitative efforts, there is a need for development of new scoring systems for the assessment in the delivery room. Herein, Modified Combined Apgar scoring system which includes two new parameters (cord blood pH and targeted oxygen saturation level) has been developed and the utility of this modified system was compared with Conventional and Combined Apgar scoring systems for prediction of hospitalization.

Detailed Description
-----------------
This is a prospective cohort study. Conventional, Combined and Modified Combined Apgar scores at minutes 1 and 5 are all recorded. For Modified scoring system, blood sample is obtained from the umbilical artery and pulse oximetry is used for measurement of oxygen saturation. Prediction of NICU hospitalization is used as a surrogate parameter to compare the scores.

Official Title
-----------------
Development of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery Room

Conditions
-----------------
Neonatal Respiratory Failure

Intervention / Treatment
-----------------
* Other: Modified Apgar Scoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term neonates Preterm neonates Parental approval Exclusion Criteria : Major congenital/chromosomal abnormalities Lack of informed consent Stillbirth Outborn infants

Ages Eligible for Study
-----------------
Maximum Age: 2 Hours

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Modified Apgar Scoring System|Modified APGAR scoring system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Combined Apgar scoring | The predictive value of Modified Combined Apgar scoring for hospitalization of infants | 10 months |
Serological Diagnostics of COVID-19 in Health Care Workers

Study Overview
=================
Brief Summary
-----------------
All health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be fulfilled.

Detailed Description
-----------------
Health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana are working with COVID-19 patients in intensive care units, operating theaters, wards and emergency department. In the care of those patients different workgroups are involved: anesthesiologists, anesthesia and ICU nurses and respiratory therapeuts.There is insufficient data on the seroprevalence in different workgroups, different areas of the hospital, insufficient data on connection between SARS-CoV2 nasal swabs and antibodies and the rate of asymptomatic infections. 300 hundred HCW will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be filled.

Official Title
-----------------
Serological Diagnostics of COVID-19 and Risk Factors for Infection Among Different Groups of Health Care Workers at Surgical Division at Tertiary Hospital

Conditions
-----------------
SARS-CoV Infection

Intervention / Treatment
-----------------
* Diagnostic Test: SARS-CoV2 nasal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: employee of Department of Anesthesiology and Intensive Care at UMC Ljubljana active current employment at the department Exclusion Criteria: current sick-leave

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: SARS-CoV2 nasal swab|SARS-CoV2 nasal swab and venous blood for SARS-CoV2 antibodies|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive nasal swab and serological test | Rate of positive nasal swab and serological tests for SARS-CoV2 among health care workers | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation of positive SARS-CoV2 tests to risky contact history | Relation of positive SARS-CoV2 tests to history of contacts with COVID-19 infected patients since the beginning of pandemia | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV2 infection, Health care worker, Serology, Nasal swab tests, Anesthesiology and Intensive Care
Chemotherapy-induced Symptoms in Sarcoma Patients and the Impact of Tumor Burden

Study Overview
=================
Brief Summary
-----------------
Assessments (survey data) in this study are designed to sample the symptom burden of patients undergoing adjuvant and neoadjuvant chemotherapy in the hospital. There will be no change in the treatment plan for these patients.

Official Title
-----------------
Chemotherapy-induced Symptoms in Sarcoma Patients and the Impact of Tumor Burden

Conditions
-----------------
Soft Tissue Sarcoma

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are receiving doxorubicin plus ifosfamide (AI) Exclusion Criteria: There is no exclusion criteria

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 |
| --- | --- |
| Sarcoma Subjects<br>Soft tissue sarcoma patients treated with the adjuvant and neoadjuvant chemotherapy protocol of doxorubicin plus ifosfamide (AI) | Other: Questionnaires<br>* Subjects will be given a series of questionnaires to assess the effect of AI chemotherapy, and the possible role of tumor load, on the amount of symptoms. The extent of nausea, vomiting, fatigue, anxiety, sleep disturbance, and cognitive changes will be measured. In adjuvant chemotherapy patients, we will also assess the relationship between tumor size and amount of chemotherapy-induced symptoms. These questionnaires will involve the following assessments: Demographic & health Trait anxiety Quality of life Nausea Expectations Anxiety & total mood disturbance Nausea & vomiting Multiple symptoms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the extent of symptom burden and quality of life in sarcoma patients receiving AI chemotherapy. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcoma, questionnaire, doxorubicin plus ifosfamide (AI)
Comparison of Visual Fields: Humphrey Field Analyzer (HFA) SITA Strategy, SCOPE (GATE Strategy) and Humphrey MATRIX Perimeter

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare three perimetric techniques regarding progression of the visual field.

Official Title
-----------------
Detection of Visual Field Defects and Scotoma Progression in Glaucomatous Optic Neuropathy, Using Short-term Intervals With Automated Scotoma-oriented Perimetry (SCOPE) and the Fast Thresholding Strategy GATE (German Adaptive Threshold Estimation)

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: three different perimeters: HFA, Octopus, MATRIX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: max. ± 8 dpt sph, max. ± 3 dpt cyl distant visual acuity > 10/20 isocoria, pupil diameter > 3 mm at least one risk of progression: optic disc (splinter) hemorrhage / cup to disc ratio (CDR) > 0.7 / inter-eye asymmetry of CDR >0.2 / notching of the optic disc /retinal nerve fibre layer (RNFL) defects / intraocular pressure( IOP) >22 mmHg / central corneal thickness < 520 µm / advanced visual field defect stage Aulhorn III / elder than 70 years Exclusion Criteria: pregnancy, nursing diabetic retinopathy asthma HIV+ or AIDS history of epilepsy or significant psychiatric disease medications known to effect visual field sensitivity infections (e.g. keratitis, conjunctivitis, uveitis) severe dry eyes miotic drug amblyopia squint nystagmus albinism any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields,disc imaging or accurate IOP readings keratoconus intraocular surgery (except for uncomplicated cataract surgery) performed < 3 month prior to screening history or signs of any visual pathway affection other than glaucoma allergies with regard to topic glaucoma medication history or presence of macular disease and / or macular edema ocular trauma medications known to affect visual field sensitivity

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| open angle glaucoma, glaucoma suspects<br>risk of progression, Latanoprost monotherapy | Device: three different perimeters: HFA, Octopus, MATRIX<br>* visual fields<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glaucoma progression |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
visual field, perimetry, glaucoma progression, grid, POAG and glaucoma suspects with prostaglandin monotherapy
A Norwegian Observational Trial Evaluating the Treatment of Advanced Renal Cell Cancer Patients Under Treatment of Afinitor

Study Overview
=================
Brief Summary
-----------------
This is a Norwegian prospective registration, observational study of patients with advanced renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI) ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.

Official Title
-----------------
Observational Study Evaluating Efficacy, Tolerability and Treatment Algorithm of Advanced Renal Cell Cancer Patients Under Afinitor Treatment

Conditions
-----------------
Metastatic Renal Cell Carcinoma (mRCC)

Intervention / Treatment
-----------------
* Other: everolimis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Confirmed diagnosis of advanced renal cell cancer Progression on or after one VEGF -TKI (e.g. sunitibin, sorafenib) Written informed consent Exclusion Criteria: None Other protocol-defined inclusion/exclusion criteria may apply

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 |
| --- | --- |
| Afinitor<br>Afinitor | Other: everolimis<br> <br> * Other names: RAD001;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (TTP) |  | maximum of 12 months after inclusion of the last patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment algorithm | Follow up documentation | at end of study | 
| Quality of life (QoL)(EORTC-QLQ C30) | Follow up documentation | maximum of 12 months after inclusion of the last patient | 
| Tolerability | This will partly be assessed by registration of compliance (patient booklet), QoL and safety. Safety assessments will consist of monitoring and recording adverse events and serious adverse events. | maximum of 12 months after inclusion of the last patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mRCC,, observational,, Afinitor,, everolimus,, 2.line
Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Study Overview
=================
Brief Summary
-----------------
This single arm, post-authorisation study is designed to evaluate the long-term safety of pirfenidone in participants with IPF. The enrolment of participants will be completed within approximately 24 months. Participants will receive pirfenidone according to the physician discretion and will be followed for 2 years. Treating physicians will collect pre-specified data at the baseline and every 3 months thereafter, for the duration of the participants' participation in study.

Official Title
-----------------
Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: Pirfenidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical decision has been made, prior to study enrolment, to prescribe Esbriet Participants who are newly prescribed Esbriet therapy Initiation of Esbriet therapy is not more than 30 days prior to study enrolment Exclusion Criteria: Participants receiving an investigational agent defined as any drug that has not been approved for marketing for any indication in the country of the participating site Participant has received Esbriet therapy 30 days or more prior to current treatment course (e.g., prior participation in clinical trials) Participant has any contraindication for the use of Esbriet, according to the current local version of the Summary of Product Characteristics (SPC)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pirfenidone<br>Participants will receive pirfenidone orally according to the physician discretion. | Drug: Pirfenidone<br>* Pirfenidone will be administered according to the physician discretion as part of standard care.<br>* Other names: Esbriet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with clinically significant ADRs of special interest |  | up to 2 years | 
| Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reactions |  | up to 2 years |
Determination of Perioperative Acute Kidney Injury Incidence

Study Overview
=================
Brief Summary
-----------------
In the last few years, acute renal injury (AKI) definition has been significantly changed. In the light of the data obtained from multicenter international studies, acute renal injury was redefined according to RIFLE, AKIN and KDIGO criteria. The common criteria of all three criteria in acute renal failure is the increment of level of creatinine as 0.3 mg/dL or 50 % increment of respective basal value of serum creatinine. In the current study, older than 40 years patients with no specific gender, who will stay at least one night in hospital will be included and cardiovascular and urological surgery patients and patients with known renal insufficiency will be excluded. It was aimed to measure serum creatinine levels in all included patients at baseline and up to 24h after surgery and will be determined acute kidney injury incidence and risk factors according to new criteria.

Official Title
-----------------
Perioperative Acute Kidney Injury Incidence and Risk Factors in Non-cardiac Surgery

Conditions
-----------------
Intensive Care Unit Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 40 years no gender specified patients who will stay at least one night in hospital patient with normal renal function Exclusion Criteria: patient with renal dysfunction and cardiovascular, urological surgery patients

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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 |
| --- | --- |
| Control<br>- older than 40 years patients with no specific gender, who will stay at least one night in hospital will be included into our study. And cardiovascular, urological surgery patients and patients with known renal insufficiency will be excluded. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum creatinine levels at 24h after surgery | AKI incidence determination using 50 % or more than 0.3 mg/dL increment of creatinine levels | Serum creatinine levels will be measured at baseline and up to 24h after surgery | 
| Correlation with use of drugs before surgery and serum creatinine level at 24h after surgery |  | Use of drug before surgery and serum creatinine level at 24h after surgery will be correlated. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Kidney Injury, Surgery, Perioperative care