linjc16/ctgov huggingface dataset:
Evaluation of the Evolution of Pregnancies in the First Trimester Following MAR Management During a COVD-19 Pandemic Period

Study Overview
=================
Brief Summary
-----------------
Because of the physiological changes inherent in pregnancy, pregnant women with lower respiratory tract infections often have more worrisome outcomes compared to non-pregnant individuals, including a higher rate of hospital and intensive care unit admissions.

Official Title
-----------------
Evaluation of the Evolution of Pregnancies in the First Trimester Following a Medically Assisted Procreation (MAR) Management During a COVD-19 Pandemic Period

Conditions
-----------------
Covid-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient included in a Medically Assisted Procreation (MAR) protocol aged between 18 and 43 years of age Patient who has already signed a consent to management Exclusion Criteria: Patient who expressed opposition to participating in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of the evolution of pregnancies in the first trimester following MAR management during a COVD-19 pandemic period |  | 12th week of Amenorrhea | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU, COVID-19, SARS-CoV-2, ARDS, Pregnant women, Pregnancy, Fetus, Middle East Respiratory Syndrome, MERS, Maternal respiratory impairment, Medical Assisted Procreation, MAR, Frozen embryos
Physical Activity in Patients After Aortic Valve Replacement (Valve-ex)

Study Overview
=================
Brief Summary
-----------------
A structured and supervised, 3-month physical activity intervention in patients after aortic valve replacement due to severe stenosis, accompanied by examination of cardiac size and function, exercise capacity and endothelial function before, three and six months after operation; comparison with a non-intervention control group.

Official Title
-----------------
Influence of Regular Physical Activity on Exercise Capacity, Cardiac Remodeling and Endothelial Function in Patients After Aortic Valve Replacement

Conditions
-----------------
Valvular Aortic Stenosis

Intervention / Treatment
-----------------
* Other: Physical activity
* Other: no Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with severe valvular aortic stenosis and indication for valve replacement Exclusion Criteria: Coronary heart disease with indication for additional bypass surgery Leading insufficiency of the valve Age < 65 or > 75 Diseases or conditions leading to additional risks during physical activity (e.g. diabetes, arthrosis, obstructive pulmonary disease)

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Training group | Other: Physical activity<br> <br> |
| Other: B<br>Controls | Other: no Intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum oxygen uptake |  |  |
Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of zoledronic acid in patients presenting with spontaneous osteonecrosis of the knee.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Proof of Concept Study of Zoledronic Acid in Spontaneous Osteonecrosis of the Knee (SONK)

Conditions
-----------------
Osteonecrosis

Intervention / Treatment
-----------------
* Drug: Zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 40-85 years of age Diagnosis of painful osteonecrosis of the knee within the last month. Exclusion Criteria: Intravenous (iv) bisphosphonates within the last 2 years. Abnormal thyroid, kidney or liver function. Abnormal blood calcium or alkaline phosphatase levels. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

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

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 |
| --- | --- |
| Other: 1<br> | Drug: Zoledronic acid<br> <br> * Other names: Reclast, Aclasta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline after 3 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline after 6 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI. |  | 6 months | 
| Safety as assessed by adverse events. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteonecrosis, zoledronic acid, knee
The Effect of Different Food Products on Post Prandial Blood Glucose in Pregnant Woman With Diabetes

Study Overview
=================
Brief Summary
-----------------
During pregnancy nutrition demands change and the pregnant woman needs to adjust her food intake and take into consideration the corrected daily recommendations for micro and macro nutrients. Pregnant woman tend to suffer from hyperemesis and this affects their food choice. Amongst pregnant women with Diabetes the glucose balance is extremely important during pregnancy. Glucose balance is a result of correct nutrition and an exact amount of insulin. This delicate balance requires from the pregnant women an ability to perform correct carbohydrate count. Hyperglycemia has already been proven to affect the fetus and the neonatal outcomes. Hypoglycemia may also have a negative effect but the main danger is immediate harm to the mother and therefore to the fetus. For those reasons glucose balance is crucial and demands delicate synchronization of nutrition and insulin therapy.

Conditions
-----------------
Type 1 Diabetes, Type 2 Diabetes, Gestational Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-45 women who suffer from type 1 diabetes, type 2 diabetes or gestational diabetes Do not suffer from any intestinal disease Accept to sign a consent form Exclusion Criteria: over age of 45 under age of 18 suffer from any intestinal disease do not accept to sign a consent form

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1 and Type 2 Diabetes<br>pregnant women which have a known condition of type 1 or type 2 diabetes | |
| Gestational diabetes<br>pregnant women which have developed Gestational diabetes | |
| Control group<br>Pregnant women whom do not suffer from any altered glucose metabolism | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post prandial blood glucose levels | For every time point blood glucose will be analyzed for blood glucose and for Insulin and C-peptide for the control group | The outcome will be measured at various time points during a 120 min OGTT: Fasting, 30, 60, 90 and 120 min |
Comparison of Different Objective Nociceptive Measurement Methods During Surgery

Study Overview
=================
Brief Summary
-----------------
Traditionally, hemodynamic response e.g. pulse and blood pressure are used to evaluate pain in humans who are anesthetized. These values, however, can be affected by factors other than pain response . In this observational study, different types of digital methods are used that can distinguish signs of pain. However, the study aim to collect data and correlate in between different methods to ensure its reliability.

Detailed Description
-----------------
In humans who undergoing anesthesia or only receiving sedation with the addition of painkillers medication under surgery. Nociceptive response usually treats on the basis of hemodynamic and/or respiratory changes. These are interpreted together with a number of other parameters. The anesthetist can't be totally sure if it is nociceptive response or to light anesthesia given. Today, there are new monitors included techniques for measuring pain (nociception), but these are not used routinely. By put sensors (adhesive patches) on the skin and connect to these new devices perhaps the anesthetist can be more sure what stimuli patient are responding from, pain or light anesthesia. These techniques measure muscle activity including sweat gland which have been shown in other research studies demonstrate a higher accuracy regarding the response to nociception. The parameters are presented on a monitor as a value, 0-10 or 0-100. This research study is an observational study and intends to observe values / figures that arise from two different types of commercial monitors and manufactures. After the anesthesia, these values will be compared and evaluated in resect as well to hemodynamic response and in between monitors. The two techniques have never before been studied simultaneously on the same human been (control).

Official Title
-----------------
Comparison of Different Objective Nociceptive Measurement Methods During General Anesthesia or Sedation Under Surgery

Conditions
-----------------
Nociceptive Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients over 18 yrs old, Patients who will be anesthetized or sedated under intervention surgery or surgery Exclusion Criteria: Not speaking Swedish Neuro cognitive diorders e.g. dementia or can't respond on information given. Chronic pain Acute brain trauma Pregnancy

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 |
| --- | --- | --- |
| An index will be observed 0-100 and hemodynamic response, heart rate and blood pressure. | Data collect only numbers. These are going to be correlated. | numbers will be collected every minute during the surgery often 1 hour |
Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis.

Study Overview
=================
Brief Summary
-----------------
Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF children are rare and the impact of most frequent viruses such as human rhinoviruses is usually not correctly evaluated. The aim of this study is to assess the frequency of lower and upper RVI during a 1 year follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and therapeutic level. Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the short term and without any particular link with a specific virus as previously described.

Official Title
-----------------
Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.

Conditions
-----------------
Cystic Fibrosis, Respiratory Viral Infection

Intervention / Treatment
-----------------
* Other: Physical assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - infant <24 months with cystic fibrosis Exclusion Criteria: - patient >24 months

Ages Eligible for Study
-----------------
Maximum Age: 24 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cystic fibrosis infants<br>1 year follow-up in CF infants | Other: Physical assessment<br>* 1 year follow-up in CF infants with clinical, microbiological and therapeutic assessments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Respiratory Viral Infection |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of respiratory viruses in throat-swabs | A panel of 10 viruses will be tested using polymerase chain reaction (PCR) and RT-PCR technology. | up to 12 months | 
| Number of antibiotics treatments (oral or IV) |  | up to 12 months | 
| Number of bronchodilator administrations |  | up to 12 months | 
| Number of corticosteroids administrations |  | up to 12 months | 
| Number of hospitalization or hospital admission due to upper or lower RVI |  | up to 12 months | 
| Identification of bacterial flora in throat-swabs |  | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cystic fibrosis, viruses, respiratory viral infection, children
Switching From Tobramycin Inhalation Treatment to Tobramycin Inhaler Treatment: The Effect on CF Patients' Adherence and Quality of Life

Study Overview
=================
Brief Summary
-----------------
Pseudomonas is a common and virulent respiratory bacteria in patients with Cystic Fibrosis (CF). With time, the infection with Pseudomonas becomes chronic and very difficult to eradicate. The standard treatment of chronic Pseudomonas infection is inhaled Tobramycin which is given every other month.. Inhalation of Tobramycin was proven as an effective treatment that improves the respiratory function and reduces the concentration of bacteria in the sputum. However, inhaled treatment lasts between 15 to 30 minutes twice a day and therefore adherence is a major problem. The effect of switching from inhalation treatment to inhaler treatment on patient's adherence and quality of life has not been studied.

Conditions
-----------------
Alteration in Quality of Life of CF Patients, Following Change of Treatment From Antibiotic Inhalation to Antibiotic Inhaler

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6 years and above, Chronic Pseudomonas infection Exclusion Criteria: Younger than 6 years; No chronic PSeudomonas infection

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| CF patients with chronic pseudomonas infection<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in quality of life |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in exacerbation events | To be measured by: Worsening of CF symptoms such as coughing, sputum, deterioration in FEV1, all of which require hospitalization | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic Fibrosis, Chronic Pseudomonas Infection, Inhaled Tobramycin
Plasma Betatrophin Levels in Non-alcoholic Fatty Liver Disease

Study Overview
=================
Brief Summary
-----------------
The study searched for answers to two questions: 1-What are the plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls. 2. Is there any relationship between plasma betatropin levels and different stage of non-alcoholic fatty liver disease 2.Is there any relationship between plasma betatropin levels and metabolic parameters in subjects with non-alcoholic fatty liver disease.

Official Title
-----------------
The Cross Sectional Study to Investigate the Plasma Betatrophin Levels in Non-alcoholic Fatty Liver Disease and Healthy Controls

Conditions
-----------------
Non-alcoholic Fatty Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with biopsy proven non-alcoholic fatty liver disease Exclusion Criteria: Taking any drugs >20 gr/day alcohol consumption chronic metabolic diseases morbid obesity

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-alcoholic Fatty Liver Disese<br>no treatment | |
| healthy controls<br>no treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-alcoholic Fatty Liver Disease, Betatrophin
Quality Of Life While Receiving Faslodex

Study Overview
=================
Brief Summary
-----------------
To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.

Official Title
-----------------
Quality Of Life And Symptoms In Postmenopausal Women With Hormone Receptor Positive Disseminated Breast Cancer While Receiving Faslodex.

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic and/or cytological proven breast cancer. Patients with metastases of breast cancer ± postmenopausal primary tumor ≥12 months. Positive oestrogen receptors (ER+), positive progesterone receptors (PgR+) or unknown hormonal receptors (if duration between surgery and metastasis occurring is not less 2 years) which are indirect confirmation of hormone sensitive tumor. ECOG performance status of ≤ 2 Patient willingness to take part in the programm Life expectancy of more than 6 months. Patient ability to complete a questionnaire. Exclusion Criteria: Contraindications for Faslodex therapy Other anticancer therapy (chemotherapy, hormonal therapy with other drugs, radiotherapy), except for radiotherapy of sites which are not only measurable or evaluable manifestation of disease.

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 |
| --- | --- | --- |
| To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QUALITY OF LIFE, POSTMENOPAUSAL WOMEN, HORMONE RECEPTOR POSITIVE DISSEMINATED BREAST CANCER, FASLODEX
A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa
* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >=18 years of age; chronic kidney disease; anemia; not on dialysis therapy; not receiving epoetin. Exclusion Criteria: women who are pregnant, breastfeeding or using unreliable birth control methods; administration of another investigational drug within 4 weeks before screening, or during the study period.

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> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* 0.6 micrograms/kg sc (starting dose) once every 2 weeks<br>|
| Active Comparator: 2<br> | Drug: darbepoetin alfa<br>* 0.45 micrograms/kg sc (starting dose) weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin response rate |  | Weeks 1-28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n |  | Throughout study |