linjc16/ctgov huggingface dataset:
Patients Reactions Towards Their Diagnosis as Having COVID-19

Study Overview
=================
Brief Summary
-----------------
Patients reactions towards their diagnosis as having COVID-19. The effect of patients' reaction toward their prospect management. How this can make many hazards. Also, obstacle and barrier to better management.

Detailed Description
-----------------
Patients reactions towards their diagnosis as having COVID-19. The effect of patients' reaction toward their prospect management. How this can make many hazards. Also, obstacle and barrier to better management. Different factors affecting the response of people toward their diagnosis as COVID-19

Official Title
-----------------
Patients Reactions Towards Their Diagnosis as Having COVID-19: A Cohort Study

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 Age 18 years of less Exclusion Criteria: Mental diseases making the communication with them difficult

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19<br>Highly educated people Low educated people | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery | Time needed to recovery from symptoms of covid-19 | Four weeks |
Treatment of Overweight Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
The intervention program Obeldicks light is developed for overweight children aged 8-16 years. This intervention is gender - and age specific. The 6-month intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. 300 participants in a randomised controlled group design will be evaluated at 4 time points: baseline, end of intervention, 6 months after end of intervention and 12 months after end of intervention.Primary outcome measure is change of weight status as standard deviation score of BMI. Drop-outs will be interviewed to improve the intervention.

Official Title
-----------------
Evaluation of the Intervention Program Obeldicks Light for Overweight Children and Adolescents

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Behavioral: behavioral intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: overweight children Exclusion Criteria: primary disease

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention arm<br>Lifestyle Intervention based on Nutrition Treatment, exercise Treatment and behavorial treatment | Behavioral: behavioral intervention<br> <br> |
| No Intervention: waiting list<br>waiting 6 months for Intervention without any intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of weight status |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of eating and exercise behaviour |  | 6 months | 
| change of quality of life |  | 6 months |
Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

Study Overview
=================
Brief Summary
-----------------
Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora

Official Title
-----------------
Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

Conditions
-----------------
Bacterial Conjunctivitis

Intervention / Treatment
-----------------
* Drug: VIGAMOX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients from 1 to 13 years of age that have diagnosis of bacterial conjunctivitis in either or both eyes (for < 3 days duration) based on clinical observation; matched healthy controls Exclusion Criteria: Cannot have had bacterial conjunctivitis symptoms as reported by parent for > 2 days

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 13 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infected Patient treated with Vigamox<br>Conjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days. | Drug: VIGAMOX<br>* 1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days<br>|
| No Intervention: Healthy Subjects<br>Healthy Subjects receiving no treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation | Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI). 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic | Day 0 and Day 42 | 
| Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation | Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI). 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic | Day 0, Day 42 | 
| Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation | Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI). 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic | Day 0, Day 42 |
A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the long-term safety, tolerability and pharmacokinetics of givosiran (ALN-AS1) in AIP patients

Official Title
-----------------
A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety and Clinical Activity of Subcutaneously Administered ALN-AS1 in Patients With Acute Intermittent Porphyria Who Have Completed a Previous Clinical Study With ALN-AS1

Conditions
-----------------
Acute Intermittent Porphyria

Intervention / Treatment
-----------------
* Drug: givosiran (ALN-AS1)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed participation in Part C of study ALN-AS1-001 Not on a scheduled regimen of hemin Women of child bearing potential must have a negative serum pregnancy test, not be nursing, and use acceptable contraception Willing and able to comply with the study requirements and to provide written informed consent Exclusion Criteria: Clinically significant abnormal laboratory results Received an investigational agent (other than ALN-AS1) within 90 days before the first dose of study drug or are in follow-up of another clinical study History of multiple drug allergies or intolerance to subcutaneous injection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: givosiran (ALN-AS1)<br> | Drug: givosiran (ALN-AS1)<br>* givosiran by subcutaneous (SC) injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of givosiran evaluated by the proportion of patients experiencing adverse events |  | Through Month 49 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacodynamic (PD) effect of givosiran on urine levels of delta-aminolevulinic acid (ALA) |  | Through Month 49 | 
| The pharmacodynamic (PD) effect of givosiran on urine levels of Porphobilinogen (PBG) |  | Through Month 49 | 
| The frequency of porphyria attacks as measured by number of attacks |  | Through Month 49 | 
| Frequency of hematin administrations |  | Through Month 49 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RNAi therapeutic, Porphyria, AIP, Heme/Haem Arginate
Sleep Disorders in Pediatric Dialysis

Study Overview
=================
Brief Summary
-----------------
Sleep disorders (SD) are common in adults with Chronic Kidney Disease (CKD) on dialysis with a reported prevalence of 60-80%. To date three studies have reported on SDs in children with CKD but these have all been based on questionnaire data alone. The findings were not confirmed with polysomnograms (PSG), the gold standard to diagnose SD, or actigraphy, a validated tool to assess the sleep/ wake cycle over a prolonged period in the home. This is highly relevant given the poor sensitivity and specificity of even validated questionnaires alone. The effect of untreated pediatric SD is pervasive. This study will provide the first objective assessment of SDs using PSGs in children with severe CKD, both on and off dialysis. Therefore, we will recognize and when possible treat SD in this severe CKD cohort potentially contributing to their immediate management (eg improved control of hypertension, improved school performance), while improving their Quality of Life (QOL) and helping ensure they achieve their full potential.

Official Title
-----------------
Sleep Disorders in Pediatric Dialysis

Conditions
-----------------
Chronic Kidney Disease (CKD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0 to 18 years Caregivers must be able to read English Patients with either Stage 4 Chronic Kidney Disease (CKD) with an estimated GFR of 15-30 ml/min/1.73m2 based on IDMS Schwartz GFR OR patients with CKD receiving outpatient hemodialysis (HD) or peritoneal dialysis (PD) for a minimum of 1 month Informed consent Exclusion Criteria: Caregivers cannot read English Informed consent not given

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum 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 |
| --- | --- |
| Pre-Dialysis<br> | |
| Dialysis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Sleep Disorders | Report the prevalence of sleep disorders in a cohort of severe Chronic Kidney Disorder children both on and off dialysis based on PSG, actigraphy, and questionnaire. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | The Pediatric Quality of Life Inventory (Peds QL) generic core (version 4.0) scale is a 23-item multidimensional instrument for measuring pediatric HRQL. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease (CKD), Pediatrics, Sleep Disorders
The Relationship Between CD138 Count of Endometrium and Reproductive Outcome

Study Overview
=================
Brief Summary
-----------------
It's well known, endometritis affects reproductive outcomes. Though CD138 counting as one new diagnosis measure for endometritis, diagnostic criterion of this measure isn't consistent. And if the CD138 counting is correlation to the outcome of reproductive is not clear. Firstly, This study aims to explore the relationship between endometrial CD138 count and pregnancy outcome following frozen embryo transfer in natural cycles. Secondly , the investigators want to find a cut-off value which is related to reproduction outcome.

Official Title
-----------------
To Explore the Relationship Between Endometrial CD138 Count and Pregnancy Outcome Following Frozen Embryo Transfer in Natural Cycles

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

Intervention / Treatment
-----------------
* Procedure: Endometrial biopsies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between20 and 38 years; regular menstrual cycles; body mass index (BMI) ranged from 18 to 25 Exclusion Criteria: uterine abnormalities; intrauterine adhesions（moderate - severe）, advanced endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids >4.0 cm and/or endometrial pressure)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 38 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endometrial biopsies<br>Endometrial biopsy was performed precisely 7 days after LH surge (LH+7) to count endometrial CD138. | Procedure: Endometrial biopsies<br>* Endometrial biopsy was performed precisely 7 days after LH surge (LH+7)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD138 counting |  | 7 days after LH surge (LH+7) | 
| clinical pregnancy rate |  | about 28 days after embryo transfer |
Expanded Access Use of INCB054329 to Treat a Single Patient With Metastatic Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Expanded access use of INCB054329 to treat a single patient with metastatic renal cell carcinoma.

Intervention / Treatment
-----------------
* Drug: INCB054329


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: INCB054329|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effectiveness of Double Incision Technique in Uterus Preserving Surgery for Placenta Percreta

Study Overview
=================
Brief Summary
-----------------
Placenta percreta is a life-threatening condition that patients are under risk of massive bleeding. It readily necessitates very complicated surgery even leads to mortality. Cesarean hysterectomy is the procedure that is acknowledged worldwide, however, recent studies discussing conservative treatment with segmental resections were published. Fetal extraction and segmental resection could be performed from same (single uterine incision) or two different (double uterine incision) incisions. In this study, the investigators aimed to evaluate the effectiveness and the results of double uterine incision.

Conditions
-----------------
Placenta Percreta

Intervention / Treatment
-----------------
* Procedure: Double uterine incision technique in uterus preserving surgery for placenta percreta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intraoperatively and pathologically confirmed diagnosis of placenta percreta Exclusion Criteria: -

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Double uterine incision technique in uterus preserving surgery for placenta percreta|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success of segmental resection (Uterus preserving surgery) | No need for hysterectomy due to massive hemorrhage or any other reason in postoperative one month | Postoperative one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
efficacy, double incision technique, uterus preserving surgery
ED Decision Making Among Hypotensive Patients

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to assess decision making skills of emergency physicians when dealing with hypotensive patients. The hypothesis is that decisions made based on physical exam and vital signs regarding fluid resuscitation by emergency physicians are not statistically equivalent to those that would be made based on the use of a non-invasive CVP measurement

Detailed Description
-----------------
If physicians can make appropriate decisions about the need for fluid resuscitation without CVP measurement, then this skill is worth being passed to physicians in training. Previously it was not possible gather enough information about the response of patients' because of the risk of using indwelling CVP sensors. But now because there is a low risk tool (Venus 1000 System), this study is now practical and safe.

Official Title
-----------------
ED Decision Making Among Hypotensive Patients

Conditions
-----------------
Hypotension

Intervention / Treatment
-----------------
* Device: Mespere Venus 1000 CVP System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients >=18 years of age who enter the Emergency Department at Hahnemann Hospital with Systolic Blood pressure < 100 mm Hg Exclusion Criteria: Those patients who are suffering from traumatic injury requiring Level I or Level II trauma evaluations. Example conditions include penetrating injuries to head, torso and proximal extremities. Additional exclusion criteria include the presence of an internal jugular or a subclavian central venous line or both external jugular veins being cannulated (attempted or successful) with peripheral IVs. Pregnant females will be excluded. Subjects under the age of 18 years will be excluded

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 |
| --- | --- |
| Patients brought to Hahnemann Hospital ED<br> | Device: Mespere Venus 1000 CVP System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correspondence of resuscitation decision and CVP value | The non-invasive CVP will be measured at the time of initial ordering decision by the ED physician. Afterwards, its relationship to the decision about whether to start intravenous fluid resuscitation will be analyzed. | At patient admission to ED | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systolic Blood pressure < 100 mm Hg
Echocardiography in Kids Intensive Care Decision Support

Study Overview
=================
Brief Summary
-----------------
A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU.

Detailed Description
-----------------
A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU. These parameters will be measured pre and post fluid bolus in children prescribed fluid bolus therapy for clinical indications on the PICU. Children will be classified as responders (>10% increase in cardiac output) and non responders (<10% increase). Appropriate statistical tests will be performed to determine the most useful predictor of an increase in cardiac output following a fluid bolus.

Official Title
-----------------
Echocardiography in Kids Intensive Care Decision Support - is Focused Echocardiography Superior to Pressure Derived Measurements at Predicting Fluid Responsiveness in Critically Ill Children?

Conditions
-----------------
Fluid Responsiveness, Cardiac Output

Intervention / Treatment
-----------------
* Other: Ultrasound cardiac output measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any ventilated child requiring fluid bolus therapy on the PICU for clinical indications Exclusion Criteria: Arrythmia Intracardiac shunt

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- |
| Children requiring fluid bolus on PICU<br> | Other: Ultrasound cardiac output measurement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid responsiveness | 10% increase in cardiac output following fluid bolus | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shock, Fluid bolus, Cardiac output, Children in intensive care