linjc16/ctgov huggingface dataset:
Role of Surgery in Treatment of Recurrent Brian Glioma:Prognostic Factors and Outcome

Study Overview
=================
Brief Summary
-----------------
role of surgery in treatment of recurrent brain glioma prognostic factors and outcome measures Role of surgery : In patients with Grade I gliomas, such as pilocytic astrocytomas, resection is potentially curative. For more diffuse invasive gliomas (Grade II or higher), initial management typically includes maximal safe resection when possible. Increasing evidence supports an association between extent of resection and prolonged progression-free and overall survival for patients with diffuse gliomas of all types and grades Many studies reported that more that 90%of patients with glioma showed recurrence at the orginal tumor location. Review the outcomes of re-operation in treatment of recurrent brain gliomas To determine the prognostic factors which can predict which patient would benefit from multiple surgery . Trail to Improve the outcome of these patients and decrease rate of complications

Official Title
-----------------
Role of Surgery in Treatment of Recurrent Brian Glioma:Prognostic Factors and Outcome

Conditions
-----------------
Recurrent Glioma, Glioma, Malignant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient previously operated and documented as a glioma with clinical and neuroimaging and pathological evidences. Patients who will undergo re-operation for treatment of a recurrent brain glioma at the time of study(one year) Histological types : Different histological types of glioma. Exclusion Criteria: patients has brain glioma that is de novo patients who are unfit for any neurosurgical interventions. Multicentric recurrent glioma.
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 |
| --- | --- | --- |
| karnofsky performance status | A standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. Karnofsky Performance Status may be used to determine a patient's prognosis, to measure changes in a patient's ability to function, or to decide if a patient could be included in a clinical trial. Also called KPS. | 1year |
L-arginine Effects on Chronic Hypertension in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of oral L-arginine administration on pregnant women at second trimester of gestation with chronic hypertension, respect with placebo.

Official Title
-----------------
Effects of Oral L-arginine on Chronic Hypertension in Pregnancy

Conditions
-----------------
Hypertension in Pregnancy

Intervention / Treatment
-----------------
* Drug: L-arginine
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women between 18-20 weeks of gestation with chronic hypertension Exclusion Criteria: Other maternal or fetal systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oral L-arginine 2 g twice a day, for 14 weeks | Drug: L-arginine<br>* Oral L-arginine 2 g twice a day for 14 weeks<br>|
| Placebo Comparator: 2<br>oral placebo twice a day for 14 weeks | Other: placebo<br>* oral placebo 2 g twice a day for 14 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate blood pressure changes during oral L-arginine or placebo administration in pregnant women with chronic hypertension at second trimester of gestation |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate if is necessary to add a conventional therapy for hypertension, to evaluate pregnancy outcomes and eventual complications, to evaluate safety of oral L-arginine administration |  | 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic hypertension in pregnancy
Benefit and Tolerability of a Probiotic Product in Infants With Abdominal Discomfort

Study Overview
=================
Brief Summary
-----------------
To demonstrate benefit and tolerability of a probiotic product in infants with abdominal discomfort.

Conditions
-----------------
Abdominal Discomfort

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics
* Dietary Supplement: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female singleton ≥ 2 weeks and ≤ 12 weeks of age Exclusively breastfed at screening Abdominal discomfort (infant colic) in the week prior to enrollment, according to the statement of the parent(s) and/or guardian(s) Episodes of fussy crying that lasted at least 3 hours a day for at least 3 days in the 7 days prior to enrollment, according to the statement of the parent(s) and/or guardian(s) Voluntary, written informed consent of the parent(s) and/or guardian(s) to participate in the study Born at full term (37-42 after last menstruation period) Birth weight: 2500 - 4500 g Weight-for-age ≥ 3th and ≤ 97th percentile according to WHO growth tables / charts Apparently healthy at birth (Apgar ≥ 8) and at screening visit No major complications during pregnancy or at birth Mother 19-45 years of age at childbirth Ability of parent(s) and/or guardian(s) to attend visits, interviews and willingness to fill out questionnaires Exclusion Criteria: Intolerance to investigational product/its ingredients Severe medical condition or illness, congenital abnormality Gastrointestinal disorders (e.g. reflux esophagitis) Intake of probiotics and/or antibiotics in the week preceding recruitment and during the study Formula feeding at screening/randomisation Allergy or atopic disease (family history) Participation in another study Mother's health condition that may interfere with her ability to take care of her infant Mother affected by hepatitis B, HIV or Guillain-Barré Syndrome Use of antibiotics by the mother in the week

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 12 Weeks

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotics<br> | Dietary Supplement: Probiotics<br> <br> |
| Placebo Comparator: Control<br> | Dietary Supplement: Control<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of abdominal discomfort as assessed by comparison of crying time |  | 28 days |
Effect of Probiotic Formula DE111® on Immune System in Preschool Children

Study Overview
=================
Brief Summary
-----------------
Healthy preschool children will be recruited, gastrointestinal infection and respiratory infection symptoms will be followed during the 8-week treatment and 4-week follow-up period, to evaluate the effect of the used probiotic formula on immune system in comparison to the group using placebo.

Official Title
-----------------
A Randomized, Parallel, Double Blind, Placebo Controlled Clinical Study Evaluating the Effect of Probiotic Formula on Immune System in Preschool Children

Conditions
-----------------
Immune System Support

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic Formula Bacillus subtilis DE111®
* Dietary Supplement: Placebo comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent by at least one parent or legal guardian children aged 2 to 6 years attending or about to start attending day-care Exclusion Criteria: body weight at birth <2500g gestational age <37 weeks severe chronic illness regular use of medication immunodeficiency parent or legal guardian not able to understand and comply with requirements of the study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Probiotic DE111® | Dietary Supplement: Probiotic Formula Bacillus subtilis DE111®<br>* Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks<br>|
| Placebo Comparator: Control group<br>Placebo | Dietary Supplement: Placebo comparator<br>* Placebo comparator, once a day for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group | Number of participants with at least one occurrence of gastrointestinal and/or respiratory infections during 12-week study period in the experimental group compared to control group. | 12-week study period (consisting of 8-week treatment plus 4-week follow-up) | 
| The incidence of adverse events occuring in the experimental group compared to control group | Number of participants with treatment related adverse events during 12-week study period for both, experimental and control group. | 12-week study period (consisting of 8-week treatment plus 4-week follow-up) |
Application of Ectoin Allergy Nasal Spray in Comparison to Beclomethasone Nasal Spray

Study Overview
=================
Brief Summary
-----------------
This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin® Allergy Nasal Spray. In addition the effectiveness and safety shall be compared to a Beclomethasone nasal spray. The patient applies Ectoin® Rhinitis Nasal Spray or Beclomethasone nasal spray according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.

Official Title
-----------------
Non Interventional Study of Ectoin Allergy Nasal Spray Compared to Beclomethasone Nasal Spray

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Other: Medical Device, drug-like
* Drug: Beclomethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed allergic rhinitis during the observational period Exclusion Criteria: Contra indications according to the label

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Ectoin Group<br>Ectoin Allergy Nasal Spray (Medical Device, drug-like) | Other: Medical Device, drug-like<br>* Ectoin Allergy Nasal Spray<br>|
| Beclomethasone Group<br>Beclomethasone nasal spray | Drug: Beclomethasone<br>* Beclomethasone nasal spray<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Nasal Symptom Score |  | Time Frame: day 1, day 7, day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in palatal itching score |  | Day 1, 7 and 14 | 
| Efficacy and tolerability assessment by the patients and by the investigator |  | day 7 and 14 | 
| Change in quality of life assessed by Rhinitis Quality of Life Questionnaire |  | Day1 and Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic Rhinitis, Ectoine, bitop, Ectoin
Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)

Study Overview
=================
Brief Summary
-----------------
Vaccines against the coronavirus type 2 causing severe acute respiratory syndrome Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have been created in a short period of time due to the rapid spread of the virus. These vaccines use different and sometimes innovative technologies, such as the use of ribonucleic acid (RNA), or a non-replicating viral vector. Efficacy ranging from 70-90% in the first weeks after the second injection of these vaccines has been reported, with side effects whose causality remains to be determined.

Detailed Description
-----------------
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Official Title
-----------------
Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)

Conditions
-----------------
SARS-CoV-2, COVID-19, Vaccines, Antibody

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must live in the Principality of Monaco Deliver a written consent to participate to the study And/Or Have been infected with SARS-CoV-2 And/Or Have been, or are about to be, vaccinated against SARS-CoV-2 Exclusion Criteria: - None of the above
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 |
| --- | --- | --- |
| Covid-19 Neutralizing Antibodies Measurment | Inform any individual who has been infected with or vaccinated against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have about their level of immune protection, through a bi-annual follow-up | 24-month period |
Body Movements Analysis During Sleep in Very Premature Infants

Study Overview
=================
Brief Summary
-----------------
Sleep is a key factor for normal brain development of the newborn. However, it is poorly studied and little is known about its characterization, especially in premature infants. Body movements during sleep are easy to evaluate but studies on their relationship to normal sleep states are scarce and limited. This project aims to characterize body movements during sleep, assessed by electroencephalography, in very premature infants. Then, a correlation between body movements, sleep organization and neurodevelopmental outcome will be evaluated at 3 years of age.

Official Title
-----------------
Characterization of Movements Occurring During Sleep in Very Premature Neonates: Relationship With Neurodevelopmental Outcome

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Diagnostic Test: electroencephalography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born between 26 and 32 weeks gestation Exclusion Criteria: Genetic abnormality Neurological pathology such as intraventricular hemorrhage > grade 2 Any medication know for altering electroencephalography recording

Ages Eligible for Study
-----------------
Minimum Age: 10 Days
Maximum Age: 15 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: very premature infants<br>Electroencephalography allowing sleep observation | Diagnostic Test: electroencephalography<br>* Sleep states definition by electroencephalograpy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body movements evaluation during sleep | number of movements observed according to sleep states | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep states organization | sleep states characterization by electroencephalography according to postmenstrual age | 3 months | 
| Type of movements observed during sleep | Movements characterization according to sleep states | 3 months | 
| Neurodevelopmental outcome | neuropsychomotor evaluation by Bayley psychometric test | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature infant, sleep state, body movement, neurodevelopmental outcome
Predictors for Retreatement of OAB After DC Mirabegron

Study Overview
=================
Brief Summary
-----------------
Recurrence of female overactive bladder syndrome (OAB) is not uncommon. It is important to decrease the recurrence of female OAB. However, factors predicting recurrence of female OAB, especially for those women who need retreatment is undetermined. Thus, the aim of this study was to elucidate factors predicting retreatment of female OAB.

Detailed Description
-----------------
The medical records, including pad testing, urodynamic studies, lower urinary tract symptoms related questionnaires and bladder diaries of all consecutive women with OAB, who visited urogynecologic clinics in a tertiary referral center, were reviewed. Persistence interval was defined from the date of prescription of mirabegron to the date of discontinuation of mirabegron treatment. Statistical analysis was performed with Kaplan-Meier estimator. Multivariable Cox proportional-hazard model with all variables with p < 0.25 in the univariate analysis was performed to predict OAB retreatment probability.

Official Title
-----------------
Predictor for Re-treatment of Overactive Bladder Syndrome After Discontinuation of Mirabegron Treatment for Female Overactive Bladder Syndrome

Conditions
-----------------
Recurrence of Overactive Bladder Syndrome

Intervention / Treatment
-----------------
* Drug: Mirabegron 25mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with overactive bladder syndrome Women complete urodynamic study and bladder diary Exclusion Criteria: Pregnant women Incomplete data Loss of follow-up Acute or chronic urinary tract infection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 received Mirabegron<br>Women with overactive bladder syndrome received Mirabegron | Drug: Mirabegron 25mg<br>* Mirabegron 25 mg per day<br>* Other names: Betmiga;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent OAB | Recurrent OAB with needs to retreatment | January 2015 to July 2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overactive bladder syndrome, beta-3 agonist, retreatment
Pharmacokinetics of Progesterone in Pregnancy-2

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.

Detailed Description
-----------------
The objective of this pilot study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.

Official Title
-----------------
Pharmacokinetics of Progesterone in Pregnancy-2

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Drug: micronized Progesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18yo Singleton gestation, ≥36 0/7 weeks gestation Scheduled cesarean delivery at Thomas Jefferson University Hospital or affiliate Exclusion Criteria: Contraindication to vaginal progesterone suppository Active hepatic disease Prior or current thrombus Known adverse reaction to progesterone Peanut allergy Bleeding disorder (such as thrombophilia) Use of 17-hydroxyprogesterone caproate in the pregnancy Use of vaginal progesterone in the pregnancy History of adverse reaction to progesterone Current vaginitis

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vaginal progesterone<br>200mg micronized vaginal progesterone placed 7am prior to scheduled cesarean delivery | Drug: micronized Progesterone<br>* 200mg micronized progesterone placed vaginally<br>|
| No Intervention: Control<br>No intervention, scheduled cesarean delivery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial (ng/mg) progesterone time/concentration profile | Concentration of progesterone in endometrium, sampled at time of scheduled c-section | 12 hours | 
| Plasma (ng/ml) progesterone time/concentration profile | concentration of serum progesterone, sampled at time of scheduled c-section | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effect survey | survey of side effects | 24hr after delivery |