linjc16/ctgov huggingface dataset:
Impact of the Development of Pediatric Palliative Care

Study Overview
=================
Brief Summary
-----------------
Despite medical advances, cancer remains the leading cause of death by disease in children. Brain tumors are the second most common cause of cancer in children after leukemia, representing 25% of pediatric cancers. The overall survival rate is about 50% with extremes ranging from less than 5% to more than 90% depending on the histological type of brain tumor. The end of life of children with a brain tumor is marked by the possibility of discomfort symptoms, painful or not, and by a progressive neurological deterioration, which makes the management of these children complex for both families and health professionals. Over the last decade, the concept of palliative care has been increasingly integrated into pediatric onco-hematology services with the primary objective of better symptom control in a global approach to the child and his or her family in order to aim at a better quality of life.

Detailed Description
-----------------
The main objective of the study is to compare the occurrence and management of end-of-life symptoms in children who died of a primary brain tumor over 2 periods, in 2009 - 2010 and in 2019 - 2020, followed in the Pediatric Oncology departments of Strasbourg, Besançon, Dijon, Nancy and Reims.

Official Title
-----------------
Assessment of the Presence of Symptoms of End-of-life Discomfort and Their Management in Children With a Primary Brain Tumor in the Grand Est Region. Impact of the Development of Pediatric Palliative Care

Conditions
-----------------
Primary Brain Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient less than 17 years of age Suffering from a primary brain tumor Died during the period 2009-2010 or during the period 2019-2020 Follow-up in one of the Pediatric Oncology departments participating in the study (Strasbourg, Besançon, Dijon, Nancy and Reims) Absence of refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes. Exclusion criteria: Refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes Patient with a brain tumor secondary to another cancer

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 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 |
| --- | --- | --- |
| Presence of symptoms of physical or psychological discomfort in the last 4 months of life |  | up to the last 4 months of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Brain Tumor, Pediatric Palliative Care
Comparison of Physical Fitness, Walking Speed, Reaction Time In Older Adults With and Without Mild Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare physical fitness, walking speed and hand reaction time measurements in older adults with different cognition levels according to the Montreal Cognitive Assessment Scale (MOCA).

Official Title
-----------------
Comparison of Physical Fitness, Walking Speed, Reaction Time In Older Adults With and Without Mild Cognitive Impairment

Conditions
-----------------
Reaction Time, Physical Fitness

Intervention / Treatment
-----------------
* Other: reaction time test
* Other: Physical fitness test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being 65 years or older Volunteering to participate in the study 10 meters independent walking Being diagnosed with mild cognitive dysfunction Not being diagnosed with cognitive dysfunction Having received five years of basic education Exclusion Criteria: Having had an upper or lower extremity surgery in the last 6 months Having a health problem that prevents completing the tests in the study

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group (mild cognitive impairment)<br>geriatric population with mild cognitive impairment | Other: reaction time test<br>* Reaction time tests consist of 3 sub-parameters as simple reaction time, selective reaction time and distinctive reaction time. Participants will do these tests on the computer.<br>Other: Physical fitness test<br>* The physical fitness test will be evaluated with the senior fitness test used for geriatrics and the 8 meter walking speed test.<br>|
| Control Group (healthy elderly)<br>healthy older adults without cognitive impairment | Other: reaction time test<br>* Reaction time tests consist of 3 sub-parameters as simple reaction time, selective reaction time and distinctive reaction time. Participants will do these tests on the computer.<br>Other: Physical fitness test<br>* The physical fitness test will be evaluated with the senior fitness test used for geriatrics and the 8 meter walking speed test.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reaction time | reaction time | Participants are expected to complete the 3 sub-parameters of reaction time measurements in an average of 20 minutes, including rest periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical fitness | physical capacity of the person | Physical fitness tests are expected to take an average of 20 minutes. |
A Study of the Pharmacokinetics of Black Cohosh

Study Overview
=================
Brief Summary
-----------------
Black cohosh is a natural supplement that has been used to treat and prevent menopausal symptoms. Remifemin is a standardized form of black cohosh. The purpose of this study is to determine the levels of components of black cohosh obtained in the blood of healthy women taking Remifemin.

Detailed Description
-----------------
As per Brief Summary

Official Title
-----------------
Interactions Between SERMs, Soy and Black Cohosh

Conditions
-----------------
Hot Flashes

Intervention / Treatment
-----------------
* Drug: Black cohosh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No prior diagnosis of cancer other than non-melanoma skin cancer or carcinoma in-situ of the cervix No current prescription medication use Negative urine pregnancy test OR greater than age 50 with no menses for at least one year OR documented status post hysterectomy Competent to understand and sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: Black cohosh|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Black cohosh, Pharmacokinetics, Alternative therapies, Natural product
Analysis of a Beneficial Effect of Prolonges Topical Steroid Treatment After Low-risk Penetrating Keratoplasty

Study Overview
=================
Brief Summary
-----------------
PURPOSE: To assess the impact of duration of topical steroid treatment on the incidence of endothelial graft rejection following normal-risk penetrating keratoplasty (PK). DESIGN: Prospective, institutional, longitudinal, randomized interventional trial including 406 eyes (age: 52 >= 19 years; follow-up: 42 >= 18months). METHODS: Postoperative treatment started with prednisolone acetate 1% eye drops five times daily and was tapered over the first 6 months. Patients were then randomised into either short-term (stop topical steroid treatment) or long-term treatment (continue steroids once daily until 12 months).

Detailed Description
-----------------
PURPOSE: To assess the impact of duration of topical steroid treatment on the incidence of endothelial graft rejection following normal-risk penetrating keratoplasty (PK). DESIGN: Prospective, institutional, longitudinal, randomized interventional trial including 406 eyes (age: 52 >= 19 years; follow-up: 42 >= 18 months). METHODS: Postoperative treatment started with prednisolone acetate 1% eye drops five times daily and was tapered over the first 6 months. Patients were then randomised into either short-term (stop topical steroid treatment) or long-term treatment (continue steroids once daily until 12 months). <=

Official Title
-----------------
Phase 3: Analysis of a Beneficial Effect of Prolonges Topical Steroid Treatment After Low-risk Penetrating Keratoplasty

Conditions
-----------------
Graft Rejection

Intervention / Treatment
-----------------
* Drug: Topical Steroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low risk keratoplasty Exclusion Criteria: High risk keratoplasty

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topical Steroids|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft survival |  |  |
The Effects of Epidural Anesthesia on the Bioavailability of Nitric Oxide and Renal Function in Patients Undergoing Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
This study was designed to investigate the effects of epidural anesthesia combined with general anesthesia during laparoscopic surgery. The investigators hypothesized that epidural anesthesia will effectively block the activation of the sympathetic nervous system during surgery, thus activating nitric oxide and reducing splanchnic ischemia and decrease in postoperative renal function.

Official Title
-----------------
The Effects of Epidural Anesthesia on the Bioavailability of Nitric Oxide and Renal Function in Patients Undergoing Laparoscopic Surgery

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Epidural anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class 1 or 2 adult patients scheduled for endoscopic prostatectomy Exclusion Criteria: Patient refusal Patients on diuretics Patients with renal failure (eGFR < 60 ml/min/1.73 m2)

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: G group<br>G group = General anesthesia group | |
| Experimental: G+E group<br>G+E group = General anesthesia + epidural anesthesia group | Procedure: Epidural anesthesia<br>* 0.5% ropivacaine infusion via epidural catheter at 5ml/hr during general anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure with heart rate variability |  | 10 minutes after anesthesia induction |
Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome

Study Overview
=================
Brief Summary
-----------------
Isolated mild fetal ventriculomegaly is a common finding in fetal ultrasound examinations. When the ventricular diameter is more than 15 mm it is usually considered as severe and connected to other malformations. Most of these children will be severely affected later in life. Less than 10 mm ventricular width considered as normal. The current medical knowledge can not answer questions regarding future development of children who were diagnosed to suffer from mild (10-14.9 mm) brain ventriculomegaly during the pregnancy. We would like to assess the development and neurological status of all children who were diagnosed as mild ventriculomegaly during the pregnancy in the last 6 years and to prospectively follow up all the children who will be diagnosed from the beginning of the study on for 6 years. We hypothesized that the course of their development is different than of other children.

Detailed Description
-----------------
Study design: Patients: All children who are currently 5-6 year-old who suffered from isolated fetal mild brain ventriculomegaly during the pregnancy. All children who will be diagnosed with isolated fetal mild brain ventriculomegaly during the pregnancy from the beginning of the study for 6 years. Methods: All children will be examined by a pediatric neurologist who will perform a neuro-developmental assessment appropriate for age. The neurologist will decide individually whether there is a need for more medical tests. All children will be assessed by a psychologist who will perform WIPPSI or BAYLEY tests according to age.

Official Title
-----------------
Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome

Conditions
-----------------
Fetal Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children who were or are diagnosed with isolated fetal mild ventriculomegaly Exclusion Criteria: Anatomic malformations IVH Hydrocephalus Metabolic disorder CNS infection

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lateral ventricles, fetal ventriculomegaly
Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units

Study Overview
=================
Brief Summary
-----------------
This bicentric, randomized, controlled trial examines the effectiveness of an automatic control of pressure support ventilation (SmartCare/PS) in critically ill patients.

Detailed Description
-----------------
During the weaning process vigilance, pulmonary mechanics and respiratory drive of the patient are changing. Consequently, ventilation settings have to be modified very often. The modifications can be conducted either according to a weaning protocol or automatically by an expert system (SmartCare/PS). This trial compares protocol-guided weaning with automatic weaning in post-surgical patients and examines the effect on total ventilation time, numbers of manipulations and alarms of the ventilator, length of stay in the ICU and in the hospital, 28- and 90-day mortality.

Official Title
-----------------
Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units - a Bicentric, Prospective, Randomized, Controlled Trial

Conditions
-----------------
Ventilator Weaning

Intervention / Treatment
-----------------
* Device: SmartCare/PS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intubated or tracheotomised patients requiring mechanical ventilation at 9:00 am for longer than 9 hours (within this time period invasive and non-invasive ventilation is permitted) Exclusion Criteria: Cerebral trauma / surgery Age < 18 years Do-not-resuscitate-order Duration of mechanical ventilation > 24 h Patient is currently participating in this trial (including 90 days follow-up 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

| Intervention/Treatment |
| --- |
|Device: SmartCare/PS|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total ventilation time during intensive care unit stay. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in the zone of respiratory comfort during invasive mechanical ventilation |  |  | 
| Number of ventilator alarms during invasive mechanical ventilation |  |  | 
| Number of ventilator manipulations during invasive mechanical ventilation |  |  | 
| Length of ICU and hospital stay |  |  | 
| 28-day and 90-day mortality |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical ventilation, ventilator weaning, closed-loop, ventilation time
Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Nexavar for unresectable hepatocellular carcinoma (HCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 2 or 3 months (dependent on sites) for Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will be recruited and followed one year since starting Nexavar administration.

Official Title
-----------------
Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received Nexavar for unresectable hepatocellular carcinoma Exclusion Criteria: Patients who are contraindicated based on the product label
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Patients who have received Nexavar for unresectable HCC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar |  | After Nexavar administration, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demography |  | Baseline | 
| Effectiveness evaluation assessment [overall survival, complete response rate, partial response rate, stable disease rate] by the Response Evaluation Criteria in Solid Tumor (RECIST) |  | After Nexavar administration, up to 1 year | 
| Effectiveness evaluation assessment [time to progression, response rate, stable disease rate, progression rate] by investigator-determined overall best response |  | After Nexavar administration, up to 1 year | 
| The status of therapy with Nexavar [duration of treatment, daily dose] in a various settings according to baseline data [such as demographic data, Child-Pugh status, ECOG-PS] |  | After Nexavar administration, up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nexavar, unresectable hepatocellular carcinoma
the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis

Study Overview
=================
Brief Summary
-----------------
This is a prospective, open-label, one-arm study. The study aims to assess the efficacy and safety of Etanercept therapy which help guide the clinical practice in real-world settings.

Official Title
-----------------
A Prospective Study With Induction Dosing Period Followed by a Maintenance Dosing Period to Evaluate the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis

Conditions
-----------------
Psoriasis, Etanercept

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.18 to 75 years of age 2.Moderate to severe chronic psoriasis, BSA≥3% 3.Duration of psoriasis≥6 months 4.Patients must be candidate for systemic therapy or phototherapy 5.No contradiction to Etanercept 6.Informed consent must be obtained 7.For female, ß-hCG test is negative and contraception is accepted Exclusion Criteria: Diagnosis of pustular psoriasis, erythroderma psoriasis or drug-induced psoriasis Having severe infections, including hepatitis, HIV and tuberculosis No live vaccines 12 weeks before enrollment, through the study and 1 year after the last dose of Etanercept Having significant allergies to biological agents Having the previous experience of biologics Having a history of malignancy Having contradictions to Etanercept Refusal of contraception Having serious or unstable/uncontrolled illnesses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients achieving PASI75 at week 12 | PASI75: 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores. PASI includes desquamation, erythema, and plaque induration/infiltration. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieved PASI90 at week 12 | PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores. | 12 weeks | 
| Percentage of patients achieved PASI90 at week 24 | PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores. | 24 weeks | 
| Percentage of patients achieved PASI90 at week 36 | PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores. | 36 weeks |