linjc16/ctgov huggingface dataset:
Retrospective Non-interventional Study of Stiripentol Use in Dravet Patients in the USA

Study Overview
=================
Brief Summary
-----------------
The present study aims to collect data regarding the history of the disease, previous and current treatments, and the clinical status of Dravet patients during the 3 months prior to stiripentol initiation, the first 3 months on stiripentol and the last 3 months on stiripentol (irrespective of stiripentol discontinuation).

Official Title
-----------------
Retrospective Non-interventional Study of Stiripentol Use in Dravet Patients in the USA

Conditions
-----------------
Dravet Syndrome

Intervention / Treatment
-----------------
* Other: Retrospective study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Dravet syndrome Treated with stiripentol for a minimum of 3 months in routine practice Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Retrospective study|Retrospective study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| management of the Dravet syndrome | Patient Information History of the Disease Clinical status of the patient during the 3 months preceding stiripentol treatment initiation Clinical status of the patient at stiripentol initiation Clinical status of the patient during the first 3 months of stiripentol treatment Clinical status of the patient during the last 3 months of stiripentol treatment Evolution on stiripentol | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Better detection of the Dravet syndrome | Patient Information History of the Disease Clinical status of the patient during the 3 months preceding stiripentol treatment initiation Clinical status of the patient at stiripentol initiation Clinical status of the patient during the first 3 months of stiripentol treatment Clinical status of the patient during the last 3 months of stiripentol treatment Evolution on stiripentol | through study completion, an average of 1 year |
Sleep Improvement Intervention for Hospitalized Antepartum Patients

Study Overview
=================
Brief Summary
-----------------
This project seeks to further study the effects of a hospital-based protocol for improving sleep in high-risk antepartum patients as piloted by Lee and Gay (2017).

Official Title
-----------------
Sleep Improvement Intervention for Hospitalized Antepartum Patients

Conditions
-----------------
Sleep Disturbance in Hospitalized Antepartum Patients

Intervention / Treatment
-----------------
* Behavioral: Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: speak, read, and write English medically stable 20 weeks' gestation or greater viable fetus hospitalized at least 24 hours Exclusion Criteria: Do not speak, read, and write English Medically unstable Less than 20 weeks' gestation Nonviable fetus Hospitalized less than 24 hours

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Improvement Intervention<br> | Behavioral: Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients<br>* Patients are getting sleep hygiene education and a sleep hygiene kit.<br>|
| No Intervention: Standard of Care (Control)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who use the sleep improvement intervention |  | Day 7 | 
| Level of satisfaction with the intervention as assessed by a Likert assessment | The scale ranges from 0-5 with 5 being extremely satisfied | Day 7 |
Evaluation of Knowledge Among Adolescents With Sickle Cell Disease.

Study Overview
=================
Brief Summary
-----------------
Evaluation of knowledge about contraception in sickle cell adolescents.

Detailed Description
-----------------
Sickle cell teenagers receive regular hospital medical care. Adolescence is the time when the pathophysiology of the disease is re-explained and when questions around puberty (possibly delayed), sexuality and contraception are discussed. Sickle cell disease, like any chronic disease, can have repercussion on the development and behavior of young patients. Knowledge and understanding of young patients with sickle cell disease around these issues may be insufficient.

Official Title
-----------------
Evaluation of Knowledge and Practices About Contraception, Sexuality and Transmission Among Adolescents With Sickle Cell Disease.

Conditions
-----------------
Sickle Cell Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with sickle cell disease followed at the CHIC Aged 14 to 19 Both sexes Exclusion Criteria: Neurological disorders that can impede understanding of the questionnaire. Refusal to participate. Not affiliated to social security.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 19 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 |
| --- | --- | --- |
| Score value of the questionnaire on general knowledge on contraception | questionnaire on general knowledge on contraception rated by 4 questions | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score value of the questionnaire on specific knowledge on the transmission of the disease |  | at inclusion | 
| Score value of the questionnaire on the transmission of the disease knowledge |  | at inclusion | 
| Score value of the questionnaire on specific knowledge about the impact of sickle cell disease on the course of puberty |  | at inclusion | 
| Score value of the questionnaire onspecific knowledge about the impact of sickle cell disease on the course of sexuality |  | at inclusion | 
| age of the patient with sickle cell disease |  | at inclusion | 
| gender of the patient with sickle cell disease |  | at inclusion | 
| number of hospitalizations of the patient with sickle cell disease |  | at inclusion |
Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.

Detailed Description
-----------------
To compare an innovative Lung Open Ventilation strategy with a proven low tidal volume strategy, hypothesizing that the Lung Open Ventilation strategy may reduce mortality, other organ dysfunction, and the duration of mechanical ventilation, intensive care, and hospital stay.

Official Title
-----------------
A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury

Conditions
-----------------
Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Procedure: Control Ventilation Strategy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Invasive mechanical ventilation Acute respiratory insufficiency (within past 28 days) Bilateral infiltrates on frontal chest radiograph Hypoxemia, defined as PaO2/FiO2<=250 Exclusion Criteria: Primary cause of respiratory failure is cardiac Anticipated duration of mechanical ventilation < 48 hours Inability to wean other experimental ventilation strategies Severe chronic respiratory disease Neuromuscular disease that will prolong mechanical ventilation Conditions where hypercapnia-induced intracranial hypertension should be avoided Morbid obesity (> 1Kg per cm body weight) Pregnancy Very unlikely to survive and lack of commitment to life support Underlying irreversible condition with 6 month mortality >= 50% Greater than 48 hours elapsed since first eligible Current participation in competing trial Lack of physician, patient or proxy consent

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 |
| --- |
|Procedure: Control Ventilation Strategy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Mortality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality attributed to respiratory failure |  |  | 
| Duration of respiratory failure and duration of mechanical failure |  |  | 
| Evaluation of respiratory function during mechanical ventilation |  |  | 
| Incidence of barotraumas |  |  | 
| Non-respiratory organ dysfunction |  |  |
The Benefit of Adding Fish Oil to the Nutrition of Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
We study whether an increased proportion of omega-3-fatty acids (contained in fish oil) in the nutrition of critically ill patients reduces systemic inflammation.

Official Title
-----------------
Comparison Between Two Different Proportions of Omega-3- and Omega-6-Fatty Acids in the Parenteral Nutrition of Critically Ill Patients

Conditions
-----------------
Sepsis Syndrome

Intervention / Treatment
-----------------
* Drug: Defined percentage of omega-3-fatty acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for parenteral nutrition Exclusion Criteria: hypertriglyceridemia coagulation disorder decompensated liver cirrhosis or acute liver failure

Ages Eligible for Study
-----------------
Minimum Age: 0 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Defined percentage of omega-3-fatty acids|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of IL-6 in serum |  |  | 
| HLA-expression on monocytes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of nosocomial infections |  |  | 
| days on mechanical ventilation |  |  | 
| duration of ICU stay |  |  | 
| mortality |  |  | 
| SOFA score |  |  |
Pelvic Floor Symptoms After Bilateral Sacrospinous Fixation

Study Overview
=================
Brief Summary
-----------------
This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.

Official Title
-----------------
Pelvic Floor Symptoms and Patients´ Satisfaction After Bilateral Sacrospinous Fixation for the Primary Treatment of Pelvic Organ Prolapse ICS-POPQ Stage IV: A Prospective Observational Study

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Procedure: Bilateral sacrospinous fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 and above pelvic organ prolapse ICS-POPQ Stage IV, with or without uterus signed informed consent Exclusion Criteria: gynecologic surgery in the three past months before planned surgery history of prolapse surgery participation in another study need to simultaneously perform other surgical procedures (i.e. rectopexy) ongoing chemotherapy of treatment with immunosuppressant drugs

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bilateral sacrospinous fixation|Bilateral sacrospinous vaginal suspension|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pelvic floor symptoms | Using the validated Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004) | Twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical outcome / Prolapse stage after surgery | Using the POP-Q classification tool of the International Continence Society (Bump RC et al, Am J Obstet Gynecol 1996) | Twelve months | 
| Changes in quality of life | Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004) | Twelve months | 
| Changes in sexual activity | Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004) | Twelve months |
Investigating the Performance of a New Adhesive Strip

Study Overview
=================
Brief Summary
-----------------
This study investigates the performance of a new adhesive

Official Title
-----------------
A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Out-put

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Other: New adhesive strip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have had a stoma for more than one year Have intact skin on the area used in the evaluation Has a stoma with a diameter up to (≤) 35 mm Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) Exclusion Criteria: Currently receiving or have within the past 2 month received radio- and/or chemotherapy Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. Are pregnant or breastfeeding Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist) Actively participating in other interventional clinical investigations or have previously participated in this investigation. 5.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances of otherwise complying with the Inclusion and exclusion criteria of this protocol (CP265)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test of new adhesive strip<br>A new adhesive strip will be tested in this investigation | Other: New adhesive strip<br>* This is a strip made of a newly developed adhesive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| trans epidermal water loss | The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged the evaporation of water increases. Thus, trans epidermal water loss can be used to assess skin damage | 24 hours |
Evaluating Health at Every Size(HAES) as an Alternative Obesity Treatment Model

Study Overview
=================
Brief Summary
-----------------
Increasingly more individuals are trying to lose weight. Indeed, many women, regardless of their size, experience a life-long battle and preoccupation with their weight. Despite the attention to weight and the increase in diet behavior, the incidence of obesity continues to rise. There is little data to show improved long term success for the majority of participants who engage in weight loss behaviors. The specific aim is to improve the psychological and metabolic health of obese women with a history of chronic dieting through encouraging Health at Every Size (HAES). This treatment model emphasizes intutitive eating, i.e., internal regulation of eating (responding to cues of hunger, appetite and satiety). The HAES model is being compared to the current standard of care in obesity treatment, energy restriction dieting, which encourages cognitive control of eating and weight reduction.

Official Title
-----------------
Evaluating Health at Every Size(HAES) as an Alternative Obesity Treatment Model

Conditions
-----------------
Hypercholesterolemia, Hypertension, Depression, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Health at Every Size (HAES)
* Behavioral: Diet (Traditional, moderate energy restriction)


Participation Criteria
=================
Eligibility Criteria
-----------------
Caucasian; female; age 30-45 years; Body Mass Index (BMI)>30 m/kg2; non-smoker; not pregnant or lactating; Restraint Scale (Herman and Polivy, 1988) score >15, indicating a history of chronic dieting; no recent myocardial infarction; no active neoplasms, Type 1 diabetes or insulin-dependent Type 2 diabetes, nor history of cerebrovascular or renal disease.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 45 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Health at Every Size (HAES)|nan|
|Behavioral: Diet (Traditional, moderate energy restriction)|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
-----------------
Type 2 Diabetes, Self-Esteem
Feasibility and Performance Evaluation of INVSENSOR00024

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.

Official Title
-----------------
Feasibility and Performance Evaluation of INVSENSOR00024

Conditions
-----------------
Evaluation of SpO2 Performance

Intervention / Treatment
-----------------
* Device: RD SET Neo SpO2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than or equal to 1 month (28 days) of age Weight ≤ 5 kg at the time of consent or last recorded weight prior to consent. Subjects admitted with standard of care (SOC) arterial blood sampling line already in place Exclusion Criteria: Subjects with both significant abnormal aortic arch and radial line in place Subjects with suspected or diagnosed critical congenital heart disease (CCHD) Subjects with underdeveloped skin Subjects with abnormalities at the planned application sites that would interfere with system measurements Subjects with known allergic reactions to foam/rubber products and adhesive tape Deformities of limbs, absence of feet, severe edema, and other at the discretion of the Principal Investigator

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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

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

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 |
| --- | --- |
| Experimental: RD SET Neo SpO2<br>All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2. | Device: RD SET Neo SpO2<br>* All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value. | up to 12 hours |