linjc16/ctgov huggingface dataset:
The Holding Study: Feeding Analgesia in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effects of mothers' skin-to-skin holding during feeding via a soother trainer with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure Hypothesis: When held by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier. Following holding during the blood collection, mothers will find no differences in their infants' feeding ability.

Detailed Description
-----------------
Research Method: In a between subjects, randomized design, 20 stable preterm infants born between 30-35 weeks gestational age will be studied. Infants will be randomized to one of two interventions which will take place during blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the holding condition, infants will be held skin-to-skin by their mothers and given breast milk using a soother trainer during the blood collection.

Official Title
-----------------
The Holding Pilot Study: Feeding Analgesia in Preterm Infants

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: breastfeeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born between 30-35 weeks gestational age Mother has fluent English Exclusion Criteria: CNS injury congenital anomaly active infection has had no surgeries or analgesics/sedatives in last 72 hours history of maternal drug exposure

Ages Eligible for Study
-----------------
Minimum Age: 3 Days

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

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 |
| --- |
|Procedure: breastfeeding|See detailed description.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States |  |  | 
| Samples taken at baseline and recovery;Salivary Cortisol sample |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain Response
Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the randomness of adrenocorticotropic hormone (ACTH) and cortisol secretion using approximate entropy in patients who have sustained a head injury. II. Determine the correlation between randomness of ACTH and cortisol secretion and stages of sleep in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are stratified according to type of injury (closed head injury due to trauma vs vascular accidents). Patients are admitted two times for overnight assessment. Admission 1: Patients receive cosyntropin IV. Blood is drawn at 30 and 60 minutes after IV infusion. Patients receive oral metyrapone before sleep. A sham sleep study is conducted through the night and patients' blood is drawn in the morning. Admission 2: At least 2 weeks after admission 1, patients return for an overnight admission. Starting in the evening, blood is drawn every 15 minutes for 12 hours. A sleep study is conducted through the night.

Conditions
-----------------
Brain Injury, Craniocerebral Trauma

Intervention / Treatment
-----------------
* Drug: cosyntropin
* Drug: metyrapone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Patients who have sustained head injury Closed head injury from trauma OR Vascular accidents like strokes and hemorrhages --Prior/Concurrent Therapy-- Endocrine therapy: No concurrent cortisol replacement Other: No blood donation during and for 1 month after study --Patient Characteristics-- Hematopoietic: Hemoglobin normal Other: No hypopituitarism No body mass index of 28 or greater Not pregnant or nursing Must have normal menstrual cycles No severe mental impairment Must not require legal guardian

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cosyntropin|nan|
|Drug: metyrapone|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
-----------------
brain injury, neurologic and psychiatric disorders, rare disease
Genetic Analysis of Thyrotoxic Periodic Paralysis

Study Overview
=================
Brief Summary
-----------------
Thyrotoxic periodic paralysis (TPP) is characterized by episodes of reversible hypokalemia and weakness in thyrotoxic patients. It is commonly found in males of Asian descent and is also seen in individuals having Native American or Hispanic ancestry. Therefore genetic etiology has been hypothesized. This study, we aim to find the susceptibility genes that associate with TPP. Both candidate genes approach and genome wide association study have been conducted.

Detailed Description
-----------------
This study is a genetic association study. It included 50 cases of TPP patients and 80 cases of male, hyperthyroid patients who didn't have hypokalemia as a well characterized controls. After informed consent were obtained, genomic DNA from leukocyte were extracted. Pooled DNA were constructed and whole genome scan using 10K GeneChip microarray were genotyped on pooled genomic DNA.

Official Title
-----------------
Genetic Analysis of Thai Patients With Thyrotoxic Periodic Paralysis

Conditions
-----------------
Thyrotoxic Periodic Paralysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TPP Hyperthyroid patients from any causes Evidence of hypokalemia (k<3.5 mg/dl)from intracellular shift (Urine K<15 mg/dl, TTKG<2) Episodic paralysis Exclusion Criteria: Hypokalemia from GI or renal loss

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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
-----------------
Thyrotoxicosis, genetic association study, periodic paralysis, whole genome scan
A Therapeutic Equivalence Study of Two Metronidazole Gel 1% Topical Treatments of Rosacea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of two Metronidazole Gels 1%, in the treatment of Rosacea.

Official Title
-----------------
A Multi-center, Double-blind, Randomized, Vehicle-controlled, Parallel-group Study Comparing Metronidazole Gel 1%, to Metrogel® (Metronidazole Gel) 1% in the Treatment of Rosacea

Conditions
-----------------
Papulopustular Rosacea, Erythematotelangiectatic Rosacea

Intervention / Treatment
-----------------
* Drug: Reference: Metronidazole Gel 1%
* Drug: Test: Metronidazole Gel 1%
* Drug: Placebo Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female subjects with at least 18 years of age; Read and signed ICF; Clinical Diagnosis of Rosacea; Exclusion Criteria: Females who are pregnant, lactating or of childbearing potential who are not using or do not agree to use an acceptable form of contraception; Any skin condition that would interfere with treatment of rosacea Use of prohibited medications

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test: Metronidazole Gel 1%<br>Metronidazole Gel 1% once daily for 70 days. | Drug: Test: Metronidazole Gel 1%<br>* Participants are assigned to one of three groups in parallel for the duration of the study<br>|
| Active Comparator: Reference: Metronidazole Gel 1%<br>Metronidazole Gel, 1% (MetroGel) Galderma S.A. once daily for 70 days. | Drug: Reference: Metronidazole Gel 1%<br>* Participants are assigned to one of three groups in parallel for the duration of the study<br>* Other names: MetroGel;|
| Placebo Comparator: Placebo<br>Placebo Gel once daily for 70 days. | Drug: Placebo Gel<br>* Participants are assigned to one of three groups in parallel for the duration of the study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the test and reference products of metronidazole topical gel 1% with regard to the mean percent change from Baseline of the inflammatory lesion counts of rosacea. |  | 70 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the test and reference product of metronidazole topical gel 1% with regard to the Investigator's Global Evaluation (IGE) of disease severity |  | 70 Days |
Eye Patch Therapy for Central Serous Retinopathy (CSR)

Study Overview
=================
Brief Summary
-----------------
First, this study will investigate the viability of 24-hour eye patching as a potential treatment modality for CSR. Second, this study will assess a potential physiologic explanation for CSR, namely if inhibition of photic stimulation of the diseased retina will aid in ameliorating disease severity and disease duration.

Official Title
-----------------
Eye Patching as a Potential Treatment Modality for and a Possible Etiological Insight on Central Serous Retinopathy

Conditions
-----------------
Central Serous Retinopathy (CSR)

Intervention / Treatment
-----------------
* Device: Eye Patching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 years of age and older Both males and females Patients diagnosed with active central serous retinopathy Patients who are willing to use an eye patch in the affected eye for 24 hours Patients who are able to make the follow up appointments as required by the study Exclusion Criteria: Individuals under 18 years of age Patients with vision less than 20/40 in the unaffected eye. Patients who are not able to undergo mfERG testing in a realiable manner.

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Eye Patching<br>Intervention | Device: Eye Patching<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in multi-focal ERG response and macular thickness after 24-hour patch therapy in patients with CSR | This study is a prospective control trial that will compare 24-hour eye patch therapy with the current standard of care in patients with central serous retinopathy (CSR). | 24 hours | 
| Change in multi-focal ERG response |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macular thickness |  | 24 hours |
Diabetes Therapy to Improve BMI and Lung Function in CF

Study Overview
=================
Brief Summary
-----------------
To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).

Detailed Description
-----------------
The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes without fasting hyperglycemia.

Official Title
-----------------
Diabetes Therapy to Improve BMI and Lung Function in CF

Conditions
-----------------
Cystic Fibrosis, Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Insulin Asparte
* Drug: Repaglinide


Participation Criteria
=================
Eligibility Criteria
-----------------
Diabetic glucose pattern by oral glucose tolerance test (OGTT) of >200 at 120 min. (stable and healthy at time of OGTT) Fasting glucose levels <126. Weight stable within 5% in previous 3 months. Free from illness for two months. Male and female 16 and older, who are done growing Willing to come in for visits every 3 months. Patients receiving infrequent short bursts of systemic glucocorticoids may be considered for the study inclusion if: a. they have not received systemic glucocorticoids steroids for at least one month, b. they did not receive the steroids for more than 14 consecutive days or 28 days total in six months

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

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: III<br>Placebo take half tab with meals tid | Drug: Insulin Asparte<br>* Insulin asparte given 0.5 units per carb per meal<br>Drug: Repaglinide<br>* 0.5mg tab with meals tid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic Fibrosis Related Diabetes, Diabetes without Fasting Hyperglycemia
Effectiveness of C-MAC Video-stylet Versus C-MAC D- Blade Video-laryngoscope for Tracheal Intubation

Study Overview
=================
Brief Summary
-----------------
Videolaryngoscopy provides a better laryngeal view and do not need airway alignment for tracheal intubation.

Detailed Description
-----------------
The C-MAC-VS can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. This device is great for cases with limited mouth opening, airway obstruction and difficult intubation. C-MAC-VS has no lumens so it's very easy to clean and it can accommodates a size ETT 6.0 and greater.

Official Title
-----------------
Effectiveness of C-MAC Video-stylet Versus C-MAC D- Blade Video-laryngoscope for Tracheal Intubation in Patients With Predicted Difficult Airway: Randomized Comparative Study

Conditions
-----------------
Difficult Mask Ventilation, Difficult Intubation

Intervention / Treatment
-----------------
* Device: C-MAC VS
* Device: C-MAC VL D -blade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with BMI ≥ 30 kg/m2, presence of any predictors of difficult intubation; Mallampati score > =3; inter-incisor distance < 3 cm; thyromental distance < 6 cm; neck extension < 80°from neck flexion; cervical spine instability; history of difficult endotracheal intubation or difficult mask ventilation Exclusion Criteria: patients have increased risk of pulmonary aspiration; have significant medical diseases in term of cardiac, respiratory, hepatic, renal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be randomly assigned into two equal groups using computer-generated randomization technique. Group C-MAC VS (VS group) included patients undergoing tracheal intubation using the C-MAC VS. Group C-MAC VL D -blade (D group) included patients undergoing intubation using the C-MAC VL D-blade.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group C-MAC VS<br>patients undergoing tracheal intubation using the C-MAC VS. | Device: C-MAC VS<br>* patients undergoing tracheal intubation using the C-MAC VS<br>|
| Placebo Comparator: Group C-MAC VL D -blade<br>patients undergoing intubation using the C-MAC VL D-blade. | Device: C-MAC VL D -blade<br>* patients undergoing intubation using the C-MAC VL D-blade.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of intubation procedure | assess duration of intubation procedure by using C-MAC VS versus C-MAC D-blade in patients with anticipated difficult airway. | 10 minutes |
Comparison Between the Expected Site of Sacral Hiatus by Conventional Method and the Real Site by Ultrasonography for Caudal Block in Children

Study Overview
=================
Brief Summary
-----------------
Caudal block is one of the most useful and popular regional block in pediatric anesthetic practice. Successful caudal block depends on the proper placement of a needle through sacral hiatus by following anatomical landmarks. The sacrum and the position of sacral hiatus are extreme variable anatomical structure. Generally, the equilateral triangle located between the apex of the sacral hiatus and posterior superior iliac spines is used in determining the location of the sacral hiatus as the conventional method. Previous study demonstrated that the triangle formed between the apex of the sacral hiatus and the posterior superior iliac spines was found to have the features of an equilateral triangle in adult. There is no study about the efficacy of the conventional method using the equilateral triangle in children. In this study, the investigators will compare between the expected site of sacral hiatus by conventional method using the equilateral triangle and the real site of the sacral hiatus confirmed by ultrasonography for caudal block in children.

Conditions
-----------------
Inguinal Herniorraphy

Intervention / Treatment
-----------------
* Other: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 0-72 months patient whho are scheduled to undergo elective inguinal herniorraphy under general anesthesia Exclusion Criteria: The history of prematurity he histories of the infection, tumor, and operation in sacrum 3. The history or suspicion of meningomyelocele

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Herniorrhapy with caudal block<br>Children aged 0-72 months who are scheduled to undergo elective inguinal herniorrhapy under general anesthesia with caudal block | Other: Ultrasonography<br>* The confirmation of the real site of the sacral hiatus by ultrasonography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the expected site of the sacral hiatus by convential method | 1)The distance bewteen the midpoint of posterior superior iliac spines and the expected site of sacral hiatus by conventional method and 2)the distance between the midpoint of posterior superior iliac spines and the real site of sacral hiatus by ultrasonography. | approximately 5 minutes after general anesthesia |
Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018

Study Overview
=================
Brief Summary
-----------------
Evaluation of the prevalence of post-traumatic stress disorder (PTSD), associated risk factors, health care consumption, and sleep disorders in a civilian population exposed to the December 11, 2018, attacks in Strasbourg. Terrorist attacks have unfortunately become all too frequent on our territory in recent years. A better knowledge of the psychological and psychiatric repercussions on exposed populations is essential in order to better prevent and treat disorders that can have a major functional impact on the lives of exposed individuals and to adapt care during future similar events

Official Title
-----------------
Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018

Conditions
-----------------
Stress Disorders, Post-Traumatic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥ 18 years old), Having been exposed to the attacks of December 11, 2018 in Strasbourg directly or indirectly (presence at the scene or close relative present at the scene) Subject who has not expressed his opposition, after information, to the reuse of his data for the purpose of this research Exclusion Criteria: Subject who has expressed opposition to participating in the study Subject under guardianship, curatorship or legal protection

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Retrospective evaluation of the prevalence of post-traumatic stress disorder (PTSD) in a population exposed to the attacks of December 11, 2018 in Strasbourg |  | Files analysed retrospectively from February 11, 2018 to November 30, 2019 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress Disorders, Disorders Post-Traumatic