linjc16/ctgov huggingface dataset:
A Substantial Equivalence Study of RD04723 and Predicate Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a developmental formulation is substantially equivalent to the predicate device in the treatment of hypertrophic and keloid scars.

Official Title
-----------------
Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars

Conditions
-----------------
Hypertrophic Scar, Keloid Scar

Intervention / Treatment
-----------------
* Device: RD047-023
* Device: Predicate Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide informed consent and release health information Ability to follow study instructions and study requirements Have a hypertrophic or keloid scar accessible for treatment and evaluation Negative pregnancy test for women of childbearing potential Agreement to use effective birth control method for study duration Exclusion Criteria: History of allergy or sensitivity to components History of diabetes History of collagen vascular disorders Anticipated need for surgery or hospitalization during the study Pregnant, nursing, or planning a pregnancy during the study Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RD047-023<br>RD-047-023 | Device: RD047-023<br>* Experimental hydrogel<br>|
| Active Comparator: Predicate Device<br>legally marketed predicate device | Device: Predicate Device<br> <br> * Other names: Kelo-Cote;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination) | Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen. | 4 weeks, 8 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and itch | Patient assessment of pain and itch. Scoring from 0-3. | 4 weeks, 8 weeks, 12 weeks | 
| Adverse Events | Number of subjects with related adverse events | Baseline, Weeks: 2, 4, 8, 12 and early termination | 
| Treatment satisfaction | Patient assessment (satisfaction) with scar treatment. Stated as: very good, good, moderate or unsatisfactory. | 8 weeks, 12 weeks |
Relevance of Sensitization to Legumes in Children Allergic to Peanut

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to determine in children allergic to peanut (i) the prevalence of sensitization to other legumes, (ii) the prevalence of allergy to each legume in patients who are sensitized to it (iii ) the severity of the allergy to legumes other than peanut

Detailed Description
-----------------
Allergy to legumes is more and more frequent, especially in children allergic to peanut, with some severe reactions but little is known about cross-reactivity and clinical meanings of legumes sensitization in children allergic to peanut. All children with a confirmed peanut allergy and followed at the University Hospital of Nancy between January 1st 2017 and February 29th 2020 will be included in order to evaluate the prevalence of sensitization and allergy to other legumes in this population. In children allergic to peanut and to at least one other legume, we will evaluate the severity of the allergy and the sIgE profiles for peanut.

Official Title
-----------------
Relevance of Sensitization to Legumes in Children Allergic to Peanut

Conditions
-----------------
Allergy;Food

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed allergy to peanut Exclusion Criteria: no available information regarding sensitization and tolerance to legumes

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- | --- |
| sensitization to legumes | skin and sIgE sensitization | 2017 to 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allergy to legumes | history of allergic reaction or oral food challenge | 2017 to 2020 | 
| severity of allergy to legumes | history of allergic reaction or oral food challenge | 2017 to 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
food allergy, peanut, legumes, sensitization
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease

Study Overview
=================
Brief Summary
-----------------
Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soybean oil. There is a suggestion in the literature that using fish oil based fats called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver damage reverses.

Detailed Description
-----------------
Babies in the newborn intensive care unit with evidence of liver damage from Total Parenteral Nutrition (TPN), as indicated by a direct bilirubin of greater than 2.5 , and who will not be fed for at least another month will be offered the trial. they will be changed from the intralipid to Omegaven as the source of their fat. We will continue routine monitoring of their nutrition and liver function.

Official Title
-----------------
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease

Conditions
-----------------
Parenteral Nutrition Associated Liver Disease

Intervention / Treatment
-----------------
* Drug: Omegaven


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants in the newborn intensive care unit TPN cholestasis of at least 2.5 mg/dl Anticipated TPN treatment for at least one month signed informed consent Exclusion Criteria: Enrollment in another trial Lack of consent

Ages Eligible for Study
-----------------
Maximum Age: 24 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>All infants will receive Omegaven | Drug: Omegaven<br>* 1 gram/kg/day daily until on feeds<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Resolution of the Direct Hyperbilirubinemia | Defined as direct bilirubin <2.0 mg/dL | At discharge or up to 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TPN cholestasis, Parenteral nutrition associate liver disease, TPN Associated Liver Disease
Studying of Natural Constituents' Treatment of Plantar Warts

Study Overview
=================
Brief Summary
-----------------
Moringa banana nigella and Banna coat extract were prepared and formulated in the form of bi gel for transdermal delivery of these plant extracts. The formulation was prepared and charterized for organoleptic charters, morphology, and penetration efficacy. The optimised formulation was assessed clinically on patients suffering from plantar warts. The clinical study was phase 1 and interventional randomised allocation.

Official Title
-----------------
In-vitro and Randomized Controlled Clinical Studying of Natural Constituents' Anti-HPV Potential for Treatment of Plantar Warts Supported With in Silico Studies

Conditions
-----------------
Plantar Wart

Intervention / Treatment
-----------------
* Drug: Banaba Leaf Extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient aged 18 years or more. Clinical evaluation Number of warts lower than 10 on the 2 feet and total diameter of warts lower than 10 cm Exclusion Criteria: Patient suspected to be immunocompromised Patient aged under 18 years Patient refusing to sign the consent Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group (Group I)<br> | Drug: Banaba Leaf Extract<br>* a herbal extract in the form of Bigel<br>* Other names: moringa banna nigella;|
| No Intervention: Control group (Group II)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clinical remission of the warts | Number of warts (counts) | 30 days | 
| Clinical assessment of warts curement | Diameter of wart in cm | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain asssesment | pain was assesed by VAS scoring (0) the least to (5) highest | 30 days |
Long-Term Follow-Up Study of Psoriasis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507.

Detailed Description
-----------------
This study will evaluate the long-term safety and lymphocyte repletion profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507. Patients must have had an ALC > 30% lower than baseline (defined as baseline prior to any MEDI-507 exposure); or an absolute CD4 count of < 250 cells/uL. This study will also evaluate the development and durability of anti-MEDI-507 antibodies.

Official Title
-----------------
Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Other: Follow up from previous treatment with MEDI-507


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has previously completed participation (i.e., completed per protocol, including any long term follow-up; or discontinued from the study due to withdrawal of consent, loss to follow-up, or other reason) in a Medimmune, Inc. study of MEDI-507 in psoriasis in which they received MEDI-507 (or placebo for patients who participated in a blinded placebo-controlled study of MEDI-507, and for whom the treatment assignment in that study has not been unblinded at the time of entry into this study) The patient had an absolute lymphocyte count (ALC) > 30% lower than baseline (defined as baseline prior to any MEDI-507 exposure; or, for patients whose treatment assignments have not been unblinded at the time of entry into this study, drug exposure) at his/her final visit (excluding any long-term follow-up visits) in the most recent Medimmune, Inc. study in which the patient participated; or the patient had an absolute CD4 count of < 250 cells/uL at his/her final visit (including any protocol-specific long-term follow up) in the most recent Medimmune, Inc. study in which the patient participated. Written informed consent obtained from the patient Exclusion Criteria: There are no exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Follow up from previous treatment with MEDI-507|There will be no investigational drugs administered under this protocol.|

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
-----------------
Previously enrolled on a MEDI-507 for psoriasis
Near-death Experience in ICU Survivors

Study Overview
=================
Brief Summary
-----------------
This observational study aims to describe the incidence of near-death experience (NDE) in patients who survived a critical illness. In order to help determine the potential risk factors of NDE, dissociative status and spirituality are also investigated. Finally, in patients who experienced NDE, a magnetic resonance imaging is performed to search for any structural modifications.

Official Title
-----------------
Incidence of Near-death Experiences Among Patients Who Survived a Critical Illness

Conditions
-----------------
Critical Illness, Near-Death Experience

Intervention / Treatment
-----------------
* Diagnostic Test: Greyson NDE scale
* Diagnostic Test: DES dissociation scale
* Diagnostic Test: WHOQOL-SRPB
* Diagnostic Test: cerebral magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients who survived critical illness Exclusion Criteria: Glasgow Coma Scale < 15/15 Confusion (CAM ICU scale) Refusal

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Greyson NDE scale|Questionnaire to detect occurence of NDE. A NDE is identified if score > or = 7/32|
|Diagnostic Test: DES dissociation scale|Screening for dissociative symptoms|
|Diagnostic Test: WHOQOL-SRPB|WHOQOL-SRPB is an instrument developed to evaluate how spirituality, religiosity and personal beliefs (SRPB) are related to quality of life in health and health care.|
|Diagnostic Test: cerebral magnetic resonance imaging|Types of images to be acquired: T1, T2, Diffusion Weighted Imaging-DWI, Fluid Attenuated Inversion Recovery and spectroscopy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NDE | NDE occurence during ICU stay, retrospectively detected by the Greyson scale. Greyson scale is a 16 items and 32 points scale. Minimal score is 0, maximal score is 32. A NDE is suspected when score is equal or higher than 7. | Greyson questionnaire is administered during the week following ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life estimation | Quality of life assessment, using EQ-5D-3L | one year after first interview | 
| NDE | NDE occurence during ICU stay, retrospectively detected by the Greyson scale. | one year after first interview | 
| MCQ (Memory Characteristics Questionnaire) | analyze of the phenomenological characteristics of real and imagined memories | one month after first interview |
Standard Treatments of Very-early Stage Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The aim of our study was to elucidate the difference in the rates of complication, hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for minimally invasive treatment of very early stage HCC.

Official Title
-----------------
The Research on Standard Treatments of Very-early Stage Hepatocellular Carcinoma: a Randomized Clinical Trial

Conditions
-----------------
Hepatocellular Carcinoma, Very-early Stage

Intervention / Treatment
-----------------
* Procedure: RFA
* Procedure: MWV
* Procedure: PEI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preoperative clinical, imaging and tumor markers were diagnosed as hepatocellular carcinoma Tumor diameter<2cm Child-Pugh class A liver function Without major organ dysfunction male or female patients > 18 years and <=70 years of age Voluntary participation in this clinical trial Exclusion Criteria: Other anticancer treatment before therapy Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer Patients with other diseases that may affect the treatment of this treatment History of other malignant tumors Patients who are participating in other clinical trials Pregnant, lactating women

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA<br>Radiofrequency ablation | Procedure: RFA<br> <br> |
| Experimental: MWV<br>Microwave ablation | Procedure: MWV<br> <br> * Other names: Microwave ablation;|
| Experimental: PEI<br>Percutaneous ethanol injection | Procedure: PEI<br>* Percutaneous ethanol injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Hepatocellular Carcinoma will recurrence in 3 years | 3 years | 
| Death |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatments, hepatocellular carcinoma
Single Incision Laparoscopy

Study Overview
=================
Brief Summary
-----------------
Laparoscopic surgery being performed with only one small incision via the umbilicus (belly button).

Official Title
-----------------
Single Incision Laparoscopy

Conditions
-----------------
Appendicitis, Cholelithiasis, Malignant Hypertension

Intervention / Treatment
-----------------
* Procedure: single incision laparoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-75 Patient has consented for a laparoscopic operation (independent of study participation) Attending surgeon decides operation can be completed via a single incision laparoscopic approach Exclusion Criteria: Patients with BMI greater than 40 Minors and cognitively impaired individuals Patients who are ASA class IV - Illness that is a constant threat to life Patients with ascites or Child's class C of liver failure Patients with known common bile duct stones Patients with coagulopathy, abnormal coagulation studies, or who take heparin, coumadin, Plavix (clopidogrel), aspirin, or other medication for the purpose of anti-coagulation and cannot be removed from the medication prior to the operation. Patients who present with incarcerated (irreducible) or strangulated hernias Patients with preoperative hematocrits less than 25. Preoperative hematocrit less than 25. Patients who have evidence of hemodynamic instability including systolic blood pressure greater than 200 or less than 80. Heart rate greater than 130 or less than 50. Respiratory rate greater than 35 or less than 6. Patients who are on continuous pressor drip for blood pressure support. Patients who present for emergency adrenalectomy. Patients with CT scan evidence of an abdominal abscess. Patients who present 48 hours after the onset of abdominal pain (appendectomy patients)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>all subjects | Procedure: single incision laparoscopic surgery<br>* Surgery will be performed with ine laparoscopic incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and efficacy of single incision laparoscopy |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
appendectomy, cholecystectomy, gastric banding, adrenalectomy, Gastric lap-band placement