linjc16/ctgov huggingface dataset:
Segment IV Hypertrophy After Liver Venous Deprivation

Study Overview
=================
Brief Summary
-----------------
before major hepatectomy, in case of insufisant future liver remanent volume or function, portal embolization is a routinely used method to enable growth of the future liver remnant. Recently liver venous deprivation has been described in some pioneer centre. The results are processing with greater and faster hypertrophy allowing probably less drop out from the embolization to surgery compared to portal embolization. In major hepatectomy, and specially in right or extended right hepatectomy the segment IV plays an important role in the proportion of future liver remnant. Despite the growing interest in the scientific community for liver venous deprivation many aspects concerning the liver hypertrophy remains unexplored. In particular the the degree of hypertrophy of segment IV after liver venous deprivation compared to portal embolization.

Official Title
-----------------
Segment IV Hypertrophy After Liver Venous Deprivation Compared to Portal Embolization in Patient Before Major Hepatectomy

Conditions
-----------------
Major Hepatectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - patient with liver tumor selected for right hepatectomy with insufficient future liver remnant who have undergoes portal embolization or liver venous deprivation Exclusion criteria: - left / extended left hepatectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Group of patient with liver venous deprivation<br>Group of patient with liver venous deprivation | |
| Group of patient with portal embolization<br>Group of patient with portal embolization | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| segment IV degree of hypertrophy | segment IV degree of hypertrophy | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | overall Survival : overall survival : is overall survival from date of hepatic surgery until the 01/04/2020 or during 5 years | 5 years | 
| recurrence free survival | recurrence free Survival : is the the survival without same deasese recurrence from the hepatic surgery date until the 01/04/2020 or during 5 years | 5 years |
A Dose Evaluation Study of the Effect of Plug Placement on the Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).

Official Title
-----------------
PPL GLAU 13: A Randomized Phase 2 Study of the Effect of Plug Placement on Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Conditions
-----------------
Glaucoma, Ocular Hypertension (OH)

Intervention / Treatment
-----------------
* Drug: Latanoprost-PPDS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female at least 18 years old Diagnosis of bilateral open angle glaucoma or ocular hypertension Unmedicated IOP must be ≥22mm Hg Exclusion Criteria: Any significant vision loss in the last year No contact lens use for the length of the study Abnormal eye lids, eye infection or diseases to the eye Recent eye surgery Uncontrolled medical conditions

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: Latanoprost-PPDS<br>* Sustained release for 12 weeks<br>|
| Experimental: Treatment B<br> | Drug: Latanoprost-PPDS<br>* Sustained release for 12 weeks<br>|
| Experimental: Treatment C<br> | Drug: Latanoprost-PPDS<br>* Sustained release for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP change from baseline |  | 12 weeks to baseline |
Viral Shedding, Symptoms and Exposure of SARS-CoV-2 in Non-hospitalized Children With COVID-19

Study Overview
=================
Brief Summary
-----------------
Data on COVID-19 in children are still scarce, and their role in SARS-CoV-2 transmission is poorly described. Furthermore, documentation of the best SARS-CoV-2 sampling methods in children are limited. In adults, saliva seems like a promising specimen to collect by noninvasive procedure to diagnose and monitor viral load of SARS-CoV-2, but this has not been tested in children yet. We want to test the following hypothesis: Shedding load and duration of SARS-CoV-2 in children are related to age, gender, clinical symptoms and exposure Salvia samples have equal or higher sensibility than nasal swaps in children for detection of SARS-CoV-2 Parental home testing of saliva and feces is feasible in children The study is a prospective cohort study of SARS-CoV-2 PCR-positive children from two test centers in the Capital Region of Denmark. Children aged 0-17 years with a PCR-positive SARS-CoV-2 test from a nasal or pharyngeal swab is included from May 2020 to January 2021 and followed-up for a period of 28 days with weekly sample collection and questionnaires. Samples include a saliva sample, a nasal swap and a rectal swap for children under four years of age. A semiquantitative RT-PCR method, will identify positive and negative samples and provide a Ct value estimating viral load. Saliva and fecal samples will be analyzed from November 2020-February 2021. Shedding duration will be related to medial history, clinical presentation, exposure, gender and age.

Official Title
-----------------
A Cohort Study of Non-hospitalized SARS-CoV-2 Positive Children in Denmark: Viral Shedding, Symptoms and Exposure

Conditions
-----------------
Covid19

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a PCR-positive SARS-CoV-2 test Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PCR|RT-PCR for SARS-CoV-2|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salvia samples have equal or higher sensibility than nasal swaps in children for detection of SARS-CoV-2 | Measured by RT-PCR | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental home testing of saliva and feces is feasible in children | measured by a questionnaire | 1 year |
Oral Supplementation of Gangliosides to Treat a Rare Metabolic Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot project is to see if a supplemental form of dietary gangliosides can serve as a potential treatment for the rare metabolic condition called ganglioside GM3 synthase deficiency.

Official Title
-----------------
Oral Supplementation of Gangliosides - A Potential Treatment for GM3 Synthase Deficiency

Conditions
-----------------
GM3 Synthase Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Supplementation of dairy-derived concentrated gangliosides.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of GM3 synthase deficiency Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 20 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: Supplementation of gangliosides<br>Supplementation of dairy-derived concentrated gangliosides | Dietary Supplement: Supplementation of dairy-derived concentrated gangliosides.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body length compared to normal pediatric growth curves. |  | Quarterly measures- change from baseline over 24 months. | 
| Change in scores of standardized developmental assessments (Vineland & Batelle) |  | Quarterly measures - change from baseline over 24 months | 
| Body Weight compared to normal pediatric growth curves |  | Quarterly measurements from baseline over 24 months | 
| Head circumference compared to normal pediatric growth curves. |  | Quarterly measures from baseline over 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of ganglioside GM3 in blood plasma |  | Six times per year over 24 months |
Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (MCI).

Official Title
-----------------
Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Conditions
-----------------
Cognitive Symptoms

Intervention / Treatment
-----------------
* Drug: Rivastigmine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females who are one year post-menopausal or without childbearing potential Between the ages of 50 and 85 years old Mild cognitive impairment confirmed by Mini Mental State Examination (MMSE) score between 23 and 27 Cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver, according to the investigator's judgement Exclusion Criteria: A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances or secondary dementia A current diagnosis of epilepsy or depression, or any other diagnosis that may interfere with the patient's response to study medication An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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: Rivastigmine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild cognitive impairment, Alzheimer's disease, Dementia, Mild Cognitive Impairment (MCI)
Case Series Assessing TissuGlu® Surgical Adhesive in Flap Surgery for Decubitus Repair

Study Overview
=================
Brief Summary
-----------------
To evaluate the impact of a high strength lysine-based adhesive (TissuGlu® Surgical Adhesive) on complications and revision rates in large flap surgery for decubitus repair.

Detailed Description
-----------------
A total of 50 subjects undergoing flap surgery for decubitus repair at the Clinic for Plastic and Aesthetic Surgery, Hand Surgery, St. Joseph's Hospital in Hagen, Germany were included in a post-market investigator initiated, retrospective observational series study.

Official Title
-----------------
Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Assessing a Lysine-Derived Urethane Adhesive (TissuGlu® Surgical Adhesive) in Flap Surgery for Decubitus Repair

Conditions
-----------------
Decubitus Ulcer

Intervention / Treatment
-----------------
* Device: TissuGlu Surgical Adhesive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing a procedure for decubitus repair be 22 years of age or older Exclusion Criteria: expected flap size less than 5 sqcm
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Standard Wound Closure with drains | |
| TissuGlu Surgical Adhesive<br>TissuGlu was used for approximation and adhesion of the flaps in conjunction with drains | Device: TissuGlu Surgical Adhesive<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduce the post-operative duration of stay | duration | 30 days | 
| reduce the surgical revision rate | rate | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of patients requiring a revision | percent | 30 days | 
| duration of wound drainage | duration | 30 days |
Efficacy of Weekly Versus Daily Folic Acid Supplementation

Study Overview
=================
Brief Summary
-----------------
Investigate the efficacy of weekly versus daily of folic acid supplementation on improving folate, vitamin B12,

Detailed Description
-----------------
460 women of a rural community in the western highlands of Guatemala were recruited for participation in the double-blinded study led by Emory University and the Institute of Nutrition of Central America and Panama (INCAP). The women were randomly assigned one of 4 vitamin treatments containing different levels of folic acid, Vitamin B12, iron and zinc. The treatments were as follows: weekly dose of folic acid at 5000ug, iron at 120 mg, zinc at 30mg, and B12 at 16.8 ug; weekly dose of folic acid at 2800ug, iron at 120mg, zinc at 0mg and B12 at 16.8ug; daily dose of folic acid at 400ug, iron at 60mg, zinc at 15mg, B12 at 2.4ug; and daily dose of folic acid at 200ug, iron at 50mg, zinc at 0mg, and B12 at 2.4ug. The women, aged 15-49, received the vitamins daily for 3 months. Anthropometric data and blood samples were taken at baseline and post-supplementation. The participants also completed a series of dietary interviews at baseline and post-intervention. No pregnant or lactating mothers were admitted into the study, nor severely anemic females. Blood samples were sent to the National Laboratory in Cuernavaca, Mexico, for analysis of serum folate levels.

Conditions
-----------------
Neural Tube Defects

Intervention / Treatment
-----------------
* Drug: multivitamin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female aged 15-49 Exclusion Criteria: pregnant lactating less than 3 months severely anemic

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 49 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: multivitamin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum folate level |  |  | 
| red blood cell folate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| homocysteine |  |  | 
| ferritin |  |  | 
| serum zinc |  |  | 
| serum B12 |  |  | 
| blood pressure |  |  | 
| depression |  |  |
Study Will Assess Skin Irritation and Sensitization for HP-1050 Patch

Study Overview
=================
Brief Summary
-----------------
A randomized, evaluator-blinded study to assess skin irritation and skin sensitization of HP-1050 transdermal system (HP-1050) in comparison to XULANE patch in healthy female volunteers.

Detailed Description
-----------------
This is a dual-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of HP-1050 transdermal system in comparison to XULANE patch in healthy female volunteers. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.

Official Title
-----------------
A Phase I Study to Assess Skin Irritation and Sensitization of HP-1050 Transdermal System Compared to XULANE in Healthy Adult Females

Conditions
-----------------
Cumulative Irritation and Sensitization

Intervention / Treatment
-----------------
* Drug: HP-1050 Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-pregnant, non-lactating females 18-35 years of age (inclusive0 and who are candidates for hormonal contraception; Subjects who have previously used hormonal contraceptives without complications or naïve subjects for whom hormonal contraceptives are not contraindicated in the opinion of the Principal Investigator; Subjects who are willing to stop using any current contraceptives for the duration of the study; Exclusion Criteria: Subjects who are currently taking or have taken oral hormonal contraceptives within 30 days prior to the first patch application; Subjects who are currently using any long-acting hormonal method of contraception or has used them within the past 3 months; Subjects who have a contraindication for estrogen or norelgestromin, or subjects who have a history of sensitivity to estrogen or norelgestromin or any related derivatives;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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: HP-1050 patch<br>HP-1050 and Xulane will be administered simultaneously. | Drug: HP-1050 Patch<br>* Both articles, HP-1050 and XULANE patch, will be applied simultaneously on the back of each subject.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Irritation Evaluation | To evaluate skin irritation after exposure to HP-1050 compared to XULANE® | 21 days | 
| Sensitization Evaluation | To evaluate skin sensitization after exposure to HP-1050 compared to XULANE® | 48 hours |
NEMO - an App for Side Effect Management in Oncology

Study Overview
=================
Brief Summary
-----------------
This study investigates the use of digital and standardized documentation by patients of frequently occurring adverse events in oncological therapies.

Detailed Description
-----------------
This research study is structured as a Phase I and II clinical trial. In phase I, the feasibility of using a smartphone application to document adverse events that have occurred during oncological therapies by the patient will be investigated. In phase II we will investigate whether the use of the smartphone app allows an improvement of patient care by reducing occurred adverse events.

Official Title
-----------------
NEMO - an App for Side Effect Management in Oncology

Conditions
-----------------
Cancer Patients

Intervention / Treatment
-----------------
* Other: Documentation of cancer treatment side effects


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infusional combination therapy with at least two chemotherapy substances with or without further targeted therapies combination of at least two immune-checkpoint inhibitors able to read and understand German Exclusion Criteria: Participants who meet any of the following criteria will be excluded: severe neurological disorders severe psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Smartphone-users<br>Cancer patients who use smartphones | Other: Documentation of cancer treatment side effects<br>* Standardized documentation of occurred side effects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: Patient acceptance of a new medium of communication | Acceptance of documentation of occurring side effects of oncological therapies with new communication media | 6 months | 
| Phase II: Change of occurred adverse events | Changes of side effects by at least 1 degree according to CTCAE scoring in comparison to the study start | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase II: Doses of chemotherapy | Maintenance of chemotherapy doses through better adverse event management | 6 months | 
| Phase II: Incidence of adverse events | Incidence of treatment-emergent adverse events as assessed by the CTCAE scale | 6 months |