linjc16/ctgov huggingface dataset:
Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended

Study Overview
=================
Brief Summary
-----------------
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure ulcers (PU).

Official Title
-----------------
Open, Non-comparative, Multi-centre Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended

Conditions
-----------------
Pressure Ulcers

Intervention / Treatment
-----------------
* Device: Fast Gelling Dressing (Exufiber)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both gender ≥18 years old. Subjects with Stage 2, 3 or 4 cavity pressure ulcer (acc to EPUAP) Exuding pressure ulcer Signed Informed Consent. Exclusion Criteria: Known allergy/hypersensitivity to the dressing. Infected wounds, (2 signs of infection/local inflammation and a positive swab) Stage 1 PU Dry wounds Subjects who will have problems following the protocol Subjects included in other ongoing clinical investigation at present or during the past 30 days

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast Gelling Dressing<br> | Device: Fast Gelling Dressing (Exufiber)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks) | the subjects will be measured by the following variables; maceration, | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance | Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm | 6 weeks |
Effect of Antiviral Therapy on HVPG in Patients With Viral Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Complications associated with portal hypertension are the leading cause of death in patients with cirrhosis. Until now, hepatic venous pressure gradient (HVPG) - the difference between the wedged hepatic venous pressure (WHVP) and the free hepatic vein pressure (FHVP)- has been the criterion standard to determine portal pressure. Antiviral therapy may decrease HVPG which needs to be verified.

Official Title
-----------------
Effect of Antiviral Therapy on HVPG in Patients With Viral Cirrhosis

Conditions
-----------------
Portal Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with viral cirrhosis were diagnosed; Age 18-80 years; Need and willing to accept measure HVPG; First HVPG measurement of more than 5 mmHg; Signed Informed Consent Exclusion Criteria: Patients with viral cirrhosis have been treated with antiviral therapy and have achieved virological response; Ready to accept or have accepted a TIPS procedure; Splenic embolization was performed; Inaccurate measurement of HVPG due to combined hepatic venous shunt; Complicated with alcoholic liver disease, autoimmune liver disease or other types of liver disease; Complicated with liver cancer or other organ malignancy; Combined with severe cardiopulmonary disease affects survival; Complicated with severe renal insufficiency; Concomitant portal vein cavernous degeneration or extensive portal vein thrombosis; Women who are planning to become pregnant or who are pregnant or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| HVPG changed and reached the response standard | HVPG response to therapy indicates a decrease in HVPG of at least 10% from baseline or to less than 12 mmHg after chronic treatment with NSBBs. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiviral therapy achieved a virological response | HBV-DNA remained undetectable for successive two times. | one year |
Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987517)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF Signed and dated Informed Consent Form Signed and dated HIPAA Form An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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

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

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

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: BAY987517<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY987517)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: SR15-74_R84-086)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Conventional Versus Modified Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
In conventional laparoscopic cholecystectomy, the cystic duct and artery are clipped by metal clips. we propose a new method in which the cystic duct is ligated and the cystic artery is cauterized. the investigators compare both methods.

Official Title
-----------------
Randomized Controlled Trial Comparing Between The Conventional Technique of Laparoscopic Cholecystectomy and A Proposed Modified Technique

Conditions
-----------------
Laparoscopic Cholecystectomy

Intervention / Treatment
-----------------
* Procedure: conventional laparoscopic cholecystectomy
* Procedure: modified laparoscopic cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopic cholecystectomy for symptomatic gallstones Exclusion Criteria: Conversion to laparotomy

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: conventional laparoscopic cholecystectomy<br> | Procedure: conventional laparoscopic cholecystectomy<br> <br> |
| Active Comparator: modified laparoscopic cholecystectomy<br> | Procedure: modified laparoscopic cholecystectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Infusion Laboratory: Protocol 4 (Dihydrexidine) - 13

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety issues pertaining to dihydrexidine (DHX), to cocaine, and to its interaction, and to determine how pretreatment with DHX modifies the subjective as well as physiological effects of cocaine infusion.

Official Title
-----------------
Infusion Laboratory: Protocol 4 (Dihydrexidine)

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Dihydrexidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 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
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of drug craving |  |  | 
| Frequency of IV drug use and sexual risk behaviors |  |  | 
| History, incidence and amount of drug use |  |  | 
| Type and severity of stimulant withdrawal symptoms |  |  | 
| Characterization of study population |  |  | 
| Population incidence of symptoms of depression, po |  |  | 
| Evidence of change in neurophysiology and brain ac |  |  | 
| Evidence of change in subjective responses to coca |  |  | 
| Clinical physiological response to cocaine challen |  |  | 
| Degree to which study medication influences change |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Iron Deficiency and TTG Normalization

Study Overview
=================
Brief Summary
-----------------
The investigators conducted a retrospective, observational cohort study which enrolled CD subjects aged 2-18y, diagnosed between Jan 2016 and Dec 2020. Demographic and laboratory data were collected at diagnosis and 1y after adherence to GFD. ID was determined according to hemoglobin and ferritin levels. The investigators compared CD subjects with and without ID at CD diagnosis in relation to TTG normalization at 1y.

Official Title
-----------------
The Association Between Iron Deficiency at Diagnosis, Female Sex and Tissue Transglutaminase Antibody Normalization in Pediatric Celiac Disease

Conditions
-----------------
Celiac Disease in Children

Intervention / Treatment
-----------------
* Other: Gluten free diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children (male and female) diagnosed with CD Age 2-18y Exclusion Criteria: Total IgA deficiency Anemia due to other causes - anyone with anemia and normal or elevated ferritin levels (e.g. thalassemia, spherocytosis) Other chronic conditions increasing the risk of anemia or falsely elevated ferritin (e.g. inflammatory bowel disease, chronic kidney disease, infection)

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 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 |
| --- | --- |
| Iron deficiency at diagnosis<br> | Other: Gluten free diet<br>* All subjects initiated a gluten free diet as mandated by their diagnosis of Celiac disease, regardless of the study<br>|
| No iron deficiency at diagnosis<br> | Other: Gluten free diet<br>* All subjects initiated a gluten free diet as mandated by their diagnosis of Celiac disease, regardless of the study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TTG normalization | normalization of tissue transglutaminase antibody | 1 year from gluten free diet initiation |
Screening for Genes in Patients With Congenital Neutropenia

Study Overview
=================
Brief Summary
-----------------
Syndromic congenital neutropenia (SCN) includes a heterogeneous group of diseases characterized by congenital neutropenia associated with the involvement of other organs. Most patients have syndromic congenital neutropenia, which does not correspond, either clinically or genetically, to any other previously described form. A large number of genes still have to be identified in these syndromic forms. The aim of this study is to identify the molecular bases of congenital neutropenias that have not yet been classified, by taking advantage of high-throughput exome sequencing.

Official Title
-----------------
Identification of the Molecular Bases of Syndromic Congenital Neutropenia With Development Anomalies

Conditions
-----------------
Congenital Neutropenia

Intervention / Treatment
-----------------
* Genetic: High-throughput exome sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons who have provided written consent Patients with congenital neutropenia and mental retardation and/or a development anomaly (malformation, facial dysmorphism) Patients who accept a clinical evaluation, and to give at least one blood sample Screening for chromosomal microrearrangements by normal array-CGH Exclusion Criteria: Persons without national health insurance cover Patients who do not meet the clinical and/or biological criteria Refusal to give written consent to take part in the study Refusal to give a blood sample Blood samples from parents not available
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with neutropenia<br> | Genetic: High-throughput exome sequencing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of a gene or genes responsible for congenital neutropenia syndromic |  | day 1 |
Impact of HPV on a Cohort of Southern Italian Women: Epidemiological, Clinical, Morphological and Microbiological Features

Study Overview
=================
Brief Summary
-----------------
HPV is known to be the causal agent in the majority of cervical cancers. However, the role of the cervical bacterial microbiome in cervical cancer is not clear

Official Title
-----------------
Impact of HPV on a Cohort of Southern Italian Women: a Prospective Observational Study About Epidemiological, Clinical, Morphological and Microbiological Features of HPV Infection

Conditions
-----------------
Cervix Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Cervical biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in fertile age Exclusion Criteria: severe comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HPV-positive patients<br>Patients who are positive for HPV DNA test | Diagnostic Test: Cervical biopsy<br>* in office Cervical biopsy<br>|
| Active Comparator: HPV-positive patients - Echinacea<br> | Diagnostic Test: Cervical biopsy<br>* in office Cervical biopsy<br>|
| No Intervention: HPV-positive patients - Standard<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Cervical microbiome |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hpv, cervical cancer, microbiome
Acetyl-L-Carnitine In Severe Hepatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
To assess the clinical efficacy of ALC in the treatment of severe hepatic encephalopathy (grade 3 of the West Haven grading scale), we performed a randomised, double blind placebo-controlled study administering ALC to cirrhotic patients, evaluating the effects on ammonia levels and performance in cognitive functions.

Conditions
-----------------
Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale)

Intervention / Treatment
-----------------
* Drug: Acetyl-l-Carnitine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with severe hepatic encephalopathy (grade 3 of the West Haven grading scale) with hepatic cirrhosis Exclusion Criteria: Patients with a history of recent alcohol abuse, patients using psychotropic drugs (e.g., antipsychotics, interferon, benzodiazepines, anti-epileptics, sedatives and antidepressants) Other exclusion criteria were the following: major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis; acute superimposed liver injury;patients with metabolic disorders such as diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease; any additional precipitating factors such as high protein intake (additional high-protein meals), constipation; illiteracy.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetyl-L-carnitine<br> | Drug: Acetyl-l-Carnitine<br>* 2g per day<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* twice per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery

Study Overview
=================
Brief Summary
-----------------
Remimazolam besylate, as a new benzodiazepine drug, has few advantages in respiratory depression and gastrointestinal motility. The study will further explore the safety and effectiveness of remimazolam besylate n the sedation of mechanically ventilated patients after oral and maxillofacial surgery in the ICU

Official Title
-----------------
RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery: a Single-center, Randomized, Non-inferiority Clinical Study

Conditions
-----------------
Remimazolam Besylate, Sedation, ICU

Intervention / Treatment
-----------------
* Drug: Remimazolam Besylate
* Drug: Propofol
* Drug: midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years old mechanical ventilation patients with expected ICU stay time <72h People who need immediate sedative treatment Exclusion Criteria: pregnancy； can not get RASS score from patients allergy to drugs

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: Remimazolam besylate<br> | Drug: Remimazolam Besylate<br>* NS 50ML+ Remimazolam besylate(50mg , 2mg:2ml），IV-Pump，maintenance dose 0.1-0.3mg/h<br>|
| Active Comparator: propofol<br> | Drug: Propofol<br>* Propofol (50ml, 0.5g), IV-Pump，maintenance dose 0.3-4.0mg/kg/h<br>|
| Active Comparator: midazolam<br> | Drug: midazolam<br>* midazolam (10mg,2ml), IV-Pump，maintenance dose 0.02-0.1mg/kg/h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in each group who reached the target analgesia score range |  | From date of using the intervention drugs until the date of extubation, up to 28 days] |