linjc16/ctgov huggingface dataset:
Impact of Continuous Defocused CO2 Laser Vaporisation on the Histological Malignant Transformation of Erosive Oral Lichen Planus in Patients

Study Overview
=================
Brief Summary
-----------------
Oral Lichen Planus (OLP) is a common condition with its erosive variant occasionally presenting a management challenge to the clinician. In addition it can have debilitating consequences on the patients' quality of life. The malignant transformation of OLP has been well documented. The aims of this work were to measure the number of patients developing malignant transformationof OLP to squamous cell carcinoma (SCC) comparing patients undergoing traditional symptomatic treatments with those patients that were treated by CO2 laser from 2004 - 2011. Outcome measures were rated by incisional biopsy (histology Report).

Official Title
-----------------
Clinical Trial Analyzing the Impact of Continuous Defocused CO2 Laser Vaporisation on the Histological Malignant Transformation of Erosive Oral Lichen Planus

Conditions
-----------------
Oral Lichen Planus

Intervention / Treatment
-----------------
* Device: CO2-Laser Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oral lichen planus Histological confirmation of diagnosis Patient willing for treatment Exclusion Criteria: Patient just does not want to participate as control/study group

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Symptomatic treatment<br>Symptomatic analgetic Treatment only was performed without any Manipulation of OLP lesions. | |
| Active Comparator: CO2-Laser Treatment<br>CO2-Laser Vaporisation was performed of OLP lesions under local anaesthesia. | Device: CO2-Laser Treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stable disease of OLP (clinical observation) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of oral cancer (histological report after incisional biopsy) |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral lichen planus, recurrence, Treatment, cancer, Primary disease Management
Residual Plasma Concentration of Sorafenib and Adverse Events in CHC

Study Overview
=================
Brief Summary
-----------------
To date, Sorafenib is the only drug therapy to have demonstrated a benefit in overall survival in patients with advanced or metastatic hepatocellular carcinoma. However, this treatment causes many adverse effects that may limit its prescription. Under these conditions, predicting and therefore potentially preventing the adverse effects of sorafenib is a major issue in the management of patients with hepatocellular carcinoma treated with this drug. Currently, there is little data available on the correlation between the pharmacokinetics of sorafenib and the side effects of this drug in patients treated for hepatocellular carcinoma. Investigators propose an observational cohort study evaluating the correlation between residual plasma concentration of sorafenib and the risk of severe adverse effects (grades 3-5) in treatment in patients treated for hepatocellular carcinoma on cirrhosis. This study should include 60 patients over an expected duration of 12 months. The aim of this work is to determine whether there is a correlation between the residual plasma concentration of sorafenib and the occurrence of severe adverse effects (grades 3-5) at treatment in patients treated for hepatocellular carcinoma on cirrhosis as well as potential influence of the etiology of cirrhosis on this relationship. The ultimate ambition is to be able to anticipate and thus prevent these adverse effects in order to increase the safety of the drug and potentially its effectiveness.

Official Title
-----------------
Relationship Between the Residual Plasma Concentration of Sorafenib and the Occurrence of Adverse Events in Patients Treated for Hepatocellular Carcinoma

Conditions
-----------------
Advanced or Metastatic Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Patients. Patients with hepatocellular carcinoma on cirrhosis. Patients treated for the first time with sorafenib for hepatocellular carcinoma. Informed information about the study. Exclusion Criteria: Patients with contraindications to sorafenib. Pregnant or lactating woman

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| residual plasma concentration of sorafenib |  | from baseline over 6 month | 
| occurrence of severe adverse effects (grades 3-5) |  | from baseline over 6 month |
Safety, Efficacy and Pharmacokinetics of BTA-C585 in a RSV Viral Challenge Study

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585 compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b virus.

Official Title
-----------------
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity Against Respiratory Syncytial Virus Infection, and the Pharmacokinetics of Multiple Oral Doses of BTA-C585 in the Virus Challenge Model

Conditions
-----------------
Respiratory Syncytial Virus (RSV) Infection

Intervention / Treatment
-----------------
* Drug: BTA-C585 oral capsule
* Drug: Matching placebo capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female Between 18 to 50 years old Body mass index of 18 to 30 kg/m2 Exclusion Criteria: Acute or chronic medical illness Abnormal lung function Positive for HIV, Hepatitis B or C Any significant abnormality of the nose or nasopharynx

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: BTA-C585<br>BTA-C585 100 mg oral capsule | Drug: BTA-C585 oral capsule<br> <br> * Other names: BTA585;|
| Placebo Comparator: Placebo<br>Matching placebo capsule | Drug: Matching placebo capsules<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) viral load of RSV-A Memphis 37b |  | Days 2-13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) of total RSV symptom scores |  | Days 1-13 | 
| Number of adverse events |  | Screening to Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Viral diseases, Antiviral, Paramyxoviridae infections, RSV, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
Lower Uterine Segment Thickness and Term Pain,Previous Cesarean Section

Study Overview
=================
Brief Summary
-----------------
the purpose of the researchers; The aim of this study is to evaluate the consistency of niche dimensions measured by ultrasonography with visual measurement of the surgeon during the operation of the patient when presenting with pain in her current pregnancy. If patients who have had previous cesarean section present to the emergency department with pain or NST pain, a panic occurs immediately for operation. Purpose of researchers; The aim of this study is to investigate whether a really fine determination of the thickness of the old incision line is associated with full-thickness rupture or incomplete rupture, which appears to be an operation, and if a relationship is found, there is a limit for this thickness.

Official Title
-----------------
Evaluation of Lower Uterine Segment Thickness in Pregnant Women Presenting With Term Pain and Previous Cesarean Section

Conditions
-----------------
Cesarean Section; Dehiscence, Cesarean Section Complications

Intervention / Treatment
-----------------
* Procedure: Measure niche thickness with ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a previous cesarean section Those in term gestational week (37-42 weeks) Those who apply to the emergency with pain Exclusion Criteria: Birden fazla sezaryen geçirilmiş öyküsü olan hastalar Önceden geçirilmiş uterin cerrahisi olan hastalar Miad olmayan gebeler Plesantal yerleşim patolojısı olan gebeler

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with previous cesarean section<br>presenting to the emergency department with pain, previous cesarean section; Patients measured niche thickness before operation | Procedure: Measure niche thickness with ultrasound<br>* in patients with previous cesarean section who applied to the emergency department with pain and underwent surgery; Measure niche thickness before operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure niche thickness with ultrasound | Ultrasonography of Lower Uterine Segment Thickness in Pregnant Women Presenting with Term Pain and Previous Cesarean Section It will be given in mm. | 1 day | 
| Measure niche thickness with visual evaluation of the surgeon | Measured Lower Uterine Segment Thickness by Visual Evaluation of Pregnant Women Presenting with Term Pain and Previous Cesarean Section no rupture have full coat rupture have incomplete rupture; will be valued as. | 1 day |
Isotopic Imaging for Prodromal Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to characterize cerebral metabolism modifications using 18F-FDG PET technology and perfusion with 99MTC-ECD SPECT in patients with prodromal Alzheimer's Disease drawn from a high risk population. We also compare PET and SPECT imaging within this framework, and search for optimal diagnostic thresholds.

Official Title
-----------------
Evaluating the Performance of Isotopic Brain Imaging of Glucose Metabolism Via PET (18F-FDG) and Perfusion SPECT (99mTc-ECD) for the Diagnosis of Prodromal Stage Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for the group with memory problems: patient consulting for memory problems caucasian memory complaint is validated by a clinical evaluation cognitive performance is sufficiently well preserved so that a diagnostic of dementia cannot be made (according to the DSM-IV-R and NINCDS-ADRDA criteria) at the time of inclusion the patient speaks French presence of an informant accepts to sign consent Inclusion Criteria for the group without memory problems (reference population): at least four years of formal education patient consulting for memory problems memory problem reported by the patient is not validated by the consultation, nor by the battery of tests specified during screening presence of an informant Clinical Dementia Rating (CDR) = 0 accepts to sign consent Exclusion Criteria: Instrumental Activities of Daily Living (IADL): at least two items > 1 Anticholinesterasic treatments and/or memantin before study inclusion major depressive syndrome, according to the Global Depressive Scale Known neurodegenerative disease or general disease or major physical problems that could interfere with cognitive functioning and testing Pathology that might lead to death in the short term (evolving cancer, non stable cardiopathy, hepatic, renal or respiratory insufficiency) contra-indications for MRI, PET or SPECT scans not affiliated with a social security regimen

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- |
| Memory problems<br>Group with clinically validated memory problems | |
| Reference group<br>Group without memory problems | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between AUCs for PET and SPECT imaging | The difference between the AUCs (area under the curve) for PET and SPECT imaging. | 1 month |
Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants

Study Overview
=================
Brief Summary
-----------------
Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3 min after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron status until six months after birth, without increasing the risk of polycythaemia or other adverse events. We hypothesize that this intervention will also benefit low birth weight infants in South Africa.

Official Title
-----------------
The Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants: a Randomised Controlled Trial in South Africa.

Conditions
-----------------
Low Birth Weight, Perinatology, Iron Status, Cord Clamping

Intervention / Treatment
-----------------
* Procedure: Cord clamping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant mothers with SFH measurements below the cutpoint are eligible for inclusion. We aim to include infants with a birth weight below 2500 grams, but the actual birthweight can only be assessed after birth. We therefore accept an error of 500 grams (20%) and will include newborns up to 3000 grams. Birthweight will be measured after randomisation and study treatment. Exclusion Criteria: twin pregnancy history of postpartum haemorrhage (PPH) (gestational) diabetes pre-eclampsia abruptio placentae caesarian section necessity of early clamping due to tight nuchal cord need for resuscitation immediately after birth major congenital abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early cord clamping<br>Within 30 seconds after birth. | Procedure: Cord clamping<br>* Early vs Delayed<br>|
| Experimental: Delayed cord clamping<br>Between 2 and 3 minutes after birth | Procedure: Cord clamping<br>* Early vs Delayed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin level |  | two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperviscosity syndrome |  | 1 day | 
| Iron status |  | two months | 
| hyperbilirubinaemia |  | 2 days |
Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this expanded access treatment protocol is to provide patients access to teclistamab prior to market authorization. The program is limited to patients with relapsed or refractory multiple myeloma who have exhausted all treatment options available as local standard of care and who are not eligible for a teclistamab clinical trial.

Official Title
-----------------
Teclistamab US Expanded Access Treatment Protocol for Patients With Relapsed or Refractory Multiple Myeloma

Conditions
-----------------
Relapsed or Refractory Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Teclistamab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient diagnosed with Relapsed or Refractory Multiple Myeloma Patient exhausted all commercially approved and clinically appropriate (not patient or physician preference) treatment options, and is ineligible for a clinical trial

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Teclistamab|Teclistamab will be administered subcutaneously (SC).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (Crohn's or ulcerative colitis) and pyoderma gangrenosum. This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2 weeks initially, then every 1-2 months later in the study.

Official Title
-----------------
An Open Label Single Center Pilot Study Investigating the Clinical Response and Mechanism of Action of Infliximab in the Treatment of Adults With Inflammatory Bowel Disease Who Have Moderate to Severe Pyoderma Gangrenosum

Conditions
-----------------
Pyoderma Gangrenosum, Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Drug: Infliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must Be ages 18-75 Must have both inflammatory bowel disease and moderate to severe pyoderma gangrenosum Must never have received Infliximab for the treatment of pyoderma gangrenosum Exclusion Criteria: Have had any previous treatment with monoclonal antibodies other than infliximab used to treat IBD or antibody fragments. Have a history of serious infections

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: Infliximab<br>Single arm open label IV Infliximab given at weeks 1,2,14,22 | Drug: Infliximab<br>* IV drug given at weeks 1,2,14,22<br>* Other names: Remicade;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease | Outcome was measured by clinical assessment of pyoderma gangrenosum. The number of patients who had improvement and/or clearance of the pyoderma grangrenosum after the infusions and through the follow up visit was assessed. | Week 26 |
A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.

Official Title
-----------------
A Second Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy, Immunogenicity and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) as an Aid to Smoking Cessation

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Biological: NicVAX Vaccine
* Biological: Placebo Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking. Smokers who are in good general health. Exclusion Criteria: Prior exposure to NicVAX or any other nicotine vaccine. Use of systemic steroids. Cancer or cancer treatment in the last 5 years. HIV infection. History of drug or alcohol abuse or dependence within 12 months. Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease. Inability to fulfill all visits for approximately 52 weeks.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Vaccine<br> | Biological: Placebo Vaccine<br>* Placebo vaccine given 6 times over 6 months<br>|
| Experimental: NicVAX Vaccine<br> | Biological: NicVAX Vaccine<br>* NicVAX vaccine given 6 times over 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate NicVAX as an aid to smoking cessation for long term abstinence (by subject self-report and carbon monoxide confirmation). |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate abstinence rates at multiple intervals (by subject self-report and carbon monoxide confirmation). |  | One year | 
| Evaluate safety based on adverse events. |  | One year | 
| Evaluate immunology based on serum antibody concentration. |  | One year | 
| Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence (based on subject self-report). |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking Cessation, NicVAX, Smoking Vaccine, Smoking Abstinence, Smoking, Tobacco Cessation