linjc16/ctgov huggingface dataset:
Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devices at 3 months follow-up.

Conditions
-----------------
Hernia, Inguinal

Intervention / Treatment
-----------------
* Device: Proflex® Mesh Mesh implantation
* Device: Marlex® Mesh Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients >=20 years =<85 years old Patients with Unilateral hernia Patients without previous operations in lower part of abdomen Patients capable to understand the explanation about purpose and method of the trial, and write an Informed Concent Form Patients capable to participate during the period of the trial Exclusion Criteria: Previous hernia repair at the same site Incarcerated hernia Strangulated hernia Patients to whom and open surgery cannot be indicated Previous urological surgery Immune incompetence of patient: AIDS, vesical fibrosis, etc. Patients with AIHD or patients who take immunosuppressive drugs Patients with liver disease (ASL, AST ≥ normal value by more than 3 times) Patients with kidney disease (creatinine>2.0mg/dL) Patients on anti-coagulants Patients with severe systematic disease Patients with malignant tumor Patients with infection or with the predicted problem of surgery site healing Participation in another clinical study within the last 30 days Patients whose participation is considered inappropriate according to other except above mentioned clinical condition

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proflex® Mesh<br>Device: Partially absorbable lightweight mesh Intervention: Mesh implantation | Device: Proflex® Mesh Mesh implantation<br>* Implantation of mesh in the incision of inguinal area<br>|
| Active Comparator: Marlex® Mesh<br>Device: Non-absorbable Heavyweight mesh Intervention: Mesh implantation | Device: Marlex® Mesh Implant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score (10-point Visual Analogue Scale) |  | Day90 after operation |
Feasibility of the Management of Severe Cervical Dysplasia in a Single Visit

Study Overview
=================
Brief Summary
-----------------
Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a multi-ethnic population of women; Set up an efficient system for interpretation of Pap smears for patients in the SVP that will minimize waiting time; Determine the follow-up rates and compare them between women assigned to the SVP and a usual care program (UCP); Determine satisfaction and compare it between women assigned to the SVP and the UCP; Determine the cost-effectiveness and compare it between the SVP and UCP

Detailed Description
-----------------
Women were recruited from underserved communities to participate in this single visit cervix cancer project. Large loop electrosurgical excision procedure (LEEP) was performed on SVP subjects with either a diagnosis of HGSIL/AGUS or suspicion of carcinoma. All other subjects with abnormal Papanicolaou smears were referred to our abnormal cytology clinics or received care in the community.

Official Title
-----------------
Single Visit Cervical Cancer Prevention Program

Conditions
-----------------
Cervical Intraepithelial Neoplasia

Intervention / Treatment
-----------------
* Procedure: Large loop electrosurgical excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years No history of invasive cervical cancer Not pregnant Exclusion Criteria: Absence of a cervix Abnormal vaginal bleeding Cervical cancer screening within the previous 12 months A known bleeding disorder Reluctance to be randomized Unwillingness to follow the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Large loop electrosurgical excision|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Treatment of Recalcitrant Hand and Foot Warts With Intense Pulsed Light - a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is for recalcitrant hand and foot warts to compare the efficacy of treatment with Intense Pulsed Light and paring versus paring alone.

Official Title
-----------------
Treatment of Recalcitrant Hand and Foot Warts With Intense Pulsed Light and Paring Versus Paring Alone - a Randomized Controlled Trial With Blinded Response Evaluation

Conditions
-----------------
Warts

Intervention / Treatment
-----------------
* Procedure: Intense Pulsed Light + paring versus paring alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Recalcitrant warts No previous IPL treatment of warts Exclusion Criteria: Immunosuppressive treatment Patients suffering from HIV, diabetes or other immunosuppressive diseases Pregnancy Previous IPL treatment Patients with a tendency to prodyce keloids or hypertrophic scars Mosaic and flat warts Lack of informed consent

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Intense Pulsed Light + paring versus paring alone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Warts, Intense pulsed light, RCT, Recalcitrant hand and foot warts
COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection

Study Overview
=================
Brief Summary
-----------------
Effect of Covid-19 disease in clotting factors levels in hospitalized patients

Detailed Description
-----------------
Effect of Covid-19 disease in clotting factors levels in hospitalized patients positive for sars-cov2 infection. Association between clotting factors levels and disease severity,morbidity and mortality in these patients. Effect of anticoagulant therapy in the clotting factors' levels in these patients

Official Title
-----------------
COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection

Conditions
-----------------
SARS-COV2 Infection, COVID-19 Disease, Hospitalized Patients

Intervention / Treatment
-----------------
* Drug: low molecular weight Heparin as standard of care treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AGE> 18 SINGED INFORMED CONSENT FORM POSITIVE PCR TEST FOR SARS-COV2 INFECTION FINDINGS IN CXR OR CT OF THE LUNGS CONSISTENT WITH INFECTION OF LOWER RESPIRATORY TRACT Exclusion Criteria: AGE<18 DENIAL TO PROVIDE INFORMED CONSENT FORM HISTORY OF MALIGNANCY PRIOR USE OF ANTICOAGULANT THERAPY PRIOR USE OF STEROIDS LONGER THAN 14 DAYS LACTATION-PREGNANCY

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 |
| --- |
|Drug: low molecular weight Heparin as standard of care treatment|STANDARD OF CARE|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFFECT OF COVID-19 DISEASE IN CLOTTING FACTORS | leves of cloting factors before and after treatment with LMWH | 6 MONTHS |
Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical investigation is to evaluate the performance and safety of the F&P Toffee nasal pillows mask in a home environment.

Official Title
-----------------
Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: F&P Toffee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons who are ≥22 years of age Persons who weigh ≥66 pounds Persons who have been prescribed PAP therapy by a physician Persons who are existing nasal pillows mask users with at ≥3 months of use prior to enrolment in the clinical trial Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial Persons who are fluent in spoken and written English Persons who possess the capacity to provide informed consent Exclusion Criteria: Persons who are intolerant to PAP therapy Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate Persons who are required to use PAP therapy for >12 hours per day or for extensive periods, not including sleep or naps Persons who are trying to get pregnant, are pregnant, or think they may be pregnant Persons who have an IPAP pressure of >25 cmH2O if on BPAP Persons who use a PAP therapy device for the delivery of medicines, except supplemental O2 Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site

Ages Eligible for Study
-----------------
Minimum Age: 22 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

| Intervention/Treatment |
| --- |
|Device: F&P Toffee|Nasal pillows mask|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index | Acceptable maintenance or lower (improved score) from baseline. Scores below 5 indicate a better outcome. | 14±5 days | 
| Epworth Sleepiness Scale | Acceptable maintenance or lower (improved score) from baseline. Scores below 11 indicate a better outcome. | 14±5 days |
Secondary Cancer Risk After Radiation Therapy for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Retrospective study comparing dose distribution of 3D conformal radiotherapy (3DCRT) and volumetric-modulated arc therapy (VMAT) to estimate secondary cancer risk for patients having had radiation therapy for rectal cancer. Twenty-five patients are included in this study. Planning CT scans are used for comparison of dose distribution and calculation of second cancer risk.

Detailed Description
-----------------
A model-based Analysis calculating the organ-specific excess lifetime attributable risk using the planning CT data sets of 25 patients to estimate second cancer risk for patients after radiotherapy for rectal cancer comparing conventional 3DCRT with VAMT techniques.

Official Title
-----------------
Estimation of Second Cancer Risk in Patients Planned With Different Radiotherapy Regimes for Rectal Cancer - A Planning Study and Model-based Analysis

Conditions
-----------------
Neoplasms, Second Primary

Intervention / Treatment
-----------------
* Other: No intervention in this retrospective study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/Female > 18 years of age pre or postoperative radiation therapy for rectal cancer Planning CT Exclusion Criteria: Planning CT not available

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

| Intervention/Treatment |
| --- |
|Other: No intervention in this retrospective study|No Intervention in this retrospective Analysis. All patients included did receive Radiation therapy Independent of this study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculation of the organ-specific excess lifetime attributable risk (LAR) (%) | LAR is calculated for variable Ages at exposure | 60 years (model-based calculation) |
A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers

Study Overview
=================
Brief Summary
-----------------
This single-center, open-label, single dose, randomized, two-way cross-over study will evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese volunteers. Subjects will be randomized to receive a single oral dose of either 10 mg or 20 mg RO4917838 and, after a washout period of at least 21 but no more than 35 days, will be re-dosed with the alternative treatment. Anticipated time on study is up to 70 days.

Official Title
-----------------
A Single-center, Open-label, Single Dose, Randomized, Two-way Cross-over Study to Investigate the Pharmacokinetics, Safety, and Tolerability of RO4917838 in Healthy Chinese Volunteers

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: RO4917838
* Drug: RO4917838


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Chinese male and female volunteers, 18 to 45 years of age inclusive at time of screening Healthy status is defined by absence of evidence of any active or chronic disease or disorder following a detailed medical and surgical history and a complete physical examination Body mass index (BMI) 19 to 28 kg/m2 inclusive Exclusion Criteria: Pregnant or currently lactating females History of any clinically relevant disorder Any history of depressive episodes or treatment with antidepressants History of drug abuse within the past 2 years or positive results for drugs of abuse at screening or Day -1 Alcohol dependence or history of this within the past 2 years or positive results for alcohol breath test at screening or Day -1 Positive for HIV, hepatitis B or hepatitis C infection Regular smoker with consumption of more than 10 cigarettes a day or equivalent amount of tobacco Participation in a clinical study with an investigational drug or device within the last 3 months prior to dosing Medical history of significant drug allergies

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: RO4917838<br>* 10 mg single oral dose<br>|
| Experimental: B<br> | Drug: RO4917838<br>* 20 mg single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the concentration-time curve (AUC) |  | 12 days | 
| Pharmacokinetics: Peak plasma concentrations (Cmax) |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 4 months |
Spontaneous Bacterial Peritonitis: Incidence, Risk Factors and Outcome

Study Overview
=================
Brief Summary
-----------------
Spontaneous bacterial peritonitis (SBP) is a severe complication of ascites in cirrhotic patients. Under clinical experience, this condition seems to be more uncommon in Finland. The aim of this study was to measure the incidence of SBP in consecutive patients with ascites requiring hospitalization in a Finnish University Hospital.

Detailed Description
-----------------
Spontaneous bacterial peritonitis (SBP) is a complication of liver cirrhosis with high mortality and low survival rates. The incidence of SBP is reported to range from 11-35% in patients with ascites requiring hospitalization. Under clinical experience, the incidence of SBP in Finland seems to be lower than reported elsewhere. Alcohol is the dominant etiologic factor of liver cirrhosis in Finland (90%), which might be a factor affecting the incidence of SBP. The aim of this study is to measure the incidence of SBP in Finland. We included consecutive patients who underwent diagnostic paracentesis for ascites in Tampere University Hospital during 2/1994 - 12/1998 and 1/2005 - 3/2007. Spontaneous bacterial peritonitis was diagnosed when the ascitic fluid contained over 250 polymorphonuclear cells / mm^3 regardless of culture and with no evidence of intra-abdominal source of infection e.g. an abscess or a perforation.

Official Title
-----------------
Spontaani Bakterielli Peritoniitti: Esiintyvyys, riskitekijät ja Vaikutus Ennusteeseen

Conditions
-----------------
Spontaneous Bacterial Peritonitis, Primary Peritonitis, Ascites

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnostic paracentesis performed during the study period
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spontaneous bacterial peritonitis, incidence, Finland, etiology, liver cirrhosis
A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.

Official Title
-----------------
A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Drug: Trafermin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vertical intrabony defect from radiographs at baseline Age of 20 years or older Exclusion Criteria: Using an investigational drug within the past 24 months Coexisting malignant tumour or history of the same Coexisting diabetes (HbA1C 6.5% or more) Taking bisphosphonates Coexisting gingival overgrowth or history of the same

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental H<br>high volume (0.6mL、0.3% Trafermin) | Drug: Trafermin<br>* Administered to the bone defect during flap operation<br>* Other names: KCB-1D;|
| Experimental: Experimental L<br>low volume (0.2mL、0.3% Trafermin) | Drug: Trafermin<br>* Administered to the bone defect during flap operation<br>* Other names: KCB-1D;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum Trafermin level |  | within 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence and level of adverse reaction |  | within 4 weeks | 
| serum anti-Trafermin antibody level |  | within 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trafermin, Periodontitis