linjc16/ctgov huggingface dataset:
The Effect of Bowel Preparation Status on the Polyp Missing Rate

Study Overview
=================
Brief Summary
-----------------
High quality bowel cleaning preparation was most important prerequisites of a accurate colonoscopy, because even a small amount of residual fecal matter can obscure small polyps and increase unnecessary procedure time. Until now, several studies evaluated the impact of bowel preparation on the quality of colonoscopy using comparison of the polyp detection rate in patients with adequate bowel preparation status to that in patients with inadequate bowel preparation status during colonoscopy. However, there was no direct measurement the effect bowel preparation status on the polyp missing rate, the quality of colonoscopy, using tandem colonoscopic evaluation in prospective setting.

Detailed Description
-----------------
1. Study flow All patients perform Colonoscopy record the polyp size, shape, location and number record the factors affecting polyp missing rate Patients' age / gender Indication of colonoscopy colonoscopist career colonoscopy withdrawal time bowel preparation status according to scale of U.S. Multi-Society Task Force on colorectal cancer, Aronchick's scale and Ottawa bowel preparation quality scale the patients needed or wanted to 2nd stage colonoscopic polypectomy (2nd stage polypectomy was performed within 6 month) record additionally detected polyp - size, shape, location and number

Official Title
-----------------
The Effect of Bowel Preparation Status on the Polyp Missing Rate During Colonoscopy: Prospective Study Using Tandem Colonoscopic Evaluation

Conditions
-----------------
Colorectal Polyps, Colonoscopy, Bowel Preparation, Polyp Missing Rate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients underwent colonoscopy and 2nd stage colonoscopic polypectomy at Konkuk University Medical Center Exclusion Criteria: Colonoscopy was not reached the caecum The patients with 10 or more polyps (who suspected polyposis syndrome) Bowel preparation was inadequate when 2nd stage colonoscopic polypectomy The patients with inflammatory bowel disease or suspected inflammatory bowel disease The patients had a history of bowel resection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| colonoscopy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Elevated Platelet Count as Prognostic Factor in Colorectal Cancer With Synchronous Liver Metastases

Study Overview
=================
Brief Summary
-----------------
Colorectal cancer (CRC) is the third most common malignancy worldwide and is often metastatic at diagnosis. Despite progresses in surgical techniques and the introduction of novel chemotherapy regimens, many patients still suffer from a poor prognosis. It is therefore of utmost importance to identify prognostic markers that may improve selection of patients. In recent years several studies demonstrated that preoperative blood tests as platelet count or neuthophil-to-lymphocyte ratio could be prognostic factors in CRC as well as other malignancies. The aim of this study was to evaluate the role of preoperative platelet count (PC) in patients with synchronous colorectal liver metastases.

Official Title
-----------------
Elevated Platelet Count as Prognostic Factor in Colorectal Cancer With Synchronous Liver Metastases: a Retrospective Single-center Cohort Study

Conditions
-----------------
Colorectal Cancer, Colorectal Carcinoma, Stage IV Colon Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Measurement of platelet count at diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorectal cancer with synchronous liver metastases Possibility to retrieve pre-operative platelet count Age of 18 years or older Availabilty of clinical-pathological data Minimum follow up of 12 months Exclusion Criteria: None

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 |
| --- | --- |
| s-CRLM<br>Patients with synchronous colorectal liver metastases who underwent surgical resection | Diagnostic Test: Measurement of platelet count at diagnosis<br>* Blood samples were drawn by expert phlebotomists in vacuum blood tubes containing K2-EDTA (Terumo Europe NV, Leuven, Belgium). The complete blood cell count (CBC) was performed using Advia 2120 (Siemens Healthcare Diagnostics, Tarrytown NY, USA). The local reference range for platelets was 150-400 x 109/L. The same analyser was used throughout the study period, and the quality and reproducibility of test results was validated by data of both internal quality control and external quality assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | correlation between high PC and overall survival | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinic-pathological variables | correlation between high PC and clinic-pathological variables | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelets, thrombocytosis, prognosis
Evaluation of Integra® Artificial Dermis for the Treatment of Leg Ulcers

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound. This is a multi-centre study on 60 patients who have a lower limb ulcer.

Conditions
-----------------
Lower Limb Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (> 10 cm²) patients in whom the surgeon has recommended that an Integra® matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis. not eligible for skin flap surgery, the patient or patient's representative has agreed to sign the information letter before any investigation required by the research. Exclusion Criteria: circumferential wound, wound infection immunosuppressed patient, known allergy to bovine collagen, bovine glycosaminoglycans or silicone, patients under legal guardianship, pregnant women patients whose health would compromise follow-up for at least 18 months, patients whose mental health would compromise completion of the self-evaluation questionnaires. wound located in an area not visible by the patient (as no self-assessment would be possible).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Proportion of patients with a greater than 50% reduction in wound surface area during the 18 months after grafting. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional complications of healing at 3, 6, 12 and 18 months |  | 3, 6, 12 and 18 months | 
| Complete wound healing (reduction in wound surface area >90%) |  | 3, 6, 12, 18 months | 
| Pain |  | 3, 6, 12, 18 months | 
| Quality of life |  | 3, 6, 12, 18 months | 
| Transcutnaeous oxygen pressure (TcPO2) |  | 6, 12 and 18 months |
Comparison of Botulinum Toxin and Sphincterotomy in the Treatment of Chronic Anal Fissure

Study Overview
=================
Brief Summary
-----------------
Intra-sphincteric injection of botulinum toxin seems to be a reliable option causing temporary alleviation of sphincter spasm and allowing the fissure to heal. study is to compare the outcome of surgical sphincterotomy and botulinum toxin injection treatments in patients with uncomplicated chronic anal fissure.

Detailed Description
-----------------
consecutive patients with uncomplicated chronic anal fissure who had failed conservative treatment were randomized to receive either intra-sphincteric injection of botulinum toxin (BT) or lateral internal sphincterotomy (LIS). Postoperative pain relief, healing of fissure, continence scores and fissure relapse during 18 weeks of follow up was the outcomes assessed.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: conservative lateral internal sphincterotomy
* Procedure: Intra-sphincteric Botulinum-toxin injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosis of chronic anal fissure was based on evidence of circumscribed ulcer at anal canal with indurations at the edges and exposure of the horizontal fibers of the internal anal sphincter at its floor. Exclusion Criteria: Anal fissure that had been operated on before, complicated fissure with cicatricial deformation, large sentinel pile, associated hemorrhoids, suspected inflammatory bowel disease, or malignancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| LIS group)<br> | Procedure: conservative lateral internal sphincterotomy<br> <br> |
| BT group<br> | Procedure: Intra-sphincteric Botulinum-toxin injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain relief, healing of fissure, continence scores |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fissure relapse |  | 18 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain after treatment, healing of fissure after treatment, continence scores after treatment
Molecular Mediators of Nerve Injury Signaling

Study Overview
=================
Brief Summary
-----------------
Specific proteins and other signaling molecules are increased and decreased following nerve injury. Some of these are important in producing pain or explaining why pain persists after traumatic nerve injuries or in disease states such as diabetes. In this study, the investigators hypothesize that it is possible to detect changes in specific signaling molecules and that these will provide insights into novel treatment strategies. The patients to be included are those who are undergoing the removal of tissue during surgery. The tissues that would otherwise be discarded will be included in the study as appropriate.

Official Title
-----------------
Molecular Mediators of Nerve Injury Signaling

Conditions
-----------------
Diabetes, Nerve Injury, Chronic Neuropathic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing surgery where tissue removal is anticipated Exclusion Criteria: age younger than 18

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetes<br> | |
| Nerve injury<br> | |
| Other<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Active Surveillance for Prostate Cancer With Indolent Features

Study Overview
=================
Brief Summary
-----------------
In patients with prostate cancer with indolent features, disease progrssion may be very slow and in many cases will never become clinically evident during the patient's lifetime. Active surveillance is a continuous process of monitoring disease characteristcs aiming to avoid the morbidity of active therapy in patients with stabe indolent parameters, while offering early detection of disease activity in others who will need active therapy to control their disease. We hypothesize that active surveillance will permit the avoidance of therapy related morbidity in the majority of appropriate patients and will be associated with maintaining their quality of life.

Official Title
-----------------
Prospective Cohort Study of Active Surveillance for Prostate Cancer With Indolent Linical Features

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men 65 years of age or older who were diagnosed with prostate cancer in the past 3 month prior to inclusion Gleason's score of 6 or less. Clinical T1C per digital rectal exam. Pre biopsy PSA serum level of 6.0ng/ml or less. The presence of cancer in a single biopsy core of at least 8 taken. The presence of cancer in no more than 10% of the length of the core involved. Patient's consent to engage in active surveillance after being informed of the benefits and potential risks of this approach as well as of alternative lines of therapy. Israeli residence with the readiness to be available for the followup schedule. Exclusion Criteria: Patients who do not meet the above eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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
-----------------
prostate cancer, active surveillance, indolent features
Influence Of Different Airflow Resistances On Drug Effect Of 50μg Salmeterol And 6 μg Formoterol

Study Overview
=================
Brief Summary
-----------------
Effect of inhaled drugs administered as dry powder is not only dependent on drug efficacy but also on technical properties of the inhalers. Different inhalers have different internal resistances and therefore it is expected that patients with limited airflow may have different exposure rates of drugs delivered from different devices

Official Title
-----------------
Single-Centre Randomised Open Crossover Study to Examine the Influence of Different Internal Resistances of Discus and Turbohaler Respectively on the Effects of Salmeterol and Formoterol in Asthmatic Subjects

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: formoterol (TURBOHALER)
* Drug: Salmeterol (DISKUS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Asthma Reversibility >15% and 200 ml in total FEV1 <85% of normal Exclusion criteria: Smoking history >20 pack years Treatment with ICS >500μg Fluticasone or aquivalent in the last 4 weeks Asthma exacerbation in the last 4 weeks

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: formoterol (TURBOHALER)|nan|
|Drug: Salmeterol (DISKUS)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1 second (FEV1) under time curve 0.5-6 hours after inhalation of study medication |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway resistances and peak FEV1 measured 0.5, 1, 2, 4 and 6 hours after inhalation of study drug |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Salmeterol, Formoterol, Airway resistance
A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
The study try to show the weekly cisplatin based CCRT is not inferior to 3-weekly cisplabe based CCRT in terms of 3-yr progression free survival rate in advanced nasopharyngeal carcinoma

Official Title
-----------------
A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma

Conditions
-----------------
Nasophayngeal Carcinoma Between Stage II and IVb

Intervention / Treatment
-----------------
* Drug: cisplatin (3 weekly)
* Drug: cisplatin (weekly)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed nasopharyngeal carcinoma age of 18 years or over stage II   IVb no history of chemotherapy, radiotherapy, or immunotherapy for NPC with measurable lesion based on RECIST 1.1 ECOG PS 0  2 good organ function (liver, renal, hematologic) Exclusion Criteria: active infectious disease requiring antibiotics uncontrolled heart disease pregnancy and on feeding state history of other malignancy within 5 years before enrollment, except for well treated non-melanomatous skin cancer, in situ cervical cancer, thyroid cancer

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 |
| --- | --- |
| Active Comparator: 3 weekly CDDP based CCRT<br>radiation (conventioal or IMRT) with 3 cycles of 3-weekly cisplatin | Drug: cisplatin (3 weekly)<br>* radiation with cisplatin (100mg/m2) on D1,D22,D43 and followed by adjuvant chemotherapy (3 cycles of FP)<br>|
| Experimental: weekly cisplatin based CCRT<br>radiation (conventional or IMRT) with 7 cycles of weekly cisplatin therapy | Drug: cisplatin (weekly)<br>* radiation with 7 cycles of cisplatin (40mg/m2) on D1,8,15,22,29,36,43, and followed by adjuvant chemothrapy (FP X3)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival rate at 3 years |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival rate |  | 36 months | 
| objective response rate |  | 36 months | 
| toxicity |  | 36 months | 
| quality of life |  | 36 months |
A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients

Study Overview
=================
Brief Summary
-----------------
A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients

Official Title
-----------------
A Phase 2, Open-Label, Multi-Center Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in De Novo Bone Marrow Transplant Recipients

Conditions
-----------------
Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Vs-Host Disease, Graft-Versus-Host Disease

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bone marrow transplantation patients aged 20-54 except for transplanted from genetically HLA matched sibling donor. The patient had been fully informed. Exclusion Criteria: The patient had severe impaired hepatic function. The patient had impaired renal function. The patient had existing complication of severe cardiac dysfunction. The patient had severe impaired pulmonary function.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 54 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tacrolimus|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
-----------------
Tacrolimus, Immunosuppression, Bone Marrow Transplantation, Graft versus Host Disease