linjc16/ctgov huggingface dataset:
Kirschner Wire and Pull-out Wire Fixation for the Treatment of Bony Mallet Finger

Study Overview
=================
Brief Summary
-----------------
The objective of this report is to describe a new surgical technique for the treatment of bony mallet finger which involves the application of both Kirschner wire and pull-out wire fixation. It is believed to decrease the risk of the complications.

Detailed Description
-----------------
From May 2003 to December 2008, we used Kirschner wire and pull-out wire fixation to carry out 54 closed bony mallet finger in 54 patients. The bony mallet finger was applicated both Kirschner wire and pull-out wire fixation.

Official Title
-----------------
Kirschner Wire and Pull-out Wire Fixation for the Treatment of Bony Mallet Finger

Conditions
-----------------
Bony Mallet Finger

Intervention / Treatment
-----------------
* Procedure: K wire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bony mallet finger; patient had failed trials of nonsurgical treatment; fracture involving more than 1/3 of the joint surface; fragment displacement or subluxation of the DIP joint. Exclusion Criteria: tendinous mallet finger; success of nonsurgical treatment; comminuted fracture; fracture involving at or less than 1/3 of the joint surface which could be successfully replaced with nonsurgical treatment.
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K wire<br> | Procedure: K wire<br>* Mallet finger treatment<br>* Other names: stainless steel wire;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The digits were assessed for skin necrosis, skin breakdown, infection. |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patients rated their pain experience by a visual analogue scale. The results were graded by Crawford's criteria. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mallet finger, extensor tendon, Kirschner wire, Fracture Fixation
Esophageal Manometry and Impedance Study in Obese Patients Before and During Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in obese patients before and during anesthesia.

Detailed Description
-----------------
Obesity is an increasing heath problem in western countries and is associated with increased risks during anesthesia. Using high-resolution solid-state manometry the investigators aim to study esophageal pressures and measure the incidence of regurgitation of gastric contents during anesthesia induction in obese patients. The investigators aim to include 16 obese patients, with BMI > 35, undergoing laparoscopic gastric by-pass.

Official Title
-----------------
Evaluation of Esophageal Pressures and Reflux in Obese Patients Before and During Anesthesia Using High-resolution Solid-state Manometry

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: Manometry and Impedance analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients aged 18-60 years BMI>35 ASA classification I-III Exclusion Criteria: Use of drugs that interfere with esophageal motility Gastro-esophageal reflux disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Obese patients<br> | Device: Manometry and Impedance analysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal pressures after laparoscopic gastric by pass |  | 2 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric by-pass surgery
SAGIT for Classification of Patients With Acromegaly in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will determine the potential use of a finalised operational version for patient classification in clinical practice and studies. In addition, this study intends to carry out a qualitative evaluation of the acceptability of SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and usefulness of the tool in practice.

Official Title
-----------------
Pilot Testing of SAGIT in Patients With Acromegaly in Clinical Practice

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Other: SAGIT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 years-old or above Patient with diagnosis of acromegaly with the presence of pituitary adenoma, elevated IGF-1 and lack of serum GH suppression after oral glucose tolerance test (OGTT) Controlled/stable, active and treatment naïve patients. Patient with the cognitive and linguistic capacities to understand the information letter of the study Patient who signed informed consent Exclusion Criteria: History of non-compliance or inability to reliably receive treatment in the foreseeable future Gaps in treatment of greater than 1 month within the 12 months prior to study entry

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acromegalic patients<br> | Other: SAGIT<br>* SAGIT is a Clinician-Reported Outcomes (ClinROs) tool<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of acromegaly patients classified using SAGIT |  | 8 months |
Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)

Study Overview
=================
Brief Summary
-----------------
The objective of this investigation is to assess safety and effectiveness of Xarelto under practice routine use in VTE secondary prevention after acute DVT, focusing on hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This study is a company sponsored, one- arm prospective cohort study with patients to whom Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard observation period (1 year) and an extension survey period (2 years, at the longest).

Official Title
-----------------
Special Drug Use Investigation of Xarelto for VTE

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy. Exclusion Criteria: - Patients who are contraindicated based on the product label and have already received Xarelto treatment.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rivaroxaban (Xarelto, BAY59-7939)<br>Rivaroxavban administration group | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Treatment parameters following the summary of product characteristics and the physician's decision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeding as a measure of Safety and tolerability |  | Up to 2 years | 
| Number of participants with symptomatic recurrent VTE (composite of DVT or nonfatal or fatal pulmonary embolism) |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite number of all-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack, or systemic embolism), clinically relevant non-major bleeding and all other adverse events/ADRs |  | Up to 2 years | 
| Number of participants with asymptomatic deterioration of thrombotic burden (change of D-dimer, imaging test such as CT or CCUS) by the end of standard observation period |  | at 1 year | 
| Frequency of VTE recurrence and adverse events/ADRs comparison between distal and/or proximal DVT localization treatment outcomes |  | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xarelto, rivaroxaban, VTE, PE, DVT, Japan, PMS, SDUI
Randomized Controlled Trial of Biofeedback Therapy for Dyssynergic Defecation

Study Overview
=================
Brief Summary
-----------------
Constipation is a common disorder and current treatments are unsatisfactory. Biofeedback may help patients with constipation and dyssynergic defecation, but its efficacy is unproven and whether this is due to behavioral modification or excessive attention is unknown. Methods: In a prospective randomized trial, the investigators investigated the efficacy of Biofeedback (manometric- assisted anal relaxation, muscle coordination and simulated defecation training), with either sham feedback therapy (Sham) or standard therapy (diet, exercise, laxatives; Standard) in 77 subjects (69 women) with dyssynergic defecation. Primary outcome measures included presence of dyssynergia, balloon expulsion time, number of complete spontaneous bowel movements (CSBM), and global bowel satisfaction. Data analyzed per protocol.

Conditions
-----------------
Dyssynergia

Intervention / Treatment
-----------------
* Procedure: Standard treatment, sham feedback and biofeedback therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients were included if they fulfilled Rome II criteria for functional constipation, and during attempted defecation demonstrated a dyssynergic pattern of defecation, and either had prolonged difficulty with expelling a simulated stool (> 1 minute) or prolonged delay (> 20% marker retention) in colonic transit. Exclusion Criteria: They were required to have no evidence of structural or metabolic diseases that could cause constipation, as assessed by colonoscopy/barium enema and routine hematological, biochemical and thyroid function tests. Patients taking drugs known to be constipating, for example opioids were either excluded or were asked to discontinue the drug prior to enrollment. Other exclusion criteria included: severe cardiac or renal disease, previous gastrointestinal, spinal or pelvic surgery except cholecystectomy, hysterectomy or appendectomy, neurologic diseases such as multiple sclerosis, stroke or spinal injury, impaired cognizance (mini-mental score < 15), legal blindness, pregnancy, rectal prolapse, anal fissure, and alternating constipation and diarrhea.

Ages Eligible for Study
-----------------
Minimum Age: 15 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Standard treatment, sham feedback and biofeedback therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Symptom Assessment With Patient Surveys

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the proposed research is to explore methods of obtaining symptom assessments from pediatric oncology patients and/or their caregivers in hopes of improving the accuracy and thoroughness of these reports. Additionally the researchers hope to simply staff efforts in obtaining detailed medical histories from pediatric oncology patients.

Official Title
-----------------
Symptom Assessment With Patient Surveys

Conditions
-----------------
Carcinomas, Squamous Cell Carcinoma, Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: Patient survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approximately 150 patients ages 0-18 years (75 for each group-intervention and control) will be enrolled. These patients will be pediatric oncology patients who have received chemotherapy within the prior four weeks and being seen in the oncology clinic for an out-patient visit.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Patient survey|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Regional Observatory on Metabolic Syndrome- LAZIO

Study Overview
=================
Brief Summary
-----------------
The aim of the study, is to assess the prevalence of Metabolic Syndrome in Italy on a regional basis, defined according to NCEP/ATPIII Guidelines criteria.

Official Title
-----------------
Regional Observatory on Metabolic Syndrome in Italy- LAZIO

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lipid profile in the last year Signed informed consent Exclusion Criteria: Subjects with serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's successful participation in the study Pregnancy or breast feeding Subject who are unwilling or unable to provide the informed consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Primary care population | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Metabolic Syndrome in Primary Care Population. |  | At Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concomitant presence of other CV risk factors. |  | At Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic Syndrome, Lipids, Waist Circumference
Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound

Study Overview
=================
Brief Summary
-----------------
This study involves patients who are scheduled for standard care brachytherapy of focal tumours within the prostate, which is normally performed under standard 2-dimensional (2D) ultrasound guidance. The purpose of this study is the acquire power Doppler ultrasound while using a simple oscillator in physical contact with the end of a brachytherapy needle. The vibrations along the needle should be visible in the power Doppler ultrasound, helping to visualize the needle position within the anatomy.

Official Title
-----------------
Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound

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

Intervention / Treatment
-----------------
* Device: Prostate Brachytherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, aged 18 years or older Willing to provide written consent Pathologically confirmed prostate cancer on previous biopsy Suitable for and consenting to high-dose-rate brachytherapy for treatment as standard of care. Exclusion Criteria: • Previous radiotherapy to the prostate

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient<br>Patient undergoing standard care prostate high dose rate brachytherapy. | Device: Prostate Brachytherapy<br>* High dose - rate (HDR) brachytherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle Trajectory | Intra-operative needle trajectories in B-mode and power Doppler ultrasound | 1 month following data collection |
Shear Wave Elastography Versus Strain Elastography With Histogram Analysis in Solid Pancreatic Lesions

Study Overview
=================
Brief Summary
-----------------
to assess the diagnostic value of strain elastography EUS and shear wave EUS in solid pancreatic lesions

Detailed Description
-----------------
Three measurements of strain ratio elastography and three measurements of shear wave elastography with VPN> 20% will be performed in the same solid pancreatic lesions. The results will be compared in the groups of adenocarcinomas, neuroendocrine tumors and benign solid pancreatic lesions.

Official Title
-----------------
Shear Wave Elastography Versus Strain Elastography With Histogram Analysis in Solid Pancreatic Lesions

Conditions
-----------------
Endoscopic Ultrasonography

Intervention / Treatment
-----------------
* Diagnostic Test: Elastography EUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with solid pancreatic masses > 2 cm in diameter at CT scan for EUS assessment Exclusion Criteria: Patients with inconclusive pathology results patients with cystic component > 20%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Strain ratio Elastography EUS<br>The solid pancreatic lesion will be assessed by using strain ratio elastography EUS | Diagnostic Test: Elastography EUS<br>* Comparison between the values of strain ratio and shear wave in concordance with the final diagnosis<br>|
| Active Comparator: Shear Wave Elastography EUS<br>The solid pancreatic lesion will be assessed by using shear wave elastography EUS | Diagnostic Test: Elastography EUS<br>* Comparison between the values of strain ratio and shear wave in concordance with the final diagnosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic sensitivity | Comparison between the diagnostic rate in both arms | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elastography
Elimination of Albumin-Bound Substances by MARS and Prometheus

Study Overview
=================
Brief Summary
-----------------
This trial compares the efficacy of two artificial liver support systems, MARS (Molecular Adsorbents Recirculating System) and Prometheus (FPSA, Fractionated Plasma Separation and Adsorption), in removing albumin-bound substances such as bilirubin, bile acids, and cytokines.

Official Title
-----------------
Effect of Extracorporeal Liver Support by MARS and Prometheus on Albumin-Bound Substances in Acute-on-Chronic Liver Failure

Conditions
-----------------
Liver Failure

Intervention / Treatment
-----------------
* Device: MARS (Molecular Adsorbents Recirculating System)
* Device: Prometheus (FPSA, Fractionated Plasma Separation and Adsorption)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive patients with acute-on-chronic liver failure (severe deterioration of chronic liver disease) unresponsive to standard medical treatment for >=48 hours Exclusion Criteria: arterial hypotension extrahepatic malignancy

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 |
| --- |
|Device: MARS (Molecular Adsorbents Recirculating System)|nan|
|Device: Prometheus (FPSA, Fractionated Plasma Separation and Adsorption)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum levels of albumin-bound substances |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma clearance of albumin-bound substances |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute-on-chronic liver failure, MARS, Prometheus, bilirubin, bile acids, cytokines