linjc16/ctgov huggingface dataset:
Registry of Local Recurrences After Breast-conserving Surgery

Study Overview
=================
Brief Summary
-----------------
The ReLoCC project is a prospective, multicenter, clinical study to register cases of local recurrence after breast-conserving surgery, in centers dedicated to the treatment of breast cancer, in Portugal and Spain. The comparison of the results obtained will allow the optimization of the treatment, making it increasingly personalized.

Official Title
-----------------
Registry of Local Recurrences After Breast-conserving Surgery in Portugal and Spain

Conditions
-----------------
Breast Cancer Recurrent

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients Age > 18 years Patients who have previously undergone breast-conserving surgery as part of the treatment of invasive or non-invasive (in situ) breast cancer and adjuvant breast RT: total (WBI) or partial (PBI) without adjuvant radiotherapy to the breast Recent histological diagnosis of homolateral, invasive or non-invasive (in situ) breast carcinoma Exclusion Criteria: Male Age < 18 years Stage 4 at diagnosis Patients operated outside the participating Centers and for whom it is not possible to obtain complete information regarding the primary treatment History of other primary invasive malignant tumor (except non-melanoma skin carcinomas) Patients already treated for another local recurrence of breast carcinoma Absence of clinical follow-up and records in clinical process

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine prevalence of local recorrence of breast cancer after conserving surgery in Portugal and Spain | Number of cases per year | 2 years | 
| Follow-up of recurrences up to 5 years after treatment of first recurrence | Number of cases per year | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of risk factors for local recurrence | Frequency of risk factors | On inclusion time (2 years) | 
| Identification of predictive and response factors | Frequency of predictive factors | On inclusion time (2 years) | 
| Determination of surgical morbidity of relapse treatment in follow up | Identification of surgical morbidity | From date of treatment until 30 days after treatment | 
| Assessment of patient quality of life | Validated questionnaire for quality of life by EORTC QLQ-C30-BR23 | First and second year after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer treatment, Local recurrences, Breast-conserving surgery
Evaluation of Multifocal ERG and Visual Field Changes After Vitrectomy and ILM Peeling

Study Overview
=================
Brief Summary
-----------------
To evulate changes in MfERG, VF and OCT after viterctomy associated with ILM peeling.

Detailed Description
-----------------
Macular epiretinal membrane (ERM) is a disorder of the vitreomacular interface characterized by ﬁbrocellular proliferation on the anterior surface of the internal limiting membrane (ILM) of the macula. Pars plana vitrectomy with ERM removal and inner limiting membrane peeling is the standard surgical treatment for an ERM. ILM peeling is performed to eliminate the scaffold for myoﬁbroblast proliferation and any microscopic ERM in order to prevent ERM recurrence. ILM peeling is indicated for other pathologies other than ERM such as, diabetic macular edema, and macular hole. ILM peeling is a traumatic procedure that may have many effects on the underlying inner retinal layers that may lead to changes in retinal function. Retinal edema, eccentric scotoma, dissociation of the nerve fiber layer, iatrogenic punctuate chorioretinopathy, and subretinal, retinal, and vitreous hemorrhage are well described secondary to the surgical trauma of peeling in addition to stain toxicity. Investigation of these changes may assist in aiding the development of minimally traumatic techniques for ILM removal . Evaluation of functional changes may include visual field and Multifocal electroretinography assessment. Visual field defect after vitrectomy a well known post operative complication usually in eyes that underwent fluid air exchange, the cause of visual field defect remain unclear. Optical Coherence Tomography (OCT), imaging is done to evaluate inner retinal layers after ILM peeling,High myopic eyes might develop more severe, scattered inner retinal defects after ILM peeling. Multifocal electroretinography (mfERG), has been used to assess visual function and the electrophysiologic responses of multiple retinal locations of the macular area

Official Title
-----------------
Evaluation of Multifocal ERG and Visual Field Changes After Vitrectomy and ILM Peeling

Conditions
-----------------
Epiretinal Membrane

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic ERM, Primary full thickness macular hole, Lamellar macular hole, and Vitromacular traction Exclusion Criteria: 1-Patients with a secondary ERM, diabetic retinopathy, venous occlusion, retinal detachment, uveitis, and trauma. 2-Other ocular pathologies that could interfere with the functional results dense cataract , glaucoma, and previous retinal surgery

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA | after ILM peeling | 6 months |
Institut Paoli Calmettes Prostate Cancer Database

Study Overview
=================
Brief Summary
-----------------
Database of Institut Paoli-Calmettes patients diagnosed with prostate cancer

Official Title
-----------------
Institut Paoli Calmettes Prostate Cancer Database

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostatic cancer Exclusion Criteria: Non applicable

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with prostate cancer diagnosis<br> | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients | Overall survival of all patients who come in the center | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patients characteristics | Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies | 10 years |
92/5000 Preoperative Efficacy of Traumeel Versus Dexamethasone in the Control of Pain, Swelling and Trismus

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of intramuscular injection of two anti-inflammatory drugs, Traumeel and Dexamethasone, used in the control of postoperative complications pain, edema and trismus after third molar extraction mandibular

Official Title
-----------------
Comparative Study of the Preoperative Efficacy of Traumeel Versus Dexamethasone in Control of Pain, Swelling and Trismus After Mandibular Third Molar Extractions

Conditions
-----------------
Molar, Third, Surgery

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Traumeel S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with indication of asymptomatic bilateral extractions of lower third molars; Aged 18 years or older; Have a good health and no disease. Exclusion Criteria: • Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Dexamethasone 4,0 mg / mL | Drug: Dexamethasone<br>* Dexamethasone 4,0 mg/mL<br>* Other names: Decadron®;|
| Experimental: Traumeel S<br>Traumeel 2,2 mg / mL | Drug: Traumeel S<br>* Traummel S 2,2 mg/mL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative sequelae following thir molar extraction | During the postoperative intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face and trismus by maximum mouth opening. The postoperative pain was self-recorded by the patient using visual analogue scale in 72 hours with an interval of eight hours | up to seven days postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Third molar, Surgery, Swelling
Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to compare the results of transanal haemorrhoidal dearterialisation and stapler haemorrhopidopexy in the treatment of grade III and IV haemorrhoids with a long-term follow-up.

Official Title
-----------------
Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy. A Randomized Trial With Long-term Follow-up

Conditions
-----------------
Haemorrhoids

Intervention / Treatment
-----------------
* Procedure: Transanal haemorrhoidal dearterialisation
* Procedure: Stapler haemorrhoidopexy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: grade III and IV hemorrhoids requiring hemorrhoidectomy. Exclusion Criteria: first and second degree hemorrhoids patients with firm and fibrotic external irreducible haemorrhoids thrombosed hemorrhoids; recurrent hemorrhoids after previous surgical treatment history of inflammatory bowel disease; history of colon, rectal or anal cancer inability to give informed consent age < 18 years pregnant women.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Haemorrhoidal dearterialisation<br>Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and addiction of rectal mucopexy. | Procedure: Transanal haemorrhoidal dearterialisation<br>* Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and a rectal mucopexy<br>|
| Active Comparator: Stapler haemorrhoidopexy<br>Haemorrhoidopexy was performed with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA.) | Procedure: Stapler haemorrhoidopexy<br>* Haemorrhoidopexy with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | A telephone interview with a structured questionnaire at a median follow-up of 42 months. | 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Pain score 24 hr after operation | 24 hr | 
| Complications | Intra and postoperative complication within 30 days. | One month |
Imaging Cardiac Electrical Remodeling With Electrocardiogram Imaging (ECGI)

Study Overview
=================
Brief Summary
-----------------
A consequence of chronic RV pacing is a process of electrical remodeling that alters myocardial repolarization to reflect the altered depolarization induced by the RV lead. When RV pacing is discontinued, the altered repolarization persists for several weeks. This phenomena is traditionally described as T-wave memory based upon the 12-lead ECG appearance of inverted T-Waves. The investigators are using the ECGI technique to produce three dimensional electroanatomical images of this phenomena in patients with dual chamber pacemakers. Echocardiography will also be used to image the mechanical effects of RV pacing and T-wave memory. The images will show the spatial distribution of altered repolarization and allow us to correlate any mechanical consequences of this phenomena that may exist.

Official Title
-----------------
Imaging Cardiac Electrical Remodeling With ECGI

Conditions
-----------------
Sick Sinus Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implanted dual chamber pacemaker for sick sinus syndrome with no history of complete heart block. Exclusion Criteria: Persistent atrial fibrillation that is not suppressed by medications.

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 |
| --- | --- | --- |
| ECGI Image |  | 1 month after RV pacing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T-wave memory, Sick Sinus Syndrome
Motivation in Alcohol Treatment Facilities

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if and to what extend a composite measure of treatment motivation and behavior change motivation predicts alcohol treatment success. It is expected that the composite measure based on the stages of the Transtheoretical Model of Behavior Change is a better predictor for treatment outcome than treatment motivation or behavior change motivation alone. Participants will be recruited from alcohol treatment centers. A baseline interview regarding their motivation, drinking behavior and personal treatment goals will be conducted. At the end of treatment, treatment staff will be asked about treatment involvement of each participant. Two follow-up interviews will be conducted after 6 and 12 months. To identify the impact of behavior change and treatment motivation on change in drinking behavior, data will be pooled with a non-treatment seeking sample. Conclusions can be drawn on what motivation pattern best predicts behavior change for those utilizing formal help and for those remitting without formal help (self-changers).

Official Title
-----------------
Stages an Processes of Change in Help-Seeking and Drinking Behavior

Conditions
-----------------
Alcohol Dependence, Alcohol Abuse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alcohol dependence Alcohol abuse Exclusion Criteria: Persons physically and mentally not capable of participating in study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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
-----------------
motivation to change, treatment motivation, alcohol use disorders
Pompe Disease Registry Protocol

Study Overview
=================
Brief Summary
-----------------
The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research related purposes. The objectives of the Registry are: To enhance understanding of the variability, progression, identification, and natural history of Pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention. To assist the Pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. To characterize the Pompe disease population. To evaluate the long-term effectiveness of alglucosidase alfa.

Detailed Description
-----------------
Study Design Time Perspective: Retrospective and Prospective

Official Title
-----------------
Pompe Disease Registry

Conditions
-----------------
Glycogen Storage Disease Type II, Pompe Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with a confirmed diagnosis of Pompe disease who have signed the informed consent and authorization form(s) are eligible for inclusion. Confirmed diagnosis is defined as documented GAA enzyme deficiency from blood, skin, or muscle tissue and/or documentation of 2 GAA gene mutations. Exclusion Criteria: There are no exclusion criteria in this Registry
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 |
| --- | --- | --- |
| Understanding of the variability, progression , identification and natural history of the manifestations of Pompe disease |  | maximum 30 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycogen Storage Disease Type II (GSD-II), GSD-II, Pompe Disease, Pompe Disease (late-onset), Acid Maltase Deficiency Disease, Glycogenosis II
Tension-free Repair of Inguinal Hernia With Undissociate Spermatic Cord

Study Overview
=================
Brief Summary
-----------------
The theory of undissected Spermatic cord (US) only transected the hernia ring ends in the abdominal cavity, the hernia ring, hernia sac and spermatic cord will not be dissected. Its significance lies in that inguinal hernia repair can get rid of the entanglement of hernia sac and spermatic cord and fundamentally change the treatment mode of hernia ring and hernia sac.

Detailed Description
-----------------
In recent years, with the deepening of the anatomical cognition of the inguinal region and the renewal of the hernia repair concept, inguinal hernia repair has become increasingly mature surgical approach. However, no matter how the hernia repair modes change, the treatment and repair of the hernia ring has always been the focus, so that the treatment of the hernia sac has been neglected. From March 2014 to May 2019, there were 132 patients underwent inguinal hernia repair with Undissociate Spermatic cord theory (Undissected Spermatic cord and hernia sac, hernia ring and sac exclusion). All the patients were followed up for 18 63 months (mean of 41.5 months) without recurrence. Its significance lies in that inguinal hernia repair can get rid of the entanglement of hernia sac and spermatic cord and fundamentally change the treatment mode of hernia ring and hernia sac.

Official Title
-----------------
The First Affiliated Hospital of Harbin Medical Uniersity

Conditions
-----------------
Inguinal Hernia, Without Mention of Obstruction or Gangrene

Intervention / Treatment
-----------------
* Procedure: Tension-free repair of inguinal hernia with Undissociate Spermatic cord


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inguinal hernia patients who can tolerate surgery Exclusion Criteria: Patients who cannot tolerate surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 72 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 |
| --- | --- |
| experimental group<br>Tension-free repair of inguinal hernia with Undissociate Spermatic cord | Procedure: Tension-free repair of inguinal hernia with Undissociate Spermatic cord<br>* patient undergoing Tension-free repair of inguinal hernia with Undissociate Spermatic cord<br>|
| control group<br>Tension-free repair of inguinal hernia with traditional method | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgery time | the operation time | 0-120minutes | 
| Bleeding | Blood loss | surgery | 
| hospital stay | the hospitalization time | 1-30days | 
| Does it recur | Does it recur | 18-63months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Undissociate Spermatic cord, Inguinal hernia, Hernia exclusion, Hernial sac