linjc16/ctgov huggingface dataset:
Electromyographic (EMG) and Mechanomyographic (MMG) Comparison

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the delay between the detection (by mechanomyography-MMG) of rectus abdominis contraction and the detection of cough in cough effort.

Official Title
-----------------
Comparison of Electromyographic With Mechanomyographic Signals of Rectus Abdominis

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Device: non invasive mechanomyographic device based on a 3 axes accelerometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More or equal than 18 years old Patient affiliated to social security or similarly regime Healthy volunteer BMI less than 30 Exclusion Criteria: Pregnant women and lactating mothers Ward of court or under guardianship Adult unable to express their consent or person under legal protection Person deprived of freedom by judicial or administrative decision Person hospitalized without their consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| accelerometric device<br> | Device: non invasive mechanomyographic device based on a 3 axes accelerometer<br>* This biomedical research consists specifically in the simultaneous acquisition of: EMG and MMG Signals of rectus abdominis of the abdomen, Respiratory flow, An electrocardiogram (ECG). These acquisitions will be conducted on 16 healthy volunteers according to a standardized protocol, at rest and during voluntary cough and various physical exercises often resulting in urinary leakage in the incontinent person.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay between the detection by mechanomyography (MMG) of rectus abdominis contraction and the detection of cough in cough effort |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower and upper spectral band frequencies values for which the majority of the MMG signal is present, thresholds for detection of rectus abdominis contraction by mechanical myography |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanography, electromyography, effort cough
Biodegradable Stent Implantation in Biliary Benign Strictures.

Study Overview
=================
Brief Summary
-----------------
Spanish registry of resorbable stent implantation in biliary benign strictures. This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain). A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).

Detailed Description
-----------------
This is an prospective observational study of patients that have been implanted a biodegradable stent in the biliary tree. Patients are recruited when the stent is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24, 36, 48 and 52 months.

Official Title
-----------------
Biodegradable Stent Implantation in Biliary Benign Strictures. Spanish Register.

Conditions
-----------------
Biliary Tract, Biliary Tract Diseases, Stenosis, Follow-Up Studies, Stents

Intervention / Treatment
-----------------
* Device: Percutaneous placement of biodegradable biliary stents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years-old Informed consent Non-lithiasic chronic bening single or multiple stenosis Possibility of follow-up plus 1 year Exclusion Criteria: Under 18 years old Unsigned consent Non treatable coagulopathy Acute signs of infection Diagnosis of neoplasia

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 |
| --- |
|Device: Percutaneous placement of biodegradable biliary stents|The bening biliary strictures stents used in this register are made of polydioxanone (PPDX) (Ella-DV biliary stent, ELLACS, Hradec Králové, Czech Republic). The stents are implanted using a percutaneous transhepatic cholangiography using the standard micropuncture technique. Before stent implantation, balloon bilioplasty may be performed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biliary duct patency: bilirubin alterations (> 2.2) | Biliary duct patency after stent implantation evaluating bilirubin alterations | 24 months | 
| Stent reabsorption: radiographic persistence of stent radiopaque marks | Radiography | 12 months |
Testing BRCA 1/2 Mutation Using Next Generation Sequencing

Study Overview
=================
Brief Summary
-----------------
Testing BRCA 1/2 mutation is important for patients with breast cancer, and Sanger sequencing is a standard method to identify BRCA 1/2 mutation. Next generation sequencing (NGS) is a high-throughput parallel sequencing that can provide genetic information with high accuracy. NGS is a faster and cost-effective method to detect gene mutations compared to Sanger sequencing. In this study, we evaluated the clinical role of NGS testing for BRCA 1/2 compared to Sanger sequencing.

Official Title
-----------------
Pilot Study of Validation of Testing BRCA 1/2 Mutation Using Next Generation Sequencing

Conditions
-----------------
Breast Neoplasms, Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Breast or ovarian cancer history in 2nd degree family members Male breast cancer Bilateral breast cancer Patient with breast cancer under 40 year of age Simultaneous breast and ovarian cancer Patients with epithelial ovarian cancer Breast cancer with other simultaneous extramammary malignancy Exclusion Criteria: -Patients who do not agree with testing BRCA 1/2 mutation

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Sanger<br>BRCA 1/2 test results by Sanger sequencing | |
| NGS<br>BRCA 1/2 test results by NGS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Accuracy | after enrollment, comparison between Sanger and NGS method will be performed. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, Specificity | Sensitivity and specificity of NGS | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast neoplasms, BRCA1, Sanger, NGS, Next generation sequencing
Measles Vaccine in Patients With Measles Virus-Positive, Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The objectives of the study are to assess the efficacy and safety of live, attenuated measles vaccine as consolidation therapy in patients with measles-positive, non-small cell lung cancer with locally-advanced (stage 3B with pleural effusion) or metastatic (stage 4) tumors in remission.

Detailed Description
-----------------
This is a single-institution, non-randomized phase 1/2 study in patients with locally-advanced or metastatic NSCLC in remission after receiving standard systemic chemotherapy of four cycles of combination chemotherapy consisting of four cycles of cisplatin combined with vinorelbine.

Official Title
-----------------
A Single-Institution, Open-Label, Single-Arm phase1/2 Study of Measles Vaccine as Consolidation in Patients With Measles Virus-Positive, Stage 3B/4 Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small Cell Lung Cancer, Measles

Intervention / Treatment
-----------------
* Biological: attenuated measles vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in remission after first-line chemotherapy Exclusion Criteria: Progressive disease

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: attenuated measles vaccine|4-week apart, two vaccines starting 4 weeks after last chemotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess progression-free survival (PFS) and overall survival (OS) in patients with NSCLC in remission receiving subcutaneous live-attenuated measles virus vaccine as consolidation therapy in patients with measles-positive tumors. |  | 2-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate additional measures of efficacy, safety, and disease/treatment-related symptoms. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
measles-positive NSCLC, measles vaccine, consolidation, Stage 3B with pleural effusion or stage 4 non-small cell lung cancer in remission
Reconstruction of the Pelvic Floor After Total Pelvic Exenteration Using the TMG Flap

Study Overview
=================
Brief Summary
-----------------
Total pelvic exenteration (TPE) is a rare operation, which is the only possible curative intervention to treat central residual or recurrent tumors of the vulvar, vaginal, cervical, or uterine malignancies after initial surgery, radiation therapy and chemotherapy. Several options for pelvic floor and vaginal reconstruction have been described. The transverse musculocutaneous gracilis (TMG) flap has been introduced for breast reconstruction as a free flap. The investigators adopted the pedicled TMG flap for reconstruction after TPE. Between November 2011 and February 2014, twelve patients underwent TPE and reconstruction with unilateral (6 patients) or bilateral (6 patients) pedicled TMG flaps. Five patients had vaginal reconstruction with bilateral TMG flaps. The investigators describe the operative procedure and the outcome of the operation in these patients.

Official Title
-----------------
Reconstruction of the Pelvic Floor and the Vagina After Total Pelvic Exenteration Using the Transverse Musculocutaneous Gracilis Flap

Conditions
-----------------
Reconstruction of the Pelvic Floor After Total Pelvic Exenteration.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the department of Gynecology in the University hospital of Tampere, who underwent total pelvic exenteration with reconstruction of the pelvic floor. Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing total pelvic exenteration<br>Patients undergoing total pelvic exenteration for gynecological malignancies and reconstruction of the pelvic floor with a TMG flap. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total pelvic exenteration.
The Need for Rehabilitation and the Connection With Attachment Styles Among Patients With Gynaecological Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide new knowledge about: Integration of rehabilitation in a highly specialized gynaecological department. Development and testing of an individually adapted rehabilitation process. Needs for rehabilitation among women with gynaecological cancer. Connection between adult attachment style for women with gynaecological cancer and their quality of life, rehabilitation needs and symptoms of depression /PTSD.

Official Title
-----------------
Rehabilitation and the Association With Attachment Styles Among Patients With Gynaecological Cancer

Conditions
-----------------
Needs for Rehabilitation, Adult Attachment Style, Quality of Life., Depression, PTSD

Intervention / Treatment
-----------------
* Behavioral: Rehabilitation goals of patients with gynaecological cancer.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspicion of gynaecological cancer surgery for gynaecological cancer Exclusion Criteria: do not speak Danish

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Rehabilitation goals of patients with gynaecological cancer.|Conversations with the nurse and supportive phone calls. Conversation are structured and placed 1 and 3 months after surgery. Phone calls are carried out at two and three months after surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Quality of life at 5 months after surgery. | EORCT QLQ-C 30 (QLQ is quality of life questionnaire) and EORCT QLQ-OV28 (OV - Ovarian) and EORCT QLQ-EN ( EN - endometrial) 24 and EORCT QLQ- CX 24 ( CX - cervix. | at baseline and 5 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Revised Adult Attachment at 5 months after surgery. | Revised Adult Attachment Scale (RAAS- 18) is used to measure attachment style among women with gynaecological cancer. | At baseline and 5 months after sugery | 
| Change from baseline in Depression at 5 months after surgery. | MDI-12 (Major Depression Inventory), ICD-10 (International Classification of Diseases), measure the depression level in the period from baseline and 5 months after surgery. | At baseline and 5 months after surgery. | 
| Change from baseline in Posttraumatic stress disorder at 5 months after surgery | To measure the Posttraumatic stress disorder we uge HTQ-17 (Harvard Trauma Questionnaire) for PTSD (Post Traumatic Stress Disorder). | At baseline and 5 months after surgery. |
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease is not only a pathology of movements. There are many non-motor symptoms that complicate and impair patients' quality of life. Among those disorders are sleep disorders. Insomnia is the most frequent symptom. Most patients report 2-5 awakenings per night and long periods of awakening which occupy 30 to 40% of their night. Apomorphine is a dopamine agonist that may be administered with a pump . The objective of the study is to assess changes in the quality of sleep in Parkinson's disease patients treated with an apomorphine pump.

Official Title
-----------------
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Apomorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease patients for whom a treatment with an apomorphine pump is indicated Exclusion Criteria: atypical parkinsonian syndrome cognitive impairment pregnancy breast feeding patient under a legal protection procedure patient denying to participate to the study lack of affiliation to a social security system

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apomorphine pump<br> | Drug: Apomorphine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the Parkinson's disease sleeping disorders (PDSD-2) score before treatment with an apomorphine pump and 3 months after the beginning of the treatment |  | Three months |
The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
An additional, intermittent bolus application in patients with intrathecal opiate administration for chronic pain syndrome may have a positive effect on the effectiveness of the treatment. Thus, the effect of an additional, intermittent bolus application in patients with intrathecal opiate administration was therefore investigated. Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each patient was submitted to two treatment periods in randomly chosen order (cross-over design): 1. standard treatment (continuous opiate administration) and 2. continuous opiate administration with intermittent opiate bolus application. Both treatment periods lasted 14 days. Patients were asked to record pain intensity, side effects and satisfaction with the treatment. The following hypotheses were tested: The application of additional opiate boli results in significantly lower pain intensity. The application of additional opiate boli does not result in a higher rate of adverse Events.

Official Title
-----------------
The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study

Conditions
-----------------
Chronic Pain Syndrome

Intervention / Treatment
-----------------
* Drug: opiate with bolus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic pain syndrome intrathecal opiate pump signed informed consent Exclusion Criteria: younger than 18 years other (than opiate) intrathecal drug administration discontent with intrathecal opiate therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| opiate without bolus<br>continuous opiate administration without bolus application | Drug: opiate with bolus<br> <br> |
| opiate with bolus<br>continuous opiate administration with additional bolus application | Drug: opiate with bolus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in pain intensity | numeric rating scale from 0 to10 | day 0. day 14, day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in satisfaction with treatment outcome | numeric rating scale from 0 to 10 | day 0, day 14, day 28 | 
| side effects | occurrence rate of side effects | from day 0 to day 28 |
A RCT COMPARING LACTULOSE AND RIFAXIMIN ASSOCIATED WITH A VEGETABLE DIET IN THE PREVENTION OF POST-TIPS OVERT HEPATIC ENCEPHALOPATHY

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial whose purpose is to evaluate the efficacy of therapy with lactulose and rifaximin associated with a vegetable diet in the prevention of post-TIPS hepatic encephalopathy.

Conditions
-----------------
Cirrhotic Patients Undergoing TIPS Placement

Intervention / Treatment
-----------------
* Drug: lattulose and rifaximine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive cirrhotic patients undergoing TIPS Exclusion Criteria: age >75 years; bilirubin levels >5 mg/dl; creatinine levels >3 mg/dl; a serious cardiac or pulmonary dysfunction; a Child-Pugh's score >11 (except for the patients candidates to early TIPS); a model end-stage liver disease (MELD) score >18; a diagnosis of hepatic carcinoma; sepsis; spontaneous bacterial peritonitis; renal insufficiency. Present HE or previous spontaneous/recurrent HE, alcohol/psychoactive drugs intake (positive alcoholaemia and/or benzodiazepines or opioid urine metabolites) at the moment of evaluation, unrelated neurological disease including dementia (mini mental state < 26).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard<br> | |
| Experimental: treatment<br>rifaximine and lattulose plus low proteine diet | Drug: lattulose and rifaximine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hepatic encephalopathy |  | one month |