linjc16/ctgov huggingface dataset:
Evaluation of Levator Injuries Using Transvaginal Endosonography

Study Overview
=================
Brief Summary
-----------------
Prospective studies to date have identified that the levator ani muscle injuries occur in 14-19% of women after vaginal delivery. In none of studies a vaginal examination was performed at the time of delivery. It has previously been shown that sonographic injuries of the anal sphincter that were believed to be occult were in fact clinically apparent but not recognised at the time of delivery. It is therefore important to correlate clinical findings to ultrasound images. 3D endovaginal endosonography has not previously been used to identify levator injuries. This should potentially provide a better view of the pelvic floor muscles. The relationship between levator injury and symptoms of pelvic floor dysfunction has not been previously established using validated questionnaires. In this study, we include validated questionnaires to evaluate urinary incontinence, faecal incontinence and vaginal symptoms. As symptoms may become apparent only in the long term it is prudent that the women are followed up in the long term. The principle objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth. The levator muscle forms a major part of the pelvic floor and damage to this muscle can potentially cause urinary, bowel and sexual problems and pelvic organ prolapse.

Official Title
-----------------
Evaluation of Levator Injuries Using Transvaginal Endosonography

Conditions
-----------------
Childbirth Related Levator Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women who have not delivered previously Singleton pregnancy Maternal age > 18 years and No previous pregnancies >20 weeks of gestation Ability to read and understand English. Exclusion Criteria: Pregnant women who have delivered previously Multiple pregnancies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nulliparous<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth. |  | Antenatal, after delivery and postnatal |
Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)

Study Overview
=================
Brief Summary
-----------------
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a peripheral destruction of platelets responsible for bleedings. Monocytes/macrophages play a double role by phagocyting platelets recognized by autoantibodies and by maintaining the autoimmune response via their antigen-presenting cell functions. Fcgamma receptors (FcγR), that are represented by activating receptors (FcγRI, FcγRIIa, FcγRIII) and an inhibiting one (FcγRIIb), are involved in the regulation of macrophages and have been reported to be dysregulated in autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematous. The aim of this study is to compare the expression of FcγR in patients with ITP on circulating monocytes and on splenic macrophages.

Official Title
-----------------
Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)

Conditions
-----------------
Immune Thrombocytopenia

Intervention / Treatment
-----------------
* Biological: blood sample
* Procedure: spleen sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ITP group Patients who have provided written consent Patients over 18 years Patients with national health insurance Patients with ITP, defined as thrombocytopenia < 100 G/L, after exclusion of infection- or drug-related thrombocytopenia and malignant hemopathy. Control Group Persons who have provided a written consent Persons over 18 years Persons with national health insurance Persons without autoimmune disease Exclusion Criteria: Patients under guardianship Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| patient<br> | Biological: blood sample<br> <br> Procedure: spleen sample<br> <br> |
| control<br> | Biological: blood sample<br> <br> Procedure: spleen sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. The expressions of the activating FcγRs and the inhibiting receptor (FcγRIIb) on monocytes will be compared between ITP patients at diagnosis and controls - physiological parameter |  | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. The expressions of the activating FcγRs and the inhibiting receptor (FcγRIIb) on splenic macrophages will be compared between ITP patients and controls. - physiological parameter |  | through study completion, an average of 2 years |
LORA-PITA IV General Investigation

Study Overview
=================
Brief Summary
-----------------
Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.

Detailed Description
-----------------
To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA for Status Epilepticus patients in Japan.

Official Title
-----------------
LORA-PITA (REGISTERED) Intravenous Injection 2 mg General Investigation

Conditions
-----------------
Status Epilepticus

Intervention / Treatment
-----------------
* Drug: Lorazepam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lorazepam<br>Patients administered Lorazepam in accordance with the indication (for Status Epilepticus, SE) and have no history of using this drug | Drug: Lorazepam<br>* The usual dose of lorazepam in adults is 4 mg administered intravenously. The drug should be given slowly with the administration rate at 2 mg/min as a guide. If necessary, 4 mg may be added but the dose should not exceed 8 mg as the sum of initial and additional doses. The usual dose of lorazepam in children aged 3 months or older is 0.05 mg/kg (up to 4 mg) administered intravenously. The drug should be given slowly with the administration rate at 2 mg/min as a guide. If necessary, 0.05 mg/kg may be added but the dose should not exceed 0.1 mg/kg as the sum of initial and additional doses.<br>* Other names: LORA-PITA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of the participants with adverse reaction |  | 24hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients whose initial seizure stopped within 10 minutes after the administration of final dose and who continued seizure-free for at least 30 minutes. |  | 24hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Status Epilepticus;, Lorazepam;, LORA-PITA;, Ativan
An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.003 trial

Official Title
-----------------
An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients

Conditions
-----------------
Early Stage Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Pardoprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have completed S308.3.003 trial Exclusion Criteria: Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308.3.003

Ages Eligible for Study
-----------------
Minimum Age: 30 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Pardoprunox<br>* 12 -42 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: laboratory data, adverse events, vital signs, ECG |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease
Indwelling Pleural Catheter for Trapped Lung

Study Overview
=================
Brief Summary
-----------------
Malignant pleural effusion (MPE) is a complication of almost any site of primary cancer as well as primary tumors of the pleura. Half of MPE patients have non-expendable trapped lungs not suitable for talc pleurodesis. Indwelling pleural catheters (IPCs), however, can be used in this cohort of patients, bringing about an improvement in dyspnea and quality of life (QOL). The aim of this study is to obtain pilot data - comparing patients receiving two different types of indwelling pleural catethers normally used in clinical practice (10 patients receiving Pleurocath® and 10 patients receiving PleurX®) - for power calculation of a Randomized Controlled Trial comparing two different drainages for MPE trapped lung.

Official Title
-----------------
Indwelling Pleural Catheter for Trapped Lung: a Pilot Study for Power Calculation of a Randomized Controlled Trial Comparing Pleurocath® Versus PleurX®)

Conditions
-----------------
Pleura; Effusion

Intervention / Treatment
-----------------
* Device: PleurX
* Device: Pleurocath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, with a clinical confident diagnosis of symptomatic malignant pleural effusion, enrolled for VATS exploration but not amenable of VATS talc poudrage because of trapped lung (patients with only partial expansion however receiving talc poudrage, but needing permanent pleural cathetes, are also eligible) Exclusion Criteria: - Age younger than 18 years Expected survival of less than 3 months Chylothorax Total white blood cell count less than 1000/microL Pregnancy or lactating mothers Irreversible bleeding diathesis Irreversible visual impairment Contraindications to general anesthesia Poor general clinical conditions ( ECOG PS >=2) Patients unable to provide informed consent

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PleurX<br>Positioning of Pleurx drainage during surgical exploration if lung does not reinflate | Device: PleurX<br>* Positioning of drainage PleurX<br>|
| Experimental: Pleurocath<br>Positioning of Pleur o cath drainage during surgical exploration if lung does not reinflate | Device: Pleurocath<br>* Positioning of drainage Pleurocath<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain) | Thoracic pain | Post operative day 4th | 
| Visual Analog Scale (VAS) range 0 (no dyspnea) - 100 (maximim dyspnea) | Dyspnea | Post operative day 4th |
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

Study Overview
=================
Brief Summary
-----------------
Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 6 weeks.

Official Title
-----------------
A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

Conditions
-----------------
Clostridium Enterocolitis, Diarrhea

Intervention / Treatment
-----------------
* Drug: Tolevamer potassium-sodium (GT267-004)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and above The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD Baseline serum potassium > 3.0 mmol (meq)/L Patient considered sufficiently stable clinically to likely complete 6 week study period.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tolevamer potassium-sodium (GT267-004)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of diarrhea |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of diarrhea |  |  | 
| Recurrence rate |  |  | 
| Number of stools |  |  | 
| Average stool consistency |  |  | 
| Treatment success |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pseudomembranous Colitis, Clostridium difficile-associated diarrhea, C. difficile, CDAD
Embryotransfer Operator and Pregnancy Rate

Study Overview
=================
Brief Summary
-----------------
Several studies had analyzed the correlation between embryo transfer operator experience and implantation, clinical pregnancy, abortion and delivery rate. The aim of the present study is determining if the probabilities of embryo implantation and pregnancy are associated to the operator performing the embryo transfer. This study allows following more than 30 different operators in a global period of 20 years with almost 20,000 procedures.

Detailed Description
-----------------
Several studies had analyzed the correlation between embryo transfer operator experience and implantation, clinical pregnancy, abortion and delivery rate. Until now, the evidences are mixed and inconclusive. The aim of the present study is determining if the probabilities of embryo implantation and pregnancy are associated to the operator performing the embryo transfer. The database includes all the fresh embryo transfers, performed between January 1997 and December 2016 at Humanitas Fertility Center after IVF-ICSI cycles. Only embryo transfers performed by the surgeon on duty for that day (Gynecologist of the Day) will be included. Secondary end point is to evaluate if it is possible to draw a learning curve for transfer in terms of pregnancies for the different surgeons. The strength of this study relies on the completeness of the preoperative factors and follow up and on the vastest dataset in literature that can permit to correct for multiple confounders and analyze a wide group of outcomes.

Official Title
-----------------
Does the Operator Performing the Embryo Transfer Significantly Influence the Cycle Outcome: A Retrospective Evaluation of Humanitas Fertility Center's Experience

Conditions
-----------------
Sterility

Intervention / Treatment
-----------------
* Other: Embryo transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fresh embryos' transfers embryo transfers performed only by the surgeon on duty for that day (Gynecologist of the Day) Exclusion Criteria: cryo thawed embryos' transfers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Embryo transfer|all the fresh embryo transfers, performed between January 1997 and December 2016 at Humanitas Fertility Center after IVF-ICSI cycles, divided per operator|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate per operator | number of viable intrauterine embryos/ total number of embryos transferred per operator | 20 years |
Automatic Evaluation of Inflammation Activity in Ulcerative Colitis Using pCLE With Artificial Intelligence

Study Overview
=================
Brief Summary
-----------------
Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables to evaluate the inflammation activity of ulcerative colitis with excellent correlation with histopathology. However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.

Official Title
-----------------
Automatic Evaluation of Inflammation Activity in Ulcerative Colitis Using Probe-based Confocal Laser Endomicroscopy With Artificial Intelligence

Conditions
-----------------
Ulcerative Colitis, Artificial Intelligence, Confocal Laser Endomicroscopy

Intervention / Treatment
-----------------
* Diagnostic Test: The diagnosis of Artificial Intelligence and endoscopist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 18 and 80; diagnosed as UC Exclusion Criteria: Patients under conditions unsuitable for performing CLE including coagulopathy , impaired renal or hepatic function, pregnancy or breastfeeding, and known allergy to fluorescein sodium; Inability to provide informed consent

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 |
| --- | --- |
| Colon mucosa observed by pCLE<br>pCLE is used to evaluate the inflammation activity in different parts of the colon mucosa | Diagnostic Test: The diagnosis of Artificial Intelligence and endoscopist<br>* When the colon mucosa is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnosis efficiency of Artificial Intelligence | The primary outcome is to test the diagnostic accuracy, sensitivity, specificity, PPV, NPV of the Artificial Intelligence for evaluation of inflammation activity of UC on pCLE examination. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists | The secondary outcome is to compare the diagnosis efficiency (including diagnostic accuracy, sensitivity, specificity, PPV, NPV ) between Artificial Intelligence and endoscopists. | 3 months |
Impact of Spiroergometer Parameters as Diagnostic Marker of Cardiac Ischemia in Pts. With Stable Angina Compared to FFR.

Study Overview
=================
Brief Summary
-----------------
In Patients with stable Angina pectoris CCS 1-3 exercise testing for ischemia detection is widely used despite the known limitations. Measurement of the FFR is invasive but gold standard for Ischemia detection. Adding of parameters of spiroergometer might help to improve diagnostic accuracy of non invasive exercise testing. Therefore the trial is evaluating diagnostic accuracy of spiroergometric parameters compared to invasive FFR measurement.

Official Title
-----------------
Impact of Ergospirometric Oxygen Uptake Under Exercise as Diagnostic Marker of Cardiac Ischemia in Patients With Stable Angina Compared to Non Invasive and Invasive (FFR) Measurement of Ischemia

Conditions
-----------------
Stable Angina

Intervention / Treatment
-----------------
* Diagnostic Test: ergospirometer test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable Angina (CCS >1-3) with suspected CAD or dyspnoea at exertion NYHA >2 or signs of ischemia within SPECT or exercise electrocardiography willingness to participate in the trial Exclusion Criteria: Unstable angina or myocardial infarction within the last 2 weeks inability to perform bicycle exercise test significant valvular disease HOCM av- block >I degree asthma bronchiales

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ergospirometer test|ergospirometric test will be done before cardiac catheterisation and invasive measurement of FFR|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| double slope sign of ΔV̇O2/ΔWR-Increase | double slope sign of ΔV̇O2/ΔWR by ergospirometer test | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FFR Measurement; exercise testing, ergospirometer