linjc16/ctgov huggingface dataset:
Treatment of Recurrent Urinary Tract Infection (RUTI) by Traditional Chinese Medicine

Study Overview
=================
Brief Summary
-----------------
Traditional Chinese Medicine (TCM) could be used to treat Recurrent urinary tract infection (RUTI).

Detailed Description
-----------------
Antibiotics and TCM are used to treat RUTI to evaluate treatment efficiencies.

Official Title
-----------------
Study on Treatment of Recurrent Urinary Tract Infection by Traditional Chinese Medicine

Conditions
-----------------
Recurrent Urinary Tract Infection

Intervention / Treatment
-----------------
* Drug: LVX-AMX
* Drug: TCM
* Drug: LVX-AMX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: uncomplicated RUTI Exclusion Criteria: complicated RUTI other disease with urinary tract infection by pathogens other than bacteria

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LVX-AMX<br>subject is treated with LAV-AMX, then followed by placebo. | Drug: LVX-AMX<br>* Subjects were treated with Levofloxacin, 200mg bid, Amoxicillin, 500mg tid for 1 week, followed by 3 week of placebo.<br>* Other names: Levofloxacin, 200mg bid, Amoxicillin, 500mg tid;Drug: LVX-AMX<br>* treatment with placebo from 2 to 4 weeks.<br>* Other names: placebo from 2 to 4 weeks.;|
| Active Comparator: TCM treatment<br>subject is treated with TCM | Drug: TCM<br>* Subject is treated with TCM for 4 weeks.<br>* Other names: TCM formula consisted of 10 herbals;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of recurrent urinary tract infection | Patients are checked at 4 weeks at the end of the treatment to confirm recovery of RUTI. | 4 weeks after study drug start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary albumin | Urinary albumin is checked in patient urine. | 4 weeks after drug start | 
| WBC conversion | Check the WBC count in patient urine. | 4 weeks after drug start | 
| Urination frequency | Checked for urination frequency at 4 weeks after drug start. | 4 weeks after drug start | 
| Recurrence | Patients are checked for recurrence rate at 6 months after drug start by telephone interview. | 6 months after drug start | 
| urgency | Check urgency 4 weeks after drug start | 4 weeks after drug start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent urinary tract infection, antibiotics, traditional chinese medicine
SVT-15652 Otic Solution for the Treatment of Otomycosis

Study Overview
=================
Brief Summary
-----------------
Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.

Official Title
-----------------
A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of SVT-15652 Otic Solution Compared to Placebo for the Treatment of Fungal Otitis Externa (Otomycosis)

Conditions
-----------------
Otomycosis

Intervention / Treatment
-----------------
* Drug: SVT-15652
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: At least 18 years of age Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated. Signs/symptoms of pruritus, otalgia and ear fullness. Debris or drainage clinically consistent with fungal infection. Main Exclusion Criteria: Known bacterial otitis externa or malignant otitis externa. Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery. Structural ear anomalies which may difficult the evaluation of the therapeutic response. Uncontrolled diabetes mellitus. Any infection requiring systemic antimicrobial or systemic antifungal therapy. Concomitant medicines that may interfere with the study evaluations.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SVT-15652<br>1 vial twice daily | Drug: SVT-15652<br>* 1 vial twice daily<br>|
| Placebo Comparator: Placebo<br>1 vial twice daily | Drug: Placebo<br>* 1 vial twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutical Cure (Clinical and Mycological Cure) | Number and percentage of subjects with therapeutic cure | Test of cure on day 24 |
Early Intervention Following Mild TBI

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to implement and measure the efficiency of a standardized acute and brief non-pharmacological intervention (Cognitive interventions on Sleep - Anxiety - Attention - Memory) following mild TBI and observe their impact pre- and post-treatments. The ultimate goal is to have patients be re-integrated to their activities faster with lesser symptoms and have patients present lesser post-concussive symptoms. Specific objectives: 1) Measure the effect of an acute and brief non-pharmacological intervention on PCS symptoms, sleep, headaches, affect, cognition and functional outcome following mild TBI; 2)To redefine a model of outcome prediction following mild TBI.

Official Title
-----------------
Acute and Brief Intervention Following Mild Traumatic Brain Injury: A Randomized Controlled Clinical Trial

Conditions
-----------------
Mild Traumatic Brain Injury

Intervention / Treatment
-----------------
* Behavioral: education and support intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Mild TBI Exclusion Criteria: Psychiatric diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: education and support intervention<br>education and support intervention | Behavioral: education and support intervention<br> <br> |
| No Intervention: waiting list<br>waiting list and regular medical follow-up | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of post-concussive symptoms |  | 1 year |
A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients

Study Overview
=================
Brief Summary
-----------------
The study is intended to test the safety, tolerability, and efficacy of long-term treatment with YM178 in patients with overactive bladder symptoms.

Official Title
-----------------
Long-term Study of YM178: Long Term Study of YM178 in Subjects With Overactive Bladder

Conditions
-----------------
Urinary Bladder, Overactive

Intervention / Treatment
-----------------
* Drug: YM178


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has symptoms of overactive bladder for >= 24 wks Subject experiences frequency of micturition at average >= 8 times per 24 hrs confirmed by the 3-day patient diary Exclusion Criteria: Subject is breastfeeding, pregnant, or intends to become pregnant during the study Subject obviously has stress incontinence Subject has an indwelling catheter or practices intermittent self catheterization Subject has evidence of symptomatic urinary tract infection, interstitial cystitis, bladder stone, etc Subject has an average total daily urine volume > 3000 mL confirmed by patient diary Subject has uncontrollable hypertension (SBP >= 180 mmHg or DBP >= 110 mmHg)

Ages Eligible for Study
-----------------
Minimum Age: 20 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. YM178<br> | Drug: YM178<br>* Oral<br>* Other names: Mirabegron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs, AEs, lab tests, ECG, post-void residual volume |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in the mean number of micturitions/24hrs |  | 52 weeks | 
| Changes from baseline in the mean number of urinary urgencies/24 hrs |  | 52 weeks | 
| Changes from baseline in the mean number of incontinence episodes/24 hrs |  | 52 weeks | 
| Changes from baseline in the mean number of urge incontinence episodes/24 hrs |  | 52 weeks | 
| Changes from baseline in the mean number of nocturnal urinations |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YM178, Urinary Bladder, Overactive, Mirabegron
New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes

Study Overview
=================
Brief Summary
-----------------
Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare neuroimmune syndromes with a wide range of clinical presentation but without pathognomonic clinical sign facilitating the diagnosis. A lot of differential diagnoses are possible such as neurodegenerative diseases or viral infections. Although rare the diagnosis of AE or PNS is essential because despite severe neurological symptoms, patients can be cured by appropriate immunotherapy. Autoantibodies highly specific of AE and PNS has been described in the serum and cerebrospinal fluid of the patients and can be used as biomarkers of the disease. Their presence can predict an autoimmune origin and in many cases a good prognosis after immunotherapy. However, if some autoantibodies are now well-characterized and industrial kits have been developed to detect them, in numerous cases of highly suspect AE or PNS no specific autoantibodies are identified leading frequently to an inappropriate treatment. Furthermore, as the mechanisms of AE and PNS is still unknown, treatments are not optimal and in some cases inefficient. There is no prognosis biomarker able to predict the patient's sensitivity to immunotherapy and there are only few clues to know how the immune system can provoke the neuropsychiatric symptoms observed in the patients. The investigators will use this project to better characterize AE and PNS patients to identify new diagnostic and prognostic biomarkers and develop new diagnostic tools.

Official Title
-----------------
New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes

Conditions
-----------------
Paraneoplastic Neurological Syndrome, Autoimmune Encephalitis

Intervention / Treatment
-----------------
* Biological: Test of biological samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria * : patient with neurological disorder patient without antibody Exclusion Criteria * : patient with characterized antibody patient without neurological disorder
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Test of biological samples|Different tests can be use on biological sample : western bloc, dot blot, immune-fluorescence, immunoprecipitation, CBA, functional test, epitope research, IgG title|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of new biomarkers | Results of diagnostics tests for each patient, description of marking | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paraneoplastic Neurological Syndrome, Autoimmune Encephalitis
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cervical cancer.

Detailed Description
-----------------
The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cervical cancer.

Official Title
-----------------
Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cervical Cancer

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Procedure: Radiofrequency ablation
* Biological: Cytokine-induced killer cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They were systematic reviews based on randomized controlled trials (rcts). They were phase II rcts comparing chemotherapy with other systemic therapy agents or with no further treatment for recurrent, metastatic, or persistent cervical cancer. they reported at least one of these outcomes: complete or partial response rate, overall or progression-free survival rate, adverse effects, or healthrelated quality of life (rcts reporting on heterogeneous populations-for example, women at a range of disease stages-were included if results were given separately for patients with recurrent, metastatic, or persistent cervical cancer). Exclusion Criteria: studies evaluating the role of radiotherapy administered with chemotherapy, or second- or subsequent-line therapy options.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: RFA alone<br>Patients undergo radiofrequency ablation alone. | |
| Experimental: RFA+CIK<br>Autologous cytokine-induced killer cells were transfer via venous one week after RFA Interventions | Procedure: Radiofrequency ablation<br>* Radiofrequency ablation is performed percutaneously under CT/US guidance<br>* Other names: RFA;Biological: Cytokine-induced killer cells<br>* The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.<br>* Other names: CIK;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival | Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up. | 1 year |
MitraClip EXPAND G4 Study

Study Overview
=================
Brief Summary
-----------------
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.

Detailed Description
-----------------
This is a post-market, multi-center, single-arm, prospective study to assess the safety and performance of the next generation MitraClip G4 System. The current protocol describes the design of this post-market study. Up to 1,100 post-market, consented patients will be treated with a MitraClip G4 device according to local guidelines and IFU from the Europe and Middle East, the United States, Canada and Japan, and will be included in the analysis for the MitraClip EXPAND G4 Study. Follow-up echocardiograms will be collected at Discharge, 30 days and 1 year and 5 year at post-procedure visits. Additional clinical follow-up visits will be at 6 months (phone call), 2, 3, 4 year (office visits). Cardiovascular adverse events will be reported through 5 years to confirm safety of the MitraClip G4 System. During the Phase 1 of the study 100 subjects were enrolled at 15 sites in the United States with the goal of evaluating the early safety and procedural outcomes associated with the MitraClip G4. The follow up duration was 30 days. Phase I was completed August 2020.

Official Title
-----------------
A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System

Conditions
-----------------
Mitral Valve Regurgitation, Mitral Regurgitation

Intervention / Treatment
-----------------
* Device: MitraClip G4 System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects scheduled to receive the MitraClip per the current approved indications for use Subjects who give consent for their participation Exclusion Criteria: 1. Subjects participating in another clinical study that may impact the follow-up or results of this study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MitraClip G4 System<br>Percutaneous mitral valve repair using the MitraClip G4 system | Device: MitraClip G4 System<br>* Percutaneous mitral valve repair using the MitraClip G4 system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with MR Reduction to ≤2+ or less at 30 days | MR Severity of 2+ or less at 30 days | At 30 days | 
| Occurrence of Major Adverse Events (MAE) at 30 days | MAE is defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications. | At 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MitraClip, MitraClip G4, Mitral Regurgitation
A Study to Compare the Efficacy of Alendronate With and Without Calcium or Calcium Alone In the Treatment of Osteoporosis in Postmenopausal Women (0217-088)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see how well alendronate and calcium as compared to calcium alone increase bone density in postmenopausal women with osteoporosis

Official Title
-----------------
A Triple-Blind, Randomized, Active-Controlled, Parallel-Group, Multicenter Study to Evaluate and Compare the Efficacy and Tolerability of Alendronate Sodium With Calcium Supplementation in the Treatment of Osteoporosis in Postmenopausal Women

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: MK0217, alendronate sodium / Duration of Treatment : 2 Years
* Drug: Comparator : calcium carbonate /Duration of Treatment : 2 Years


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Patient is postmenopausal (or surgically menopausal) for at least 5 years. Patient must be diagnosed with osteoporosis Patient has spinal anatomy suitable for DEXA of the lumbar spine Exclusion Criteria : Patient is receiving or has received treatment prior to randomization which might influence bone turnover Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss) Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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: MK0217, alendronate sodium / Duration of Treatment : 2 Years|nan|
|Drug: Comparator : calcium carbonate /Duration of Treatment : 2 Years|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD of the lumbar spine determined by a DEXA scan at 2 years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD of the hip trochanter and femoral neck determined by a DEXA scan and biomarkers of bone turnover (BAP, NTX) at 2 years |  |  |
Natural History of Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
20 patients will be recruited. The aim of the study is to determine the natural progression of atherosclerotic disease.

Official Title
-----------------
Natural 1-year History of Atherosclerosis in Asymptomatic Patients With Mild to Moderate Carotid Stenosis

Conditions
-----------------
Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable carotid artery disease not requiring revascularization asymptomatic carotid artery stenosis < 80% or symptomatic patients with stenosis < 60 % prophylactic therapy with aspirin (> 100mg/day, statin, blood pressure therapy if indicated (goal < 130/80 mmHg)) informed consent Exclusion Criteria: non atherosclerotic occlusive disease (Bürgers disease) uncontrolled BP (DBP > 110 mmHg and/or SBP > 200 mmHg) hemorrhagic disease or platelet count < 100'000 mm^3 Known active liver disease (elevations of GPT GOT or increased ammonia) impaired renal function (crea > 180 mmol/l) pregnancy severe claustrophobic reactions short - term life - threatening pathology physically unable to participate in the study compliance not guaranteed
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>asymptomatic patients with mild to moderate carotid artery stenosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of atherosclerotic plaque |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atherosclerotic disease, progression, natural progression of atherosclerotic disease, natural history of atherosclerosis at the level of the carotid artery as evaluated by MRI