linjc16/ctgov huggingface dataset:
Pelvic Floor Muscle Training(PFMT) on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on Lower Urinary Tract Symptoms (LUTS) in men after stroke. 120 men with LUTS or increased LUTS after stroke is included and randomized into a treatment group or a control group. The subjects in the treatment group follows a 12 week standard PFMT program, while the control group is not given specific treatment of their LUTS but like the treatment group follows the standard rehabilitation program for stroke patient. Outcome are measured by 5 questionnaires Voiding diary 24-hour pad test pelvic floor muscle assessment test

Official Title
-----------------
The Effect of Pelvic Floor Muscle Training on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke

Conditions
-----------------
Male, Stroke, Urinary Incontinence

Intervention / Treatment
-----------------
* Other: Pelvic Floor Muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men, diagnosed with stroke clinical defined according World Health Organisation (WHO 1989) and confirmed by CT and MRI scan Onset of last stroke ≥ 1 month Normal cognitive function (minimal mental examination score > 25 ) (Folstein, Folstein et al. 1976). LUTS according to ICS definition (Abrams, Cardozo et al. 2002), with start or aggravation in close relation to the stroke Independent walking abilities indoor > 100 m with/without aids Independence in toilet visits Age > 18 years Exclusion Criteria: Prior history of LUTS surgery, pelvic surgery or trauma More than 2 hospital diagnosed stroke Other severe neurological diseases including dementia Severe dysphasia Severe psychiatric disease Prostate cancer Do not speak Danish or English

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

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

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

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: Treatment<br>Treated with Pelvic Floor Muscle Training in 12 weeks | Other: Pelvic Floor Muscle training<br>* 12 week training program including home exercises<br>|
| No Intervention: Control<br>Receives standard rehabilitation after stroke | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAN-PSS-1 questionnaire |  | 2010-2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Floor Muscle Assessment test |  | 2010-2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PFMT, Stroke, LUTS, Men
Deep Sequencing of the Breast Cancer Transcriptome

Study Overview
=================
Brief Summary
-----------------
This project is a pilot study designed to investigate transcriptional regulation in breast cancer. Although the main focus of the present study will be triple negative breast cancer where all of the clinically relevant receptors - estrogen receptor (ER), progesterone receptor (PR) and herceptin (HER2) - are absent, all breast tissue biospecimens, including normal and mammary dysplasia, stored in the UAMS Tissue bank, procured from outside collaborators or purchased from commercial vendors will eventually be investigated. We will use high throughput molecular profiling techniques such as microarrays and next generation sequencing to correlate gene expression and gene expression regulation with clinical parameters such as tumor size, time to relapse and overall survival.

Official Title
-----------------
Deep Sequencing of the Breast Cancer Transcriptome

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

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: There is no inclusion criteria. This study is a retrospective tissue bank study analyzing tissue collected from a previous clinical trial. No subjects will be enrolled. Exclusion Criteria: There is no exclusion criteria. This study is a retrospective tissue bank study analyzing tissue collected from a previous clinical trial. No subjects will be enrolled.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tissue Bank Samples<br>Because this study is a retrospective tissue bank study, there are no subjects actively participating in this study. All samples studied will be obtained through the UAMS Tissue Bank. | Other: No intervention<br>* Because this study is a retrospective tissue bank study, there are no subjects actively participating in this study, thus no intervention. All samples studied will be obtained through the UAMS Tissue Bank.<br>|

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
-----------------
Identify novel genes and predict putative proteins in breast cancer., Find biomarkers that can be used for early detection, diagnosis, and prognosis.
The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.

Detailed Description
-----------------
This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.

Official Title
-----------------
The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer: An Open-label, Multi-center, Prospective and Randomised Study

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Epirubicin
* Drug: Oxaliplatin
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Major inclusion criteria had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)1.1 an Eastern Cooperative Oncology Group performance status of 0 to 2 adequate renal, hepatic, and hematologic function Major exclusion criteria previous chemotherapy or radiotherapy (unless in the adjuvant setting) uncontrolled cardiac disease, or other clinically significant, uncontrolled coexisting illness or previous or concurrent cancer accumulated dose of Epirubicin exceeds 300mg/m2 HER2 positive and willing to use trastuzumab

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: XELOX<br>oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14； | Drug: Oxaliplatin<br> <br> * Other names: 130mg/m2 ivgtt d1;Drug: Capecitabine<br>* 1000mg/m2 po d1-14<br>* Other names: Xeloda;|
| Active Comparator: EOX<br>Epirubicin 50mg/m2 d1； oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14； | Drug: Epirubicin<br>* 50mg/m2 ivgtt d1<br>Drug: Oxaliplatin<br> <br> * Other names: 130mg/m2 ivgtt d1;Drug: Capecitabine<br>* 1000mg/m2 po d1-14<br>* Other names: Xeloda;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 10 months | 
| overall response rate |  | 2 months | 
| Number of Participants with Adverse Events |  | 2 months | 
| quality of life questionnaire |  | 2 months |
Evaluation of Adipose Derived Stem Cells Exo.in Treatment of Periodontitis

Study Overview
=================
Brief Summary
-----------------
The adipose stem cells exosomes will be extracted from adipose stem cells isolated autogenously from the patient to be injected locally into the periodontal pockets in order to evaluate their regenerative effect.

Official Title
-----------------
Effect of Adipose Derived Stem Cells Exosomes as an Adjunctive Therapy to Scaling and Root Planning in the Treatment of Periodontitis: A Human Clinical Trial

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Biological: adipose derived stem cells exosomes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced periodontitis (Stage III or IV) Healthy patients. Exclusion Criteria: Smokers, Diabetic, Pregnant ladies, Under corticosteroids or contraceptive treatment,poor oral hygiene.

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

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

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

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: Exosomes<br> | Biological: adipose derived stem cells exosomes<br>* they are small extracellular vesicles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in gingival inflammation | Gingival index (GI) | 0, 3 and 6 months | 
| change in pocket depth | Probing depth (PD) | 0, 3 and 6 months | 
| change in attachment level | Clinical attachment level (CAL) | 0, 3 and 6 months | 
| change in Bone level | Cone beam C.T (CBCT) | 0 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontitis, SRP, ADSCs, Exosomes, treatment
Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare voucher-based contingency management (CM) procedures to a lower-cost CM system that provides opportunities to win prizes. Cocaine-dependent outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus usual magnitude prize CM, (c) standard treatment plus higher magnitude prize CM, or (d) standard treatment plus voucher CM. Urine and breath samples are collected 2-3x/week for 14 weeks. Follow-up interviews are conducted at 1,3,6 and 9 months following intake during which substance use and psychosocial functioning are assessed.

Official Title
-----------------
Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients

Conditions
-----------------
Cocaine Dependence

Intervention / Treatment
-----------------
* Behavioral: Contingency management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age > 18 years current DSM-IV diagnosis of cocaine dependence received methadone treatment at the clinic for at least 3 months on a stable dose of methadone (no changes in dosing) for at least one month and not presently requesting a dose alteration submitted one or more clinic-collected cocaine positive urine samples in the previous 3 months English speaking pass a brief quiz related to understanding of the informed consent form Exclusion criteria: have a serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) have dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975) are in recovery from pathological gambling

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>standard treatment plus usual magnitude prize CM | Behavioral: Contingency management<br>* Rewards (prizes) for abstinence<br>|
| Experimental: 2<br>standard treatment plus higher magnitude prize CM | Behavioral: Contingency management<br>* Rewards (prizes) for abstinence<br>|
| Experimental: 3<br>standard treatment plus voucher CM | Behavioral: Contingency management<br>* Rewards (prizes) for abstinence<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine use |  | baseline and each follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Substance Abuse, Contingency Management
Surgical Consent During the COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
Multiloop audit of consenting practice in surgical procedures during the COVID-19 pandemic

Official Title
-----------------
Consent for Surgery During the COVID-19 Pandemic

Conditions
-----------------
Consent

Intervention / Treatment
-----------------
* Behavioral: Educational meetings and visual prompts


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Children (under 18 years old) Participants who lack capacity and therefore cannot be consented appropriately

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 |
| --- | --- |
| 1<br>First cycle of the audit on consenting practice pre intervention | |
| 2<br>Second cycle of the audit on consenting practice to assess change following intervention | Behavioral: Educational meetings and visual prompts<br>* Information was disseminated to trainees via informal meeting or dedicated audit meetings with the aid of visual prompts<br>|
| 3<br>Third cycle of the audit on consenting practice to assess long term compliance | Behavioral: Educational meetings and visual prompts<br>* Information was disseminated to trainees via informal meeting or dedicated audit meetings with the aid of visual prompts<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to consenting practice | The number of patients being consented for COVID-19 infection in the lead up to surgery | 3 months |
Clopidogrel Response in Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to determine the prevalence rate and risk factors for chemical laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.

Official Title
-----------------
Prevalence of Low Response to Clopidogrel in Patients After Acute Ischemic Stroke. The Bochumer CRISP Study

Conditions
-----------------
Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute ischemic stroke admittance to stroke unit clopidogrel medication Exclusion Criteria: no consent prior bleeding disorders severe liver disorders current gastrointestinal disorders congestive heart failure life-threatening malignancies

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 |
| --- | --- | --- |
| Result of platelet function test | Aggregometry result of antiplatelet therapy | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Clopidogrel, Aggregometry, Antiplatelet therapy, Platelet function tests
A User Study With Vernivia® for Bacterial Vaginosis.

Study Overview
=================
Brief Summary
-----------------
This is an open user study to evaluate D005 vagnial mousse with regards to user-friendliness, and measure time from start of treatment to symptom relief and measure the clarity of instructional material. The study will be conducted at seven sites in Sweden, the study population will consist of up to 100 female subjects.

Official Title
-----------------
A User Study With Vernivia® for Bacterial Vaginosis (USV01) Evaluation of User-friendliness, Measure Time From the Start of Treatment to Symptom Relief and the Clarity of Instructional Material

Conditions
-----------------
Bacterial Vaginoses

Intervention / Treatment
-----------------
* Device: D005 vaginal mousse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 16 - 49 years Informed consent to take part in the study Bacterial vaginosis (based on self-assessment or diagnosed by a doctor or midwife) Access to a smartphone Exclusion Criteria: Symptoms of vaginal candida infection and/or Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 49 Years

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

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 |
| --- | --- |
| Other: One dose daily for 7 consequtive days (dose acc to IFU)<br>Open user study with Vernivia once daily for 7 consequtive days. Dosage according to IFU/Instructions For Use. | Device: D005 vaginal mousse<br>* D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.<br>* Other names: Vernivia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate symptom relief during treatment with Vernivia®. | Evaluation of number of days from start of treatment until symptom relief | 1-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported grading of malodorous discharge (0-3) | Evaluate how the user experiences the product with regards to malodorous (1 = Not likely, 10 = Very likely) | 1-7 days | 
| Net Promotor Score regarding user-friendliness | Evaluate how the user experiences the user-friendliness (1 = Not likely, 10 = Very likely) | 1-7 days | 
| Clarity of the IFU (Instructions For Use) | Evaluate how the user experiences the IFU (Instructions For Use) (1= Not at all informative, 5= Very informative) | 1-7 days | 
| Clarity of instructional video | Evaluate how the user experiences the instructional video (1= Not at all informative, 5= Very informative) | 1-7 days |
Labor Progress Indices and the Dynamics of the Individual Contraction During the Active Stage of Labor

Study Overview
=================
Brief Summary
-----------------
Objective of the study: to obtain new data on the dynamics of the labor process, cervix dilatation and head station on the labor process and to develop a new progress indices. Background: the best method used today to supervise the labor process is to follow cervix dilatation and head station. Today, the physician or the midwife use manual examination to estimate cervix dilatation and head station. This examination is perform many times in a normal labor process, and even more if there is any delay. The information from these examinations is inaccurate and non-continuous. In case of delay in the labor process, the delay will diagnosed late, because the frequency of the manual examination is about once an hour. With the assistance of the BirthTrack device we can get continuous data on the labor process and get indices to estimate the labor process progress without the use of vaginal (manual) examination. 40 women in an active labor will take part in the study. Method: by connecting sensors to the woman abdomen, to the cervix and to the baby head we follow the cervix dilatation and the fetus head station.

Official Title
-----------------
Physiological Study of the Active Stage of Labor

Conditions
-----------------
Labor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparous women 18 years or older admitted to the labor and delivery unit in active labor (3cm dilatation and contractions). Parturients with epidural anesthesia Singleton fetus in vertex presentation Gestational age 37 or more Reassuring fetal heart tracing The woman is able to read and understand the consent form Exclusion Criteria: Parturients in natural birth without epidural anesthesia Low lying placenta Known or suspected fetal or maternal infection Maternal thrombocytopenia Maternal bleeding disorder Known major fetal malformation Suspected fetal growth restriction Subjects with significant psychiatric history Subjects with indication for immediate delivery Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Control<br>Patients in active phase of labor not augmented | |
| Augmented<br>Augmentation leading to normal progress | |
| Caesarean section<br>Augmentation leading to Caesarean section | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth Track measurements versus manual measurements |  | 1 year |