linjc16/ctgov huggingface dataset:
A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP)

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Acupuncture procedure of He's Santong Methods could be an option to treat nonspecific low back pain.

Detailed Description
-----------------
He's Santong Methods is a combined manipulated needling methods, including filiform needling, fire needling and bloodletting needling, which was created by Dr. He Puren who is one of the most famous TCM doctors in China.

Official Title
-----------------
A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP) (ANLBP)

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Acupuncture Treatment
* Other: Sham acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient who is suffering the Non-specific Low Back Pain which meets the diagnostic criterion of posterior ramus of lumbar spinal nerve syndrome. The patient who is from 18 to 79 years old. The patient who can comprehensively understand and fill in the questionnaires about the disease. The patient who suffered problems no less than 12 weeks. The patient who have not the other diseases which can result in back pain. The patient who received the clear examinations of X-ray, CT scan or MRI. The patient who wrote the informed consents. Exclusion Criteria: The patient whose low back pain is the consequences of spondyloschisis, Spondylolysis, osteoarthritis, osteoporosis, internal disease, metastatic tumor. The patient who have the hemorrhagic disease such as hemophilia. The patient who have the spinal diseases which have not been diagnosed clearly.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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: Verus acupuncture<br> | Other: Acupuncture Treatment<br>* Acupuncture is a technique of inserting and manipulating fine needles into specific points on the body to relieve pain or for therapeutic purposes.<br>|
| Sham Comparator: Sham acupuncture<br> | Other: Sham acupuncture<br>* Sham acupuncture is inserting needles superficially, without manipulating, into specific points on the body.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of SF-36 |  | 4 weeks, 8 weeks, 12 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) |  | 4 weeks, 8 weeks, 12 weeks, 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low Back Pain, Acupuncture, RCT
The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms and Sexual Function

Study Overview
=================
Brief Summary
-----------------
Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography.

Detailed Description
-----------------
Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography.

Official Title
-----------------
The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms and Sexual Function

Conditions
-----------------
Pelvic Organ Prolapse, Sexual Dysfunction, Lower Urinary Tract Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with lower urinary tract symptoms and will undergo urodynamic studies Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 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 |
| --- | --- |
| Lower urinary tract symptoms<br>Women with lower urinary tract symptoms | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the correlation of bladder descent and lower urinary tract symptoms. | To assess the correlation of bladder descent and lower urinary tract symptoms, and identify which symptoms is best correlated with bladder descent during Valsalva maneuver. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the correlation of bladder descent with sexual dysfunction. | To identify which parameters of sexual dysfunction is best correlated with the bladder descent. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic organ prolapse, lower urinary tract symptoms, sexual dysfunction
Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial

Study Overview
=================
Brief Summary
-----------------
The standard non surgical therapy of locally advanced esophageal cancer is based on a definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin. One of the alternative regimen which is being studied is the combination of a weekly cisplatin and irinotecan schedule with radiotherapy. This multicentric phase II clinical trial primarily aimed to evaluate the clinical complete response rate and secondary objectives were toxicity profile and survival.

Detailed Description
-----------------
Chemotherapy with weekly cisplatin 30 mg/m2 AND Irinotecan 60 mg/m2 was administered at days1,8,22,29 and concurrently with radiotherapy t days 43,50,64,71. Radiotherapy was delivered day 43 to 75 with 50Gy in 25 fractions/5 weeks.

Official Title
-----------------
Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial

Conditions
-----------------
Esophageal Neoplasms

Intervention / Treatment
-----------------
* Drug: irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: esophageal carcinoma (squamous cell or adenocarcinoma) histologically confirmed performance status <OR=2 (ECOG) caloric intake>1500 KCal/d serum albumin >32 gr/l serum creatinine<120 microgr/l total serum bilirubin < 1.5 mg/ml no prior chemotherapy or radiotherapy or surgery for esophageal neoplasm no prior history of malignancy other than cell carcinoma of the skin, in siyu cervical carcinoma, or head and neck carcinoma with complete response since 3 years written informed consent Exclusion Criteria: Gilbert's syndrome cardiac disease as NYHA class 3 or 4 myocardial infarction within the previous 6 months metastatic disease histologically proved invasion of tracheobronchial tree metastatic disease

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: irinotecan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity profile |  |  | 
| overall survival rate at one and two years |  |  |
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Tumor assessment will be performed according to RECIST 1.1 criteria.

Official Title
-----------------
KN035, a Single Domain PD-L1 Subcutanuous Injection Antibody, in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer

Conditions
-----------------
HER2-positive Breast Cancer

Intervention / Treatment
-----------------
* Biological: KN035
* Biological: Trastuzumab
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Female subjects with age 18 to 70 (inclusive) years at the time of consent LVEF ≥50% at baseline ECOG performance status of 0-1 Have not received 1L treatment for recurrent or metastatic breast cancer Adequate organ function Exclusion Criteria: History of exposure to the cumulative doses of doxorubicin > 400 mg / m2 or equivalent History of autoimmune diseases Active brain metastasis Concurrent diseases that compromise patient's safety

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KN035 in combination with trastuzumab and docetaxel<br> | Biological: KN035<br>* KN035 5 mg/kg s.c. Q3W<br>Biological: Trastuzumab<br>* 8 mg/kg IV loading followed by 6 mg/kg Q3W IV<br>Drug: Docetaxel<br>* 100 mg/m2 Q3W IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response | To estimate the overall response rate (CR + PR) of KN035 in combination with trastuzumab and docetaxel in patients with recurrent or metastatic HER2-positive breast cancer. • Overall Response rate will include confirmed complete response (CR) + confirmed partial response (PR), as determined as per RECIST v1.1 criteria and assessed by the local investigator | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | To characterize the toxicity of KN035 in combination with trastuzumab and docetaxel as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HER2-positive breast cancer, PD-L1 immune checkpoint
Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates

Study Overview
=================
Brief Summary
-----------------
Comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting [low dose rate (LDR) and high dose rate (HDR)]

Detailed Description
-----------------
Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate, Tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities.

Official Title
-----------------
Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates

Conditions
-----------------
Anal Canal Cancer

Intervention / Treatment
-----------------
* Radiation: Brachytherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated by brachytherapy anal canal to boost. Exclusion Criteria: Patients below age of 18 years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low Dose Rate<br>Patients treated with brachytherapy at low dose rate of the anal canal with aim of boost | Radiation: Brachytherapy<br>* Brachytherapy<br>|
| High Dose Rate<br>Patients treated by brachytherapy with a high dose rate of the anal canal aiming for boost | Radiation: Brachytherapy<br>* Brachytherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the efficacy of interstitial brachytherapy of the anal canal | Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate | 1 year | 
| Evaluation of the tolerance of interstitial brachytherapy of the anal canal | Tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of local control | Local control defined as the time between the date of diagnosis and the date of local relapse or death or recent news | 1 year | 
| Estimation of disease free survival | Disease free survival defined as the delay between the date of diagnosis and the date of local or locoregional or distant relapse or death or recent news | 1 year | 
| Estimation of overall survival | Overall survival defined as the time between the date of diagnosis and the date of death or latest news | 1 year | 
| Comparison of the incidence of toxicities (CTCAE v4) between the 2 groups | rate of toxicities | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anal Canal Cancer, brachytherapy
A Study to Obtain Additional Information on the Use of CorMatrix® CanGaroo ECM® Envelope

Study Overview
=================
Brief Summary
-----------------
Actively gather additional information on the use of CorMatrix CanGaroo ECM Envelope in a post market observational study.

Official Title
-----------------
A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix® CanGaroo ECM® Envelope

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Device: CorMatrix CanGaroo ECM Envelope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject who has received the CorMatrix CanGaroo ECM Envelope for an implantable electronic device following battery change out or upgrade. Signed Informed Consent Exclusion Criteria: 1. Known sensitivities to porcine material.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Implantable electronic device placement<br>CorMatrix CanGaroo ECM envelope for an implantable electronic device placement following a battery change out or upgrade. | Device: CorMatrix CanGaroo ECM Envelope<br>* Subjects who have received CorMatrix CanGaroo ECM Envelope for an implantable electronic device placement following a battery change or upgrade.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Related Adverse Events |  | 1 day post-operative follow up visit |
The Effects of Sex, Body Mass Index, Day-to-Day Subject Variability for the ProLung Test and Variability of a Single Device When Volume-Averaged Thoracic Bioconductance is Measured With the ProLung Test

Study Overview
=================
Brief Summary
-----------------
Assess the repeatability of the ProLung Test

Detailed Description
-----------------
This repeatability study of the ProLung Test enrolled sixty subjects, 30 male and 30 female, half of each sex with a body mass index (BMI) of 30 or more, and half with a BMI of 28 or less. Each subject was scanned twice on Day One and twice on Day Two. All scans were done by the same operator on the same device. Fifty-nine subjects produced evaluable data. Four models (algorithms) were tested.

Official Title
-----------------
The Effects of Sex, Body Mass Index, Day-to-Day Subject Variability and Variability of a Single Device When Volume-Averaged Thoracic Bioconductance is Measured With the ProLung Test

Conditions
-----------------
Healthy Volunteers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 35 to 70 years Able to understand and fulfill all requirements of this protocol Provide signed informed consent Exclusion Criteria: Pacemaker or other implanted medical device Current life-threatening medical condition Current or recent use of systemic corticosteroids Pregnant or lactating Unusually strenuous exercise within previous 24 hours Current abuse of alcohol or drugs Medical or anatomical condition that precludes testing of all 62 measurement points Other condition or reason at the discretion of the Principal Investigator or medical monitor

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify EPN Scanner variability in transcutaneous volume-averaged thoracic bio-conductance when measured twice on the same subjects by the same operator on a single same day using the same EPN Scanner | The null hypothesis is that same-day variability has no effect on scan results (i.e. when scanned twice on the same day). | 1 day | 
| Quantify day-to-day within-subject variability when the same operator uses the same EPN Scanner on the same subjects to measure transcutaneous volume-averaged thoracic bio-conductance on two different days within one week. | The null hypothesis is that day-to-day variability has no effect on scan results (i.e. when scanned twice on separate days). | 1 week | 
| Effects of BMI and Sex on transcutaneous volume-averaged thoracic bio-conductance | The null hypothesis is that BMI has no effect on scan results. The null hypothesis is that sex has no effect on scan results. | 1 week | 
| Number of participants with device-related adverse events from thoracic bio-conductance measurement. | time to complete scan. | 1 day |
Prevalence of H.Pylori in Patients With Acne Vulgaris Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to investigate prevalence of H.Pylori infection among acne vulgaris patients.

Detailed Description
-----------------
The study included patients with acne vulgaris and healthy control participants. The study recruited both sexes, all grades of acne, adolescents and young adults. All patients were subjected to complete history, general and skin examination Acne vlugaris Patients were classified into mild, moderate and severe according to the classification of American Academy of dermatology for acne vulgaris. Detection of H. pylori infection: Blood and stool samples were taken from each participant and was directly transferred to laboratory for detection of H. Pylori antigen and antibody. An enzyme-linked immune sorbent assay (ELISA) was used for quantitative assessment of IgG antibodies against H.Pylori in human serum. A monoclonal antibodies based enzyme-linked immunosorbent assay was used to detect H.Pylori specific antigen in stool samples.

Official Title
-----------------
Prevalence of Helicobacter Pylori in Patients With Acne Vulgaris

Conditions
-----------------
Helicobacter Pylori Infection, Acne Vulgaris

Intervention / Treatment
-----------------
* Other: Blood and stool samples collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acne vulgaris patients Healthy volunteers (control) Exclusion Criteria: Patients with a history of drug intake that affects H. Pylori such as proton-pump inhibitors, clarithromycin, tetracyclines, amoxicillin or metronidazole within previous two weeks were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 60 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 |
| --- | --- |
| acne vlugaris group<br>Included recruited patients with acne vulgaris Intervention: Blood and stool samples collection | Other: Blood and stool samples collection<br>* Collection of blood and stool samples from each participants for H.pylori antigen/ antibody detection<br>|
| Control group<br>Included healthy participants Intervention: Blood and stool samples collection | Other: Blood and stool samples collection<br>* Collection of blood and stool samples from each participants for H.pylori antigen/ antibody detection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H.pylori infection | Prevalence of H.pylori infection among acne group and control group | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acne vlugaris, prevalence, Helicobacter Pylori