linjc16/ctgov huggingface dataset:
Study Evaluating the Safety, Tolerability and Pharmacokinetics of Desvenlafaxine Succinate SR in Healthy Chinese Male and Females

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine succinate SR in healthy male and female Chinese subjects. The amount of drug in the body and the effects of the drug will also be evaluated.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Desvenlafaxine Succinate Sustained Release Administered Orally to Healthy Chinese Subjects.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: desvenlafaxine succinate SR
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Men or non-pregnant, non-lactating women, 18 to 45 years of age inclusive on study day 1. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG) Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) a day. Exclusion: Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. History of epilepsy or seizure disorder (except history of a single childhood febrile seizure).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: desvenlafaxine succinate SR<br>desvenlafaxine succinate SR | Drug: desvenlafaxine succinate SR<br>* desvenlafaxine succinate SR<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECG and clinical laboratory results. |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics as evaluated from blood and urine concentrations of desvenlafaxine |  | 2 months |
Empowering Immigrants in the Greater Boston Area to Connect to HBV Care

Study Overview
=================
Brief Summary
-----------------
This Study will attempt to provide information / linkage to HBV care for persons at risk in the Greater Boston area.

Detailed Description
-----------------
Specific Aims Provide HBV education at community sites where immigrants at risk for HBV could be informed of the risks related to HBV, in a culturally and linguistically sensitive manner. Chelsea, Charlestown, and Revere MGH Community Health Centers: posters, pamphlets, and telephone line to provide HBV education Senegalese Community Center: community meeting, posters, and pamphlets African Students' Association, Suffolk University: community meeting, posters, and pamphlets Revere Cambodian Community Centers: community meeting, posters, and pamphlets Provide at-risk persons with the tools to develop an HBV diagnosis plan with his / her provider. Provide counseling on the significance of different testing results prior to testing Connect to testing, and appropriate post-test follow-up appointments Provide an education hub for patients and providers to return to with questions regarding: test interpretation, available treatments for those who test positive, and screening for hepatocellular carcinoma in those who are infected. Provide copy of an easy to understand US HBV treatment algorithm in native languages Provide information related to genotype-specific risks for HCC (increased with GT C).

Official Title
-----------------
Empowering Immigrants in the Greater Boston Area to Connect to HBV Care

Conditions
-----------------
Hepatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all persons interested in hearing more information about HBV - Exclusion Criteria: children -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Improved understanding of HBV by Questionnaire | Participants will be provided questionnaires by D. Fusco | 1 year |
Development and Validation of a Web-based Nomorgam to Predict Postoperative Complications

Study Overview
=================
Brief Summary
-----------------
The incidence of complications after gastrectomy remains high among elderly patients with gastric cancer. The investigators sought to establish and validate a web-based nomorgam for predicting total complications among elderly patients undergoing resection of gastric cancer.

Official Title
-----------------
Development and Validation of a Web-based Nomorgam to Predict Postoperative Complications After Radical Gastrectomy Among Elderly Gastric Cancer Patients

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

Intervention / Treatment
-----------------
* Other: data analysis; validating the nomogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with gastric cancer by endoscopy or pathology planned to receive radical surgery for the first time aged 60 or older Exclusion Criteria: received preoperative radiotherapy or chemotherapy with other sites of malignant tumors

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| training cohort<br>The training cohort was used for data analysis. | Other: data analysis; validating the nomogram<br>* Not Applicable. Our study did not involve intervention<br>|
| validation cohort<br>The validation cohort was used for validating the nomogram | Other: data analysis; validating the nomogram<br>* Not Applicable. Our study did not involve intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications during hospitalization | the investigators captured it from electronic medical records | about 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer;postoperative complications;nomogram
Determinants of Success, Characterizing the Facilitators of Integrated Abortion Provision

Study Overview
=================
Brief Summary
-----------------
This national, qualitative study of physicians who provide abortion care aims to better understand the facilitators of abortion provision among generalist clinicians in OB-GYN and Family Medicine.

Detailed Description
-----------------
This is a nationwide qualitative study of 20 to 40 physicians who provide abortion services as part of their scope of practice. Providers will participate in a semi-structured interview using an interview guide that addresses 4 domains of interest including: (1) initiation of abortion services, (2) barriers to abortion provision, (3) facilitators of abortion provision and (4) acquired expertise and coaching for success.

Official Title
-----------------
Determinants of Success, Characterizing the Facilitators of Integrated Abortion Provision

Conditions
-----------------
Pregnancy Termination

Intervention / Treatment
-----------------
* Other: Semi-structured interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Practicing obstetrician-gynecologists and family medicine physicians who currently provide or in the past have provided abortion services (medication abortions, surgical abortions and/or induction abortions) as part of their clinical practice will be eligible for study participation. All providers who meet these criteria will be eligible regardless of providers' gestational age cutoff, abortion indication limitations and/or restrictions, or number of abortions provided. Exclusion Criteria: Physicians who work solely at a designated abortion facility, e.g., Planned Parenthood, without an alternate practice site, or who provide only abortions, are not eligible for study participation.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Semi-structured interviews|Providers will participate in a semi-structured interview using an interview guide that addresses 4 domains of interest including: (1) initiation of abortion services, (2) barriers to abortion provision, (3) facilitators of abortion provision and (4) acquired expertise and coaching for success.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integration of Abortion Care | To qualitatively interview obstetrician/gynecologists and Family Medicine physicians who have successfully integrated abortion care into their practice scope and to explore their experiences with abortion provision. | April 2017-February 2018 |
TOT, TVT And Burch Colpo-Suspension for Treatment of Female Mixed Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
This prospective interventional randomized controlled trial will recruit women with MUI scheduled for surgical treatment where patients will be randomized to either Burch colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2 years. The primary outcome measures will be the objective and subjective cure rates.

Official Title
-----------------
Trans-Obturator Tape, Tension-Free Vaginal Tape and Burch Colposuspension for Treatment of Female Mixed Urinary Incontinence: A Randomized Clinical Trial

Conditions
-----------------
Treatment

Intervention / Treatment
-----------------
* Procedure: TOT
* Procedure: TVT
* Procedure: Burch Colposuspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with mixed urinary incontinence. Exclusion Criteria: Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study. Women who improved on medical treatment with persistence of stress element only were also excluded.
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TOT<br>TOT | Procedure: TOT<br>* 70 patients<br>* Other names: Trans-Obturator Tape;|
| Active Comparator: TVT<br>TVT | Procedure: TVT<br>* 70 patients<br>* Other names: Tension-Free Vaginal Tape;|
| Active Comparator: Burch colposuspension<br>Burch colposuspension | Procedure: Burch Colposuspension<br>* 70 patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective cure rate |  | 2 years | 
| subjective cure rate |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mixed urinary incontinence, Transobturator tape (TOT), Tension-Free Vaginal Tape (TVT), Burch colposuspension, Urinary incontinence
Italian Registry on Unprotected Left Main

Study Overview
=================
Brief Summary
-----------------
The RITMO (Registro Italiano sul trattamento del Tronco coMune non protettO) observational study will appraise the prevalence, management strategy, and prognosis of unprotected left main coronary artery disease in Italy.

Detailed Description
-----------------
The RITMO (Registro Italiano sul trattamento del Tronco coMune non protettO) observational study will be a prospective, multicenter, observational study aiming to appraise the prevalence, management strategy, and prognosis (up to 5 years) of unprotected left main coronary artery disease in Italy. A total of 45 Italian secondary and tertiary care centers will participate, and enroll patients during a period of 12 to 18 months. Patients will be included provided that they complete a written informed consent form and significant unprotected left main coronary artery disease is established at diagnostic coronary angiography. The primary end-point will be the 12-month rate of major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization).

Official Title
-----------------
Italian Registry on Treatment for Unprotected Left Main Disease (Registro Italiano Sul Trattamento Del Tronco coMune Non protettO)

Conditions
-----------------
Cardiovascular Disease, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: angiographic evidence of significant unprotected left main disease lack of patent bypass grafts for the left coronary system willingness to complete written informed consent form willingness to comply with subsequent follow-up contacts Exclusion Criteria: lack of written informed consent form inability to comply with subsequent follow-up contacts
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 |
| --- | --- | --- |
| major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cerebro-cardiovascular events |  | 60 months | 
| Canadian Cardiac Society functional class |  | 60 months | 
| quality of life (EuroQoL) |  | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular disease, coronary artery bypass grafting (CABG), coronary artery disease (CAD), percutaneous transluminal coronary angioplasty (PCI), unprotected left main disease
Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation

Study Overview
=================
Brief Summary
-----------------
Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival.

Official Title
-----------------
Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation: a Prospective, Exploratory Study

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Icotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma with 19 or 21 exon mutation The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1 The patients signed the written informed consent Exclusion Criteria: Patients with unresected tumor Wild EGFR type Allergic to the study drug Patients have severe non-cancerous diseases Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Icotinib<br>Patients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery. | Drug: Icotinib<br>* Icotinib is administered 125 mg three times per day.<br>* Other names: BPI-2009;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year Survival Rates |  | 1 year | 
| 3-year Survival Rates |  | 3 years | 
| Number of patients suffered adverse events | Adverse events are evaluated and coded by Common Terminology Criteria for Adverse Events version 4.0 | 42 months |
Evaluation Study on Corneal Lens for Vision Correction

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens, made of silicone commonly used in the contact lens industry, on healthy eye with or without astigmatism.

Official Title
-----------------
Evaluation Study on Corneal Lens for Vision Correction

Conditions
-----------------
Astigmatism

Intervention / Treatment
-----------------
* Device: Astigmatic Correction Lens (Nexis ACCL lenses)
* Device: Toric Soft Contact Lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with good corneal health Age 18-65. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements. Best corrected visual acuity of 20/20 or better in the study eye/s Exclusion Criteria: Any other anterior segment abnormality. No previous corneal procedures, including Laser Vision Correction. Any abnormalities associated with the eye lids. Clinically significant inflammation or infection within six (6) months prior to study. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator. Participation in any study involving an investigational drug or device within the past 30 calendar days, or ongoing participation in a study with an investigational material except studies using corneal lenses. Intolerance or hypersensitivity to topical anesthetics, fluorescein, or components of the material. Specifically known intolerance or hypersensitivity to contact lenses. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Astigmatic Correction Lens<br>Nexis ACCL lenses vs commercial Toric Lenses | Device: Astigmatic Correction Lens (Nexis ACCL lenses)<br>* Astigmatic refractive error correction<br>|
| Active Comparator: Toric Soft Contact Lenses<br>commercial toric soft contact lenses | Device: Toric Soft Contact Lenses<br>* astigmatism correction using toric optics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | 30 mins |
Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain

Study Overview
=================
Brief Summary
-----------------
Phantom limb pain is a complication of amputation. Although pre-empitve epidural analgesia was once thought to prevent such a com plication, recent studies did not demonstrate this. Peripheral blocks are more powerful then epidurals, and can even influence somatotropic representation in the brain. This a prospective case series in which the investigators hope to show a decrease, against historical control, of the incidence of post-operative amputation lower limb phantom pain. The investigators established the block at least 24 hours pre-operative and continue it for at least 2 days. Patient are followed daily for the 1st 3 days and then up to 3 month for the incidence of phantom limb pain. The investigators hope to recruit 30 patients.

Official Title
-----------------
a Prospective Case Series of Pre-emptive Pre-amputation Sciatic Nerve Block to Prevent Lower Limb Phantom Pain

Conditions
-----------------
Phantom Limb Pain

Intervention / Treatment
-----------------
* Procedure: sciatic nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for lower limb amputation Exclusion Criteria: Inability to consent Contraindication to peripheral nerve block Inability to perform the block Inadequate time frame (less than 24 hours prior to surgery)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sciatic block<br>One arm, all patient studied received a block | Procedure: sciatic nerve block<br>* Sciatic nerve block, Labatt approach, with a stimuplex needle and catheter. Once localized, a bolus of 20 mL ropivacaine 1,0% is given through the catheter and is followed by a perfusion of ropivacaine 0,2% 6-10 mL/hre for at least 24 hours pre-op and 48 hours post-op<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of lower limb phantom pain |  | 3 month post amputation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-emptive analgesia, Peripheral nerve block (sciatic), phantom lomb pain