linjc16/ctgov huggingface dataset:
Study Evaluating the Effect of Physician Education on Smoking Cessation Counselling

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to see if a short seminar educating physicians about smoking cessation counselling will effectively improve their smoking counselling cessation practices.

Official Title
-----------------
Pilot Study Evaluating the Influence of Physician Education Regarding the 5A's Smoking Cessation Counselling Strategy, as Evaluated by Patient Interpretation of the Strategy Principles

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: Physician Educational Seminar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18yrs and over that visit the participating physicians and agree to compete the study questionnaire

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?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Patients<br> | Behavioral: Physician Educational Seminar<br>* Participating Physicians will attend an hour long seminar on smoking cessation counselling.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient assessment questionnaires |  | Within a month after the seminar. |
Registry for CADASIL

Study Overview
=================
Brief Summary
-----------------
This study is being done in order to create a registry (list) of people interested in Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) research. It may be that you have a family member or other loved one with CADASIL, or that you may have CADASIL or are at risk. Participation means that your name will be added to a list of people who will be invited to participate in future research studies on CADASIL. Participants must be 18 years or older, and will remain on the registry until they request to be removed.

Detailed Description
-----------------
The purpose of this registry is to allow Dr. Jane Paulsen and her CADASIL research teams to contact individuals on the list who may fit a study's eligibility requirements. All individuals interested in CADASIL research who either have a family member or loved one, or are at risk themselves, are eligible to participate in this registry. Information collected as part of the registry will be used solely to determine potential participant's eligibility to participate research. A patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s).

Official Title
-----------------
Research Registry for Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)

Conditions
-----------------
Cerebral Autosomal Dominant Ateriopathy With Subcortical Infarcts and Leukoencephalopathy

Intervention / Treatment
-----------------
* Other: Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older have a loved one or a family member with CADASIL, or are at-risk for CADASIL themselves Exclusion Criteria: Under 18 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| CADASIL Registry Participants<br>Have a loved one or family member with CADASIL, or anyone with or at risk for CADASIL | Other: Registry<br>* Registry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) Registry | Create a list of persons willing to volunteer for CADASIL-related research to facilitate efficient recruitment. | Up to 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CADASIL
New Therapeutic System of Ruptured Intracranial Aneurysms Based on Big Data From Chinese Population

Study Overview
=================
Brief Summary
-----------------
This study aims at clarifying the current situation of Emergency treatment of aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the safety and efficacy of the treatment strategy between interventional treatment and open surgery, so as to improve the diagnosis and treatment of aneurysmal SAH.

Official Title
-----------------
New Therapeutic System of Ruptured Intracranial Aneurysms Based on Big Data From Chinese Population

Conditions
-----------------
Subarachnoid Hemorrhage, Aneurysmal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients presented with subarachnoid hemorrhage on CT or lumbar puncture. the intracranial hemorrhage was caused by rupture of aneurysm and was confirmed on CTA、MRA or DSA. patients willing to participate in this clinical trial and attach to regular follow up. Exclusion Criteria: intracranial aneurysm correlating to AVM. dissection, false, traumatic and infectious aneurysms. the rupture of the aneurysm can not be confirmed on CTA、MRA or DSA. patients unwilling to participate in this clinical trial and attach to regular follow up.
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 |
| --- | --- | --- |
| mRS score | the mRS score after treatment | 1 year after treatment | 
| cure rate | the proportion of the cured-patient according Raymond Class | 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate | the proportion of the recurrence of the patient | through study completion, an average of 1 year | 
| complication rate | the proportion of complication happened after treatment including ischemic, hemorrhage, retreat, and so on | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment strategy
Bladder Cancer Case Control Study of Arsenic in Water

Study Overview
=================
Brief Summary
-----------------
This study is examining the relationship between ingested arsenic and bladder cancer in two areas of California where a large percentage of the population was exposed to drinking water containing arsenic at low to moderate levels.

Detailed Description
-----------------
Water supplies in many parts of the world contain naturally occurring arsenic. Previous studies have shown that arsenic at high doses can cause cancer of the bladder. The risk at lower doses is unknown. This study is examining the relationship between ingested arsenic and bladder cancer in central Nevada and Kings County, California, two areas where a large percentage of the population was exposed to drinking water containing arsenic at low to moderate levels. Approximately 200 people with bladder cancer and 400 people without bladder cancer will be included. Subjects are interviewed by telephone about past residences, occupations, diet, drinking water consumption, and other lifestyle factors. Arsenic measurements in well water have been collected from the appropriate state agencies and are being matched with residences and drinking water consumption rates to estimate lifetime arsenic exposures for each subject. People with bladder cancer will then be compared to those without to see if people with cancer were more likely to have lived in areas with arsenic in their drinking water.

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Cases must meet the following criteria: Diagnosed with primary bladder cancer from January 1, 1997 until December 31, 2000. Live in the following counties at the time of diagnosis: Churchill, Lyon, Mineral, Storey, Douglas, Carson City, Nevada, and Kings County, California Ages 20-85 at the time of diagnosis. Controls will be matched to cases based on gender and five year age groups.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arsenic, Bladder Cancer, Drinking Water
Irinotecan and Anlotinib for Epithelioid Sarcoma

Study Overview
=================
Brief Summary
-----------------
Epithelioid sarcoma is a rare soft tissue sarcoma characterized by SMARCB1/INI1 deficiency. Much attention has been paid to the selective EZH2 inhibitor tazemetostat, where other systemic treatments are generally ignored. To explore alternative treatment options, we studied the effects of irinotecan-based chemotherapy in a series of epithelioid sarcoma patients.

Official Title
-----------------
A Retrospective Study Investigating the Combination of Irinotecan, Vincristine and Anlotinib for Epithelioid Sarcoma

Conditions
-----------------
Objective Response, Overall Survival

Intervention / Treatment
-----------------
* Drug: VIA combination treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Grade 2 or 3 ES confirmed histologically using the American Joint Committee on Cancer (AJCC) system ; (2) patients presented with measurable lesions using the Response Evaluation Criteria In Solid Tumors (RECIST1.1) and were not amenable to surgical resection or radiotherapy; (3) primary or secondary metastatic disease; (4) received more than two courses of the VIA regimen; (5) no concurrent treatment was given while on the VIA regimen; (6) follow-up information and evaluation after chemotherapy were available. Exclusion Criteria: less than 4 cycles of treatment; medical records were not complete.

Ages Eligible for Study
-----------------
Minimum Age: 3 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: VIA treatment Group<br> | Drug: VIA combination treatment<br>* a 90-minute intravenous infusion of irinotecan at a dose of 50 mg/m2/d for 5 days every 3 weeks, vincristine given at a dose of 1.4 mg/m2 (maximum 2 mg) on days 1 and 8, and oral administration of Anlotinib once daily on days 1-14 within a 21-day cycle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Based on RECIST1.1 criteria, clinical evaluation was done once every 6 weeks | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epithelioid sarcoma, systemic treatment, objective response, toxicity
480 Biomedical Sinus Drug Depot

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis.

Official Title
-----------------
An Exploratory Safety Study of 480 Biomedical Sinus Drug Depot in Adult Subjects With Chronic Sinusitis

Conditions
-----------------
Chronic Sinusitis

Intervention / Treatment
-----------------
* Drug: 480 Mometasone Furoate Sinus Drug Depot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CS. Female study subjects of child-bearing potential must have a negative pregnancy test and must agree to not become pregnant during the course of the study. The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site. The study subject agrees to comply with all study requirements Exclusion Criteria: Known history of intolerance to corticosteroids. Oral-steroid dependent condition. Having had corticosteroids with potential systemic effect (e.g., oral, parenteral, or high dose topical) 1 month prior to screening visit. Subjects with acute or chronic intracranial or orbital complications of chronic rhinosinusitis (e.g., brain abscess, related problems with eyes or central nervous system). Known history of hypothalamic pituitary adrenal (HPA) axial dysfunction or having morning serum cortisol level at screening outside of normal range. Previous pituitary or adrenal surgery. History or diagnosis (in either eye) of glaucoma, ocular hypertension, or cataracts. Recent participation in another clinical trial within 1 month of screening visit. Subjects currently participating in an investigational drug or device study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 480 Mometasone Furoate Sinus Drug Depot<br>480 Mometasone Furoate Sinus Drug Depot | Drug: 480 Mometasone Furoate Sinus Drug Depot<br>* Management of Chronic Sinusitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product related serious adverse events from baseline visit to 4 weeks post procedure |  | 4 weeks post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment |  | Up to 24 weeks |
Safety, Tolerability and Efficacy of the Transdermal System in Elderly Subjects With Major Depression

Study Overview
=================
Brief Summary
-----------------
Objective of this 16-week, open-label study is to assess the safety and tolerability of once daily application of three doses of STS during continuous dosing in the treatment of elderly subjects with major depression. Subjects will have study visits (clinic visits) at beginning of study (baseline) and study weeks 1, 3, 5, 8, 12, and 16.

Official Title
-----------------
A Phase III, Open-Label Study of the Safety, Tolerability and Efficacy of the Selegiline Transdermal System in Elderly Subjects With Major Depression

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Drug: Selegiline Transdermal System


Participation Criteria
=================
Eligibility Criteria
-----------------
Men/Women in good health 65 years or older Ability to read, understand and sign study informed consent Major depression- mild to severe based on rating scale

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Selegiline Transdermal System|nan|

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
-----------------
Depression
Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

Study Overview
=================
Brief Summary
-----------------
A study of the safety and pharmacokinetics of solithromycin capsules in adolescents

Official Title
-----------------
A Phase 1, Open-label, Multi-center Study to Determine the PK and Safety of Solithromycin as Add-on Therapy in Adolescents With Suspected or Confirmed Bacterial Infection

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Solithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12 to 17 yo male or female with suspected or confirmed bacterial infection Exclusion Criteria: Bacterial meningitis Clinical significant concomitant medical condition

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 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: Solithromycin<br> | Drug: Solithromycin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents |  | 5 days |
PHA-739358 for the Treatment of Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the antitumor activity of PHA-739358 as single agent IV infusion in adult patients with Multiple Myeloma who have a history of at least 2 previous lines of treatment for the disease.

Official Title
-----------------
An Exploratory Phase II Study of PHA-739358 in Patients With Multiple Myeloma Harbouring the t(4;14) Translocation With or Without FGFR3 Expression

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: PHA-739358


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: active multiple myeloma progressing after at least 2 prior lines of treatment measurable disease t(4;14) translocation life expectancy of at least 3 months Exclusion Criteria: uncontrolled hypertension myocardial infarction, unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the past 6 months. pregnancy or breast feeding active infections, including HIV

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PHA-739358<br>* Weekly IV infusion for 3 consecutive weeks in a 4-week cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma. |  | At end of each cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall safety profile |  | All cycles |
Trial of IW-1973 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers, in fed and fasted states, in a single-dose crossover study. Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple ascending-dose study with optional up-titration of dose level within cohort.

Official Title
-----------------
A 2-stage Phase 1 Study of Safety, Tolerability, PK, and PD of IW-1973 Tablet in Healthy Volunteers in an Open-label, Single-dose Stage, and a Randomized, Double Blind, Placebo-controlled, Multiple-ascending-dose Stage

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

Intervention / Treatment
-----------------
* Drug: IW-1973
* Drug: Matching Placebo Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is an ambulatory male or female between 18 and 55 years old at the Screening Visit Subject's body mass index score is > 18.5 and < 30.0 kg/m2 at the Screening Visit Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception Subject is in good health and has no clinically significant findings on a physical examination Other inclusion criteria per protocol Exclusion Criteria: History of any clinically significant medical condition Other exclusion criteria per protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IW-1973<br>1973 Escalating Doses | Drug: IW-1973<br>* IW-1973 Tablet<br>|
| Placebo Comparator: Placebo<br>Matching Placebo | Drug: Matching Placebo Tablet<br>* Matching placebo tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Adverse Events |  | 42 Days | 
| Maximum observed plasma concentration (Cmax) |  | 42 Days | 
| Blood Pressure |  | 42 days | 
| Area under the plasma concentration time curve during a dosing interval (AUC) |  | 42 Days | 
| Time of maximum observed plasma concentration (Tmax) |  | 42 Days | 
| Heart rate |  | 42 Days | 
| Serum cGMP |  | 42 Days |