linjc16/ctgov huggingface dataset:
Transarterial Infusion of PD-1 Antibody Plus TACE-HAIC for Unresectable HCC: a Single-arm, Phase 2 Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Hepatocellular carcinoma (HCC) is a common disease in East Asia. Less than 20% of newly diagnosed patients can undergo radical resection. For those with unresectable BCLC C stage, transarterial chemotherapy and targeted therapy are recommend to prolong survival. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Transartery infusion of agents provide promising outcome when compared systemic infusion. Furthermore, our pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC plus hepatic artery infusion PD-1 antibody would improve survival for unresectalbe BCLC C stage patients is still unknown. A single arm, phase 2 clinical trial is aimed to answer this question.

Official Title
-----------------
Transarterial Infusion of PD-1 Antibody Plus Chemoembolization and FOLFOX-based Chemtherapy for Unresectable BCLC C Stage HCC: a Single-arm, Phase 2 Clinical Trial

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: PD-1 inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BCLC C stage with unresectable diseasehigh-recurrence risk factor; Child-Pugh A or B (7 score) liver function; Anticipated survival more than 3 moths Exclusion Criteria: Pregnant woman or sucking period; With other malignant cancer; Received anti-HCC therapy before this study

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
Interventional Model Description: Trans hepatic arterial infusion of PD-1 antibody, chemoembolization and FOLFOX-based chemotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIPD-1<br>Trans hepatic artery infusion of PD-1 antibody, chemoembolization, FOLFOX-based infusion chemotherapy | Drug: PD-1 inhibitor<br>* Transarterial hepatic chemoembolization and FOLFOX-based infusion<br>* Other names: TACE-HAIC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate | defined as the sum of complete responses (CRs) and partial responses (PRs) over a specified time period | 12 month |
Osteoporosis and Fall Prevention Education

Study Overview
=================
Brief Summary
-----------------
Objective: The study is to increasing osteoporosis awareness with fracture risk assessments and management as well as fall prevention among elderly in northern region of Taiwan. Method: Six community osteoporosis and fall prevention educational programme will be held at northern region of Taiwan. A questionnaires design including demographic variables , FRAX variables, nutritional variables and osteoporosis and fall knowledge variables as well.The pretest-posttest method was used to analyse the effect on education. Expected outcomes : (1)Fall prevention educational programme will hold in northern region of Taiwan at different communities in order to increasing osteoporosis awareness with fracture risk assessment tool, establishing fall knowledges among elderly and some fall prevention skills.(2)Elderly with 10-year probability of major osteoporotic fracture risk who more than 20% and 10-year probability of hip fracture risk who more than 3% will identify as high risk of osteoporosis. (3) To estimate number of cases who identified as high risk will recommend for BMD measurement.

Official Title
-----------------
Osteoporosis and Fall Prevention Education With High Risk Population Telephone Follow up Study

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults between the ages of 40 to 90. Adults who been fractures prior to assessment. Adults who have ability, well conscious to complete the questionnaires. Exclusion Criteria: 1.Adults who have treatment currently will not include in this study.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Measurement of effects of fall prevention education. | The primary outcomes is to determine the effects after investigaor given the fall prevention education. The pretest-posttest method was used to analyse the effect on education. | 6-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, fall prevention, high risk population
Droperidol on Prevention of Cannabis Hyperemesis Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of droperidol as a treatment of cannabinoid hyperemesis syndrome.

Detailed Description
-----------------
Patients presenting to the Emergency Department with nausea, vomiting and/or abdominal pain with a significant history of cannabis use and symptoms in a cyclic pattern will be assessed for study inclusion. After given written informed consent, patients will be treated with droperidol and diphenhydramine and symptoms will be assessed using a visual analog scale at time intervals up to 120 minutes. Patient will then be contacted at 24 and 48 hour intervals to assess symptoms on the same scale. This is a multicenter, prospective interventional study with results compared to a historical cohort using haloperidol.

Official Title
-----------------
Droperidol on Prevention of Emesis From Cannabinoid Hyperemesis Syndrome

Conditions
-----------------
Cannabis Hyperemesis Syndrome

Intervention / Treatment
-----------------
* Drug: Droperidol Injectable Product
* Drug: Diphenhydramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 years of age or older and presenting with cannabis hyperemesis syndrome requiring intravenous medication. Exclusion Criteria: any patient with a contraindication to the use of droperidol Corrected QT interval on ECG greater than 440 milliseconds for males and greater than 450 milliseconds for females any prisoners pregnant females.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once | Drug: Droperidol Injectable Product<br>* Treatment<br>* Other names: Inapsine;Drug: Diphenhydramine<br>* Treatment<br>* Other names: Benadryl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in symptoms after treatment with droperidol and diphenhydramine | The Visual Analog Scale is a 100-mm patient-reported score measurement used to assess nausea and/or vomiting and/or abdominal pain. Possible scores range from 0 (symptom-free) to 10 (worst possible symptom) | Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours. |
The Effect of Smoking on Perception

Study Overview
=================
Brief Summary
-----------------
The purpose of the experiment is to examine the effect of smoking on how individuals recognize and interpret sensory information.

Detailed Description
-----------------
Participation requires one 90-minute visit on the American University campus that involves completing questionnaires and computer tasks, watching a film, and smoking a cigarette. Participants earn 30 dollars.

Conditions
-----------------
Nicotine Dependence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between ages 18 and 60 Regular, daily smoker Smoke for at least 1 year Exclusion Criteria: Color Blind Smoking Related Health Problems (Chronic Bronchitis, Chronic Obstructive Pulmonary Disease, Emphysema)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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
-----------------
Smoking
Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation

Study Overview
=================
Brief Summary
-----------------
A prospective study to evaluate the safety and efficacy of a piggyback sulcoflex toric intraocular lens in pseudophakic patients for correcting refractive errors following corneal transplantation

Conditions
-----------------
Refractive Error, Corneal Implantation, Intraocular Lens Implantation

Intervention / Treatment
-----------------
* Procedure: toric intraocular lens implantation
* Procedure: Sulcoflex intraocular lens implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: after corneal transplantation with refractive errors after cataract removal and intraocular lens implantation Exclusion Criteria: other ophthalmologic disorders limiting vision including glaucoma, AMD, profound amblyopia

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sulcoflex<br>Sulcoflex intraocular lens implantation | Procedure: toric intraocular lens implantation<br>* piggyback Sulcolflex toric intraocular lens implantation<br>Procedure: Sulcoflex intraocular lens implantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected and uncorrected visual acuity | Best corrected and uncorrected visual acuity following the IOL implantation | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular complications | pigmentary dispersion, iris bulging, inter lenticular opacifications, lens decentration | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sulcoflex, toric, corneal implantation
Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims

Study Overview
=================
Brief Summary
-----------------
Obesity is a public health phenomenon affecting more than 17% of women in France, and more than 20% of men and women in Champagne-Ardenne. Obese women are more likely to have an unplanned pregnancy, whereas these pregnancies are more at risk than women of normal weight and should be planned or considered after weight loss. These women are also often less well followed in terms of gynecology and especially on contraception. More and more patients are opting for bariatric surgery. However, bariatric surgery is not trivial. Indeed, the important loss of weight expected is at risk of nutritional deficiencies. In addition, a large number of patients are still obese during the months following surgery. This is why pregnancy is theoretically contraindicated within 12 or 18 months postoperatively. Women with bariatric surgery must have been properly informed of these risks so that they can choose a contraceptive method, and that can be adapted to both their risk factors and the surgical technique performed.

Detailed Description
-----------------
The purpose of this study is to describe contraception in obese women who have undergone bariatric surgery in Champagne-Ardenne.

Official Title
-----------------
Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims

Conditions
-----------------
Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Other: data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between 18 and 50 years old Followed at Reims University Hospital after bariatric surgery Pre-menopausal status Accepting to participate in the study Exclusion Criteria: Women less than 18 or more than 50 years old Women with postmenopausal status Women refusing to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| bariatric surgery group<br>Women between 18 and 50 years, who undergone bariatric surgery at the University Hospital of Reims. | Other: data collection<br>* data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contraception method | Presence of contraception during the postoperative 3 months consultation | Day 0 |
Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine 5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically analgesic effect after unilateral open inguinal hernia repair.

Official Title
-----------------
Does Ultrasound-guided Ilioinguinal-iliohypogastric Block Improve Postoperative Pain Outcome After Unilateral Inguinal Hernia Repair?

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Drug: bupivacaine
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 18 years unilateral primary inguinal repair open surgery a.m. Lichtenstein informed consent Exclusion Criteria: age below 18 years secondary surgery laparoscopic surgery lack of communicative skills

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine<br>perineural bupivacaine 5 mg/ml 20 ml | Drug: bupivacaine<br>* perineural bupivacaine 5 mg/ml 20 ml<br>|
| Placebo Comparator: saline<br>perineural isotonic saline 20 ml | Drug: saline<br>* perineural isotonic saline 20 ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain at mobilization using 100 mm VAS |  | within the first 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain at rest using 100 mm VAS |  | within 24 hours postoperatively | 
| perceived illness | using short form-8 index | within 24 hours postoperatively | 
| ability of daily living | using the Barthel/100 index | within 24 hours | 
| amount of analgesics |  | within 24 hours postoperatively |
An Online Study of the Reliability of the Brain Performance Test (BPT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate test-retest reliability of each subtest (correlation coefficients for Time 1 and 2) in the Brain Performance Test (BPT, Lumos Labs, Inc.).

Detailed Description
-----------------
This is an open-label, randomized online study in which participants will be invited to take versions of the Brain Performance Test (BPT) on two consecutive days. In parallel, all current Lumosity subscribers are invited to take the BPT at the beginning of their premium Lumosity experience and again every 10 weeks.

Official Title
-----------------
An Online Study of the Reliability of the Brain Performance Test (BPT)

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

Intervention / Treatment
-----------------
* Other: BPT, Computerized Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Electronically signed informed consent English-speaker Current Lumosity free user (test-retest portion) OR current Lumosity subscriber (longitudinal portion) Exclusion Criteria: Visual or physical impairment that impedes computer use or completion Under 18 years of age

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPT, Computerized Assessment<br>Participants will first take the Brain Performance Test (BPT) on two consecutive days | Other: BPT, Computerized Assessment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation coefficients (Pearson's r) | Correlation coefficients (Pearson's r) of scaled scores of BPT subtests at Time 1 compared to Time 2 | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intercorrelation coefficients (Pearson's r) | Intercorrelation coefficients (Pearson's r) of scaled scores of BPT subtests at Time 1 | 1 day | 
| Principle component analysis | Principle component analysis of scaled scores of BPT subtests at Time 1 | 1 day | 
| Longitudinal BPT Grand Index and Subtest scaled scores |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive assessment, Brain Performance Test, Lumosity, test-retest reliability, computerized assessment
The Effect of Aerobic Endurance Training in Patients With Drug Addiction

Study Overview
=================
Brief Summary
-----------------
Physical health does not have a high priority in today's treatment of patients with substance use disorder (SUD) patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the lifestyle that addiction causes. There are today few studies that provide information about SUD patients' physical health. One of the project's aims is to document the physical health of SUD patients in treatment, using objective measures. After completion of various physical tests, an 8 week period of high intensity aerobic training intervention will follow. It will be investigated if the SUD patients are able to engage and participate throughout the whole training intervention, to what degree the participants improve their physical health and the effect of physical health improvement on substance abuse treatment.

Official Title
-----------------
The Effect of Aerobic Endurance Training in Patients With Drug Addiction

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: high intensity aerobic training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: substance use disorder diagnosed ICD10 written informed consent residential treatment Exclusion Criteria: not been using drugs the last six months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: training group<br>high intensity aerobic training 3 weekly sessions for 8 weeks | Behavioral: high intensity aerobic training<br> <br> |
| No Intervention: care as usual<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in maximal oxygen consumption (VO2 max) | Directly measurement of maximal oxygen consumption. Measurement of work efficiency and lactate measurements. Insomnia Severity Index and Hospital Anxiety and Depression scale is used to measure mental health. | from baseline to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Oxygen Consumption, mental health