linjc16/ctgov huggingface dataset:
A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
This study is a post-marketing observational study of lenvatinib in participants with unresectable hepatocellular carcinoma. The primary objective of this study is assessment of risk factors for hepatic encephalopathy.

Official Title
-----------------
A Drug Use Investigation of LENVIMA 4 mg Capsules - A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Patients With Unresectable Hepatocellular Carcinoma

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

Intervention / Treatment
-----------------
* Drug: Lenvatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with unresectable hepatocellular carcinoma who were administered the lenvatinib mesilate for the first time within the registration period. Have provided informed consent. Underwent case registration by 14 days after the start of administration of drug.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Lenvatinib<br>Participants receiving lenvatinib capsules 12 milligrams (mg) based on participant's body weight greater than or equal to (>=) 60 kilograms (kg) or 8 mg based on participant's body weight less than (<) 60 kg, orally, once daily dose will be centrally registered and observed prospectively for up to 1 year after the administration of dose. | Drug: Lenvatinib<br>* Lenvatinib capsule<br>* Other names: E7080;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hepatic Encephalopathy Risk Factors | Hepatic encephalopathy risk factors such as constipation, dehydration, infection, gastrointestinal hemorrhage will be assessed. | Baseline up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Hepatic Encephalopathy |  | Baseline up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular Carcinoma, Lenvima, Post-marketing surveillance, LEN02T, Lenvatinib Mesilate
Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb Spasticity

Study Overview
=================
Brief Summary
-----------------
Multicenter, randomized, double-blind, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in Subjects with Post-stroke Upper Limb Spasticity

Official Title
-----------------
A Randomized, Double-blind, Active-controlled, Multicenter Phase I Trial to Investigate the Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb

Conditions
-----------------
Post-stroke Upper Limb Spasticity

Intervention / Treatment
-----------------
* Drug: CKDB-501A
* Drug: Botox®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients ≥ 19 years History of stroke more than 24 weeks prior to screening ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of finger flexor and elbow flexor as measured on MAS(0 to 4) ≥ 2 points in one of the targeted functional disability item (i.e. hand hygiene, clothing, upper extremity, or pain for evaluation on DAS Exclusion Criteria: Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis Fixed joint/muscle contracture in the target limb History(within 24 weeks of screening visit) or planned(during study period) treatment with phenol or alcohol injection(chemodenervation) or surgery in the target limb History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb History(within 12 weeks of screening visit) treatment with Botulinum Toxin Concurrent treatment with an intrathecal baclofen Known allergy or sensitivity to the study medication or its components (Clostridium botulinum toxin type A, albumin, Sodium chloride, etc.) Male and Female who are not willing to take any appropriate means of contraception during the study period Patients who are not eligible for this study at the discretion of the investigator.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKDB-501A<br> | Drug: CKDB-501A<br>* Muscle Spasticity<br>|
| Active Comparator: Botox®<br> | Drug: Botox®<br>* Muscle Spasticity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | severity and frequency of reported adverse events | up to week 12 |
Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if short-term wear of a spherical rigid contact lens, called a scleral lens, will raise intraocular pressure in ocular hypertensive patients.

Official Title
-----------------
Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear

Conditions
-----------------
Ocular Hypertension

Intervention / Treatment
-----------------
* Device: Scleral Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ocular hypertension (IOP >22 in each eye during at least two visits over the previous 3 years) May have had cataract extraction and IOL Not on topical medication for glaucoma No History of ALT/SLT Any Age, 18 years or older History of contact lens wear (except scleral lenses), as long as they are willing to not wear their lenses the day of the study Exclusion Criteria: On topical medication for glaucoma Eye disease Inability to wear scleral lenses Any intraocular surgery other than uncomplicated cataract extraction.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Eye<br>One eye will be randomly selected to wear the scleral lenses to be worn during study measurements | Device: Scleral Lens<br>* 15.0 mm diagnostic spherical rigid contact lens<br>|
| No Intervention: Control Eye<br>Non-lens wearing eye | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | Change in intraocular pressure measured in millimeters of mercury (mm Hg) | Baseline, every half hour for 4 hours |
Effect of Covid-19 on Outcomes of Pregnancy

Study Overview
=================
Brief Summary
-----------------
To study the effect of getting Covid-19 infection during pregnancy on the outcomes of the mother and the fetus including morbidity and mortality

Official Title
-----------------
Effect of Covid-19 on Outcomes of Pregnancy

Conditions
-----------------
Pregnancy Without Complications Except Getting Covid-19 Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Covid-19 PCR , IGM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal single pregnancy Exclusion Criteria: Pregnancy with any chronic diseases Multiple pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with Covid-19 infection<br> | Diagnostic Test: Covid-19 PCR , IGM<br>* test for Covid-19<br>|
| without Covid-19 infection<br> | Diagnostic Test: Covid-19 PCR , IGM<br>* test for Covid-19<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal morbidity |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, Covid-19
Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension, 0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating inflammation in the eye.

Official Title
-----------------
Preoperative and Postoperative Nevanac 0.1% Compared to Acular LS for the Treatment of Ocular Inflammation Associated With Cataract Surgery

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Nepafenac Ophthalmic Suspension, 0.1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned cataract extraction with posterior chamber intraocular lens implantation Exclusion Criteria: Under 10

Ages Eligible for Study
-----------------
Minimum Age: 10 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

| Intervention/Treatment |
| --- |
|Drug: Nepafenac Ophthalmic Suspension, 0.1%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who are a clinical success at Day 14 postoperative visit (where a clinical success is defined as aqueous cells < grade 1 and aqueous flare = grade 0 at the current visit and all subsequent visits). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who are clinically cured, clinical successes, treatment failure, clinically significant inflammation |  |  |
Family History in Prostate Cancer Patients in Taiwan

Study Overview
=================
Brief Summary
-----------------
To investigate the prevalence of family history in prostate cancer patients in Taiwan and evaluate the association of variation of diseases and family history

Detailed Description
-----------------
We retrospectively reviewed the medical charts of prostate cancer patients at NTUH from 1978 to 2002. The initial presentations, systemic diseases, smoking habits, clinical stages, Gleason scores, pathological stages, treatments, and outcome were recorded. Post-hoc questionnaires were completed with OPD visits, admission visits, telephone interviews and mails. The questionnaires included the family histories of prostate cancer, colon cancer, breast cancer, hepatoma and so on. If patients is passed away, the first degree relatives will fill the vacant position. The prevalence of family histories of prostate cancers in these patients was determined. The associations of family histories and clinical presentations were analyzed. Besides, the characteristics of patients with and without responses were discussed.

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer patients who were recorded at National Taiwan University Hospital from 1977 to 2002. Exclusion Criteria: Patients or their family who refused our contact or were unable to be contacted

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostatic neoplasms, Family history
Phase I Dose-Escalation Study to Evaluate Tolerability, Safety & PK of INO-8875 in Healthy Older-Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye drops at different concentrations to normal older healthy adult volunteers for two weeks.

Official Title
-----------------
Phase I, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate Tolerability, Safety & PK of BID Topical Ocular Application of INO-8875 in Healthy Older-Adult Volunteers

Conditions
-----------------
Health

Intervention / Treatment
-----------------
* Drug: INO-8875
* Other: Placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male, or a female with a negative pregnancy test and without childbearing potential aged 35 to 65 years body weight is ≥50 kg and ≤115 kg Exclusion Criteria: Subject has glaucoma or any active ophthalmologic disease including conjunctivitis Subject has a central retinal vein occlusion in either eye at any time in the past Subject is currently on any drug that might affect IOP including oral or ocular glucocorticoids or ephedrine Subject has history of ocular trauma or surgery (except for non-incisional surgery performed at least 3 months prior to the Screening visit) Subject has a prosthetic eye or any ocular abnormality precluding reliable applanation tonometry in either eye including an immobile pupil. Subject is not able to refrain from use of contact lenses during the Treatment Period

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Vehicle control | Other: Placebo control<br>* Matched placebo<br>|
| Experimental: INO-8875<br>Active drug | Drug: INO-8875<br>* eye drops for 14 days in one eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenosine agonist, eye drop, elderly volunteer, older healthy volunteer
Remifentanil Requirement in Patients Receiving Surgical Treatment of Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease (PD) is one the main neurodegenerative disease with an incidence of about 3% in patients older than 65 years. Anesthesia in PD patients has been focused by several studies for concerning the interactive reaction between anesthetics and anti-Parkinsonian medication or Parkinsonian symptoms. However, our previous experience showed that the patients undergoing pulse generator placement were more prone to be involved in delayed emergence in the recovery room, which had been not reported yet. We speculated that PD patients might be a special population with abnormal pharmacodynamic characters of anesthetics, though no related evidence could be found to support this hypothesis. Therefore, in this project we investigated whether remifentanl requirement to inhibit patients' response to trachea intubation and skin insertion in PD patients undergoing DBS and pulse generator placement was different from non-PD patients undergoing intracranial surgery for reasons other than PD.

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement Adult non-Parkinsonian patients undergoing intracranial surgery Exclusion Criteria: ASA score higher than Class II predicted difficult airway alcohol or drug abuser informed consent was not provided

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| PD group<br>Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement | |
| non-PD group<br>Non-Parkinsonian patients undergoing intracranial surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations required to inhibit response to trachea intubation and skin incision |  | Anesthesia induction to 5min after skin incision | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, remifentanil, deep brain stimulator, cardiovascular response
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

Official Title
-----------------
A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms

Conditions
-----------------
Menopause, Postmenopausal Vaginal Atrophy

Intervention / Treatment
-----------------
* Drug: estradiol, 10 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women whose last menstruation was at least two years prior to the time of screening At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity Generally healthy Exclusion Criteria: Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months

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

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vagifem® 10 mcg<br>One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks | Drug: estradiol, 10 mcg<br>* Tablets, administered intravaginally twice weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies | The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52. | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transvaginal Ultrasound: Endometrial Thickness | Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial. | Week 0, week 52 |
Spine Registry University Hospital of Cologne- Department of Orthopedics

Study Overview
=================
Brief Summary
-----------------
Between January 2008 and December 2020 all patients with spine diseases were registered prospectively in the former European Spine Tango registry and later german DWG registry at the department of orthopedics and trauma at the university of cologne.

Detailed Description
-----------------
The following data were prospectively collected after enrollment: age, sex, body mass index (BMI), length of hospital stay, affected spine segment, previous surgical procedures on the spine, conservative or operative treatment including type of surgical treatment and American Society of Anesthesiologists (ASA) Physical Status Classification System. In addition the following quality of life scores were collected: Oswestry Disability Score (ODI), Core Outcome Measures Index(COMI), Short Form- 36 (SF- 36) and Euroqol- 5D (EQ- 5D).

Official Title
-----------------
Former Spine Tango Registry Now DWG Registry

Conditions
-----------------
Outcome, Fatal, Spondylodiscitis, Vertebral Osteomyelitis

Intervention / Treatment
-----------------
* Other: Treatment (non- surgical/surgical)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spine disease Exclusion Criteria: younger than 18 years

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Treatment (non- surgical/surgical)|Treatment Outcome based on different aspects|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Data after surgery | Definition of Thresholds | 2008- 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Treatment Failure, Relapse, Spondylodiscitis, Vertebral Osteomyelitis