linjc16/ctgov huggingface dataset:
Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
A single centre, open label, study to assess the safety, tolerability and biodegradation of PA5108 ocular implant in adults who have Open Angle Glaucoma (Primary or Secondary).

Detailed Description
-----------------
Participants who are currently managing their Open Angle Glaucoma with combination drop therapy will be recruited. Drop therapy will cease in the treatment eye and continue in the contralateral eye. The treated eye will receive via injection, a single PA5108 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.

Official Title
-----------------
An Open-label Phase I Study to Evaluate the Safety, Tolerability and Biodegradation Period of PolyActiva PA5108 Ocular Implant When Administered Intracamerally to the Anterior Chamber of the Eye

Conditions
-----------------
Open-angle Glaucoma

Intervention / Treatment
-----------------
* Drug: PA5108


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Grade 3 or 4 open angle glaucoma (Shaffer-Etienne scale) Visual acuity in non-study eye same or better than study eye Currently taking topical ocular hypotensive medication including a prostaglandin analogue Exclusion Criteria: Aphakic eyes Only one eye History of, or current uveitis, Cystoid Macular Edema (CME) or cornea edema Intraocular surgery or cornea/refractive surgery in study eye in past 6 months or anticipate need for eye surgery (including laser) in study eye during study period Current retinal detachment Uncontrolled infection in the eye

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: PA5108<br>PA5108 ocular implant (study eye) and topical prostaglandin analogue therapy (non-study eye) | Drug: PA5108<br>* single ocular implant, administered on day 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by the occurrence of adverse events |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timeframe to complete implant biodegradation based on implant size and location |  | 6 months |
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Atorvastatin for at Least 4 Weeks.

Study Overview
=================
Brief Summary
-----------------
To determine the effects of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on atorvastatin therapy for at least 4 weeks.

Official Title
-----------------
Efficacy of WelChol as an Add-on to Atorvastatin Therapy

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: colesevelam HCl tablets, and atorvastatin tablets
* Drug: colesevelam HCl placebo tablets and atorvastatin tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female > or greater than 18 years of age On a stable dose of atorvastatin LDL-C > or = to 115 mg/dL and < or = to 250 mg/dL TG < or = to 300 mg/dL Women are not pregnant or breast-feeding or planning to become pregnant Women of child-bearing potential had a hysterectomy or tubal-ligation, or women were post menopausal, or women practiced an acceptable method of contraception as specified in the protocol Exclusion Criteria: BMI > 40 kg/m2 History of allergic or toxic reaction to colesevelam HCl History of swallowing disorders Any serious disorder that could impact the conduct of the study History of drug or alcohol abuse

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>colesevelam tablets and atorvastatin tablets | Drug: colesevelam HCl tablets, and atorvastatin tablets<br>* colesevelam HCl tablets,6 tablets/day; atorvastatin tablets, 1 tablets/day for 6 weeks<br>|
| Placebo Comparator: 2<br>colesevelam HCl placebo tablets and atorvastatin tablets | Drug: colesevelam HCl placebo tablets and atorvastatin tablets<br>* colesevelam HCl placebo tablets, 6 tablets/day for 6 weeks atorvastatin tablets, 1 tablet/day for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute change in LDL-C from baseline to endpoint |  | 6 weeks | 
| The absolute change and % change in total cholesterol |  | 6 Weeks | 
| The absolute change and % change in triglycerides |  | 6 Weeks | 
| The absolute change and % change in HDL-C |  | 6 Weeks | 
| The absolute change and % change in C-reactive protein |  | 6 weeks |
Effectiveness of a Novel Protocol for Glenohumeral Internal Rotation Deficit in General Population With Shoulder Pain

Study Overview
=================
Brief Summary
-----------------
Shoulder pain is one of the most common joint problems and disabling complaint in general population., but there is a lack of evidence about the relation between shoulder pain and glenohumeral internal rotation deficit (GIRD) in general population. This study aimed to determine if the novel proposal for treatment of GIRD could be effectiveness and gain further evidence in the Range of Motion an Pain.

Official Title
-----------------
Effectiveness of a Novel Protocol for Glenohumeral Internal Rotation Deficit in General Population With Shoulder Pain

Conditions
-----------------
Shoulder Pain, Glenohumeral Internal Rotation Deficit

Intervention / Treatment
-----------------
* Other: Manual therapy and therapeutic exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Shoulder pain Exclusion Criteria: Patient under 18 years old, Pain in both shoulders Joint prosthesis in at least one of the two shoulders.

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: Treatment<br>The Treatment sequence including joint Manual therapy techniques and soft tissue release techniques is proposed. | Other: Manual therapy and therapeutic exercise<br>* Gliding over the deltoid superficial fascia. Anterior-Posterior mobilization of the clavicle. myofascial release of the shoulder joint complex techniques. Myofascial release external rotation with glenohumeral decoaptation will be carry out in prone position facility the triangular space, quadrangular space and triceps hiatus. anterior and posterior, superior and inferior glenohumeral inferior glide mobilization in adduction will perform in a prone position to facilitate glenohumeral re centration. scapular musculature myofascial release including mobilization with a scapulothoracic joint decoaptation, and angular of the scapula. Supine mobilization of the posterior capsule in 90º shoulder flexion and the adduction. Finally the patient will be instructed to adapt the daily active biological stimulus at home to maximize the benefits of the manual therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glenohumeral internal rotation | measure in supine position on a physiotherapy bench. The shoulder will held at 90° abduction with 90° flexion in the elbow. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
general population., Manual therapy, Therapeutic Exercise
Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of IV Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who require supplemental oxygen.

Official Title
-----------------
A Randomized Controlled Trial to Evaluate the Safety of Intravenous Ampion™ in Adult COVID-19 Patients Requiring Oxygen Supplementation

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: Ampion
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 years to 89 years old (inclusive). Hospitalized and diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-COV-2. Patient is receiving supplemental oxygen (e.g. oxygen saturation (SpO2) <88%, labored breathing, increased respiratory rate, dyspnea on rest or exertion). A signed informed consent form from the patient or the patient's legal representative must be available. Exclusion Criteria: In the opinion of the clinical team, progression to death is imminent and inevitable, irrespective of the provision of treatments. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.). Patient is on chronic immunosuppressive medication. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate). Patient has known pregnancy or is currently breastfeeding. Participation in another clinical trial. Baseline QT prolongation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ampion<br>Ampion | Biological: Ampion<br>* Ampion, administered by intravenous infusion<br>Other: Standard of Care<br>* Standard of Care<br>|
| Other: Standard of Care<br>Standard of Care | Other: Standard of Care<br>* Standard of Care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events | Incidence and severity of adverse events | Primary endpoint at day 5 |
Reliability of 6-Minutes Walking Test in Hip Fracture Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the relative (ICC) and absolute intertester reliability of the 6-Minutes Walking Test in hip fracture patients (N=50) in an outpatient facility. The data collection is conducted by two physiotherapists, who are blinded to each other. The physiotherapists are randomized so they each are doing an equal number of baseline tests.

Official Title
-----------------
The Relative and Absolute Reliability of 6-Minutes Walking Test in Hip Fracture Patients

Conditions
-----------------
Hip Fracture

Intervention / Treatment
-----------------
* Other: 6 minutes walking test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 years or above Hip fracture patients with a Intra - or Extra Capsular hip fracture Testing within 3 - 5 weeks postsurgery in an outpatient facility No weightbearing restrictions on the fractured limb Normal cognitive level (Mini Mental State Examination(MMSE) - score ≥20 points) Participants should not experiencing hip related pain more or less than moderate according to Verbal Ranking Scale when resting To have the ability to write and understand danish language Exclusion Criteria: - MMSE score ≤19 points

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 6 minutes walking test<br> | Other: 6 minutes walking test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 6-Minutes Walking Test | The 6-Minutes Walking Test performed according to International Guidelines, will be performed on hip fracture patients 3 to 5 weeks after surgery. The testing will be conducted on the same person by two physiotherapists with a one day pause in between test sessions. | 3 to 5 weeks post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip Fracture, 6-minutes walking test, Reliability
A Phase II Study to Evaluate the Efficacy and the Safety of Flumatinib in CML-AP or CML-BP Patients

Study Overview
=================
Brief Summary
-----------------
Multi-center, single stage, phase II study to evaluate the efficacy and safety of Flumatinib in accelerated or blastic Phase chronic myelogenous leukemia patients.

Detailed Description
-----------------
Multi-center, single-arm, open-label,phase II study to investigate efficacy and safety of Flumatinib in Chinese patients with accelerated or blastic Phase chronic myelogenous leukemia. The starting daily oral dose of Flumatinib is 600mg，core test is six cycles (each cycle is 28 days), collecting the core test data for primary efficacy analysis. The longest treatment time is 12 cycles.

Official Title
-----------------
Multi-center, Single Stage Phase II Study to Evaluate the Efficacy and Safety of Flumatinib in Accelerated or Blastic Phase Chronic Myelogenous Leukemia Patients

Conditions
-----------------
Chronic Myelogenous Leukemia

Intervention / Treatment
-----------------
* Drug: Flumatinib mesylate tablet 600 mg qd


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients age 18-75 year-old; ECOG 0 - 2; Newly diagnosed or previously treated Ph+ CML patients in accelerated or blastic Phase; Adequate organ function; Written informed consent prior to any study procedures being performed. Exclusion Criteria: Patients in Chronic and Blastic Phases; Previously treated with Flumatinib; Previously documented T315I mutations; Previous therapy within protocol defined timeframe, including: hydroxyurea within 24 hr, Imatinib or Nilotinib or Dasatinib within 28 days) Cardiac dysfunction ; History of congenital or acquired bleeding disorders unrelated to CML; Central nervous system leukemia; Previous malignancy except CML; Acute or chronic liver or severe kidney disease unrelated to CML; Pregnant, breastfeeding, child bearing potential but failed to take effective contraception.

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: Flumatinib mesylate tablet 600 mg qd<br>Flumatinib, 600mg, qd | Drug: Flumatinib mesylate tablet 600 mg qd<br>* Flumatinib mesylate tablet 600 mg qd in CML-AP or CML-BP patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed overall hematologic response（OHR）at 6 months |  | 6 months |
Concentration of Plant Sterols in Serum and Aortic Valve Cusps

Study Overview
=================
Brief Summary
-----------------
This study investigates the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations of plant sterols. We assume that consumption of margarine supplemented with plant sterol esters increases serum and cardiovascular tissue concentrations of plant sterols (sitosterol; campesterol).

Detailed Description
-----------------
The role of plant sterols in cardiovascular diseases is controversially debated. There is an increasing body of evidence that indicates that increased plant sterol serum concentrations are correlated with an increased cardiovascular risk. Functional foods such as margarines supplemented with plant sterol esters are advertised to patients with hypercholesterolemia. Numerous studies show that margarines supplemented with plant sterol esters reduce serum cholesterol concentrations significantly. However, there are no studies available investigating relevant clinical endpoints. Nor are there any studies availabe investigating the effect of the consumption of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations. This study is done to investigate the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations.

Official Title
-----------------
Concentrations of Plant Sterols in Serum and Aortic Valve Cusps: a Prospectiv Observational Study

Conditions
-----------------
Aortic Valve Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aortic valve stenosis - Exclusion Criteria:familial hypercholesterolemia. -

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plant sterols, serum, aortic valve cusps
Study of Placental Function in Healthy and Pathological Pregnancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a tissue and data repository consisting of samples of human placentas, umbilical cord blood, and maternal blood, collected at the time of delivery. Specimens will be used in cellular, molecular, and functional studies to learn more about changes in placental structure and function, which can result in serious pregnancy complications and determine life-long health by programming the fetus for future metabolic and cardiovascular disease.

Official Title
-----------------
Study of Placental Function in Healthy and Pathological Pregnancies

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women delivering at term Women with pregnancy complications such as: pre-term birth, intrauterine growth restriction, diabetes, and obesity. Exclusion Criteria: Women: under stress, experiencing pain of labor. Pregnancies complicated by other pathologies.

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

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

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 |
| --- | --- | --- |
| Collecting, processing, and archiving human specimens from 1250 subjects | Human placental tissue, umbilical cord blood, and maternal blood samples will be collected from pregnant women at the time of their delivery. The samples will be used to enhance understanding of the role of the placenta in the development of pregnancy complications and in programming of adult disease. | Specimens will be stored for 50 years in repository |
A Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained

Official Title
-----------------
A Domestic, Prospective, Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice

Conditions
-----------------
Gastroscopic and Colonoscopic Sedation

Intervention / Treatment
-----------------
* Drug: Remimazolam Tosilate for Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation Patients need to sign informed consent Exclusion Criteria: Patients who are participating in or planning to participate in any interventional clinical trial The investigator considers that there are any other reasons for the patient's ineligibility for the study
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 |
| --- | --- |
| Cohort 1<br>Painless gastroscopic sedation cohort | Drug: Remimazolam Tosilate for Injection<br>* Remimazolam Tosilate for Injection<br>|
| Cohort 2<br>Painless colonoscopy sedation cohort | Drug: Remimazolam Tosilate for Injection<br>* Remimazolam Tosilate for Injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE | Within 3 days of receiving gastroscopy and colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse events | Refer to SAE definition standards | Within 3 days of receiving gastroscopy and colonoscopy | 
| Adverse drug reactions | By evaluating the association of adverse events with drugs | Within 3 days of receiving gastroscopy and colonoscopy | 
| Injection pain questionnaire | By observing and asking | Within 3 days of receiving gastroscopy and colonoscopy |