linjc16/ctgov huggingface dataset:
Evaluation of the Difference in the Acromion Humerus Gap at Sitting,Lying

Study Overview
=================
Brief Summary
-----------------
The Objective is to evaluation the difference between the upper end of the Humerus head and the bottom end of the Acromion in sitting and lying, and to examine this difference to shoulder pain.

Conditions
-----------------
Shoulder Impingement Syndrome.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women with or without shoulder pain. Exclusion Criteria: unwillingness to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- |
| rotator cuff tear, pain<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of pain as measured by the visual analogue score |  |  |
The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis

Study Overview
=================
Brief Summary
-----------------
Currently, lots of researches aimed at quality of life of patients with peritoneal dialysis and hemodialysis related issues. There is no study related to establish the predictive model of quality of life. This study will investigate the predictive model of quality of life in terms of peritoneal dialysis (PD) or hemodialysis (HD) patients. These results will offer the further evidence to the government to develop the effective interventions for dialysis patients. The optimal goal is to promote the quality care.

Official Title
-----------------
The Study Will Investigate the Quality of Life in PD or HD Patients

Conditions
-----------------
Peritoneal Dialysis, Hemodialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 20 years old PD or HD patients conscious clear and no psychosis literate and can communicate willing to participate and sign informed consent Exclusion Criteria: Not volunteer subject felt weak or uncomfortable and patients decision to withdraw from the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| peritoneal dialysis and hemodialysis patients<br>peritoneal dialysis and hemodialysis patients | |

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
-----------------
peritoneal dialysis, hemodialysis patients
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan

Study Overview
=================
Brief Summary
-----------------
The primary objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world data generated in patients with SSc-ILD.

Official Title
-----------------
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan

Conditions
-----------------
Lung Diseases, Interstitial

Intervention / Treatment
-----------------
* Drug: Nintedanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in Japan with SSc-ILD who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients newly initiating Ofev®/Nintedanib Capsules<br> | Drug: Nintedanib<br>* Capsules<br>* Other names: Ofev®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions (ADRs) | Focus on gastrointestinal symptoms including diarrhea and nausea | up to 3 years and 9 months |
Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with bronchopulmonary dysplasia

Detailed Description
-----------------
The purpose of this study is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in 10 patients with bronchopulmonary dysplasia at Vinmec International Hospital, Hanoi, Vietnam

Official Title
-----------------
Outcomes of Human Umbilical Cord-derived Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia

Conditions
-----------------
Bronchopulmonary Dysplasia

Intervention / Treatment
-----------------
* Combination Product: stem cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is diagnosis Bronchopulmonary Dysplasia (premature and depends on oxygen until 28 days old Gender: either sex Year old < 6 months Weight ≥ 2 kg Agree to participate in the study. Exclusion Criteria: Severe congenital malformation. Other severe conditions (active pulmonary bleeding, evidence of active infections).

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 6 Months

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: Stem cell transplantation<br>1 million umbilical Cord Mesenchymal Stem Cells per body kg will transplant via the intravenous at baseline, and the second transplantation will be performed 1 week after the first transplantation | Combination Product: stem cell transplantation<br>* Transplantation of umbilical cord mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and serious adverse events | Incidence of the adverse events or serious adverse events after transplantation | during 9 months post treatment | 
| The proportion of patients win from oxygen | To identify the proportion of patient with Bronchopulmonary Dysplasia win from oxygen after stem cell transplantation. | during 9 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The lung fibrosis | Changes of the lung fibrosis on chest CT at 6 months compared with baseline | at 6 months post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchopulmonary dysplasia, umbilical cord mesenchymal stem cells
The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether we can predict the intracranial pressure using near infra-red spectroscopy

Detailed Description
-----------------
The management of intracranial hypertension requires the presence of an intracranial pressure monitor. We are investigating whether the waveforms obtained from a near infrared spectroscopy device can predict what the intracranial pressure is non-invasively. Patients with intracranial hypertension who are intubated and ventilated in the ICU will be recruited we will record there intracranial pressure and systemic arterial pressure recordings from the near infrared device will be recorded and analysed off-line we will correlate the waveform tracings from near infrared spectroscopy and the arterial tracing

Official Title
-----------------
The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)

Conditions
-----------------
Intracranial Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an intracranial pressure monitor and arterial catheter who are admitted to the ICU Exclusion Criteria: Less than 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Intracranial hypertension<br>Patients with raised intracranial pressure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracranial elastance | Intracranial elastance (δP/δV)will be measured by dividing the pulse pressure of an invasive arterial blood pressure by the amplitude of high frequency oscillations in the near infrared (NIR) absorbance waveforms. | Participants will be followed while an arterial line and intracranial pressure monitor is present duing the ICU admission. This is expected to be an average of 5 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intracranial hypertension, intracranial elastance
A Pilot Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Dry AMD

Study Overview
=================
Brief Summary
-----------------
The safety and comfort of repeated administrations of a topically-administered ophthalmic formulation of MC-1101 will be established through investigator assessments and subject reporting over a 3 day period. Safety assessments will be performed on both normal, healthy subjects as well as those with the signs and symptoms of early non-exudative age-related macular degeneration (dry AMD).

Official Title
-----------------
A Pilot, Single-Center, Open-Label Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Non-exudative Age-Related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: MC-1101
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of dry AMD or; Normal, healthy volunteer Exclusion Criteria: Uncontrolled systemic disease Women who are pregnant, nursing, or planning a pregnancy during the study's duration

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Topical administration of MC-1101 | Drug: MC-1101<br>* MC-1101 1.0%<br>|
| Placebo Comparator: Vehicle<br>Vehicle | Drug: Vehicle<br>* Vehicle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular safety |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choroidal blood flow assessment |  | 3 days |
A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Zonisamide
* Drug: Topiramate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients over 13 years old (complete the elementary school course). Patients had at least two seizures in the past and at least one seizure for the last 3 months before screening. Patients had no antiepileptic drugs for the last 4 months. Women of childbearing age who agree to contraception during participating this clinical trial. Exclusion criteria: Pregnancy Patients who have progressive neurologic disease Allergy to sulfonamides Use of acetazolamide within a year Hemolytic anemia Patients who have abnormal liver function (GOT or GPT) values more than twice the normal values. Patients who have abnormal renal function (BUN or Creatinine) values more than three times the normal values. Patients who have history of drug or alcohol abuse. Glucose-6-phosphate dehydrogenase deficiency. Patients who were detected with renal stones on KUB (Kidney-Ureter-Bladder) test. Patients who have progressive internal or surgical disease. Patients who have progressive psychiatric disease. Patients who have mental retardation (IQ 70 and less). Patients taking Vit C.

Ages Eligible for Study
-----------------
Minimum Age: 13 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: 1<br> | Drug: Zonisamide<br>* Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.<br>* Other names: Zonegran;|
| Active Comparator: 2<br> | Drug: Topiramate<br>* Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure frequency |  | 2, 4, 8, 12, 16, 20, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function |  | 0, 24 weeks |
The Effect of Suture Materials With Different Absorption Times on Isthmocele: Prospective Randomized Study

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the effect of suture materials with different absorption times on istmocel.

Official Title
-----------------
The Effect of Suture Materials With Different Absorption Times on Isthmocele: Prospective Randomized Study

Conditions
-----------------
Suture, Complication, Istmocel

Intervention / Treatment
-----------------
* Procedure: Suture materials effect on istmocel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary cesarean section single pregnancy 18-45 age Exclusion Criteria: Diabetes mellitus disease inflammatory bowel disease systemic lupus erythematosus disease rheumatoid arthritis disease previous uterine surgery

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Rapid vicryl will used in study group and vicryl will used in control group for uterine closure in cesarean section.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vicryl<br>Single layer locked uterine closure with vicryl suture material | Procedure: Suture materials effect on istmocel<br>* Effect of suture materials with different absorption times on istmocel<br>|
| Experimental: rapide vicryl<br>Single layer locked uterine closure with rapide vicryl suture material | Procedure: Suture materials effect on istmocel<br>* Effect of suture materials with different absorption times on istmocel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Istmocel | Istmocel area measurement with saline-infusion ultrasonography | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rapid, suture material, istmocel
Hereditary Haemorrhagic Telangiectasia Flight Safety Study

Study Overview
=================
Brief Summary
-----------------
Hereditary Haemorrhagic Telangiectasia (HHT) is a condition in which sufferers have abnormal blood vessels which makes them more likely to bleed than other people, particularly in the lungs, which results in low blood oxygen levels. Flying may make this worse and cause problems. The investigators want to know if there are an increased number of problems on flights compared to on land. The investigators currently do not have any evidence based guidelines on air travel to best advice people who suffer with HHT. The investigators would therefore like to ask individuals who have HHT about their experience on a flight, using a postal questionnaire.

Detailed Description
-----------------
Individuals with Hereditary Haemorrhagic Telangiectasia (HHT) previously reviewed at HHTIC London will be sent an invitation to participate in a short questionnaire study. Quantitative variables from the questionnaires for statistical analysis will be the number of individuals responding (and number of questionnaires sent out); number of flights taken and number of complications, subgrouped by type, and flight duration in hours. Complication rates will be expressed as proportion of person flight hours. The quantitative data from the questionnaire will then be compared with quantitative data from patients' medical records using non parametric methods such as Mann Whitney for univariate analyses.

Official Title
-----------------
A Questionnaire Based Study to Evaluate the Safety of Flying in Hereditary Haemorrhagic Telangiectasia (HHT)

Conditions
-----------------
Hereditary Haemorrhagic Telangiectasia

Intervention / Treatment
-----------------
* Other: Aeroplane flight in the past- no active intervention for study
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HHT Exclusion Criteria: Unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Pateints with hereditary haemorrhagic telangiectasia<br> | Other: Aeroplane flight in the past- no active intervention for study<br>* Aeroplane flight(s) previously taken by study participants<br>Other: Questionnaire<br>* Flight by aeroplane (previous)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported medical complication |  | During or in 6 weeks post flight | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Previous flight by aeroplane
A Study of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the dose limiting toxicity (DLT) of BMS-582664 and the maximum tolerated dose(MTD) in subjects with advanced or metastatic solid tumors.

Official Title
-----------------
Phase I Multiple Ascending Dose Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Japanese Patients With Advanced or Metastatic Solid Tumors

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: Brivanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have measurable disease Documented failure to standard therapies exist, or which are determined to be inappropriate by the investigator ECOG PS: 0-1 Exclusion Criteria: Subjects with centrally located squamous cell carcinoma of the lung

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>4 dosages | Drug: Brivanib<br>* Tablet, Oral, Brivanib 300 mg, 600 mg, 800 mg, 1000 mg, once daily (cycle 1: Day 1, Day 8 - 35), more than 5 weeks depending on response/toxicity<br>* Other names: BMS-582664;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicity |  | at the end of the first cycle of the study | 
| Maximum Tolerated Dose |  | at the end of the first cycle of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess any preliminary evidence of anti-tumor activity observed with BMS-582664 |  | at the end of the study |