linjc16/ctgov huggingface dataset:
Patient's Perception in Symptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the perception of chronic obstructive pulmonary disease (COPD) patients in symptoms related to morning activities. Also the researchers investigated how to describe the impact of symptoms on sleep quality and how to use the medication in Korea COPD treatments.

Official Title
-----------------
Prospective, Observational, Multi-center, Non-interventional Study to Assess Patients Perception in SYmptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD outpatients over 45 years old Lung function: post-FEV1 < 50% Current or ex-smoker > 10 packs per year Patients who were not on medication of ISC/FC at least 2 weeks Exclusion Criteria: Ongoing exacerbation of COPD or within the previous 3 months History of asthma or allergic rhinitis Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis Current participation in an interventional clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| 1<br>Morning Symptoms (+) | |
| 2<br>Morning Symptoms (-) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the perception of COPD Patients in symptoms related to morning activities |  | At baseline and last visit (after 2 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the patient's perception of the variability of symptoms |  | At baseline and last visit (after 2 3 months) | 
| To describe how patients use their COPD treatments |  | At baseline and last visit (after 2 3 months) | 
| To investigate factors that may influence the patient's perception of symptom variability (such as patient characteristics, COPD treatments, co morbidities, etc…) |  | At baseline and last visit (after 2 3 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Symptom, Morning activity, Questionnaire
Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor

Study Overview
=================
Brief Summary
-----------------
This research may explain whether a shortage of three special compounds called aromatic amino acids is responsible for the severe illness and high death rate of children with the kwashiorkor type of malnutrition and whether supplying adequate amounts of these compounds in the treatment diet will speed up recovery from this condition. We propose that decreased availability of the aromatic amino acids may be the reason why children with kwashiorkor are sicker and more difficult to treat.

Conditions
-----------------
Kwashiorkor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malnourished children between 6 to 18 months of age. To standardize for degree of malnutrition, only patients whose weight is < 80 % of that expected for age will be enrolled. By the Wellcome Classification (22), enrolled patients will have marasmus (< 60 % weight/age and no edema), marasmic-kwashiorkor (< 60 % weight/age plus edema) or kwashiorkor (< 80 % weight/age plus edema). Presence of infection at admission. Infection will be defined by the presence of two or more of the following: Leukocyte count >11,000 cells/dl, temperature at admission > 99 oF, positive blood or urine cultures. Exclusion Criteria: Criteria for exclusion will include presence of cardiovascular, hepatic, renal, gastrointestinal, metabolic disease or HIV/AIDS.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Months

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 |
| --- | --- | --- |
China Red Eye Study

Study Overview
=================
Brief Summary
-----------------
This study intends to use a hospital-based multi-center cross-sectional study to understand the disease composition of red-eye patients in Chinese ophthalmology clinics. This study will provide important clinical diagnosis and treatment data for common eye diseases in China with red eye as the main performance.

Detailed Description
-----------------
Red eye is a common sign of eye diseases. Eye diseases such as ocular surface inflammation, glaucoma, and uveitis can be expressed as red eyes. The disease with red eye as the main complaint is the most common condition that clinicians need to identify. It is not uncommon to be misdiagnosed and missed clinically. The collection and analysis of the disease composition of the red eye in Chinese ophthalmology clinics will help to understand the current status of red eye related diseases and provide a systematic and comprehensive clinical basis for the differential diagnosis of red eye.

Official Title
-----------------
China Red Eye Study

Conditions
-----------------
Red Eye

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmation of signs under the slit lamp is red eye Exclusion Criteria: The investigator believes that there are any unsuitable reasons for participating in the trial.
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 |
| --- | --- | --- |
| medical diagnosis of each patient | the investigators record patients' diagnosis on questionnaire when the patient come to the doctor | 1 day (when the patient come the the doctor) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
red eye, conjunctival congestion, ophthalmology clinic
Will Erectile Dysfunction Increase the Risk of Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The rationale for investigating the hypothesis that there is an association between erectile dysfunction (ED) and the subsequent development of prostate cancer is based on three assumptions: 1) baseline ED is common in most if not all of the cross-sectional studies in men with prostate cancer; 2) the development of ED and prostate cancer may have certain shared common risk factors; and 3) the use of testosterone for the treatment of ED has been suspected to be associated with prostate cancer development. Controversy exists over whether men with ED have an increased risk of subsequent prostate cancer. Few studies have evaluated the risk of developing prostate cancer for men with ED. The investigators, therefore, conducted a population-based longitudinal study with eight years' follow-up to examine this association and to evaluate the magnitude of the risk.

Official Title
-----------------
Erectile Dysfunction and the Future Risk of Prostate Cancer: a Population-based Longitudinal Follow-up Study With Concurrent Double Comparison Cohorts

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Other: Erectile dysfunction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men 50 years and older with no pre-existing prostate cancer Exclusion Criteria: less than 50 years old pre-existing prostate cancer

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Erectile dysfunction group<br>Group contains men with physician-diagnosed erectile dysfunction | Other: Erectile dysfunction<br>* Patients with ED are considered belonging to the exposure group.<br>|
| General population men without ED<br>Men 50 years and older having no ED and pre-existing prostate cancer | |
| Symptomatic BPH group without ED<br>Men 50 years old older with symptomatic prostatic hypertrophy but with no ED nor pre-existing prostate cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident prostate cancer |  | through study completion, up to 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cohort study, prostate cancer, population-based study, benign prostatic hypertrophy
Treatment With AX200 for Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The AXIS study is a randomized, double-blind, placebo-controlled, dose-escalating phase IIa trial to investigate treatment with AX200 (granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke. The primary objective of the present phase IIa study is to assess the safety and tolerability of AX200 compared to placebo in subjects suffering from acute stroke. The secondary objective is to assess the effect of AX200 on subject outcome in comparison to placebo.

Official Title
-----------------
AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke

Conditions
-----------------
Cerebral Stroke

Intervention / Treatment
-----------------
* Drug: AX200 (G-CSF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stroke onset within 12 hours prior to start of study agent administration Ischemic stroke in the middle cerebral artery (MCA) territory confirmed by magnetic resonance imaging (MRI) Exclusion Criteria: Time interval since stroke onset impossible to determine Carotid T-occlusion (magnetic resonance angiography [MRA]) Subarachnoid hemorrhages Several safety parameters

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AX200 (G-CSF)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological outcome |  |  | 
| ischemic lesion growth |  |  |
Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis

Study Overview
=================
Brief Summary
-----------------
To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.

Official Title
-----------------
Prospective Randomized Trial to Study the Effectiveness of an Intraperitoneal Mesh With an Overlap of 3cm Versus a Rives-Stoppa Repair With an Overlap of 6cm With Patients With a Hernia Umbilicalis

Conditions
-----------------
Hernia, Umbilical

Intervention / Treatment
-----------------
* Device: Ventralex versus Leight Weight Vypro II prothesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic hernia umbilicalis > 18 years old Exclusion Criteria: -

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ventralex<br> | Device: Ventralex versus Leight Weight Vypro II prothesis<br>* Ventralex and Leight Weight Vypro II prothesis are compared.<br>|
| Active Comparator: Leight Weight Vypro II prothesis<br> | Device: Ventralex versus Leight Weight Vypro II prothesis<br>* Ventralex and Leight Weight Vypro II prothesis are compared.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of relapses after 1 and 3 years |  | after 1 and 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery |  | Depends from type of surgery. | 
| Duration of hospitalisation |  | Depends from type of surgery. | 
| Frequency of complications |  | After 1 and 3 years. | 
| Pain assessment |  | After 1 and 3 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hernia umbilicalis
Insulin Tolerance Test Study in Patients With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Insulin Tolerance Test Study to Assess the Safety, Tolerability, and Pharmacodynamics OF Pitolisant in Patients With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes, Hypoglycemia

Intervention / Treatment
-----------------
* Drug: Pitolisant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria: Diagnosis of diabetes => 4yrs, On Insulin => 4yrs, HbA1c<= 10%, At least one episode of severe hypoglycemia in past 12 months, fasting c-peptide <0.7 ng/ml Exclusion Criteria: Hypoglycemia unawareness, DKA within 3 months prior to randomization, Reduced renal function, Anxiety and depression

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitolisant<br> | Drug: Pitolisant<br>* Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated.<br>|
| Placebo Comparator: Matching placebo<br> | Drug: Pitolisant<br>* Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Peak Glucagon Response to Hypoglycemia | Change in peak glucagon concentration from day 1 ITT (baseline) to day 7 ITT (on treatment). Serial glucagon collected during ITT's, occurred at -10, 0, 15, 30, 45, 60, 90, 120 and 180 minutes just prior to and during the ITT. | Change in peak glucagon during ITT Day 1 vs. Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Returning to Blood Glucose =>70 mg/dL | Number of patients that returned to blood glucose =>70 mg/dL during ITT | Day 7 |
Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance (PMS) study is designed to investigate the efficacy and safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.

Official Title
-----------------
Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)

Conditions
-----------------
Liver Diseases

Intervention / Treatment
-----------------
* Drug: Azathioprine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who undergo liver transplantation and azathioprine tablet was administered Exclusion Criteria: As this is PMS study, there are no exclusion criteria but contraindications are as follows. Subjects with hypersensitivity to the ingredients of azathioprine tablet Subjects who is pregnant or might be pregnant Subjects whose white count is lower than 3000/cubic millimeter
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed azathioprine tablet<br>Subjects prescribed azathioprine tablet during study period after the liver transplantation | Drug: Azathioprine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of incidence of adverse events related to azathioprine tablets and serious adverse events |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antirejection
SVT-40776 in Patients Suffering From Overactive Bladder Syndrome

Study Overview
=================
Brief Summary
-----------------
The study will examine which dose of SVT-40776 is best in terms of efficacy, safety and tolerability compared to placebo and tolterodine

Conditions
-----------------
Overactive Bladder (OAB)

Intervention / Treatment
-----------------
* Drug: SVT-40776


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from OAB for at least 6 months prior to inclusion Exclusion Criteria: Pregnant and breastfeeding women Any medical condition or need for co-medication which interferes with the drug under investigation (SVT-40776) or the comparator (tolterodine)

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SVT-40776|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2

Study Overview
=================
Brief Summary
-----------------
Capsule endoscopy has been shown to be the first-line endoscopic procedure for small bowel disease. This study was aimed to compare the performance between the frequency-altering AKE-1 capsule and the Pillcam SB2 in patients with suspected small bowel disease.

Official Title
-----------------
A Double-center Randomized Head-to-head Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2

Conditions
-----------------
Intestinal Diseases, Gastrointestinal Hemorrhage

Intervention / Treatment
-----------------
* Device: AKE-1
* Device: Pillcam SB2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obscure gastrointestinal bleeding chronic diarrhea suspected Crohn's disease chronic abdominal pain neoplastic lesions of small bowel Exclusion Criteria: patients with any contraindication to capsule endoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pillcam SB2 first<br>patients were assigned to swallow PSB first, followed by the AKE | Device: AKE-1<br> <br> Device: Pillcam SB2<br> <br> |
| Experimental: AKE-1 first<br>patients were assigned to swallow AKE first, followed by the PSB | Device: AKE-1<br> <br> Device: Pillcam SB2<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| judgement of normal or abnormal of gastrointestinal tract | If a lesion is detected by capsule endoscopy in gastrointestinal tract in a patient, the result will be judged as abnormal. | 5 weeks after the examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete small-bowel examination rate |  | 5 weeks after the examination | 
| diagnostic yield | The finding that could explain the symptom and resulted in clinical impact was considered as diagnosis.Diagnostic yield of a capsule endoscopy is the proportion of patients with positive diagnosis over total patients. | 5 weeks after the examination | 
| total recording time |  | 5 weeks after the examination | 
| gastric transit time |  | the comparison was completed 5 weeks after the examination | 
| small-bowel transit time |  | the comparison was completed 5 weeks after the examination | 
| total number of images captured |  | the comparison was completed 5 weeks after the examination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Capsule Endoscopy
The Effect of Adalimumab on the Bone Microstructure in Crohn's Disease (CD) Patients

Study Overview
=================
Brief Summary
-----------------
The investigators will study the effect of Adalimumab on the bone microstructure. Trial with medicinal product

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Application of Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: CDAI > 220 und < 450 Biologika naiv CD seit > 6 Monaten Exclusion criteria: other TNF-Blocker Steroids > 40 mg Malignoma in der Anamnesis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Application of Adalimumab|Adalimumab will be applied according to manufacture's instruction and official guidelines.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |