linjc16/ctgov huggingface dataset:
Evaluation of the Duration of Oral Combination Therapy in Type 2 Diabetes, Prior to the Initiation of Insulin in the UK

Study Overview
=================
Brief Summary
-----------------
Carry out the cost-effectiveness analysis of rosiglitazone on a population in line with the rosiglitazone license and using UK costs

Official Title
-----------------
Evaluation of the Duration of Oral Combination Therapy in Type 2 Diabetes, Prior to the Initiation of Insulin in the UK

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rosiglitazone Type II Diabetes studies Exclusion Criteria: Studies without the required outcome
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br> | Drug: Rosiglitazone<br>* Rosiglitazone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of rosiglitazone |  | From literature |
Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of C-KAD Ophthalmic Solution in improving visual acuity relative to placebo in patients with age-related cataract

Official Title
-----------------
A Phase 2, Randomized, Placebo-Controlled, Double-Masked, Multicenter Safety and Efficacy Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Acuity Due to Age-Related Cataract

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

Intervention / Treatment
-----------------
* Drug: C-KAD Ophthalmic Solution
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of age-related cataract in the study eye Best-corrected visual acuity of 20/25 to 20/50 in the study eye Exclusion Criteria: Any other clinical condition in the eye that may compromise vision Presence or History of Glaucoma Presence or history of diabetes Use of eyedrops Use of steroids

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: C-KAD Ophthalmic Solution<br>* 4 drops applied daily for 120 days<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 4 drops applied daily for 120 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity by ETDRS |  | 120 Days |
Creon in HIV Patients With Steatorrhea

Study Overview
=================
Brief Summary
-----------------
The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.

Official Title
-----------------
Double-blind, Cross-over, Randomized, Placebo-controlled, Multi-center Study to Investigate the Effect of Creon®25 000 on the Coefficient of Fat Absorption of HIV-infected Patients

Conditions
-----------------
Steatorrhea

Intervention / Treatment
-----------------
* Drug: Creon 25000
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria HIV positive patients with clinically stable disease (Karnofsky Performance Status > 40); Steatocrit > 2 %; Females of child-bearing potential must have a negative pregnancy test during prestudy or the subject must be surgically sterile or be at least 1 year postmenopausal as judged by the investigator; Women of child-bearing potential must be using a medically acceptable method of birth control throughout the study Exclusion Criteria Known allergy to pancreatin or any history of abnormal drug reaction; Known diagnosis of pancreatic exocrine insufficiency due to e.g. chronic pancreatitis or cystic fibrosis or pancreatectomy; Intake of an experimental drug within four weeks prior to entry into the study; Alcohol abuse within the last six months; Suspected non-compliance or non-cooperation; Any other lack of fitness, in the investigator's opinion, to participate in or to complete the study; Patients with a stool fat excretion <= 7 g/day according to van de Kamer during the run-in period

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Creon 25000<br>* 6 to 9 capsules Creon 25000 per day<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 6 to 9 capsules placebo per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficient of fat absorption (CFA) |  | After 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool fat excretion |  | After 2 weeks | 
| Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day |  | After 2 weeks | 
| Response (yes, no) with respect to stool fat excretion, i.e. improvement in stool fat excretion as compared to baseline |  | After 2 weeks | 
| Stool weight |  | After 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Steatorrhea
The Effect of a Blue Light Filtering IOL

Study Overview
=================
Brief Summary
-----------------
To compare the effect on blood retinal barrier disruption 3 and 12 months after implantation of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light filtering intraocular lens(UV-filtering IOL).

Detailed Description
-----------------
The following parameters were measured for evaluation of blood retinal barrier disruption. the incidence of macular leakage by fluorescence angiography (FA) the mean fluorescein concentration in the vitreous by fluorophotometry (VFP) the thickness of the macula by optical coherence tomography (OCT) Results the incidence fo macular leakage decreased significantly from 24%(3 months) to 5% (12 months) in the blue-filtering IOL group (P<0.05), and was significantly lower compared with the UV-filtering IOL group at 12 months. the VFP significantly decreased in both group from 3 to 12 months. the OCT decreased from 175 (3 months) to 166 um (12 months) in the blue- filtering IOL group.

Official Title
-----------------
The Effect of a Blue Light Filtering Intraocular Lens on Blood Retinal Barrier After Cataract Surgery

Conditions
-----------------
to Compare the Effect of Two Types of IOLs, on the Incidence of Cystoid Macular Edema, After Cataract Surgery

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cataract patients All eligible for intraocular lens implantation Exclusion Criteria: Patients had undergone an intraocular operation Patients had hypertensive retinopathy Patients had diabetic retinopathy Patients had ange-related macular degeneration no observable fundus The cataract operation was more than 30 minutes in duration

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: letter<br>a blue-filtering IOL an UV-filtering IOL | Procedure: intraocular lens implantation<br>* Intraocular lens implantation<br>* Other names: an UV-filtering IOL (ES-13, Menicon Co.Ltd, Japan);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure FA, VEP and OCT. |  | At 3 and 12 months after IOL implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macula edema, intraocular lens, prospective randomized parallel clinical design
The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to monitor the safety and effectiveness of the Occlutech AFR device in patients with heart failure for 3 years following AFR device implantation.

Detailed Description
-----------------
Prospective, multicentre, international, follow-up registry to monitor the safety and the performance of the Occlutech AFR device in patients with Heart Failure, evaluated by vital signs, laboratory tests, quality of life questionnaire, ECG, and echocardiography data. Patients will be treated according to the instruction-for-use of the device and according to clinical routine by experienced physicians.

Official Title
-----------------
A Multicentre, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech Atrial Flow Regulator in Heart Failure Patients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Occlutech Atrial Flow Regulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients for whom Occlutech AFR Implantation is indicated and planned Age 18 years or older Written informed consent is available Exclusion Criteria: Any condition that, in the opinion of the investigator might interfere with the implantation of affect the patients well-being Sepsis (local or generalized) or acute infections Allergy to anti-platelet, anti-coagulant or ani-thrombotic therapy Allergy to nickel and/or Titanium and or nickel-titanium-based matierials

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 |
| --- |
|Device: Occlutech Atrial Flow Regulator|The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety in the 1 year following implantation | Percentage of patients with at least one SADE | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Placement | Device in situ in the 3 years following implantation | 3 years | 
| Left-Right shunt through AFR device | Evidence of left to right shunt through the AFR device in the 3 years following implantation | 3 years | 
| NYHA status |  | 3 years | 
| Change in Quality of life | Change in quality of life as assessed by KCCQ | 3 years |
Immunity Against AAV in Crigler Najjar Patient

Study Overview
=================
Brief Summary
-----------------
The proposed research protocol aims at addressing these points by pre-screening CN patients for their AAV serology in link with their medical history and current medical status. A first objective is to assess the presence of neutralizing AAV antibodies in the serum of CN patients.

Official Title
-----------------
Study of the Prevalence of Pre-existing Immunity Against the Adeno-associated Virus (AAV) in Patients With Crigler-Najjar Syndrome

Conditions
-----------------
Crigler Najjar Syndrome

Intervention / Treatment
-----------------
* Biological: Blood sample for immunology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has a Crigler-Najjar syndrome The molecular diagnosis has been confirmed by UGT1A1 gene DNA sequencing Exclusion criteria: The patient is liver transplanted The patient is suffering from severe associated pathologies precluding further enrolment in a future interventional clinical study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Blood sample for immunology|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the presence of neutralizing AAV antibodies in the serum of CN patients |  | 1 day visit |
Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting (ESOPE)

Study Overview
=================
Brief Summary
-----------------
The primary objective is to compare the phenotype and genotype of the primary tumor with those of its metastases in order to optimize the treatment of metastatic disease, in patients presenting with first metastatic progression of breast cancer.

Official Title
-----------------
Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Other: biopsy or cytopuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be eligible to participate in the study, patients must fulfill all of the following criteria: Female patients. Age ≥ 18 years. ECOG performance status ≤ 2. Metastatic breast carcinoma, either at diagnosis or at first metastatic relapse. Available FFPE +/- frozen primary tumor samples. Evaluable metastatic disease. Metastatic disease outside any previous radiotherapy field (e.g. sub-clavicular or internal mammary lymph nodes). Metastatic disease accessible to either percutaneous or surgical sampling. Signed written informed consent (approved by an Independent Ethics Committee and obtained prior to any study-specific screening procedure). Social and psychological welfare in concordance with compliance to the study. Exclusion Criteria: To be eligible to participate in the study, patients must fulfill none of the following criteria: Bilateral or multifocal breast cancer. Isolated local or contralateral relapse. Solitary bone and/or brain metastatic disease unless : Metastatic sites eligible for a therapeutic surgery. Metastatic sites sampled for diagnosis purpose. Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin. Carcinoma in situ of the cervix. Any coagulopathy contraindicating tumor biopsy. Presence of a contraindication to general anesthesia, if required.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: biopsy or cytopuncture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the phenotype ant genotype discrepancies regarding hormonal receptor, FISH status and proliferation between the primary tumor and the first metastatic progression. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic breast cancer, Tumor biopsy, Phenotype and genotype characterization
Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma basing on immune microenviroment.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.

Official Title
-----------------
Clinical Research of Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma Basing on Immune Microenviroment

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

Intervention / Treatment
-----------------
* Drug: Yang Yin Fu Zheng therapy
* Drug: Routine medical care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed of stage HBV-HCCⅡb、Ⅲa、Ⅲb; Ages Eligible for Study: ≤75 years old; TCM syndrome is deficiency of both Qi and Yin; Confirmed of CHB; Surgery cannot be allowed; Informed consent from the patient. Exclusion Criteria: Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD; Serious problem of heart, lung, or kidney with severe dysfunction; Pregnant or child breast feeding women; Mental or cognitive disorders; Participating in other drug trials; Who are allergic to the study drug.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yang Yin Fu Zheng therapy<br> | Drug: Yang Yin Fu Zheng therapy<br>* Yang Yin Fu Zheng is a Chinese herbal compound.<br>Drug: Routine medical care<br>* Routine medical care<br>|
| Placebo Comparator: Routine medical care<br> | Drug: Routine medical care<br>* Routine medical care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 2 years | 
| quality of life(QOL) |  | 2 years |
Most Preventable Surgical Option to Reduce Primary Spontaneous Pneumothorax Patients' Postoperative Recurrence: A Prospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
To investigate the most preventable option to reduce primary spontaneous postoperative recurrence.

Detailed Description
-----------------
Pneumothorax is a disease in which air in the lungs leaks into the pleural cavity. It is a disease that occurs most often in young people with active social activities, and it occurs in about 100,000 people in 14 cases. The recurrence rate is as high as 17% to 54%, and the delay of the rehabilitation by the ambulatory with the treatment and prolongation of the hospitalization becomes a problem. It becomes a large failure for the youth who requires early rehabilitation. According to the latest report from the Japanese Society of Surgery, approximately 12,000 pneumothorax surgeries are performed annually in Japan. Many of them applied absorbent material to the surgical stump (coverage technique). However, there are no prospective studies, and efficacy does not appear adequately tested. It is necessary to accumulate prospective data from multiple centers to investigate the coverage technique's real effect.

Official Title
-----------------
Most Preventable Surgical Option to Reduce Primary Spontaneous Pneumothorax Patients' Postoperative Recurrence: A Prospective Cohort Study

Conditions
-----------------
Spontaneous Pneumothorax, Recurrence, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have spontaneous pneumothorax diagnosed by radiography and plan to underwent initial VATS bullectomy. Patients who receive informed consent to attend this study, and the agreements are provided in a document. The consent of parents is also required, in case patients are under 20-years old. Exclusion Criteria: History of ipsilateral chest surgery. Patients who only underwent exploratory surgery. Patients who are judged ineligible by the investigator and the attending surgeon.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 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 |
| --- | --- | --- |
| Recurrence rate of pneumothorax | Rate of ipsilateral pneumothorax recurrence detected by radiography at two years after surgery | within 2 years after the surgery |