linjc16/ctgov huggingface dataset:
Near-infrared Autofluorescence (NIRAF) in Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Centers

Study Overview
=================
Brief Summary
-----------------
Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown. In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid centers is needed. This is the overall aim of our current studies. The objective of this specific study is to evaluate the impact of NIRAF on transient and permanent hypoparathyroidism following total thyroidectomy in low-volume, non-parathyroid centers.

Detailed Description
-----------------
Patients referred for total thyroidectomy will undergo NIRAF-assisted surgery (Fluobeam LX). PTH and ionized calcium will be assessed preoperatively, on postoperative day 1 (POD1) and 6 months following surgery. The rates of transient and permanent hypoparathyroidism will be assessed and compared to a historic cohort.

Official Title
-----------------
Prevention of Postoperative Hypoparathyroidism Following Thyroid Surgery by Using Intraoperative Autofluorescence

Conditions
-----------------
Autofluorescence, Thyroidectomy, Hypoparathyroidism, Hypocalcemia

Intervention / Treatment
-----------------
* Device: Fluobeam LX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred for total thyroidectomy Age > 18 Able to understand patient information Able to give informed consent Exclusion Criteria: Completion lobectomy Need for accelerated surgery Insufficient biochemical profile

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: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (A): NIRAF-assisted surgery<br>Patients undergoing NIRAF-assisted total thyroidectomy | Device: Fluobeam LX<br>* See arm description<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of permanent hypoparathyroidism |  | Will be assessed one year following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of transient hypoparathyroidism |  | Will be assessed one year following surgery | 
| Parathyroid identification rate |  | Will be assessed at the time of surgery | 
| Autoimplantation rate |  | Will be assessed at the time of surgery | 
| Rate of inadvertently excised parathyroid glands |  | Will be assessed 1 month following surgery |
Study of Metastatic Ocular Melanoma

Study Overview
=================
Brief Summary
-----------------
This study evaluates treatment with combination versus monotherapy for patients with metastatic ocular melanoma.

Detailed Description
-----------------
Treatment of patients with metastatic ocular melanoma with combination chemotherapy Gemcitabine and Treosulfan versus monotherapy with Treosulfan as first-line chemotherapy.

Official Title
-----------------
Randomized Phase II Study to Compare a Combination Therapy With Gemcitabine and Treosulfan Versus a Monotherapy as First-Line Chemotherapy for Patients With Metastatic Ocular Melanoma

Conditions
-----------------
Ocular Melanoma

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: Treosulfan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic ocular melanoma Exclusion Criteria: Prior treatment with chemotherapy Active 2nd malignancy Cerebral metastasis

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|nan|
|Drug: Treosulfan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic ocular melanoma
A Study of Safety and Effectiveness of NovoThirteen® (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. Tha aim of this study is to investigate Safety and Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in Japan.

Official Title
-----------------
A Multicentre, Non-interventional Post Marketing Study of Safety and Effectiveness of NovoThirteenR (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan

Conditions
-----------------
Congenital Bleeding Disorder, Congenital FXIII Deficiency

Intervention / Treatment
-----------------
* Drug: recombinant factor XIII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male of female patients, regardless of age, requiring treatment with NovoThirteenR for whom the treating physician has decided to use NovoThirteenR (rFXIII) treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NovoThirteen®<br> | Drug: recombinant factor XIII<br>* No treatment given.Patients will be treated according to routine clinical practice at the discretion of the treating physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with NovoThirteen®, comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect |  | Year 0-9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All serious adverse events |  | Year 0-9 | 
| All adverse events |  | Year 0-9 | 
| All medical event of special interest |  | Year 0-9 | 
| All medication errors collected |  | Year 0-9 | 
| All technical complaints |  | Year 0-9 | 
| Use of NovoThirteen® for other uses than for the approved indication |  | Year 0-9 | 
| Frequency of bleeding episodes |  | Year 0-9 |
Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients

Study Overview
=================
Brief Summary
-----------------
There is currently no effective treatment of bronchiectasis other than treating its complications such as infection, bleeding, etc. Roflumilast is a newly developed anti-inflammatory drug that has proven to be effective in stable COPD. We hypothesized that Roflumilast might be effective in symptomatic bronchiectasis patients

Conditions
-----------------
Symptomatic Bronchiectasis

Intervention / Treatment
-----------------
* Drug: Roflumilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bronchiectasis on CT chronic (>3 months) cough or sputum Exclusion Criteria: needs hospitalization life expectancy of less than six months pregnancy or breast feeding history of acute respiratory infection within 4 weeks history of taking antibiotics within 4 weeks active hemoptysis %predicted FEV < 30% severe liver disease (Child Pugh Class B or C)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>single arm study | Drug: Roflumilast<br>* 500 microgram once daily for 16 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of CASA-Q score |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of FEV1 |  | 16 weeks | 
| change of FVC |  | 16 weeks | 
| alanine transaminase |  | 4 weeks |
Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa

Study Overview
=================
Brief Summary
-----------------
Epidermolysis Bullosa(EB) is an inherited bullous disease. Tetracycline is believed to have anti inflammatory properties. 20 patients with EB older than 13 years will be treated for 4 months with tetracycline or placebo. After one month of wash out they will be treated for additional 4 m with placebo or tetracycline. The patients will be examined each month to estimate bulla formation,rate of healing .

Detailed Description
-----------------
Epidermolysis Bullosa(EB) is an inherited bullous disease. Tetracycline is believed to have anti inflammatory properties. 20 patients with EB older than 13 years will be treated for 4 months with tetracycline or placebo. After one month of wash out they will be treated for additional 4 m with placebo or tetracycline. The patients will be examined each month to estimate bulla formation,rate of healing .

Official Title
-----------------
Randomised Double Blind Crossover Placebo Controlled Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa

Conditions
-----------------
Epidermolysis Bullosa

Intervention / Treatment
-----------------
* Drug: tetracyclin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as epidermolysis bullosa not pregnant active disease more than 5 bulla- Exclusion Criteria: age less than 13 known sensitivity to tetracyclin abnormal liver and kidney tests.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Drug: tetracyclin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no of blisters |  |  |
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who did not respond to previous treatment.

Official Title
-----------------
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Subjects With Genotype 2 Hepatitis C, Who Did Not Respond to Previous Treatment

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: MP-424 (generic name:Telaprevir)
* Drug: Ribavirin
* Drug: Peginterferon alfa-2b


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genotype 2, chronic hepatitis C Non-responders (patient who did not respond to previous treatment) Able and willing to follow contraception requirements Exclusion Criteria: Cirrhosis of the liver or hepatic failure Hepatitis B surface antigen-positive or HIV antibodies-positive History of, or concurrent hepatocellular carcinoma History of, or concurrent depression, schizophrenia,; or suicide attempt in the past Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MP-424<br> | Drug: MP-424 (generic name:Telaprevir)<br>* 750mg q8h for 12 weeks<br>Drug: Ribavirin<br>* 400 - 1000 mg/day based on body weight for 24 weeks<br>Drug: Peginterferon alfa-2b<br>* 1.5mcg/kg/week for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) |  | After 24 weeks of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genotype 2
the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis

Study Overview
=================
Brief Summary
-----------------
Geneswell BCT is a precise and qualitative in vitro diagnostic test. The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group. This test provides prognostic information to assess the risk of recurrence. The BCT score calculated by geneswell BCT was associated with the risk of recurrence. The higher the BCT score, the more likely it is to relapse, and vice versa.

Official Title
-----------------
A Retrospective, International Multicenter, Single Arm Clinical Trial of the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis

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

Intervention / Treatment
-----------------
* Diagnostic Test: Geneswell BCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients were diagnosed with invasive breast cancer with positive hormone receptor (including positive estrogen receptor or progesterone receptor) and negative human epidermal growth factor receptor 2 (HER2) Axillary lymph node assessment : pN0 or PN1 Women aged 18 and over Patients without chemotherapy after operation Exclusion Criteria: Patients with negative hormone receptor （both estrogen and progesterone receptor are negative） Human epidermal growth factor receptor 2 （HER2） positive Pathological nodule evaluation: pN2 or pN3 Male patients Patients receiving chemotherapy after surgery

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| low risk<br>BCT Score <4 | Diagnostic Test: Geneswell BCT<br>* Geneswell BCT is a precise and qualitative in vitro diagnostic test. The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group.<br>|
| high risk<br>BCT Score ≥4 | Diagnostic Test: Geneswell BCT<br>* Geneswell BCT is a precise and qualitative in vitro diagnostic test. The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative assessment between risk groups | By evaluating the 5-year disease-free survival rate (DFS) of patients in high and low risk groups, the statistical differences between the two groups were compared. | Month 9 |
Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss

Study Overview
=================
Brief Summary
-----------------
The study assesses the accuracy of cell-free DNA (cfDNA) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage.

Official Title
-----------------
Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss

Conditions
-----------------
Early Pregnancy Loss

Intervention / Treatment
-----------------
* Genetic: cfDNA analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5-20 weeks of gestation by ultrasound Miscarriage diagnosed by ultrasound Pregnancy tissue still present in utero, including an empty sac, and not completely expelled Exclusion Criteria: Maternal age < 18 years No visible pregnancy tissue on ultrasound Multiple fetal gestation (> than singleton) Pregnancy was conceived using in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A) performed on the transferred embryo No microarray testing is planned on the product of conception Previous normal non-invasive prenatal testing (NIPT) or diagnostic testing (chorionic villous sampling or amniocentesis) in the current pregnancy Patient unable to provide consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: cfDNA analysis|sequencing data from cfDNA analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microarray analysis of products of conception (POC) | chromosome anomalies | 7 days |
Education Programme on Continuous Positive Airway Pressure Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether an education programme would enhance continuous positive airway pressure (CPAP) adherence.

Detailed Description
-----------------
Obstructive sleep apnoea (OSA) is a common sleep disorders associated with excessive daytime sleepiness and cardiovascular disease. It is prevalent both in populations of western and eastern countries. Continuous positive airway pressure (CPAP) therapy is an effective standard treatment and is widely prescribed for patients with OSA. However, the use of CPAP for such patients is disappointingly low. Low patient CPAP adherence limits the effectiveness of treatment. To determine whether there is a need for an extended education programme for the OSA patient in order to improve CPAP usage.

Official Title
-----------------
The Efficacy of a Brief Motivational Enhancement Education Programme on Continuous Positive Airway Pressure Adherence in Obstructive Sleep Apnea: A Randomised Controlled Trial

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Behavioral: CPAP education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or over. Newly diagnosed of OSA and will be starting CPAP therapy Exclusion Criteria: Not suitable for CPAP therapy Previously received CPAP therapy Possesses restrictive and obstructive pulmonary diseases Possesses hypoventilation Under unstable health conditions pregnant History of psychiatric illness

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Standard care (SC)<br>Standard care | Behavioral: CPAP education<br>* Standard CPAP education plus an session and one telephone follow up<br>|
| Active Comparator: Extended education (ME+SC)<br>Motivational enhancement education + Standard care | Behavioral: CPAP education<br>* Standard CPAP education plus an session and one telephone follow up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP usage | To examine the efficacy of an education programme in enhancing the adherence of using CPAP. | 12-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime Sleepiness | To examine the efficacy of an education programme in enhancing the improvement in OSA-related health outcomes | 12-week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Continuous Positive Airway Pressure treatment, Adherence, Education