linjc16/ctgov huggingface dataset:
Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients

Study Overview
=================
Brief Summary
-----------------
Moderate and severe asthma bronchiale is treated by fixed combination (budesonide/formoterol or salmeterol/fluticasone) in the Czech Republic. There is a hypothesis that doctors should prescribe to each patients per year: six units of fixed combination budesonide/formoterol, or seven units of fixed combination budesonide/formoterol in approach SMART, or twelve units of fixed combination salmeterol/fluticasone. With regard to current prices the treatment by fixed combination budesonide/formoterol should cost less. The investigators do not have any data about real life utilization of fixed combination in asthma treatment in Czech Republic The investigators propose to conduct a non-interventional multicentric retrospective epidemiological study looking into the patients records kept by specialist - allergists and pulmologists. Retrospective data for eligible patients will be reviewed by participating investigators, physicians taking care of their patients, and recorded in the electronic CRF. Only patients who have been treated for asthma bronchiale (classification of severity - moderate or severe persistent asthma) with fixed combination for at least one year could be included into the study. There are no scheduled visits for any patient participating in the study.

Official Title
-----------------
Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients in Real Life Condition in Czech Republic (UFO)

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 6 years or over Asthma bronchiale, classification of severity - moderate or severe persistent Documented fixed combination (budesonide/formoterol or salmeterol/fluticasone) therapy for at least 18 months

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- | --- |
| Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma severity in patients treated with fixed combination |  | 1 year | 
| Strength/dose of prescribed fixed combination |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma bronchiale, fixed combination
Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to assess the impact on response to Herceptin-based therapy in patients with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in Herceptin sensitivity. Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET, IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN, KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.

Official Title
-----------------
Observational Study Assessing Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

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

Intervention / Treatment
-----------------
* Genetic: Gene mutation analyses and FISH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hystological diagnosis of breast cancer Availability of tumor tissue Availability to assess the response to Trastuzumab according to RECIST criteria Availability of clinical data Exclusion Criteria: Unavailability of tumor tissue Impossibility to assess the response to Trastuzumab according to RECIST criteria

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 |
| --- | --- |
| Observation<br>Breast cancer patients treated with Herceptin-based therapy | Genetic: Gene mutation analyses and FISH<br>* FISH and mutation analyses of multiple genes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of a specific biomarker with response to Herceptin-based therapy |  | Response after two months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of a specific biomarker with time to progression survival and patient's characteristics |  | At the end of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR, HER-2, HER-3, MET, KRAS
The Prognostic Value of Human Papilloma Virus in Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
It is well established that HPV infection has a casual and is a prognostic factor in several cancer types, including oropharynx. We wish to examine if HPV infection has a prognostic significance in nasopharyngeal carcinoma.

Official Title
-----------------
The Prognostic Value of Human Papilloma Virus in Nasopharyngeal Carcinoma

Conditions
-----------------
Nasopharyngeal Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nasopharyngeal carcinoma patients treated in our institute between 2008-2018 Exclusion Criteria: missing clinical data 2nd Head and neck primary cancer very locally advanced or distant metastatic nasopharyngeal carcinoma Prior radiation therapy to the head and neck region
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 |
| --- | --- | --- |
| Overall survival |  | 6 months |
Sedation Versus No Sedation for Detection Rates of Precancerous Lesions and Cancer

Study Overview
=================
Brief Summary
-----------------
The influence of sedation on the endoscopic detection rate of the precancerous lesions and cancer of upper digestive system has not been assessed. In the daily medical routine of China, patients have the right to choose the sedation style according to his or her own situation, whose detailed endoscopic data of patients are recorded in the endoscopy quality control system. The aim of this research is to detect whether the use of sedation can help improve detection rate of precancerous lesions and cancer of upper digestive system.

Detailed Description
-----------------
The influence of sedation on the endoscopic detection rate of the precancerous lesions and cancer of upper digestive system has not been assessed. In the daily medical routine of China, patients have the right to choose the sedation style according to his or her own situation, whose detailed endoscopic data of patients are recorded in the endoscopy quality control system. The aim of this research is to detect whether the use of sedation can help improve detection rate of precancerous lesions and cancer of upper digestive system.

Official Title
-----------------
Sedation Versus No Sedation for Diagnostic Esophagogastroduodenoscopies and Detection Rates of Precancerous Lesions and Cancer: a Case-control Study

Conditions
-----------------
Early Detection of Cancer

Intervention / Treatment
-----------------
* Other: Sedation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged more than 18 years with or without GI symptoms attending for endoscopy from 2012 to 2019. Exclusion Criteria: Patients unable to cooperated the endoscopy or unable to complete it. People with endoscopy contraindications are naturally excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| No sedation<br>The group of patients who did endoscopies without sedation. | |
| Sedation<br>The group of patients who did endoscopies with sedation. | Other: Sedation<br>* The group of patients who did endoscopies with or without sedation. (This is a choice of themselves)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of precancerous lesions and cancer of upper digestive system improvement | Detection rate of precancerous lesions and cancer of upper digestive system improvement | 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early Detection of cancer, Gastrointestinal Neoplasms, Endoscopy, Gastrointestinal
Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine, guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough treatment.

Detailed Description
-----------------
STUDY DESIGN Open-label, superiority, prospective, parallel group, intent to treat trial Experiment duration: 7 days 3 visits (days 1, 2 and 7) Reduction cough symptoms Adverse events evaluation

Official Title
-----------------
Multicentric, Randomized, Open-label Trial to Evaluate the Superiority of Fixed Dose Combination of Oxomemazine, Guaifenesin and Potassium Iodate to Guaifenesin Monotherapy in Acute Cough Treatment

Conditions
-----------------
Cough

Intervention / Treatment
-----------------
* Drug: Syrup of oxomemazine, guaifenesin and potassium iodate
* Drug: Syrup of guaifenesin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be able to understand the study procedures agree to participate and give written consent. Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day. Cough score superior to 3. Exclusion Criteria: Pregnancy or risk of pregnancy. Lactation. Fever above 38º C. Patients with bacterial infections of the upper respiratory tract. Any pathology or past medical condition that can interfere with this protocol.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DRUG 1<br>Syrup of oxomemazine, guaifenesin and potassium iodate | Drug: Syrup of oxomemazine, guaifenesin and potassium iodate<br>* 5ml each 4 hours<br>|
| Active Comparator: DRUG 2<br>Syrup of guaifenesin | Drug: Syrup of guaifenesin<br>* 5ml each 4 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction/improvement of cough symptoms | The reduction of cough symptoms will be evaluated by comparative score index basal and final score | DAY 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance | Adverse events will be collected and followed in order to evaluate safety and tolerability | DAY 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cough, symptoms, cold, flu
The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.

Detailed Description
-----------------
The controlled clinical trial held in NTUH in 2001 revealed that the bioavailability of tacrolimus when combined with sirolimus is lower than that reported in the literature where tacrolimus was not combined with sirolimus. To determine if the difference was due to the drug interaction between sirolimus and tacrolimus, a controlled clinical trial was proposed. The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.

Official Title
-----------------
The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: sirolimus, tacrolimus, mycophenolate mofetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: De novo kidney transplant patients Aged 13 - 65 years Having aminotransferase concentrations within 2 times the upper limit of normal Exclusion Criteria: Pregnancy Tuberculosis Hepatitis B or C carrier status Human immunodeficiency virus-positive status Retransplantation or multi-organ transplantation History of rheumatoid arthritis

Ages Eligible for Study
-----------------
Minimum Age: 13 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sirolimus, tacrolimus, mycophenolate mofetil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tacrolimus, Sirolimus, Mycophenolic acid, Immunosuppressive Agents, Immunosuppression, Kidney Transplantation, Transplantation
Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors

Study Overview
=================
Brief Summary
-----------------
To evaluate the use of unrelated donors for hematopoietic cell transplantation in the treatment of hematologic and lymphoid malignancies.

Detailed Description
-----------------
Stem Cell Transplantation from Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY). To administer high dose radio-chemotherapy followed by stem cell transplantation from a matched unrelated donor or a partially matched related donor.

Official Title
-----------------
Stem Cell Transplantation From Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY)

Conditions
-----------------
Blood Cancer, Blood and Marrow Transplant (BMT)

Intervention / Treatment
-----------------
* Procedure: ablative allogeneic hematopoietic cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- acute leukemia chronic leukemia lymphoblastic lymphoma MDS MPS Exclusion Criteria:- organ dysfunction HIV positive

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 50 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

| Intervention/Treatment |
| --- |
|Procedure: ablative allogeneic hematopoietic cell transplantation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  |  | 
| Event Free Survival |  |  |
Standard Follow-Up Program (SFP) for Patients With Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
Motive: In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from esophageal cancer patients. Goal: To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life. A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

Official Title
-----------------
Standard Follow-up Program (SFP) for Esophageal Cancer Patients Treated With Radiotherapy or Chemoradiation

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with esophageal cancer Patients receiving a radiotherapy dose > 40 Gy Exclusion Criteria: Failure to comply with any of the inclusion 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity |  | Highest during and within 2 weeks after last day of radiation therapy | 
| Late toxicity |  | Highest within one year after last day of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | At 1,2,3,4 and 5 years after first day of radiation therapy | 
| Loco-regional tumor control |  | At 1,2,3,4 and 5 years after first day of radiation therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute toxicity, Late toxicity, Prediction models
Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the relation between the vascularity of uterine septum and obstetric performance with Transvaginal 3D Power Doppler Ultrasound

Detailed Description
-----------------
Research hypothesis: In women with uterine septum vascularity of the septum may affect obstetric performance. Research question: In women with uterine septum does vascularity of the septum affect obstetric outcome?

Official Title
-----------------
Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound

Conditions
-----------------
Septum; Uterus

Intervention / Treatment
-----------------
* Diagnostic Test: Transvaginal 3D Power Doppler Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with septate uterus diagnosed by office hysteroscopy Exclusion Criteria: Women with previous uterine scar. Women with suspected or confirmed pregnancy. Women with active pelvic infection or old one. Women with abnormal uterine bleeding. Fibroids, adenomyosis or ovarian swelling.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Transvaginal 3D Power Doppler Ultrasound|Samsung H60 ultrasound machine with 4-9 MHz volume transducer using VOCAL system and Histogram Facility|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium | Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium and its relationship to either primary infertility or recurrent abortion | About 18 months |