linjc16/ctgov huggingface dataset:
A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer Primary Purpose: response rate Secondary purpose: toxicity, progression-free survival, overall survival

Official Title
-----------------
A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Doxorubicin/Genexol-PM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older adult women Instrumentation measurable lesions with histologically confirmed advanced (recurrent or metastatic) breast cancer ECOG 0-2 Advanced breast cancer in the past, patients who did not receive chemotherapy Recurrence if adjuvant chemotherapy and adjuvant chemotherapy in the past for more than 6 months until the patient life expectancy more than 3 months Agree in writing before the party to participate in a clinical trial to patients Exclusion Criteria: immunohistochemical staining 3 + or FISH positive anti-HER 2 therapy patients Severe infections requiring antibiotic therapy Clinically significant heart disease Pregnant or lactating woman Uncontrolled symptoms in the central nervous system (CNS) metastases Patients diagnosed with malignant tumors of other organs

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: doxotubicin/Genexol-PM<br> | Drug: Doxorubicin/Genexol-PM<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with adverse events |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, doxorubicin, genexol-PM, paclitaxel
A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.

Study Overview
=================
Brief Summary
-----------------
To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.

Official Title
-----------------
An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Drug: Adempas (Riociguat, BAY63-2521)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Pulmonary Arterial Hypertension (PAH) participating or having participated in the Bayer-sponsored studies 12935, 16719 or 18588, who have completed the main study phase and are still being treated with riociguat (either while still being on treatment with the respective study drug or by commercial means with Adempas) and who, in the opinion of the investigator, are expected to continue to have an overall positive benefit/risk from continuing treatment. Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and 30 days after the last administration of study drug. Exclusion Criteria: Ongoing serious adverse event (SAE) from originating study that is assessed as related to riociguat Pregnant women or breast-feeding women Any contra-indication to Adempas treatment listed in the BAY63-2521 / Riociguat Investigators's Brochure Concomitant participation in another clinical study with the study drug Patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY63-2521<br>Single-arm, uncontrolled | Drug: Adempas (Riociguat, BAY63-2521)<br>* 0.5 to 2.5 mg in 0.5 mg increments (according to individual adapted optimal dose determined in originating study) administered three times daily (tid)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability |  | Up to approx. 3 years |
The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effect of a telerehabilitation approach to patients with Duchenne Muscular Dystrophy and evaluate patients' motor function, parents' anxiety and depression levels before and after the intervention

Official Title
-----------------
The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy

Conditions
-----------------
Duchenne Muscular Dystrophy

Intervention / Treatment
-----------------
* Other: Telerehabilitaton
* Other: Home exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Duchenne muscular dystrophy Exclusion Criteria: Patients without the ability of independent ambulation

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation<br> | Other: Telerehabilitaton<br>* Patients will receive telerehabilitation sessions that include strengthening, stretching and range of motion exercises<br>|
| Active Comparator: Home exercise<br> | Other: Home exercise<br>* Patients will be given a home-based exercise program without telerehabilitation supervision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick motor function test |  | 2 months |
CAREGIVER KNOWLEDGE AND EXPERIENCE OF CHEWING PROBLEM

Study Overview
=================
Brief Summary
-----------------
Chewing is the process of making the food taken into the mouth as a bolus with rhythmic, coordinated, and sequential movements. To normal chewing function oral and perioral sensory integrity; adequate lip closure and intraoral pressure; intraoral bolus transport; normal structure and coordination of lips, palate, tongue, jaw joint, chewing muscles should be ensured. Problems that occur in bolus formation starting from taking food into the mouth are called chewing problems. The underlying cause of the chewing problem can be very diverse. The chewing problem can be seen in genetic, neuromuscular, gastrointestinal pediatric diseases as well as cognitive, behavioral problems or in healthy children. Many different health professionals take part in the rehabilitation of the chewing problem, but the family is at the center of the rehabilitation. For this reason, the level of knowledge, experience, and approach of the family is very important. The aim of this study is to determine the swallowing-chewing problem knowledge levels, experiences and approaches of the caregivers of the child with chewing problems.

Official Title
-----------------
CAREGIVER KNOWLEDGE AND EXPERIENCE OF CHILDREN WITH CHEWING PROBLEMS

Conditions
-----------------
Caregiver Awareness, Chewing Problem

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being a primary caregiver of oral feding children, followed about chewing and swallowing problem more than 6 months Exclusion Criteria: Don't except participate to study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chewing awareness | A one-to-one interview will be held with the caregivers in a quiet room, accompanied by a voice recorder. During interview; caregivers perspective, experiences and knowledge of the child's chewing and swallowing problem will be ask. The interviews will continue for a minimum of 20 minutes until sufficient data is collected for thematic analysis. 15 participants will be included in the study. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chewing Function | Karaduman Chewing Performance Scale (KCPS) developed by developed by Arslan et al., chewing function is classified at 5 different levels between 0 - 4 (Level 0= normal chewing function, Level 4= The child cannot bite and chew). | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caregiver, awareness, experience, chewing problem
Register Kardialer Computertomographie

Study Overview
=================
Brief Summary
-----------------
The aim of this Heidelberg Cardiac CT Registry (Register kardiale Computertomographie) is to assess the diagnostic and prognostic perfomance of cardiac CT exminations in a real-world patient population.

Detailed Description
-----------------
Anthropometric data, medical history and results of the CT examinations are collected in a database in order to adressing various scientific questions.

Official Title
-----------------
Register Kardialer Computertomographie

Conditions
-----------------
Evaluation of CT in Coronary Artery Stenosis

Intervention / Treatment
-----------------
* Diagnostic Test: cardiac CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Subjects referred for cardiac CT examination by their physician Exclusion Criteria: • none
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: cardiac CT|The cardiac CT examinations are indicated by the referring physician. The participation in this study has no influence on the further diagnostic and therapeutic regimen.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coronary CT angiography | Evaluation of degree of coronary artery stenosis | 10 years | 
| coronary CT angiography | Assessment of coronary plaque composition | 10 years | 
| Agreement with other imaging modalities | Agreement with other imaging modalities | 10 years | 
| Occurence of MACE | Occurence of major adverse events | 10 years |
Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009g

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to assess the relationship (both crude and adjusted) between voriconazole utilization and the development of non-melanoma skin cancer among adult patients who received a lung or heart/lung transplant and were continuously enrolled in a large U.S. commercial health plan.

Detailed Description
-----------------
N/A. All patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database were sampled.

Official Title
-----------------
Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009

Conditions
-----------------
Non-Melanoma Skin Carcinoma

Intervention / Treatment
-----------------
* Drug: voriconazole (Vfend)
* Other: no voriconazole (Vfend)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database will be initially included in the study. Exclusion Criteria: Patients who are younger than 18 years of age and who are not enrolled for at least 180 days before and 180 days after the date of transplant will be excluded.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Any Voriconazole<br> | Drug: voriconazole (Vfend)<br>* Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.<br>* Other names: Vfend;|
| No Voriconazole<br> | Other: no voriconazole (Vfend)<br>* Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.<br>* Other names: Vfend;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC) |  | Baseline until non-melanoma skin cancer diagnosis, loss-to-follow-up due to death or termination of the health plan or end of the study, assessed up to Year 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
voriconazole, non-melanoma skin cancer, confounding, statistical adjustment, risk adjustment, lung transplant, heart/lung transplant, immunosuppression
The Use Of Growing Rods In Pediatric Long Bones Deformity Correction

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the value of growing rods for the correction of long bone deformities in pediatric cases attending Sohag University Hospital and follow up aiming at determining benefits and obstacles to this technique

Detailed Description
-----------------
The participants will be subjected to surgical correction using growing rods as a novel technique for their long bone deformities. Procedure will be done under anaesethia Osteotomy , fracture reduction , deformity correction will be done , then introduction of the growing rod

Official Title
-----------------
The Use Of Growing Rods In Pediatric Long Bones Deformity Correction

Conditions
-----------------
Deformity of Limb

Intervention / Treatment
-----------------
* Procedure: operative deformity correction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cases of osteogenesis imperfecta metabolic bone deformities cases of hemimelia traumatic bone deformities complex or simple deformities Exclusion Criteria: adult deformities short bone deformities very narrow medulla osteopetrosis

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: operative deformity correction|The participants will be subjected to surgical correction using growing rods as a novel technique for their long bone deformities. Procedure will be done under anaesethia Osteotomy , fracture reduction , deformity correction will be done , then introduction of the growing rod|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Use Of Growing Rods In Pediatric Long Bones Deformity Correction | - Evaluation of deformity angles correction after use of growing rods in comparison with preoperative angle | 2 years |
Evaluation of the Risk of VTE Among Patients Hospitalized in Non-surgical Departments

Study Overview
=================
Brief Summary
-----------------
Patients hospitalized in internal wards are at risk for VTE. The current guidelines recommend the use of thromboprophylaxis for 7-10 days among patients who are at increased risk for VTE. Yet several retrospective studies have shown that the compliance with this guideline is low. Physicians are often reluctant to administer LMWH to their fragile patients mainly because they are not convince that the risk associated with such therapy is greater than the risk for VTE. In the current study, data concerning the use of thromboprophylaxis among patients admitted to the medical wards will be collected. The occurrence of bleeding or thrombotic event will be evaluated prospectively.

Detailed Description
-----------------
Data concerning the use of LMWH among patients admitted to the medical wards at the Hadassah University Hospital will be collected prospectively from the electronic medical records. The occurrence of bleeding episodes or thrombotic events will be followed for the next 90 days following discharge from the hospital. The percent of patients actually treated by LMWH among patients entitled for such therapy according to the most updated international guidelines will be evaluated. The risk of minor and major bleeding will be compared among those given thromboprophylaxis and those who were not treated. Similar comparison will be made for thrombotic events.

Official Title
-----------------
The Risk for VTE Among Patients in the Medical Wards - Prospective Observational Study.

Conditions
-----------------
Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the medical wards at the Hadassah University Hospital Exclusion Criteria: None
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 |
| --- | --- | --- |
| Thrombosis | Rate of thrombotic events within 90 days following discharge | 90 days | 
| Bleeding | Rate of minor and major bleeding episodes within 90 days following discharge | 90 days | 
| Compliance | Rate of compliance with ACCP guidelines concerning thromboprophylaxis of non-surgical patients. | 90 days |
Early Renal Replacement Therapy in COVID 19 Patients With AKI Does it Improve the Outcome?

Study Overview
=================
Brief Summary
-----------------
patients will be divided into two equal groups, each group including 50 adult patients with a confirmed diagnosis of covid, patients with acute kidney injury, the first group will be treated with early hemodialysis, second group will be conservative until there is an urgent need for dialysis

Official Title
-----------------
Early Renal Replacement Therapy in COVID 19 Patients With AKI Improves the Prognosis of the Disease

Conditions
-----------------
Multi Organ Failure

Intervention / Treatment
-----------------
* Procedure: haemodialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (≥18 years old) with confirmed severe acute respiratory syndrome coronavirus 2 infections admitted to the ICU. Exclusion Criteria: •Malignancy. Immuno-deficiency diseases. Chronic diabetic, cardiac and hypertensive patients autoimmune diseases.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: covid positive with acute kidney injury receiving early renal replacement<br> | Procedure: haemodialysis<br>* continuous venovenous hemodiafiltration (CVVHDF) at a prescribed dose of 30-35 mL/kg/h of effluent and with regional citrate anticoagulation<br>|
| Experimental: covid positive with acute kidney injury under conservative management<br> | Procedure: haemodialysis<br>* continuous venovenous hemodiafiltration (CVVHDF) at a prescribed dose of 30-35 mL/kg/h of effluent and with regional citrate anticoagulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of Sequential Organ Failure Assessment Score | prevention of multi-organ failure associated with covid including respiratorym circulatory, liver and renal failure | 2 weeks |