linjc16/ctgov huggingface dataset:
Calf Muscle Strength and Standing Efficiency in Children With Spastic Diplegia

Study Overview
=================
Brief Summary
-----------------
It will be hypothesized that strengthening the calf muscles will improve standing efficiency in children with spastic diplegia.

Official Title
-----------------
CALF MUSCLE STRENGTH AND STANDING EFFICIENCY IN CHILDREN WITH SPASTIC DIPLEGIA: A RANDOMIZED CONTROLLED TRIAL

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Other: Strengthening exercise + Electrical stimulation of calf muscle
* Other: selected physical therapy program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children age will be ranging between 2 and 4 years. They are classified at level III by GMFCS-ER, i.e. they can stand with minimal support. Full mobile lower limbs joints. Children with mild and moderate spasticity ( i.e. grade 1 and 2, according to Modified Ashworth Scale). Exclusion Criteria: Children with severe spasticity ( i.e. grade 4, according to Modified Ashworth Scale). Fixed deformities. Uncontrolled seizures.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 4 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: calf muscle strengthenig group<br>experimental group will receive the same selected physical therapy program in addition to manual and mechanical strengthening exercises and electrical stimulation program for calf muscles of both lower limbs. | Other: Strengthening exercise + Electrical stimulation of calf muscle<br> <br> Other: selected physical therapy program<br> <br> |
| Other: No calf muscle strengthening group<br>control group will receive only the selected physical therapy program | Other: selected physical therapy program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Measure |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonography | To measure calf muscle thickness | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral palsy, standing, strengthening
Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy

Study Overview
=================
Brief Summary
-----------------
In the first part of the the study two new outcome measurements (force reproducibility and subacromial space) will be tested for reproducibility. Therefore 30 healthy people will be assessed. In a second part of the study 60 patients will be randomly allocated to two groups. Group A (n=30) will perform a traditional training program and group B (n=30) will perform an eccentric training program. Before the onset of the training programs, pain, function, maximal force, range of motion, subacromial space and force reproducibility will be assessed. Both training programs will be accomplished at home. The first six weeks there will be an appointment with the therapist once a week to explain, correct and when necessary, aggravate the exercises. The next six weeks these appointments will be diminished to once every two weeks. After 6 and after 12 weeks of training the patients will be reassessed for all the parameters.

Official Title
-----------------
Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy

Conditions
-----------------
Chronical Rotator Cuff Tendinopathy

Intervention / Treatment
-----------------
* Procedure: Eccentric training program
* Procedure: Traditional training program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: global tendon thinning inhomogeneous echo partitioning calcifications at the insertion symptoms present for at least 3 months: painful resisted isometric abduction, painful palpation of the supraspinatus tendon, impingement tests positive Exclusion Criteria: documented full thickness rotator cuff rupture other lesions than CRCT at the moment of the study echographic criteria for ruptures (focal thinning, fluid-filled gap,compressibility)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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: 1<br>Eccentric training program | Procedure: Eccentric training program<br>* Eccentric training program<br>|
| Active Comparator: 2<br>Traditional training program | Procedure: Traditional training program<br>* Traditional training program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum force, pain and function,range of motion, force reproduction, subacromial space |  | After 6 and after 12 weeks of training |
Analysis of Passive Leg Raise Test on Blood Pressure in Critically Ill Patients.

Study Overview
=================
Brief Summary
-----------------
Positioning intensive care patients in Trendelenburg position to identify fluid responsiveness assessed by PiCCO device.

Detailed Description
-----------------
It is a prospective observational study. Patients admitted to Intensive Care Unit of University Clinical Centre of Gdańsk, receiving advanced hemodynamic monitoring with PiCCO method will be enrolled. After blood pressure measurement, PiCCO will be calibrated with transpulmonary thermodilution with 10 - 20 ml of cold saline. Readings will be noted. The patient will be positioned in Trendelenburg position with it's head 15 degrees down. The increase of blood pressure after positioning in relation to the values obtained before the trial will be correlated to the parameters that asses patent's volaemia. After 5 minutes patient will be back to supine position and hemodynamic parameters will be recorded for another 5 minute.

Official Title
-----------------
Analysis of Passive Leg Raise Test on Blood Pressure in Critically Ill Patients.

Conditions
-----------------
Shock, Hypovolemia, Hemodynamic Instability

Intervention / Treatment
-----------------
* Diagnostic Test: Trendelenburg position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodynamic instability mechanical ventilation Exclusion Criteria: increased intracranial pressure increased intraabdominal pressure lower limbs sequential compression system agitation patients exposed to pain stimulus before the test aortic aneurysm left to right cardiac shunt severe valvular insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Trendelenburg position|Positioning the patient with head 15 degrees down|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of SVV with increase in blood pressure | Stroke volume variation (SVV) is a validated parameter that assess fluid responsiveness. In patients in whom SVV value is higher, theoretically Trendelenburg position will increase blood pressure in greater degree, than in patients in whom SVV is lower. We want to identify whether such correlation exist. | 10 minutes |
Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the clinical results of combining a pedicle connective palatal flap with a trapezoid buccal flap with the standard buccal flap alone in the closure of oro-antral fistula (OAF), and the buccal flap combined with leukocyte and platelet rich fibrin.

Official Title
-----------------
Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication

Conditions
-----------------
Oroantral Fistula

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible population among those older than 18 y.o, systemically healthy, with a diagnosis of OAC (OroAntral Communication), or with a strong pre-extractive radiographic suspicion of potential OAC, and associated symptoms (varying among cheek pain with nasal obstruction, purulent rhinorrhea, foul odor, foul taste, headaches, anterior maxillary tenderness, and postnasal drip) . Exclusion Criteria: i) received antibiotic therapy in the last 3 months ii) requiring anticoagulation therapy iii) had systemic diseases that could interfere with oral tissue healing process/bleeding iv) were using bisphosfonates v) were pregnant vi) had mental/physical disabilities vii) underwent radiation treatment to the head or neck region.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Buccal flap<br>The buccal flap is slid over the fistula and sutured to the undermined palatal mucosa using horizontal mattress sutures. | |
| Double-layer<br>A combination between a buccal trapezoidal flap and a palatal connective pedicle flap. | |
| Buccal flap with L-PRF<br>A L-PRF plug is interposed between the fistula and the buccal sliding flap. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure success | Measured with probing and Valsalva test | One month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported Pain | Pain on a VAS scale | Each week for one month |
COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH in Poland

Study Overview
=================
Brief Summary
-----------------
In the light of ONTARGET and TRANSCEND studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. It is well known and accepted that the Real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the organized and scheduled setting of the clinical trial. Because there are not much data on the cough in relation to telmisartan, therefore it would we worth to observe the cough frequency and general treatment tolerance in patients treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.

Official Title
-----------------
COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - hypertension age > 18 ACE-I related cough Exclusion Criteria: - Current treatment with telmisartan Cholestatic disorders and severe hepatic failure Allergy to telmisartan Pregnancy and lactation period

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 |
| --- | --- |
| Group 1<br> | Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)<br>* Patients treated with telmisartan tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough |  | 4 months after initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General tolerability and safety of telmisartan treatment among patients, who had to stop their previous ACE-I treatment due to cough |  | 4 months after initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cough, Telmisartan, Bradykinin, Tolerability
Study In Patients With Kidney Cancer Treated With Sutent

Study Overview
=================
Brief Summary
-----------------
Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.

Detailed Description
-----------------
Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy

Official Title
-----------------
Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With Sutent

Conditions
-----------------
Advanced or Metastatic Renal Cell Carcinoma, Renal Cancer

Intervention / Treatment
-----------------
* Drug: Sutent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy Exclusion Criteria: Hypersensitivity to sunitinib malate or to any of the excipients Any other contraindication to the use of sunitinib malate (based on decision of the treating physician).

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 |
| --- | --- |
| Patients treated with Sutent<br>125 consecutive patients in outpatient care with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy | Drug: Sutent<br>* 50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause<br>* Other names: sunitinib malate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose modifications |  | 36 months | 
| Incidence of new diagnosed hypertension |  | 36 months | 
| Incidence of new diagnosed hypothyroidism |  | 36 months | 
| Safety of sunitinib malate in real-life setting |  | 36 months | 
| Efficacy of sunitinib malate in real-life setting |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal cell carcinoma, sunitinib malate
E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe

Study Overview
=================
Brief Summary
-----------------
The primary objective is the collection of real-world data of cancer patients treated with radiotherapy, to support radiotherapy research and to provide evidence of the role of radiation oncology in a multidisciplinary approach. This is an open ended prospective non-interventional non-therapeutic multi-cohort study.

Official Title
-----------------
E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed cancer. Written informed consent for E²-RADIatE according to applicable legal and ethical requirements Planned use of radiotherapy Eligibility of the patient confirmed for at least one cohort confirmed Patients of 12 years and older

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OligoCare<br>Patients with oligometastatic disease treated with radical radiotherapy | |
| ReCare<br>Patients treated with high-dose Re-irradiation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients treated with radiotherapy enrolled in the program |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 5 years | 
| Loco-regional control |  | 5 years | 
| Distant metastasis free survival |  | 5 years | 
| Overall survival |  | 5 years | 
| Incidence of adverse events related to radiotherapy |  | 5 years |
Urdu Version of Lower Extremity Functional Scale: Reliability and Validity Study

Study Overview
=================
Brief Summary
-----------------
The objective of the research is to translate and to culturally familiarize the Lower extremity functional scale into the Urdu language along the investigation if the Lower Extremity Functional Scale is reliable and validate in the Pakistani population with Lower extremity musculoskeletal disorders and to check the correlation with Short Form - 36.

Detailed Description
-----------------
The questionnaire will be translated into Urdu and cross-culturally modified. Internal consistency, test-retest reliability, conceptual validity, discriminative validity, responsiveness, and concurrent validity will be examined in 150 participants seeking treatment for lower extremity dysfunction using the Urdu version of the Lower Extremity Functional Scale.

Official Title
-----------------
Psychometric Analysis of Urdu Version of Shoulder Pain and Disability Index: A Reliability and Validity Study

Conditions
-----------------
Musculoskeletal Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: From16 years Old to 60 Years Old Presence of an Lower extremity musculoskeletal disorders like soft tissue injuries, joints and muscles injuries No intervention between the test-retest assessments Exclusion Criteria: To complete the forms because of a psychological Impairment. Illiteracy or lack of understanding of Urdu Language The presence of any kind of bone fracture

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Lower Extremity Functional Scale | Lower Extremity Functional Scale is a valid and reliable instrument to determine the functional status for acute and chronic lower extremity musculoskeletal dysfunction due to the importance of evidence-based health care | 1st day | 
| Short Form-36 | Short Form-36 is one of the most widely used and evaluated generic health-related quality of life questionnaires. | 1st day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower Extremity Functional Scale, Musculoskeletal Disorder, Cultural adaptation, Validity, Urdu Version, Reliability, Lower Extremity
Health Status of Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2018)

Study Overview
=================
Brief Summary
-----------------
The overall project aim is to study outcomes following aortic valve replacement with either mechanical valves or bioprostheses by retrieving data from the main social security carriers in Austria for the years 2010-2018.

Detailed Description
-----------------
The purpose of this research project is to evaluate mortality (primary outcome) and incidence of heart attack, stroke, reoperation and first diagnosis of heart insufficiency (secondary outcomes) after aortic valve replacement. We aim to compare those outcomes between mechanical valves and bioprostheses. Data will be retrieved from the main social security carriers in Austria (covering 98% of its population) from 2010-2018.

Official Title
-----------------
Health Status of Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2018)

Conditions
-----------------
Aortic Valve Disease

Intervention / Treatment
-----------------
* Device: Aortic Valve Replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: isolated surgical aortic valve replacement in Austria Exclusion Criteria: below 18 years of age concomitant heart surgery

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 |
| --- | --- |
| Aortic valve replacement with mechanical valves<br> | Device: Aortic Valve Replacement<br>* Surgical replacement of aortic valves<br>|
| Aortic valve replacement with bioprostheses<br> | Device: Aortic Valve Replacement<br>* Surgical replacement of aortic valves<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | all cause mortality after aortic valve replacement | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reoperation | incidence of reoperation after aortic valve replacement | 8 years | 
| stroke | incidence of stroke after aortic valve replacement | 8 years | 
| heart attack | incidence of heart attack after aortic valve replacement | 8 years | 
| heart insufficiency | incidence of heart insufficiency after aortic valve replacement | 8 years |