linjc16/ctgov huggingface dataset:
A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.

Official Title
-----------------
An Open, 3-cohort, Phase II Trial Testing Oral Administration of Lucitanib in Patients With FGFR1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: lucitanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed breast adenocarcinoma. Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample. Prior first-line systemic therapy in the metastatic setting. Demonstrated progression of disease by radiological or clinical assessment. Female patient, aged ≥18 years old. Estimated life expectancy >3 months. Normal Left ventricular function Adequate haematological, hepatic and renal functions. For women with childbearing potential, a negative pregnancy test prior to initiation of the study drug and willingness to use an effective contraception. Ability to swallow oral capsules or tablets. Exclusion Criteria: More than two lines of chemotherapy with or without targeted therapy in the metastatic setting. Previous treatment with bevacizumab within 3 months of first dose of Investigational Medicinal Product. Active central nervous system metastases, cerebral oedema, and/or progressive growth. Patients with impaired cardiac function. Uncontrolled arterial hypertension Patients with history of thrombotic disorders or hereditary risk factors of thromboembolic events Serum potassium level below Lower Limit of Normal Uncontrolled hypothyroidism. Pregnant or breastfeeding women.

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: lucitanib<br>Hard gelatine capsules of 2,5, 5 and 10 mg or film coated tablets of 5 and 7,5 mg. 5 to 10 mg orally on a daily basis until unacceptable toxicity according to the investigator, disease progression or withdrawal of consent | Drug: lucitanib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Tumor evaluation every 8 weeks throughout the study | Every 8 weeks |
Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective study was to assess the different outcomes of early (performed on the patient's first admission for acute cholecystitis) and delayed cholecystectomy (done on a second admission) at King Abdulaziz University Hospital in Jeddah, Saudi Arabia.

Detailed Description
-----------------
This study was conducted retrospectively through reviewing patients medical records

Official Title
-----------------
Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital

Conditions
-----------------
Acute Cholecystitis

Intervention / Treatment
-----------------
* Procedure: Cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients who presented to the Emergency Department of KAUH with an acute cholecystitis Exclusion Criteria: Patients with no acute cholecystitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| First Admission<br>Cholecystectomy during first admission | Procedure: Cholecystectomy<br>* Cholecystectomy (removal of the gallbladder) for acute cholecystitis<br>|
| Second Admission<br>Cholecystectomy during second admission | Procedure: Cholecystectomy<br>* Cholecystectomy (removal of the gallbladder) for acute cholecystitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of surgery | Laparoscopic cholecystectomy or Laparoscopic cholecystectomy converted to open | Intraoperative (during surgery) - surgery takes an hour on an average | 
| Blood Transfusion need | Yes No | Intraoperative (during surgery) - surgery takes an hour on an average | 
| ICU admission: | Yes No | Post operation after surgery immediately | 
| Duration of Surgery | How many minutes did the surgery take (range) | minutes intraoperative (surgery takes 1 hour on an average) | 
| Time to operation room (hours) | How many hours from admission to surgery | hours pre surgery | 
| Length of stay after surgery | How many days did patients stay after surgery (range) | Days ( usually 2 days on an average ) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute cholecystitis, Cholecystectomy, overweight, BMI, early, delayed
The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the connection between gait variability parameters and balance performance in children with physical disability

Detailed Description
-----------------
Step length and step time variability will be measured with an electronic walkway, strength of 4 lower-extremity muscle groups will be tested bilaterally with a hand held dynamometer, walking performance as will be assessed by the 2 minute walk test, energy expenditure index (EEI) and rating of perceived exertion (OMNI scale).

Official Title
-----------------
The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability

Conditions
-----------------
Brain Injury, Cerebral Palsy

Intervention / Treatment
-----------------
* Other: walking and balance performance evaluation
* Procedure: muscle strength, walking and balance performance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3 years of age and older Ambulate, with or without an aid - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>TD | Other: walking and balance performance evaluation<br> <br> Procedure: muscle strength, walking and balance performance<br>* HHD- muscle strength, Balance performance - TUG, FRT, Walking performance- gaiterite and 2 min walk test<br>|
| Experimental: 2<br>TBI | Other: walking and balance performance evaluation<br> <br> Procedure: muscle strength, walking and balance performance<br>* HHD- muscle strength, Balance performance - TUG, FRT, Walking performance- gaiterite and 2 min walk test<br>|
| Experimental: a<br>Cerebral palsy | Other: walking and balance performance evaluation<br> <br> Procedure: muscle strength, walking and balance performance<br>* HHD- muscle strength, Balance performance - TUG, FRT, Walking performance- gaiterite and 2 min walk test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Influence of Intruding Angle on Non-graft Osteotome Sinus Elevation

Study Overview
=================
Brief Summary
-----------------
The contour of maxillary sinus matters in osteotome sinus elevation. So does the implant intruding angle between the axis of the implant and the tangent line of the sinus floor contour. The investigators have been engaged in studying the relationship between the outcome of bone formation and the intruding angle, which could guide our clinical decision-making.

Official Title
-----------------
Influence of Implant Intruding Angle on Osteotome Sinus Elevation Without Grafting

Conditions
-----------------
Partial-edentulism, Osteotome Sinus Lift

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with residual bone height >4mm and osteotome sinus elevation together with simultaneous implant placement without grafting Exclusion Criteria: Smokers or patients with systemic disease.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| concave group<br>the group whose level of sinus floor is lower than both of the adjacent teeth | |
| angle group<br>the group whose level of sinus floor is lower than one of the adjacent teeth and higher than the other one of the adjacent teeth | |
| flat group<br>the group whose level of sinus floor is similar to both of the adjacent teeth | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endosinus bone change | endosinus bone change after osteotome sinus elevation without grafting | from the time of performing the implanting surgery to the latest recalling period, accessed up to 100 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteotome sinus lift, endosinus bone gain, sinus floor configuration, intruding angle
The Effect of Fat Mass, Fat-free Mass and Resting Metabolic Rate on Energy Intake

Study Overview
=================
Brief Summary
-----------------
The present study was based on secondary analysis using the non-intervention control conditions of five separate studies with common measures. The current analysis examine the indirect and direct effects of fat-free mass, fat mass and resting metabolic rate on energy intake in individuals at or close to energy balance.

Detailed Description
-----------------
The current analysis examine the indirect and direct effects of fat-free mass, fat mass and resting metabolic rate on energy intake in individuals at or close to energy balance. The present study was based on secondary analysis using the non-intervention control conditions of five separate studies conducted between the dates of 1998 and 2007. In total, 242 subjects (114 males; 128 females; mean body mass index = 25.6 ± 5.0 kg/m2) were included. In these studies, body composition (air displacement plethysmography), energy expenditure (indirect calorimetry and flex heart rate) and energy intake (weighed dietary records) were measured using common procedures.

Official Title
-----------------
Biological and Psychological Mediators of the Relationships Between Fat Mass, Fat-free Mass and Energy Intake

Conditions
-----------------
Appetitive Behavior

Intervention / Treatment
-----------------
* Behavioral: Dietary energy restriction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight stable (weight change of <2 kg in the previous three months) Non smoker Not dieting, No history of eating disorders, Free from disease Exclusion Criteria: Taking medication known to effect metabolism or appetite Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The baseline non-intervention control arm only used in the present secondary data analysis
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Habitual dietary intake<br>Habitual dietary intake | |
| Experimental: Energy Restriction<br>Match period (to comparator) of dietary energy restriction | Behavioral: Dietary energy restriction<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy Intake- weighed dietary record method | Cross-sectional measurement of energy intake taken at baseline using the weighed dietary record method | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appetite, Energy Intake, Body Composition, Energy Expenditure
Observational Study to Assess the Frequency of Lidocaine Ineffectiveness in Hard-to-treat ADHD

Study Overview
=================
Brief Summary
-----------------
This work will assess the prevalence in hard-to-treat ADHD of the ineffectiveness of the anesthetic Lidocaine.

Detailed Description
-----------------
Using a non-invasive, pain-free, taste-based approach to assess lidocaine effectiveness, the study will assess the frequency of ineffectiveness in the target population.

Official Title
-----------------
Prevalence of Lidocaine Ineffectiveness in Those With Hard-to-treat ADHD

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: Lidocaine gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADHD Exclusion Criteria for both arms: known adverse reactions to lidocaine epilepsy, IQ <80, severe head trauma, birth weight <2270 grams, and severe autism; treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers; generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness); mouth sores; Ehlers Danlos syndrome, and red hair.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Using a taste-based test before and after the application of lidocaine gel to the tongue, we will assess the degree to which lidocaine is effective at blocking taste in those with hard-to-treat ADHD
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Observational study of prevalence in hard-to-treat ADHD<br>Subjects will be tested with lidocaine gel. | Drug: Lidocaine gel<br>* Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg<br>* Other names: Intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD | Subjects will be asked to identify each taste and its intensity. | on day of testing, approximately 30 minutes for clinic visit |
Changes in High Sensitive C Reactive Protien With Different Treatment Modalities in Acute Pancreatitis

Study Overview
=================
Brief Summary
-----------------
changes in high sensitive C reactive protien with different treatment modalities in acute pancreatitis

Official Title
-----------------
Changes in High Sensitive C Reactive Protien With Different Treatment Modalities in Acute Pancreatitis

Conditions
-----------------
Pancreatitis, Acute

Intervention / Treatment
-----------------
* Diagnostic Test: High sesitive C reactive protien


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>=18 years Diagnosis of acute pancreatitis confirmed by at least 2 of the following: Typical epigastric abdominal pain Elevation amylase/lipase >3 times upper limit normal and/or Confirmatory findings on cross-sectional imaging Enrollment within 8 hours of presentation Exclusion Criteria: Class II or greater NYHA heart failure Oxygen dependent COPD Chronic kidney disease>stage 2 Existing necrosis on abdominal CT Organ dysfunction prior to enrollment Sepsis Acute respiratory distress syndrome Malignancy not in remission for at least 5 years Active drug use Known allergy to dexamethasone Altered mental status Insulin-requiring diabetes Abdominal surgery within 60days

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with acute pancreatitis<br>All patients will recive different lines of treatment {saline,antibiotics,dexamethasone} | Diagnostic Test: High sesitive C reactive protien<br>* High sesitive C reactive protien will be evaluated at admission time and after 36 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High sesitive C reactive protien | Level of High sesitive C reactive protien expected to be changed with different lines of treatment and will be compaered | 72hours | 
| Serum Amylase | Level of Serum Amylase expected to be changed with different lines of treatment and will be compaered | 72hours | 
| Serum Lipase | Level of Serum Lipase expected to be changed with different lines of treatment and will be compaered | 72hours |
Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States

Study Overview
=================
Brief Summary
-----------------
This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations.

Detailed Description
-----------------
This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations. Treatment with carbidopa/levodopa/entacapone will be compared with treatment with standard formulation levodopa/carbidopa.

Official Title
-----------------
Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: carbidopa, levodopa, entacapone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of idiopathic Parkinson's disease exhibiting at least 2 or 3 symptoms Motor functions must be regarded as non-disabling by the patient Exclusion Criteria: History, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism History of dyskinesia Previous or current use of entacapone or tolcapone Unstable Parkinson's disease patients requiring/receiving regimens of levodopa Subjects taking levodopa/DDCI controlled release or extended release formulations

Ages Eligible for Study
-----------------
Minimum Age: 30 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

| Intervention/Treatment |
| --- |
|Drug: carbidopa, levodopa, entacapone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom control change from baseline |  |  | 
| Change from baseline in number of wearing-off symptoms |  |  | 
| Change from baseline in proportion of patients experiencing wearing-off |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, levodopa, motor fluctuations