linjc16/ctgov huggingface dataset:
Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions

Study Overview
=================
Brief Summary
-----------------
In 12 patients with corticalization and hypertrophic pseudarthrosis were present after dynamization, the old nail was removed and nail exchange was performed with a longer and larger diameter nail to pass the region formed in the cortex approximately 2-3cm inferior from the old nail.

Detailed Description
-----------------
Corticalization is cortex-like sclerosis in the distal of the nail and it may indicate the early sign of dynamization treatment failure in hypertrophic nonunion after femoral transverse diaphyseal fractures. When corticalization is seen during follow-up after dynamization is performed because of non-union of a femoral transverse fracture, nail exchange should be performed without further delay. More rigid fixation should be applied with a longer and thicker nail crossing the area of corticalization.

Official Title
-----------------
Sclerotic Bone Formation (Corticalisation) on the Intramedullar Nail Tip in Hypertrophic Non-union Developing After Femoral Transverse Diaphyseal Fractures

Conditions
-----------------
Pseudoarthrosis of Bone, Implant Breakage

Intervention / Treatment
-----------------
* Procedure: exchange nailing with larger, thicker nail crossing corticalization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subtrochanteric fractures Nonunion with Pain Exclusion Criteria: Infection Pathological Fracture (Tumor)

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 49 Years

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

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

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 |
| --- | --- |
| Other: hypertrophic non-union developing after femoral transverse diaphyseal fractures<br> | Procedure: exchange nailing with larger, thicker nail crossing corticalization<br>* exchange nailing with larger, thicker nail crossing corticalization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provide Bone Union | Achievement of bone union with detecting callus formation on radiography after passing the region of corticalisation with a longer and thicker nail | 6 months | 
| Relieving pain in the nonunion area | Detection of reduction of pain scores in the nonunion area and enabling patients to load on the extremity in the early period postoperatively | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertrophic pseudarthrosis, dynamization, corticalisation
Vasoactive Hormones and Oxygen Saturation During Apneic Events in Patients With Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The mechanisms involved in development and maintenance of hypertension in obstructive sleep apnea are not clarified. We hypothesize that patients with obstructive sleep apnea have an abnormal level of some vasoactive hormones during apneic events during sleep.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with Obstructive sleep apnea Inclusion Criteria: Severe obstructive sleep apnea (apnea-hypopnea index > 30) Exclusion Criteria: Drug or alcohol abuse Pregnancy History or clinical signs of disease in the heart, lungs, brain, liver, kidneys or endocrine organs Diabetes Healthy Controls Inclusion Criteria: Apnea-hypopnea index < 10 Exclusion criteria: Drug or alcohol abuse Pregnancy History or clinical signs of disease in the heart, lungs, brain, liver, kidneys or endocrine organs Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renin, Noradrenalin, Endothelin-1, Angiotensin II, Arginine vasopressin, Aldosterone, Atrial natriuretic peptide, Brain natriuretic peptide, Blood pressure, Apnea
Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC

Official Title
-----------------
A Phase II, Multicentre, Non-Comparative, Open-Label Study To Evaluate The Efficacy And Tolerability Of ZD1839 (Iressa™) In Asymptomatic Radio-Naive Patients With Brain Metastases From Non-Small Cell Lung Carcinoma (NSCLC) Who Have Relapsed Following Prior Chemotherapy

Conditions
-----------------
Brain Neoplasms, Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Iressa (Gefitinib)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radiologically confirmed brain metastases from Non Small Cell Lung Cancer No symptoms due to brain metastases No previous radiotherapy treatment for the Brain metastases Exclusion Criteria: No prior chemotherapy No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iressa (Gefitinib)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate (complete response, partial response and stable disease) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response |  |  | 
| Time to progression |  |  | 
| Overall Survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non symptomatic brain metastases, Iressa
Observational Study of Lamotrigine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess efficacy, safety and tolerability of lamotrigine as used in a natural clinical setting, to examine the positive effects of lamotrigine, and the reasons why some patients choose to continue or discontinue lamotrigine.

Detailed Description
-----------------
There have been numerous randomized, double-blind controlled trials demonstrating the value of lamotrigine in the treatment of seizures. However, randomized trials take place in artificial experimental conditions with many restrictions imposed. There hasn't been much focus on positive effects on the patient, such as improvement in mood and level of alertness related to the drug. Other factors related to quality of life that affect the decision to continue or discontinue the drug are also important. Anecdotal experience suggests that lamotrigine is associated with increased alertness, enhanced energy levels and improved general sense of well-being. Observational studies that promote awareness of such distinguishing features and other aspects of efficacy are essential for guiding decision-making when prescribing anti-epileptic drugs.

Official Title
-----------------
Observational Study of Lamotrigine

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are about to be prescribed lamotrigine as an appropriate treatment for their epileptic disorder Exclusion Criteria: Patients with mental retardation

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Quality of life
Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines

Study Overview
=================
Brief Summary
-----------------
This study to assess aesthetic improvement following treatment with QM1114-DP.

Detailed Description
-----------------
This is an open-label, single-center multi-center study to assess aesthetic improvement in the Glabellar and Lateral Canthal regions following treatment with QM1114-DP.

Official Title
-----------------
Open-label Study to Assess Aesthetic Improvement Following Treatment With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines

Conditions
-----------------
Glabellar Frown Lines, Canthal Lines

Intervention / Treatment
-----------------
* Biological: QM1114-DP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female 18 years or older Moderate to severe bilaterally symmetrical LCL as assessed by the investigator Moderate to severe GL at maximum frown as assessed by the Investigator Exclusion Criteria: Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment Female who is pregnant, breast feeding or intends to conceive a child during the study. Known allergy to hypersensitivity or any component of the Investigational product

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open Label single site study for treatment of GL and LCL with single treatment of QM1114-DP
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QM1114-DP<br>QM1114-DP | Biological: QM1114-DP<br>* QM1114-DP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum frown at Month 1 | Responder Rate is defined as a subject who responds at least Improved on the GAIS at maximum frown | 1 month | 
| Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum smile at Month 1 | Responder Rate is defined as a subject who responds at least Improved on the GAIS at maximum smile | 1 month |
Influence of an Inverse Pressure Ramp in Long-term Non-invasive Ventilation on Dyspnea in the Morning After Therapy

Study Overview
=================
Brief Summary
-----------------
Patients being treated with non-invasive home mechanical ventilation (NIV) may experience morning dyspnea after each night of NIV use, when the therapy is abruptly ended. This study aims to show that dyspnea intensity can be significantly reduced by a gentle NIV therapy end, delivered by a continuously decreasing pressure level (inverse pressure ramp) after therapy end in the morning, a feature called softSTOPP, which can configured in prismaVENT NIV devices. This could also improve therapy adherence.

Official Title
-----------------
Einfluss Einer Inversen Druckrampe Bei Der Langzeit-Therapie Mit Nicht-invasiver Ventilation Auf Dyspnoe am Morgen Nach Therapie-Ende. Influence of an Inverse Pressure Ramp in the Long-term Therapy Mit Non-invasive Ventilation on Dyspnea in the Morning After Therapy.

Conditions
-----------------
Noninvasive Ventilation, Dyspnea

Intervention / Treatment
-----------------
* Other: softSTOPP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Diagnosis of a chronic obstructive pulmonary disease (COPD) with chronic hypercapnic insufficiency Therapy with prismaVENT 30, firmware V 3.3 or higher, mode S/T, stable device settings at the time of inclusion without need to adapt ventilation parameters May have co-existing obstructive sleep apnea syndrome Subjective dyspnea ≥3 (Borg scale) after end of ventilation therapy in the morning Written informed consent for study participation including data protection Exclusion Criteria: Missing written informed consent for study participation including data protection Contraindication for positive airway pressure therapy Use of the softSTOPP feature before study inclusion Participation in another study, which influences NIV therapy by defining device settings or titration Concomitant oxygen therapy

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 |
| --- | --- |
| Active Comparator: softSTOPP active<br> | Other: softSTOPP<br>* Non-invasive ventilation device setting in prismaVENT 30 device enabling an inverse pressure ramp after therapy end<br>|
| No Intervention: softSTOPP inactive<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of dyspnea level from baseline to 12 weeks | Delta value of morning dyspnea from baseline to 12 weeks as measured by the Borg Scale. The Borg Scale ranges from 0 (no perceived dyspnea at all) to 10 (maximum perceived dyspnea). | 12 weeks |
Lean Body Mass and Side Effects in Patients With Lymphoma

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to investigate the relationship between the dose of chemotherapeutic agents per kilogram of lean body mass (LBM) and the development of side effects induced by chemotherapy in patients with lymphoma. Secondarily, the maximum tolerable dose of chemotherapeutics (MTD), patients' quality of life (QOL), nutritional status and physical activity during the course of treatment are estimated.

Official Title
-----------------
The Relation Between Lean Body Mass and Side Effects Induced by Chemotherapy in Patients With Lymphoma: A Prospective Cohort Study

Conditions
-----------------
Malignant Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving myelosuppressive treatment for malignant lymphoma assessed by the investigator. Legal of age Exclusion Criteria: ECOG Performance Status ≥2 People who cannot speak and understand Danish Pregnant and breastfeeding Dementia

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 |
| --- | --- |
| Malignant lymphoma patients<br>Identification of the patients who are/are not dose-reduced due to chemotherapy, and then look at the body composition in connection with this. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean Body Mass (LBM) | LBM measured by bioelectrical impedans corelated to the dosis of chemotherapeutics given | 8 weeks (two treatment cycles) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal tolerable dose of chemotherapeutics (microg/ml/kg LBM), | Patients with side effects - correlation between dose of cytostatics/ kg LBM compared to patients without side effects | 8 weeks (two treatment cycles) | 
| Quality of life (QOL) (score EORTC) | Correlation of score and difference in LBM (kg) | 8 weeks (two treatment cycles) | 
| nutritional status at inclusion (NRS2002 - scale) | Predictive value of scale for ocurrence of side-effects (binary) | 8 weeks (two treatment cycles) | 
| physical activity (scale - questionaire) | Corelation between cytostatic dose/kg LBM and scale | 8 weeks (two treatmenr cycles) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lymphoma, body composition, lean body mass, chemotherapy, quality of life (QOL), nutritional status, physical activity
Anti-hyperglycemic Effect of Short-term Arginyl-fructose Supplementation in Subjects With Pre-diabetes and Newly Diagnosed Type 2 Diabetes: Randomized, Double-blinded, Placebo-controlled Trial.

Study Overview
=================
Brief Summary
-----------------
In this double-blind, placebo-controlled study, subjects with prediabetes and type 2 diabetes were randomly assigned to the placebo control group or the test (Arginyl-fructose: AF) group. We determined fasting serum levels of glucose, hemoglobin A1c (HbA1c), insulin, and free fatty acids (FFAs), were measured by 2-h oral glucose tolerance tests (OGTTs) at baseline and after the 6-week intervention.

Conditions
-----------------
Pre-diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Arginyl-fructose
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All subjects are with prediabetes (IFG or IGT) or newly diagnosed type 2 DM (T2DM) no taking medicine. IFG was defined as fasting glucose between 100 and 125 mg/dL and IGT was defined as 2-h OGTTs glucose levels 140-199 mg/dL. Newly diagnosed type 2 diabetes was defined as fasting glucose ≥126 mg/dL or 2-h OGTTs level ≥ 200 mg/dL. Exclusion Criteria: - Exclusion criteria included 1) glucose lowering medications or insulin injections; 2) abnormal liver or renal function; 3) chronic stomach and intestines disease; 4) chronic alcoholism; 5) pregnancy or intending to become pregnant during time of study. 6) complications; 7) an occupation that could be dangerous if hypoglycemia should occur.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEST<br>Arginyl-fructose Supplementation | Dietary Supplement: Arginyl-fructose<br> <br> |
| Experimental: Placebo<br>Placebo Supplementation | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-h oral glucose tolerance tests (OGTTs |  | 6 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-hyperglycemic effect
Assessment of Urinary Diversions Outcomes Post Radical Cystectomy in Asyut University Urology Hospital

Study Overview
=================
Brief Summary
-----------------
Radical cystectomy (RC) for bladder cancer requires reconstruction of the lower urinary tract. Both continent and incontinent diversions are available for urinary reconstruction after RC. Types of urinary diversions include ( ileal conduit, uretero-cutaneous, ureterosigmoidostomy and orthotopic bladder) The decision process is complex and involves consideration of issues related to cancer stage, patient comorbidities, treatment needs, and patient desires related to Quality of life and intraoperative findings. Outcomes of urinary diversions include 1- survival rate (cancer specific or overall survival). 2- Oncological failure (local, distant or LNs). 3- Complications (perioperative, intraoperative or post-operative). In this study, all these outcomes will be analyzed.

Official Title
-----------------
Assessment of Urinary Diversions Outcomes Post Radical Cystectomy in Asyut University Urology Hospital

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Procedure: urinary diversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * All patients underwent radical cystectomy more than 1 year Exclusion Criteria: incomplete data patients underwent RC outside urology department and presented for treatment of complications.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: urinary diversion|follow up outcomes of urinary diversion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients presented by complications | such as (change from baseline of the SCR - urinary tract infections - stone formation - stricture at site of anastomosis or stromal stenosis ) | 1 year post operative | 
| Rate of patients developed recurrence | recurrence of cancer | 1 year post operative | 
| Survival rate (overall survival & cancer specific) | patient live post operative | 1 year post operative |