linjc16/ctgov huggingface dataset:
Use of Ulna Length to Predict Tidal Volume in Adult Egyptians

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the ability of ulna length to predict accurate protective lung tidal volume in Egyptian people in reference to their standing height.

Detailed Description
-----------------
After approval of local ethical committee and informed consent, one hundred healthy volunteers will be rnrolled in this study. Height of each subject will be measured while standing upright against a wall. Then, the left ulna will be measured with a measure tape from the olecranon to mid point of styloid process. From ulna length, height is estimated as advised by Malnutrition Advisory Group, British Association of Parenteral and Enteral Nutrition. October 2008. Malnutrition Universal Screening Tool.Protective lung tidal volume is calculated as 6 ml/kg predicted body weight (PBW) as follow: PBW= 50*0.91 (centimetres of height - 152.4) in males and 45.5*0.91(centimetres of height - 152.4) in females. Each measurement will be performed only once for each subject. Agreement between measurements will be expressed by the Bland-Altman method.

Official Title
-----------------
Use of Ulna Length to Predict Protective Lung Tidal Volume in Adult Egyptians

Conditions
-----------------
Tidal Volume

Intervention / Treatment
-----------------
* Other: Measuring the ulna length using meauring tape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Healthy adult Egyptian Exclusion Criteria: - Deformity or previous surgery in the left arm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Measuring the ulna length using meauring tape|the left ulna will be measured with a measure tape from the olecranon to mid point of styloid process.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protective lung tidal volume |  | measurement of left ulna while standing for each volunteer throught the study completion, average 6 months |
Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate genetic mutations affecting prognosis using whole genome sequencing in patients with biliary tract cancer.

Detailed Description
-----------------
Recently, as genome technology such as next-generation sequencing has progressed, precision medicine using genetic analysis in lung cancer, colorectal cancer, and melanoma has been actively studied. The need for such precision medicine is also increasing in biliary tract cancer patients. Although whole genome sequencing is relatively costly, it is known to provide more accurate information than other methods such as exome analysis and RNA sequencing in identifying promoter mutations, regulatory regions, and structural variants. Pancreatic cancer and melanoma have been studied by whole genome sequencing, but there is no previous study using whole genome sequencing method in biliary tract cancer.

Official Title
-----------------
Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing

Conditions
-----------------
Biliary Tract Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Endoscopic retrograde cholangiopancreatogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with biliary tract cancer via endoscopic retrograde cholangiopancreatogram Exclusion Criteria: Pregnancy Other active tumors within 5 years Coagulopathy Severe mental illness

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 |
| --- |
|Diagnostic Test: Endoscopic retrograde cholangiopancreatogram|Biopsy specimens are attained via endoscopic retrograde cholangiopancreatogram in patients with suspicious biliary tract cancer.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate | Comparisons of overall survival rates between patients with gene mutations and without. | 48 months |
Deep Brain Stimulation for Treatment Resistant Depression

Study Overview
=================
Brief Summary
-----------------
This study will investigate the safety and efficacy of deep brain stimulation (DBS) in lateral habenula (LH) for patients with treatment-resistant depression.

Official Title
-----------------
Safety and Efficacy of Deep Brain Stimulation for Treatment Resistant Depression

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Device: Deep brain stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70, regardless of gender; Diagnostic And Statistical Manual Of Mental Disorders 5th Ed (DSM-V), for Psychiatrists' Examination of Severe Depressive Disorders; Same diagnostic conclusions based on DSM-V made by two independent psychiatrists; A minimum of 24 months of depressive history, over 2 or more adequate antidepressant trials with Hamilton Depression Rating Scale (HAMD) reduction rate ≤20% (including MECT) ; HAMD-17 scores ⩾ 20 at screening; Functional General Assessment Table (GAF) rating ≤50; Able to comply with the operational and administrative requirements of participation in the study, and able to give written informed consent. Exclusion Criteria: Patients with severe or unstable mental, liver, kidney, endocrine, hematological diseases, or those with psychotic co-morbidities, including personality disorders; History of substance abuse in the past 12 months; history of epilepsy, or febrile seizure in childhood; Patients who have attempted suicide within the past 6 months, or have had a secondary suicide attempt within the past 2 years; Women who are breastfeeding, pregnant, or intend to be pregnant during the clinical study; Any surgical contraindications to undergoing deep brain stimulation (DBS); Patients who cannot give full informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Deep brain stimulation|Electrical stimulation of lateral habenula|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale | Change in Hamilton Depression Rating Scale score from baseline to 52 weeks after surgery | 52 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deep brain stimulation, lateral habenula
Measurement of the Distance Between the Corresponding Anatomical Landmarks in the Thoracic Cavity and the Incisors

Study Overview
=================
Brief Summary
-----------------
Patients who agree to receive pneumonectomy will be arranged to measure the distance from the incisors to the corresponding anatomical landmarks, including the cardia, the inferior pulmonary vein, the carina, the azygos vein, the lower edge of the aortic arch, the upper edge of the aortic arch, and the cupula of pleura through  fiber measurement method within nasogastric tube  . After building regression equations with the above data, the distance from the incisors to these corresponding anatomical landmarks could be inferred by means of indexes including height and so on.

Official Title
-----------------
Measurement of the Distance Between the Corresponding Anatomical Landmarks in the Thoracic Cavity and the Incisors

Conditions
-----------------
Pulmonary Resection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing thoracic operation(such as radical lung cancer resection, pulmonary lobectomy, pulmonary segmentectomy, etc.) under endotracheal anesthesia ,which can expose the corresponding anatomical landmarks; Patients undergoing nasogastric intubation due to their condition. Exclusion Criteria: Patients with diseased or deformed esophagus; Patients with obvious thoracic deformity, spinal deformity or dysplasia; Patients whose thoracic anatomical landmarks can not be exposed or exposed clearly during operation; Patients who do not agree to be measured.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the distance from the incisors to the corresponding anatomical landmarks | The distance from the thoracic anatomical landmarks (the lower edge of the cardia, the inferior pulmonary vein, the condyle, the lower edge of the azygous vein, the lower edge of the aortic arch, the upper edge of the aortic arch, and the pleural apex) to the incisors. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary resection, Esophageal segmentation, Regression equation
Systemic Consolidation Therapy After Chemoradiation Therapy Following Operation for High Risk Early Stage Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following radical hysterectomy and adjuvant chemoradiation for high risk early stage cervical cancer.

Detailed Description
-----------------
Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (3 cycles per 3 weeks) for high risk early stage cervical cancer will elevate the therapeutic efficacy by removing the microscopic metastatic lesions which could not be identified by naked eye and diagnostic imaging tests.

Official Title
-----------------
A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Radical Hysterectomy and Adjuvant Chemoradiation for High Risk Early Stage Cervical Cancer

Conditions
-----------------
Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent radical hysterectomy for cervical cancer stage IB-IIA Patients who had at least one of the following risk factors in pathologic results; lymph node metastasis, positive residual resection margin, parametrial invasion above 20 years GOG performance status 0-2 Informed consent Platelet>100K, Hb> 10.0 g/dl, ANC>1500/mm3, Cr <1.25*upper normal limit, bilirubin<1.5mg/dl, AST & ALT<*3 upper normal limit Expected life > 6 months Exclusion Criteria: Peripheral neurotoxicity > NCI grade 2 Sever infection Previous history with chemotherapy or radiation therapy Pleural effusion, pericardial effusion, and ascites which could cause dyspnea > NCI grade 2 Paraaortic lymph node metastasis Allergy with platinum Previous history of atrial or ventricular arrhythmia or congestive heart failure Uncontrolled infection, diabetes mellitus, hypertension, ischemic heart disease, myocardiac infarct within 6 months Severe disease such as acute or chronic renal failure and acute cerebral infarct, cerebral hemorrhage, recurrent hepatitis, liver cirrhosis, unknown fever above 39 degrees centigrade

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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 |
| --- | --- | --- |
Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe Chronic Obstructive Pulmonary Disease (COPD) (DACOTA)

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease (COPD) is a progressive and largely irreversible lung disease characterized by chronic bronchitis and/or emphysema, resulting in breathlessness, cough and sputum. As COPD progresses, patients experience increasing deterioration of their health-related quality of life, with greater impairment in their ability to work and declining participation in social and physical activities. The aim of this non-interventional study is to evaluate data on quality of life in COPD patients in Germany in a real life medical setting under therapy with the phosphodiesterase-inhibitor (PDE-4) roflumilast (Daxas). Evaluation is based on two COPD specific questionnaires to assess the patient's health status over six months. During the study, lung function measurements such as spirometry will be conducted according to common medical standard. Daxas (tablet) will be administered once daily. The study will provide further data on the safety and tolerability of Daxas.

Official Title
-----------------
Daxas for COPD Therapy (DACOTA)

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Daxas


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: severe COPD Main Exclusion Criteria: Child pugh (classified B and C)

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 |
| --- | --- |
| DACOTA<br> | Drug: Daxas<br>* 500 microgram, oral, once daily as add-on therapy to existing therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-/post comparison of the COPD status based on patients health status | Evaluation of treatment success by a COPD-specific patient questionnaire | after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness during treatment | Evaluation of treatment success by a health status patient questionnaire | after 6 months | 
| Pre-/post comparison of spirometry data |  | after 6 months | 
| Evaluation of tolerability | assessment of adverse drug reactions | after 6 months | 
| Evaluation of symptom reduction of sputum and cough |  | after 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Quality of life, lung function, spirometry, roflumilast, Daxas, severe COPD
An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor

Study Overview
=================
Brief Summary
-----------------
CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.

Official Title
-----------------
An Extension Trial to a Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: Gimatecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients completing the core protocol (CLBQ707A1101, NCT00410358) exhibiting stable disease, or a partial or complete response as defined by the core protocol. If patients only have non-measurable lesions, he/she must not be exhibiting progressive disease Exclusion criteria: Documented progressive disease as defined by the core protocol Patients with performance status of 3 or 4 on the ECOG scale Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Gimatecan<br> | Drug: Gimatecan<br> <br> * Other names: LBQ707;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability assessed by Adverse Events |  | 2.8 years | 
| Anti-tumor activity assessed by RECIST criteria |  | 2.8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gimatecan, topoisomerase I inhibitor, advanced solid tumors
Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine wether coenzyme Q10 is effective in reducing markers of endothelial dysfunction in pediatric patients with type 1 diabetes mellitus and aslo to investigate its effect on glycemic control and lipid profile of those patients and its effect on patient's quality of life.

Official Title
-----------------
Effect of Coenzyme Q10 on Markers of Endothelial Dysfunction in Pediatric Patients With Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Dietary Supplement: Coenzyme Q10
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: patients from 8 to 18 years old. Outpatient with at least 1 year history of type 1 diabetes mellitus. Insulin requirement of more than or equal 0.5 U/Kg/day. Approval to participate and give informed consent. Exclusion Criteria: Presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism. Preexisting cardiovascular disease or hypertension. Chronic kidney disease or chronic liver disease. Significant mental illness. Intake of other antioxidants such as ascorbic acid and α-tocopherol and omega3 supplement within the last 3 months. Intake of coenzyme Q10 within the last 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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 |
| --- | --- |
| Experimental: Group I<br>this group of patients will receive their standard insulin treatment in addition to 100 mg of coenzyme Q10 soft gelatin capsule once daily for three month | Dietary Supplement: Coenzyme Q10<br>* Coenzyme Q10 soft gelatin capsule 100mg<br>Drug: Insulin<br>* multiple dose insulin injection therapy<br>|
| Active Comparator: Group II<br>this group of patients will receive their standard insulin treatment only | Drug: Insulin<br>* multiple dose insulin injection therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in soluble interacellular adhesion molecule level | it will be assessed at baseline and after three months of treatment | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes mellitus, Coenzyme Q10, endothelial dysfunction, pediatric patients
Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the short term success and feasibility of ileal transposition with sleeve gastrectomy in non-morbidly obese patients with poorly controlled Type 2 Diabetes Mellitus

Official Title
-----------------
Phase IV Study of Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Procedure: Surgical Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed Type 2 Diabetes for 3 to 5 years. Poorly controlled blood sugar despite standard of care* as demonstrated by HbA1c 8-11 for at least 6 months and 3 office visits. Standard of care is based on the ADA (American Diabetes Association) guidelines which include nutrition, exercise, education, behavior modification and pharmacological treatment. A co-investigator endocrinologist will ensure that the above standard of care has been met. BMI between 25.0 and 34.4. Stable weight as determined by no more than a 3% change in body weight in the last 3 months. Age between 35 and 65 (both men and women will be included). Able to provide Informed Consent. Able to comply with follow-up procedures. Exclusion Criteria: Previous history of major abdominal surgery which may lead to a hostile abdomen. Pregnancy Patients who have an incurable malignant or debilitating disease Serious uncorrectable impairment of coagulation (INR>1.4, PTT > + 3 secs), lungs, kidney or heart Diagnosed severe eating disorder Use of medication for weight loss in the last 6 months Untreated endocrine disorder Active peptic ulcer Untreated H. pylori Cognitive Impairment Diabetic autonomic neuropathy Symptomatic gastroparesis

Ages Eligible for Study
-----------------
Minimum Age: 35 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ileal transposition with SG<br>Procedure: Surgical Treatment | Procedure: Surgical Treatment<br>* Ileal transposition with sleeve gastrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment sucess based on patients' glycemic control |  | 12 Months |