linjc16/ctgov huggingface dataset:
Effect of Antiseizure Medication on Hormone Levels and Sexual Function in Men With Epilepsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if antiseizure drugs affect hormone levels and sexual function in men with seizures.

Detailed Description
-----------------
This study involves donating two small tubes of blood for hormonal testing, which will be drawn at the same time as your routine blood draw for the monitoring of your antiseizure medication. You will also be asked to fill out a short confidential questionnaire regarding your sexual interest and function.

Official Title
-----------------
Antiseizure Medication-Induced Elevation of Serum Estradiol and Reproductive Dysfunction in Men With Epilepsy

Conditions
-----------------
Seizure Disorder, Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a male between 18-50 years of age Must have seizures Must be on antiseizure medication for at least six months duration Exclusion Criteria: Must not have taken hormones, major tranquilizers or antidepressants for at least 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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
-----------------
Seizure Disorder, Hypogonadism, Sexual Function, Epilepsy
An Observational Study Investigating the Safety and Effectiveness of Repaglinide in Chinese Patients

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is, under normal clinical practice conditions, to investigate the clinical safety and effectiveness in Chinese patients with type 2 diabetes who have never received anti-diabetic treatment before.

Official Title
-----------------
The Clinical Safety and Effectiveness of Repaglinide in Treatment-naive Type 2 Diabetes Subjects in China. A 16-week Multicentre, Prospective, Open Label, Non-interventional Study.

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: repaglinide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HbA1c more than 6.5%, no anti-diabetes treatment accepted before entering the study Exclusion Criteria: Subjects who received any anti-diabetic treatment previously Known or suspected allergy to trial product(s) or related products. Subjects who previously enrolled in this study. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.

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 |
| --- | --- |
| Repaglinide<br> | Drug: repaglinide<br>* Repaglinide prescribed at the discretion of the investigator, according to local labelling, and evaluated at week 0, 8 and 16 of the study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse drug reactions (SADRs) including major hypoglycaemic (low blood sugar) events |  | at Visit 2(8 weeks) and visit 3(16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of minor hypoglycaemic (low blood sugar) episodes |  | at Visit 2(8 weeks) and visit 3(16 weeks) | 
| Number of adverse drug reactions (ADRs) |  | at Visit 2(8 weeks) and visit 3(16 weeks) | 
| Change in HbA1c |  | after 16 weeks of treatment | 
| Change in fasting blood glucose (FBG) |  | after 8 and 16 weeks of treatment | 
| Change in postprandial blood glucose (PBG) |  | after 8 and 16 weeks treatment |
The CArdiac Imaging RegistrY Study

Study Overview
=================
Brief Summary
-----------------
In this prospective longitudinal observational investigator-led single centre cohort study we will include patients undergoing cardio-CT for clinical reasons, to evaluate the role of cardio-CT terms of its diagnostic and prognostic value, as well as risk-benefit ratio. Particular aims include: To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models To determine associations between CAD severity and plaque type and: with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking) blood markers of increased cardiovascular risk To determine predictive associations of between CAD with outcome (endpoint definitions in appendix) To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

Detailed Description
-----------------
Particular aims include: To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models To determine associations between CAD severity and plaque type and: with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking) blood markers of increased cardiovascular risk To determine predictive associations of between CAD with outcome (endpoint definitions in appendix) To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

Official Title
-----------------
The CArdiac Imaging RegistrY Study: Computed ToMogrAphy for Risk Stratification and Diagnostic Safety

Conditions
-----------------
Coronary Artery Disease (CAD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (=/>18 years of age) Able to provide informed consent Clinical indication for cardio-CT in line with the latest clinical guidelines Exclusion Criteria: standard contraindications to CT (in line with local roles and guidelines - please see Appendix) known allergy to iodinated contrast agent suspected acute kidney injury unstable hemodynamic status or arrhythmias suspected acute coronary syndrome manifest thyrotoxicosis

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 |
| --- | --- | --- |
| Survival | number of deaths | 2 year | 
| Survival | number of deaths | 5 year |
Coagulation System In STereotactic Radiotherapy Of NSCLC

Study Overview
=================
Brief Summary
-----------------
The risk of thromboembolism is elevated in lung cancer patients. The present project investigates whether stereotactic body radiation therapy (SBRT) further increases the risk of thromboembolic disease in lung cancer patients. If coagulation is activated by SBRT, this study could form the basis of new clinical trials investigating whether lung cancer patients may benefit from thromboprophylaxis during and after stereotactic body radiation therapy.

Detailed Description
-----------------
In this study, the patients will have blood samples drawn three times (prior to start of stereotactic body radiation therapy, immediately after stereotactic body radiation therapy completion, four to six weeks after completing stereotactic body radiation therapy). The blood sample at the completion of stereotactic body radiation therapy is an extra compared to normal gathering of blood samples of patients with NSCLC treated with stereotactic body radiation therapy. Also extra glasses with blood will be gathered at each blood sample for storage in a biobank in order to be able to make future analysis on this material. There is a minimal risk of developing infection or hematoma in connection with blood sampling but we consider this risk to be negligible. The total volume of 120 ml blood drawn over a period of 6 weeks is an inconsiderable risk for the patient.

Official Title
-----------------
Impact of Stereotactic Body Radiation Therapy on the Coagulation System in Patients With Non-small Cell Lung Cancer

Conditions
-----------------
Thromboembolism, Lung Cancer, NSCLC, Radiotherapy; Complications

Intervention / Treatment
-----------------
* Radiation: x


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Planned stereotactic body radiation therapy of lung cancer Exclusion Criteria: Inability to provide informed consent Venous thrombosis within the last three months Active cancer within the previous year except for lung cancer

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 |
| --- |
|Radiation: x|Stereotactic body radiation therapy for localized NSCLC|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in coagulation | endogenous thrombin | From start of SBRT to end and 5 weeks after SBRT |
Effect of Benadryl Sedation During ERCP or EUS

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if adding Benadryl improves sedation for patients scheduled to undergo ERCP or EUS procedures.

Detailed Description
-----------------
The usual sedatives used for endoscopy are meperidine (Demerol) and midazolam (Versed). Benadryl (Diphenhydramine) is often used in addition to these medications in an effort to improve sedation. There is little published information regarding the use of diphenhydramine in conscious sedation. It is recognized that certain patients have features that predict difficult sedation such as prescription sedative use or heavy alcohol use. In addition, prolonged procedures like ERCP and EUS require higher doses of sedatives. Diphenhydramine may improve the quality of sedation in patients undergoing endoscopic retrograde cholangio-pancreatography (ERCP) or endoscopic ultrasound (EUS) procedures. You are being asked to participate because you are already scheduled to undergo one of these procedures.

Official Title
-----------------
Effect of Diphenhydramine Sedation During Endoscopic Retrograde Cholangio-pancreatography (ERCP) or Endoscopic Ultrasound (EUS)

Conditions
-----------------
Gallbladder Disease, Gallstones, Pancreatitis, Abdominal Pain, Jaundice

Intervention / Treatment
-----------------
* Drug: Benadryl versus Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18 and 65 years of age who present for outpatient ERCP or EUS at Strong Memorial Hospital Endoscopy Center will be included Exclusion Criteria: Allergy to diphenhydramine, narrow angle glaucoma, or inability to consent

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Benadryl versus Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of sedation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, EUS
A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area

Study Overview
=================
Brief Summary
-----------------
Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the correction of wrinkles in the décolletage area.

Official Title
-----------------
A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area

Conditions
-----------------
Wrinkle

Intervention / Treatment
-----------------
* Device: GAL1906


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects willing to comply with the requirements of the study and providing a signed written informed consent. Non-pregnant, non-breastfeeding females, over the age of 21. Subjects seeking treatment for the décolletage. Exclusion Criteria: Known/previous allergy or hypersensitivity to any injectable HA gel or to gram positive bacterial proteins. History of allergy or hypersensitivity to lidocaine or other amidetype anesthetics, or topical anesthetics or nerve blocking agents (if such products are intended to be used for that subject).

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GAL1906<br>Experimental product for correction of wrinkles | Device: GAL1906<br>* hyaluronic acid dermal filler gel<br>|
| No Intervention: Control<br>No treatment control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of responders on the Galderma Décolletage Scale, as assessed live by the Blinded Evaluator, at Week 12. | Responder defined as at least one grade improvement from baseline | 12 weeks after initial injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wrinkles in the Décolletage Area
Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 50 μg/ 75 μg Tablets

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the area under the curve (AUC0-48h; extent of systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered as a reference solution without iodine.

Official Title
-----------------
Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 50 μg/ 75 μg Tablets

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: levothyroxine
* Drug: levothyroxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Euthyroid men Age: 18 - 50 Normal values for fT4 und TSH Good state of health Exclusion Criteria: Thyroid function disorders in terms of subclinical or overt hyper- or hypothyroidism History of thyroid function disorders Focal or diffuse autonomies of the thyroid gland Thyroid nodules >1 ml according to sonographic examination Any acute or chronic illness Dermatitis herpetiformis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: with iodine<br> | Drug: levothyroxine<br> <br> |
| Experimental: without iodine<br> | Drug: levothyroxine<br> <br> |

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
-----------------
bioavailability, levothyroxine
Phase1 Syudy to Evaluate the Safety and PK/PD of Human Antithrombin III

Study Overview
=================
Brief Summary
-----------------
To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1 study in healthy male subjects was designed

Official Title
-----------------
Single-Dose, Open Label, Randomized Comparative Clinical Trial to Evaluate the Tolerability, Safety and PK/PD of Human ATIII Products, SKATIII Injection andATIII Injection in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: SK Antithrombin III


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 19 to 40 Body weight: More than 50kg Healthy male subject Exclusion Criteria: Hb<14g/dL, Hct<42% ATIII hypersensitivity

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antithrombin III<br> | Biological: SK Antithrombin III<br> <br> |
| Experimental: SK Antithrombin III<br> | Biological: SK Antithrombin III<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ATIII activity |  | within 20min after injection ATIII | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ATIII antigen |  | within 20min after injection ATIII | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Male subjects
Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Medical therapy that can lower PJK rates are also being sought. Teriparatide (TP), a recombinant human parathyroid hormone (PTH 1-34), is a bone forming agent mainly used to treat osteoporotic patients with high risk of osteoporotic fracture. There has been reports suggesting protective effect of prophylactic TP to osteoporotic patients receiving ASD surgery concerning PJK.6 Although it had limitations of small sample size and surgical selection bias owing to study design being retrospective. We hypothesized prophylactic TP would act as to reduce the incidence of PJK and therefore reduce PJF and necessity of revision surgeries in patients after ASD correction surgery. Our study can consolidate the beneficial effect of prophylactic TP to patients receiving ASD surgery by reducing the incidence of PJK.

Official Title
-----------------
Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial

Conditions
-----------------
Spine Deformity

Intervention / Treatment
-----------------
* Drug: Forsteo
* Drug: Denosumab Prefilled Syringe [Prolia]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients between 50 years to 80 years of age with ASD Multilevel instrumented fusion Cobb angle above 25̊ in coronal plane deformities, Lumbar lordosis below 20̊ in sagittal plane deformities Minimum follow-up of 1 years Exclusion Criteria: Diagnosis being tumor or infectious condition like Tb spondylitis were excluded Patients with adverse reactions or contraindications to TP were excluded; side effects to TP or bone cancer or metastasis

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br> | Drug: Denosumab Prefilled Syringe [Prolia]<br>* Patients were administered 60mg of denosumab (Prolia) subcutaneously once 6months from the day on before 3months to after 3months about surgery.<br>|
| Experimental: TP group<br> | Drug: Forsteo<br>* Patients were administered 20mcg of TP (Forsteo) subcutaneously once a day from the day between before 3months to after 3months about surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PJK | PJK prevalance | 15months |
Phase I Study of PEG-Paclitaxel In Patients With Advanced Solid Tumors & Lymphomas

Study Overview
=================
Brief Summary
-----------------
Studies of PEG-paclitaxel have been terminated

Official Title
-----------------
Phase I Study of PEG-Paclitaxel In Patients With Advanced Solid Tumors and Lymphomas

Conditions
-----------------
Neoplasm, Lymphomas, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: PEG-paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
None - Study has been terminated.

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: PEG-paclitaxel|nan|

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
-----------------
Phase I, Open label, Safety/efficacy, Lymphomas, Advanced primary and/or metastatic solid tumors, Neoplasms, Neoplasm metastasis