linjc16/ctgov huggingface dataset:
Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.

Official Title
-----------------
A Randomized, Single Center, Open-label, Phase I Study to Evaluate the Effect of Food and Fasting on the Pharmacokinetics of ASC41 Tablets in Healthy Volunteers

Conditions
-----------------
Healthy, NAFLD, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: ASC41 tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: 19kg/m2 ≤ BMI <40kg/m2. Key Exclusion Criteria: A history of thyroid disease. History of, or current liver disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>ASC41 one tablet, on Day 1 before meal；ASC41 one tablet, on Day 15 after meal. | Drug: ASC41 tablet<br>* Oral tablet<br>|
| Experimental: Group 2<br>ASC41 one tablet, on Day 1 after meal；ASC41 one tablet, on Day 15 before meal. | Drug: ASC41 tablet<br>* Oral tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of ASC41 | Evaluate the Area under the plasma concentration versus time curve after single oral dose of ASC41 administered to healthy volunteers. | Up to 19 days | 
| Cmax of ASC41 | Evaluate the Peak Plasma Concentration after single oral dose of ASC41 administered to healthy volunteers. | Up to 19 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| t1/2 of ASC41 | Evaluate the Terminal-Phase Half-Life after single oral dose of ASC41 administered to healthy volunteers. | Up to 19 days | 
| CL/F of ASC41 | Evaluate the Apparent Systemic Clearance after single oral dose of ASC41 administered to healthy volunteers. | Up to 19 days | 
| Vd/F of ASC41 | Evaluate the Apparent Volume of Distribution after single oral dose of ASC41 administered to healthy volunteers. | Up to 19 days | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 19 days | Up to 19 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers, NAFLD, NASH, Hyperlipidemia, LDL-C
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).

Official Title
-----------------
Double-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the Effect of Ursofalk 500 mg Tablets od Versus Ursofalk 250 mg Capsules od on Liver Enzymes in the Treatment of Primary Biliary Cirrhosis

Conditions
-----------------
Primary Biliary Cirrhosis

Intervention / Treatment
-----------------
* Drug: UDCA (Ursodeoxycholic acid)
* Drug: UDCA (Ursodeoxycholic acid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Negative pregnancy Signed informed consent Histologically proven non-cirrhotic liver disease Exclusion Criteria: histologically proven cirrhosis PBC stage II+IV Positive HIV serology

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ursodeoxycholic acid (UDCA)250 mg<br>UDCA 250 mg capsule | Drug: UDCA (Ursodeoxycholic acid)<br>* 250 mg<br>|
| Experimental: Ursodeoxycholic acid (UDCA)500 mg<br>UDCA 500 mg tablet | Drug: UDCA (Ursodeoxycholic acid)<br>* 500 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of liver enzymes between baseline and the end of the treatment-period with Ursofalk 250 mg capsules and the end of treatment-period with Ursofalk 500 mg tablets. |  | Between baseline and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | Between baseline and week 24 |
Switch From Metformin Monotherapy to a Bitherapy With Metformin and Repaglinide

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to investigate the efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical practice

Official Title
-----------------
REPAMET 2: Observational Study of the Switch From Metformin Monotherapy to Bitherapy With Metformin and Repaglinide

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Metformin monotreatment HbA1c greater than 7% Treatment according to SPC Informed consent obtained Exclusion Criteria: Any contraindication to the use of repaglinide (according to the SPC)

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 |
| --- | --- |
| A<br>Repaglinide add-on to metformin. | Drug: repaglinide<br>* Start dose and frequency at the discretion of the physician following clinical practice<br>* Other names: NovoNorm®;Drug: metformin<br>* Start dose and frequency at the discretion of the physician following clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | After 12-20 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPG |  | After 12-20 weeks. | 
| Number of hypoglycemic events |  | After 12-20 weeks. | 
| Variability in FPG (Fasting Plasma Glucose) |  | After 12-20 weeks. |
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone

Study Overview
=================
Brief Summary
-----------------
It is the aim of this study to detect the effect of Betamethasone on the maternal inflammatory parameters C-reactive protein (CRP) and leukocytes of a pregnant woman under threat of preterm delivery, for example because of a cervical infection.

Detailed Description
-----------------
BACKGROUND Cortisone influences the maternal number of leukocytes and CRP of a pregnant woman. Because of that, it is difficult to know if the medical treatment of an infection was successful and accordingly if the diagnosis was justified. METHODS In this study, the blood results of 75 pregnant women under threat of preterm delivery (week of gestation 23+0 to 34+6), treated with Betamethasone will be analysed. 65 pregnant women without complications serve as control group.

Official Title
-----------------
Assessment of Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone Under Threat of Preterm Delivery

Conditions
-----------------
Preterm Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: week of gestation 23+0 until 34+6 Exclusion Criteria: infectious diseases f.e. hepatitis B or C, HIV diseases of the thyroid gland 75 Patients facing preterm labour 65 Patients acting as a control group, without preterm labor

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case Group<br>75 woman between the age of 18 to 50 years, week of gestation 23+0 - 34+6, threatening preterm delivery, application of Betamethasone | |
| Control Group<br>65 woman between the age of 18 to 50 years, week of gestation 23+0 - 34+6, no threatening preterm delivery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP | The CRP values in mg/dL before and 48h after the first Betamethasone application | 48h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leucocytes | The Leucocyte values in G/L before and 48h after the first Betamethasone application | 48h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preterm birth, corticosteroids, inflammatory parameters, betamethasone, leukocytes
Acetylamantadine Excretion by Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Several factors discourage the implementation of cancer screening to the population in general, which would result in earlier diagnosis and an expected improved survival. Concurrent in vivo and in vitro research has shown that drug acetylation activity is increased in cancer. Amantadine may be of value in detecting the presence of cancer. Accordingly, this study will examine how Amantadine is eliminated by the body in cancer patients. This is an important step in validating a cancer detection method that can be implemented economically for screening of large numbers of people.

Detailed Description
-----------------
The study will involve the screening of volunteer patients with various types of cancer to provide a first indication of which types of cancer and at what stage of tumor burden acetylamantadine will be found in patients' plasma, saliva and urine samples. Volunteers will provide complete first morning urine collection prior to amantadine ingestion. The volunteers will then ingest a therapeutic dose of amantadine (200 mg: 2x100mg capsules), at least 2 hours before breakfast (nothing to eat or drink except water after midnight before the scheduled appointment), and their complete urine will be collected at 2 and 4 hours (plus or minus 1 hour) after amantadine ingestion. In addition, blood samples will be taken by venipuncture before and at 2 and 4 hours after drug ingestion. The patients will be asked to provide a saliva sample at the same time as the urine samples are taken after drug ingestion.

Official Title
-----------------
Urinary Excretion of Acetylamantadine by Cancer Patients

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

Intervention / Treatment
-----------------
* Drug: Amantadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed or untreated cancer (GI, lung, prostate and breast cancer) - Exclusion Criteria: Any previous adverse reaction to Amantadine currently pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Amantadine<br>Lung cancer patients being prescribed chemotherapy | Drug: Amantadine<br>* Amantadine is a drug that has been on the market for several years and is currently approved for the treatment of Parkinson's disease and for prevention against influenza A infection. Amantadine may be of value in detecting the presence of cancer.<br>* Other names: Systemic chemotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetylated Amantadine levels in urine | Change in acetylamantadine excretion | 2 and 4 hours after Amantadine ingestion |
Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine

Study Overview
=================
Brief Summary
-----------------
To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan.

Official Title
-----------------
A Multicenter Double-blind, Randomized Placebo Controlled, Parallel Group, Study of the Efficacy and Safety of Oral Eletriptan in Subjects With Acute Migraine

Conditions
-----------------
Migraine With or Without Aura

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Eletriptan 20 mg
* Drug: Eletriptan 40 mg
* Drug: Eletriptan 80 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria. Capable of taking study medication as outpatients and recording its effects. Exclusion Criteria: Pregnant or breast-feeding women Migraine subjects who also suffered from concomitant frequent (non-migraine) headache, defined as more than six headaches per month on average Migraine attacks that were thought to be atypical and had consistently failed to respond to medical therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* matching placebo<br>|
| Experimental: Eletriptan 20 mg<br> | Drug: Eletriptan 20 mg<br>* 20mg oral<br>|
| Experimental: Eletriptan 40 mg<br> | Drug: Eletriptan 40 mg<br>* 40mg oral<br>|
| Experimental: Eletriptan 80 mg<br> | Drug: Eletriptan 80 mg<br>* 80mg oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache responder rate at two hours after the first dose for the first attack. | A headache response was defined as a subject having improvement in headache severity from grade 2 or 3 at baseline to 0 or 1 at two hours post-dose. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain free responder rate at two hours after the first dose for the first attack. | Pain free response was defined as improvement from grade 2 or 3 at baseline to grade 0 at two hours post-dose. | 2 hours |
18F-FSPG PET/CT Imaging in Patients With Cancers

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the diagnostic performance of 18F-FDG and 18F-FSPG PET/CT in lung, breast, and abdominal cancers before undergoing therapy. In addition, the role of 18F-FSPG PET/CT in evaluating therapy response and prognosis will also be evaluated.

Official Title
-----------------
(4S)-4-(3-[18F]Fluoropropyl)-L-glutamate Radiotracer (FSPG) PET/CT for Imaging xC- Transporter Activity in Cancers

Conditions
-----------------
Breast Neoplasms, Abdominal Cancer, Pulmonary Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are given the opportunity to participate in the study if Age ≥ 20 years old. Confirmed diagnosis of primary cancer of the following: NSCLC, breast or abdominal cancers ECOG performance status 0 to 2. Life expectancy > 3 months. Consent to perform additional 18F-FSPG and 18F-FDG PET prior to therapy. Sexually active subjects agree to use condoms and/or their partners of reproductive potential to use a method of effective birth control during imaging period of 2 weeks. Exclusion Criteria: Patients with any of the following conditions will be excluded Had received previous treatment (excluding neoadjuvant therapy). Pregnant or lactating women. Known malignancy in other organs. Evaluated by primary care physician as unsuitable. Known hypersensitivity to the study drug.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Staging ability of 18F-FSPG PET/CT | Sensitivity, specificity, diagnostic accuracy of 18F-FSPG and 18F-FDG PET/CT will be compared according to patient-based and lesion-based analysis using paired t-test or Krusal-Wallis test. | 3 years | 
| Ability of 18F-FSPG PET/CT in therapy response evaluation and prognosis prediction | Comparison between 18F-FSPG and 18F-FDG PET/CT will be done using both qualitative and quantitative measures | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of 18F-FSPG | Standardised uptake values (SUV) will be compared between 18F-FSPG and 18F-FDG | 3 years | 
| Safety of 18F-FSPG PET/CT | Number of reported adverse events | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
system xC-transporter, 18F-FSPG, (4S)-4-(3-[18F]fluoropropyl-)-L-glutamate, PET/CT
Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify potential markers for curve progression in adolescent idiopathic scoliosis (AIS). Despite its prevalence and impact on child health, the etiology of AIS and molecular mechanisms underlying its development and progression remain poorly understood. Clinical criteria and features cannot adequately predict which children, diagnosed with mild disease, will undergo subsequent curve progression requiring intervention. The investigators hypothesize that alterations in specific genetic markers will be correlated with the progression of AIS curves over time. Thus, these markers could be used in the future to develop a reliable, inexpensive and relatively non-invasive cell based diagnostic test to (1) predict spinal curve progression in AIS, (2) select patients likely to benefit from early surgical intervention, and (3) potentially screen for asymptomatic children at risk of developing idiopathic scoliosis.

Official Title
-----------------
Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis

Conditions
-----------------
Adolescent Idiopathic Scoliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females aged 10-13 years Diagnosed with mild-moderate spine deformity (Cobb angle 15-30 degrees) Exclusion Criteria: Patients with scoliosis other than idiopathic Trauma Inflammatory disease Malignancies Diabetes History of previous spine surgery

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 13 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 |
| --- | --- | --- |
| Scoliosis Curve Progression | Cobb angle, disc wedging, vertebral body wedging, coronal balance, sagittal balance | 3 years |
Efficacy and Safety of Levemir® Used as Basal Insulin

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is to evaluate efficacy and safety of insulin detemir (Levemir®) used as basal insulin on the glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes treated with insulin NPH under normal clinical practice conditions in Slovakia.

Official Title
-----------------
An Observational 3-months Study to Evaluate Efficacy and Safety of Insulin Levemir® Used as Basal Insulin on the Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or type 2 diabetes treated with insulin NPH
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Levemir® users<br> | Drug: insulin detemir<br>* Prescribed insulin detemir and insulin aspart based on the clinical judgement of the physician. The insulin preparations were prescribed by the physician solely as a result of a normal clinical evaluation. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any.<br>Drug: insulin aspart<br>* Prescribed insulin detemir and insulin aspart based on the clinical judgement of the physician. The insulin preparations were prescribed by the physician solely as a result of a normal clinical evaluation. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight |  |  | 
| Change in fasting plasma glucose (FPG) |  |  | 
| Change in 4-points glucose profiles |  |  | 
| Change in lipid profile |  |  | 
| Number of hypoglycaemic events |  |  | 
| Number of adverse events |  |  |