linjc16/ctgov huggingface dataset:
Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes

Study Overview
=================
Brief Summary
-----------------
This study will help determine which types of drugs that may interact with Lu AF35700

Official Title
-----------------
Interventional, Open-label, Multiple-dose Study to Investigate the Effects of Multiple Doses of Lu AF35700 on the Pharmacokinetics of Cytochrome P450 (CYP450) Substrates Dextromethorphan (CYP2D6), Caffeine (CYP1A2), Omeprazole (CYP2C19), and Midazolam (CYP3A4/5) in Healthy Young Adults

Conditions
-----------------
Drug Reactions

Intervention / Treatment
-----------------
* Drug: Lu AF35700
* Drug: Midazolam
* Drug: Cocktail of CYP450 substrates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight at least 50 kg and Body Mass Index 19 - 30 kg/m2 Good general health ascertained by a detailed medical history, laboratory tests and physical examination Exclusion Criteria: -Pregnant or lactating women Other protocol defined inclusion and exclusion criteria may apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AF35700 and Cocktail of CYP450 substrates<br>Day 1 oral midazolam administration, Day 2 Cocktail of CYP450 substrates administration. Daily Lu AF35700 administration from Day 5 to Day 28 with co-administration on Day 27 with oral midazolam and Day 28 with CYP450 substrate cocktail | Drug: Lu AF35700<br>* tablets for oral use, 10 mg/day<br>Drug: Midazolam<br>* syrup for oral use, 4mg/day<br>Drug: Cocktail of CYP450 substrates<br>* Caffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity | Area under the plasma concentration-time curve from zero to infinity for oral midazolam and metabolite and all drug cocktail components and their metabolites | Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for cocktail components. | 
| Cmax: Maximum observed concentration | Maximum observed concentration of oral midazolam and all drug cocktail components and their metabolites | Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for Cocktail components. |
Blood Products in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Blood transfusion is a common procedure essential for the treatment of patients undergoing cardiac surgery. Inappropriate transfusions, however, not only incur needless healthcare costs, but increase unnecessary risks due to transfusion reactions and infectious and immunomodulative causes. Safe and appropriate patient care requires evaluated blood component prescription practices. Practically all patients undergoing cardiac surgery in Finland have a blood product booking from the Finnish Red Cross Blood Service. This registry contains large volumes of transfusion-related information on all Finnish patients undergoing cardiac surgery in Finnish centers. Participating hospitals were scattered to all geographical areas in Finland and concentrated to the most populated regions. Data on the blood product use, laboratory findings one month pre-operatively and 12 months post-operatively were available. Finnish hospitals have been required to provide information on hospital visits for the Finnish National Research and Development Centre for Welfare and Health for healthcare planning purposes. We used in part the original data sent by hospitals to the Finnish Hospital Discharge Register (FHDR).

Detailed Description
-----------------
Registry includes >21 000 patients who underwent coronary bypass, >4500 patients with aortic valve replacement, >4000 mitral valve operation.

Official Title
-----------------
The Use of Blood Products in Patients Undergoing Cardiac Surgery

Conditions
-----------------
Anemia, Renal Impairment, Thrombocytopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac surgery performed in Finnish University and Central hospitals Blood product booking for surgery Exclusion Criteria: -

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 |
| --- | --- |
| Cardiac surgery<br>Patients who have undergone cardiac surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red blood cell infusions |  | 12 months | 
| Platelet infusion |  | 12 months | 
| Fresh frozen plasma |  | 12 months | 
| Octaplas |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 12 months | 
| myocardial infarction |  | 12 months | 
| TIA/stroke/arterial embolism |  | 12 | 
| re-operation due to bleeding |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anemia, renal impairment, thrombocytopenia, anticoagulation, Coronary bypass, Aortic valve surgery, Mitral valve surgery, red blood cell, platelet, fresh frozen plasma, octaplas
Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the effect of monascus garlic fermented extract on serum lipid concentrations in subjects with moderately elevated serum triglyceride.

Official Title
-----------------
Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level: a Double-Blind, Randomized Controlled Trial

Conditions
-----------------
Hypertriglyceridemias

Intervention / Treatment
-----------------
* Dietary Supplement: Monascus Garlic Fermented Extract
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as based on medical history and physical examination Fasting serum triglyceride 120 to 200mg/dl Willing not to serve as blood donor during the study Informed consent signed Exclusion Criteria: Female subjects who are pregnant or nursing a child Participation in any clinical trial up to 90 days before Day 1 of this study Renal or hepatic dysfunction Heart disease Under medication Subjects who are taking functional food designed for weight loss or serum lipid reduction

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monascus Garlic Fermented Extract<br> | Dietary Supplement: Monascus Garlic Fermented Extract<br> <br> |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting triglyceride level |  | Every 4 weeks (Overall 20 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal circumference |  | Every 4 weeks (Overall 20 weeks) | 
| Visceral fat area by CT scan |  | Week 0 and Week 12 | 
| Serum total cholesterol and LDL cholesterol levels |  | Every 4 weeks (Overall 20 weeks) | 
| Serum adiponectin level |  | Week 0 and Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moderately Elevated Serum Triglyceride
Marathon and Half Marathon Runners, Older Than 70 Years Old: Who Are They?

Study Overview
=================
Brief Summary
-----------------
Through this study, the investigators intend to describe the profile of marathon and half marathon runners older than 70 years old, in terms of medical, social and psychological characteristics. First, in order to acquire a better knowledge of these aged runners: who they are; on a medical, social and psychological point of view; to figure out their motivations; to assess the impact on their life, their health and aging process. Then, in order to be able to offer them a better medical care, in terms of prevention, treatment and follow-up care.

Official Title
-----------------
Marathon and Half Marathon Runners, Older Than 70 Years Old: Who Are They?

Conditions
-----------------
Follow-up Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 70 years old Marathon or Half marathon runner To give an agreement to use medical datas for research study Exclusion Criteria: - Refusal to give an agreement to participate

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of medical, social and psychological characteristics via a questionnare |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Marathon, Half Marathon, Runners, Ederly, Aging process, Sport Addiction
Changing Diabetes® World Tour

Study Overview
=================
Brief Summary
-----------------
This study is conducted in the Middle East, Northern Africa and Europe. The aim of this study is to contribute to the design of a simple screening strategy for countries in scope, by exploring the association between risk factors and undiagnosed diabetes in a screening study.

Official Title
-----------------
Changing Diabetes® World Tour a Study on the Association of Risk Factors and the Presence of Undiagnosed Diabetes in the Middle East, Northern Africa and Europe

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

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained Exclusion Criteria: Subjects with known diabetes (exception: women with a history of gestational diabetes should not be excluded) Pregnant women or women who have given birth within less than a month Subjects suffering from severe illness Subjects with the inability to read and understand the information given (either due to illiteracy or vision problems) and therefore unable to give an informed consent Subjects with mental impairment Subjects treated with systemic cortico-steroids
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total study population<br> | Other: No treatment given<br>* The screening test includes a combination of a risk assessment questionnaire and biochemical tests.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (Glycosylated Haemoglobin) level |  | measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with diabetes (type 1 and 2) |  | measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country) | 
| The presence of retinopathy |  | measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country) |
Effects of Nicotine in Tobacco Smokers

Study Overview
=================
Brief Summary
-----------------
This study will examine mechanisms linking Obsessive-Compulsive Disorder symptomatology to tobacco dependence.

Official Title
-----------------
Mechanisms Linking Obsessive-Compulsive Symptoms and Tobacco Dependence

Conditions
-----------------
Smoking, Tobacco, Smoking (Tobacco) Addiction

Intervention / Treatment
-----------------
* Drug: Cigarette 1
* Drug: Cigarette 2
* Drug: Patch 1
* Drug: Patch 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 21 years old Daily smoking at least 2 years Exclusion Criteria: Currently pregnant or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition 1<br> | Drug: Cigarette 1<br>* Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)<br>Drug: Patch 1<br>* A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)<br>|
| Experimental: Condition 2<br> | Drug: Cigarette 2<br>* Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)<br>Drug: Patch 1<br>* A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)<br>|
| Experimental: Condition 3<br> | Drug: Cigarette 1<br>* Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)<br>Drug: Patch 2<br>* A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)<br>|
| Experimental: Condition 4<br> | Drug: Cigarette 2<br>* Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)<br>Drug: Patch 2<br>* A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Urge | Smoking urge is measured using questionnaires that ask about a desire to smoke. | Throughout study completion, an average of two weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking
A Clinical Study in Male Pediatric Patients With Cerebral X-linked Adrenoleukodystrophy (Cald) to Assess the Effects of MIN-102 Treatment on Disease Progression Prior to Human Stem Cell Transplant (HSCT)

Study Overview
=================
Brief Summary
-----------------
An Open-Label, multicenter study in male pediatric patients with cerebral x-linked adrenoleukodystrophy (cald) to assess the effects of MIN-102 treatment on disease progression prior to human stem cell transplant (HSCT)

Official Title
-----------------
An Open-label, Multicenter Study in Male Pediatric Patients With Cerebral X-linked Adrenoleukodystrophy (Cald) to Assess the Effects of MIN-102 Treatment on Disease Progression Prior to Human Stem Cell Transplant (HSCT)

Conditions
-----------------
Cerebral Adrenoleukodystrophy

Intervention / Treatment
-----------------
* Drug: MIN-102


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males aged ≥2 and ≤12 years with a diagnosis of X-linked ALD White matter involvement as determined by cerebral MRI lesions without Gd enhancement at baseline (Population 1), or with Gd enhancement at baseline (Population 2). Major Functional Disabilities (MFD) score of 0. Baseline Loes score >0 and ≤10 Gadolinium Intensity Score >2 Exclusion Criteria: Previous HSCT Too far progressed inflammatory brain lesions

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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: MIN-102<br> | Drug: MIN-102<br>* Once-daily dosing with a volume specified by the pharmacokineteic specialist to achive the desired plasma exposure. Min-102 Oral suspension, strength 15mg/ml.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate whether MIN-102 can halt disease progression of cALD if administered prior to hematopoietic stem-cell transplantation (HSCT), as determined by serial clinical and MRI investigations in pediatric subjects. |  | 6 months- 2 years | 
| arrested disease will be assessed at 24 weeks and at 96 weeks | arrested disease is defined using: Cahnge in NFS from Baseline, Free of MFD and lack of lesion progression on MRI | at 24 weeks and 96 weeks |
Effects of Collagen Protein on the Amino Acid Profile of the Blood

Study Overview
=================
Brief Summary
-----------------
This project aims to investigate the absorption of enzymatically hydrolysed and non-enzymatically hydrolysed collagen on the Amino acid profile of the blood

Official Title
-----------------
Effect of Intake of Enzymatically Hydrolyzed and Non-enzymatically Hydrolyzed Collagen Protein on the Amino Acid Profile of the Blood

Conditions
-----------------
Collagen Protein

Intervention / Treatment
-----------------
* Dietary Supplement: Collagen protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: Medicine influencing protein turnover Diabetes Smoking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effects of collagen protein.<br>Non-hydrolized collagen protein | Dietary Supplement: Collagen protein<br>* Collagen protein<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amino acid profile of the blood | AA concentrations in blood samples is determined using 1H NMR spectroscopy | Blood samples is collected at pre, 0 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min and 240 min. |
Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine

Official Title
-----------------
Dose Escalation Study of the Combination of ZD6474, Gemcitabine and Capecitabine in Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Vandetanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma ECOG performance status <1 Measurable disease Exclusion Criteria: Severe or uncontrolled systemic disease Clinically significant cardiac event such as myocardial infarction Any concomitant medication that may cause OTc prolongation, include Torsades de Pointes

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dose level 1<br>Vandetanib 100mg/day plus Gemcitabine | Drug: Vandetanib<br>* 100mg/300mg<br>* Other names: Zactima;|
| Active Comparator: Dose level 2<br>Vandetanib 300mg/day plus Gemcitabine | Drug: Vandetanib<br>* 100mg/300mg<br>* Other names: Zactima;|
| Active Comparator: Dose level 3<br>Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose | Drug: Vandetanib<br>* 100mg/300mg<br>* Other names: Zactima;|
| Active Comparator: Dose level 4<br>Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose | Drug: Vandetanib<br>* 100mg/300mg<br>* Other names: Zactima;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define Maximum Tolerated Dose (MTD) |  | during whole study | 
| Define Recommended Dose (RD) |  | during whole study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety profile |  | during whole study | 
| Determine antitumour activity as determined by overall response rate (RR), progression free survival (PFS), disease control rate and duration of response |  | every 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cancer, pancreatic adenocarcinoma, pancreas cancer, dose escalation study, locally advanced unresectable pancreatic adenocarcinoma, Zactima, Vandetanib, ZD6474