linjc16/ctgov huggingface dataset:
Pharmacogenetically Based Dosing of Thiopurines in Childhood Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
In a population-based study to explore the impact of TPMT-status on the risk of relapse and of second cancer among all patients treated according to the NOPHO ALL2000.

Detailed Description
-----------------
The thiopurines 6-mercaptopurine (6MP) and 6-thioguanine (6TG) are widely used in the treatment of childhood acute lymphoblastic leukemia (ALL). They primarily exert their cytotoxicity through conversion into 6-thioguanine nucleotides (6TGN) that are incorporated into DNA. Interindividual variations in response to thiopurine therapy are influenced by genetically determined polymorphisms in the activity of the enzyme thiopurine methyltransferase (TPMT). TPMT competes with the formation of 6TGN, as it methylates the thiopurines (especially 6MP) and some of their metabolites. Approximately ten percent of all individuals are TPMT heterozygous, with one wild type and one low activity allele, and one in three hundred individuals are TPMT deficient with two low activity alleles. During the maintenance therapy phase of the treatment of childhood ALL, which may last several years, 6MP is given on a daily basis at a starting dose of 75 mg/m.sq./day, which is subsequently adjusted to a white blood cell count of 1.5-3.5 x109/L. We have previously demonstrated that the risk of relapse is reduced by more than 50%, but the risk of second cancer was increased 3-fold among TPMT low activity patients. Accordingly, the Nordic ALL2000 protocol recommended the dosing of 6MP to be based on the patients TPMT activity. In the present study of almost 1000 Nordic patients, we will explore whether this strategy of TPMT-based individualised 6MP dosing have benefitted the patients by reducing their risk of second cancer while preserving their low risk of relapse.

Official Title
-----------------
Pharmacogenetically Based Dosing of Thiopurines in Childhood Acute Lymphoblastic Leukemia - Influence on Cure Rates and Risk of Second Cancer

Conditions
-----------------
Acute Lymphoblastic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: included in the NOPHO ALL2000 protocol entered 6-mercaptopurine/Methotrexate maintenance therapy in first remission available TPMT phenotype and/or genotype Exclusion Criteria: children with Down Syndrome

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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 |
| --- | --- | --- |
| Cumulative risk of relapse and risk of second cancer by Kaplan-Meier analysis with Gray's test comparisons at 10 years | The risks will be reported as percentages. | Up to 10 years from diagnosis |
Efficacy of Transfer Factor to Prevent Upper Respiratory Tract Infections in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The goals of our study are to critically evaluate if a healthy population supplemented with Transfer factor experiences fewer incidences of colds and flu, or experience shorter duration of illness compared to an identical population taking placebo. In this study we will give either Transfer factor or a placebo to two groups of healthy adult men and women for a period of 7 weeks in a double-blind experimental design. The frequency and duration of colds and flu-like symptoms will be recorded during the course of the study. Saliva samples will be collected weekly and assessed for salivary IgA secretion rate. Data from this study will establish the efficacy of Transfer Factor to support a healthy immune system.

Official Title
-----------------
A Double Blind Study on the Efficacy of a Colostrum and Egg Yolk Supplement vs. Placebo to Reduce Frequency and Duration of Upper Respiratory Tract Infections in Healthy Adults

Conditions
-----------------
Upper Respiratory Tract Infections Due to Influenza or Rhinovirus

Intervention / Treatment
-----------------
* Dietary Supplement: transfer factor
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females (18 - 40) who are in good health Exclusion Criteria: Subjects who are allergic to eggs (on which the supplement is based). If a volunteer is not sure if they are allergic to eggs or milk. Those who are currently smoking, have cardiovascular disease, cancer, diabetes, liver disease, renal insufficiency, any chronic disease that might interfere with study participation, BMI above 40 kg/m2, consumption of >12 alcoholic drinks weekly, or unwillingness to stop current supplement intake. Women who are pregnant or lactating will also be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Active Comparator: Transfer Factor<br>Transfer factor supplement; 2 capsules per day | Dietary Supplement: transfer factor<br>* capsules, 2 per day by mouth for 7 weeks.<br>|
| Placebo Comparator: Sugar pill<br> | Dietary Supplement: Placebo<br>* cornstarch, 2 capsules per day by mouth.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study to Investigate the Safety and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
To investigate the safety, tolerability and pharmacokinetic characteristics of LC28-0126 in healthy male subjects

Official Title
-----------------
A Dose Blocked-randomized, Double-blind, Placebo-controlled, Single Dosing and Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: LC28-0126
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects between the ages of 20 and 45 years at screening. Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive) Exclusion Criteria: Participation in a clinical research study within the previous 2 months Regular alcohol consumption >21 units per week.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Experimental: LC28-0126<br>LC28-0126(IV) | Drug: LC28-0126<br>* LC28-0126<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | up to 6 days post-dose | 
| AUC |  | up to 6 days post-dose |
A Study to Prospectively Assess Disease Progression in Male Children With X-ALD

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional, multi-center study that follows general principles of periodic assessment of X-ALD patients in routine practice. No study drug treatment will be given and no changes to patient treatment are necessary.

Detailed Description
-----------------
This is a non-interventional, multi-center study that follows general principles of periodic assessment of X-ALD patients in routine practice. No study drug treatment will be given and no changes to the patient treatment are necessary. Patients with X-ALD will be recruited and invited to attend a baseline visit. After eligible patients are enrolled, retrospective and baseline data will be collected. After enrollment, patients will be seen approximately every 6 months until they meet withdrawal criteria or the Sponsor terminates the study.

Official Title
-----------------
A Non-interventional Study to Prospectively Assess Baseline Status and Disease Progression in Male Children With X-Linked Adrenoleukodystrophy

Conditions
-----------------
X-Linked Adrenoleukodystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent by patient's parent(s)/legally acceptable representative(s). In addition, signed children's assent form according to local requirements. Males patients 2-13 years of age with a confirmed diagnosis of X-ALD that fall into one of the following: Asymptomatic patients without MRI evidence of cerebral involvement Patients with MRI evidence of cerebral involvement (Loes score ≥0.5) with or without clinical symptoms Patient who have HSCT within 3 months from enrollment Exclusion Criteria: Patients who are 14 years of age or older Patients who are in a vegetative state Patients (or their guardians) who are unwilling or unable to comply with the study procedures Patients who received HSCT more than 3 months before enrollment

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 13 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 |
| --- | --- | --- |
| Loes score | Percent change from baseline in brain lesions assessed as Loes score will be calculated | baseline and 24 weeks | 
| Plasma VLCFA levels | Change from baseline plasma VLCFA levels | baseline and 24 weeks | 
| Neurological symptoms | Development of new neurological symptoms throughout the study | baseline and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adrenoleukodystropy, X-ALD, ALD
Improving the Diagnosis of Diarrhoea in Emergency Rooms

Study Overview
=================
Brief Summary
-----------------
A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of diarrhoea caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of diarrhoea after POC tests.

Conditions
-----------------
Diarrhoea

Intervention / Treatment
-----------------
* Other: Nasopharyngeal Swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted at hospital for diarrhoea requiring, for the emergency physician, a microbiological examination with a POC diarrhoea kit. Patient who has freely signed the informed written consent Patient affiliated to a social security scheme Exclusion Criteria: Pregnant woman, parturient or nursing Adult major under guardianship Patient deprived of liberty under court order Patient refusing or unable to sign the informed consent form.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Diarrhoea<br>Patients admitted in emergency room with Diarrhoea | Other: Nasopharyngeal Swab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients admitted in emergency rooms for diarrhoea with confirmed etiological diagnosis |  | 1 day |
Preference Study Between NovoFine® Autocover™ and a NovoFine® 8 mm Needle

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this clinical trial is to assess the preference of 2 different needles used by nurses and health assistants. The trial consists of a handling test followed by a 12 week cross-over study.

Official Title
-----------------
An Open-label, Multicenter, Handling Test and Prospective Cross-over Study on Nurse/Health Assistants Preference Between NovoFine® Autocover™ and 8 mm NovoFine® Needle

Conditions
-----------------
Diabetes, Healthcare Professionals, Delivery Systems

Intervention / Treatment
-----------------
* Device: NovoFine® needle 8 mm
* Device: autocover needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant must have been either a diabetes nurse or a diabetes health assistant with competence in subcutaneous injections of insulin for at least 4 weeks Participants must demonstrate proficiency with the injection device in the handling test prior to testing the NovoFine® Autocover™ Needle in patients
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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NovoFine® needle 8 mm|nan|
|Device: autocover needle|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device preference |  | after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the adverse device effects (occlusion/activation/locking problems/manufacturing defects) |  |  | 
| Comparison of the frequency of adverse device effects |  |  | 
| Comparison of the frequency of adverse events (needle stick injuries) |  |  |
Physiotherapy Techniques in Adult Neck Pain

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of thoracic manipulation and MET on chronic mechanical neckache

Detailed Description
-----------------
it is a randomized control clinical trail to compare the effectiveness of physical exercises for the management of chronical mechanical neckache .so we employed thoracic manipulation for experimental group and MET (muscle energy technique) for control group

Official Title
-----------------
Comparison of Thoracic Manipulation & MET for Chronic Mechanical Neckache; a Single Blinded Clinical Trail

Conditions
-----------------
Neckache

Intervention / Treatment
-----------------
* Other: thoracic manipulation
* Other: muscle enegy technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients with mechanical neck pain having age group of 18 to 60 years. Mechanical neck pain having activities of daily living Mechanical Neck pain affecting sleep Exclusion Criteria: Patients with following conditions will be excluded Osteoporosis Radiculopathy Pregnancy Systemic inflammatory condition Neurological deficit Arthritic conditions Head injuries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Interventional Model Description: 2 groups , geoup A named as control group and group B named as experimental group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>thoracic manipulation group | Other: thoracic manipulation<br>* thoracic manipulation for unlocking of facet joints<br>|
| Active Comparator: control<br>MET group | Other: muscle enegy technique<br>* to release muscle spasm of cervical musces<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NPRS | MINIMUM MEANS NO PAIN AND MAXIMUM SCORE MEANS WORST PAIN | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of pain | MINIMUM MEANS NO PAIN AND MAXIMUM SCORE MEANS WORST PAIN | 6 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neckache
The Impact of Internationalize Medical Services to localPeople Seeking Medical Care

Study Overview
=================
Brief Summary
-----------------
Recently The Department of Health of Taiwan has launched the Internationalize Medical Services Flagship Program, expecting to promote Taiwan's high-quality of medical services to the international market, and anticipating customers stroll in, medical services walked out. In order to avoid expansion of this program might alienate the rights and best interests of local people seeking medical services, therefore, this research project is a join effort of experts to form an advisory counsel; by collecting most current international medical services data; then using both qualitative and quantitative questionnaires to investigate whether by implementation of internationalize medical services will cause great impact on local people. To study the various of insurance income of health care organization after they promote international medical services; and to understand the impact of assess to medical care and quality of medical services to local people due to internationalize medical services. The last through advisory counsel, to make specific recommendations on mechanism of management and to set evaluation of indicators to monitor international health care, to avoid edge out local people the right of seeking medical care to ever happened, and to aid future planning of policy and implementation.

Detailed Description
-----------------
The main objectives of this study are: To understand the impact from internationalize medical services to local People seeking medical care, and the impact to management of health care organization, make specific recommendations for assessment, management mechanisms and measurable indicators, and aid future planning of policy and implementation. To avoid expanding the flagship program of internationalization of medical services might jeopardize local people's right to seek medical care, assess the impact to local people after the program implemented.

Official Title
-----------------
To Understand the Impacts of Internationalize Medical Services on Local People Seeking Medical Care, and to Establish Responsive Management Mechanism

Conditions
-----------------
Administrative Staff in Hospital of Taiwan

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Administrative staff in Hospital Hospital provide the internationalize medical services Exclusion Criteria: -
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 |
| --- | --- | --- |
Fingertip Pulse Oximeter Clinical Test

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the SpO2 accuracy of pulse oximeter equipment in comparison to gold-standard measurements of blood SaO2 by a CO-oximeter

Conditions
-----------------
SPO2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects participate in the study on a voluntary basis All subjects should be in good health at the time of the study. Unless specified otherwise in the protocol, the following values could be applied: COHb<3 %, MetHb<2 %, ctHb>10 g/dl; Inclusion criteria should serve the purpose of the study Exclusion Criteria: Smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels, unless specific dyshaemoglobins are called for in the study protocol. Individuals subject to conditions that result in elevated levels of methaemoglobin, unless specific dyshaemoglobins are called for in the study protocol. Subjects who would be placed at undue medical risk associated with any procedures called for in the protocol (e.g. arterial cannulation or hypoxia). Age: young person and that of more than 50 years old.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 32 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fingertip Pulse Oximeter<br>SPO2 measurement range: 70%-99% | |
| CO-oximeter<br>SaO2 measurement range: 70%-99% | |

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
-----------------
SPO2