linjc16/ctgov huggingface dataset:
Assistance Multidisciplinary in Hypertensive Patient: Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if multidisciplinary care improves the health condition of hypertensives.

Detailed Description
-----------------
A multidisciplinary approach in managing hypertensive patients has shown benefits in reducing blood pressure and risk factors for hypertension.

Official Title
-----------------
Assistance Multidisciplinary in Hypertensive Patient: Randomized Clinical Trial

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: Multidisciplinary assistance
* Other: Conventional treatment and follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years of age Diagnosis of hypertension Exclusion Criteria: Secondary hypertension Hypertensive patients with congenital cardiopathy Surgical patients Proven myocardial infarction

Ages Eligible for Study
-----------------
Minimum Age: 41 Years
Maximum Age: 67 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Group<br>Conventional treatment and follow up | Other: Conventional treatment and follow up<br>* Assistance was effected by physician and nurse and consisted about adapting to the drug<br>|
| Experimental: Multidisciplinary Group<br>Multidisciplinary assistance | Other: Multidisciplinary assistance<br>* Multidisciplinary group assistance was effected every two months by all professionals (physician, nurse, dietitian, physiotherapist and psychologist) and consisted in orientations and mechanisms to medication and non-pharmacological adherence (lifestyle changes).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Systolic and Diastolic Blood pressure |  | Measured at the first appointment and 1 year later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ambulatory care,, hypertension,, health personnel,, clinical trial
Re-examination Study of EMEND (Aprepitant) (MK-0869-184)

Study Overview
=================
Brief Summary
-----------------
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the clinical usefulness of EMEMD (aprepitant) through collecting the safety information according to the Re-examination Regulation for New Drugs.

Official Title
-----------------
Re-examination Study For General Drug Use to Assess the Safety and Efficacy Profile of EMEND in Usual Practice

Conditions
-----------------
Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: EMEND


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who are treated with EMEND for the first time as per the EMEND label Exclusion Criteria: Contraindication to EMEND

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 |
| --- | --- |
| Korean Participants Treated With EMEND (aprepitant)<br>Participants receiving EMEND on Treatment Days 1, 2, and 3 concomitantly with a corticosteroid and a 5-hydroxytryptamine 3 (5-HT3) antagonist. | Drug: EMEND<br>* EMEND (Aprepitant,125 mg oral capsules) is administered 1 hour prior to chemotherapy on treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.<br>* Other names: MK-0869;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy | The investigators assessed a participant's response to therapy with EMEND to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy when used concomitantly with other antiemetics. The response categories were: excellent (best possible anticipated response, considering the severity and stage of disease), good (good response, but less than the best possible anticipated response), fair (definite response, but could be better), poor (minimal response, unacceptable), or none (no response, absence of drug effect). | Up to 14 days following the cessation of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nausea, Vomiting, Chemotherapy, Post-chemotherapy
Mechanisms Linking Depression to Cardiovascular Risk

Study Overview
=================
Brief Summary
-----------------
To examine the role of depression on risk for cardiovascular disease in twins.

Detailed Description
-----------------
BACKGROUND: Multiple studies have demonstrated a higher risk of cardiovascular disease and worse cardiovascular disease (CVD) prognosis associated with depression that appear to synergistically and significantly adversely impact health. Because these initial studies are observational, much work remains to understand this area. If these conditions are mechanistically inter-related, identification of both conditions in the same subject may provide a means of enhancing risk stratification and most appropriately targeting therapy. If the interaction between the conditions is causal not simply associative, appropriate therapy interventions can be designed and tested. DESIGN NARRATIVE: The project is designed to clarify the role of depression on CVD risk by using a co-twin study design. The study will examine twin pairs from the Vietnam Era Twin Registry (VET). Twin pairs will be invited to participate if they meet two criteria: (1) neither has a history of CVD as of 1990 and (2) one twin is diagnosed with depression as of 1992. The study investigates the effects of depression on two indicators of early CVD: coronary flow reserve, assessed by means of Positron Emission Tomography (PET) myocardial infusion imaging; and heart rate variability (HRV) assessed by ambulatory electrocardiographic monitoring. It is hypothesized that within each pair, the twins who have clinical depression will exhibit lower coronary vascular reserve and lower heart rate variability compared with their co-twins without a history of depression. Moreover, by comparing the size of the intra-pair difference in these parameters between depression discordant monozygotic and dizygotic twins an estimate of the relative contributions of gene and environmental factors can be ascertained. In addition to the PET and HRV assessments, subjects will complete the Statistical Clinical Interview of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV SCID) to document a history of depression, a psychometric battery including the Early Trauma Inventory and Hamilton Depression Scale, and such risk factors as cigarette smoking, physical activity, blood pressure and blood lipids, glucose and insulin, indices of inflammation and thrombogenicity including levels of reactive protein C, fibrinogen, and P-selectin, and neurohormones such as adrenocorticotropic hormone, cortisol, and dehydroepiandrosterone sulphate.

Conditions
-----------------
Depression, Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
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 |
| --- | --- | --- |
Hepatitis Vaccination in HIV Infection: Role of Adjuvant Interleukin-2

Study Overview
=================
Brief Summary
-----------------
The response to vaccination for hepatitis is reduced in patients with HIV infection. The hypothesis of the study is that adjuvant interleukin-2 administered subcutaneously at the time of vaccination improves the response rate.

Conditions
-----------------
HIV Infections, Hepatitis A, Hepatitis B

Intervention / Treatment
-----------------
* Biological: Twinrix
* Biological: interleukin-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with stable antiretroviral therapy and negative for hepatitis A or B Exclusion Criteria: Prior hepatitis A or B

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Twinrix|nan|
|Biological: interleukin-2|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response to hepatitis A and hepatitis B |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interleukin-2, vaccination, treatment experienced
An Open-Label Treatment Protocol With UX003 rhGUS Enzyme Replacement Therapy for an Advanced Stage MPS 7 Patient

Study Overview
=================
Brief Summary
-----------------
Emergency access granted to treat a single patient with advanced Mucopolysaccharidosis Type 7 with UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy via IV administration every other week (QOW) for up to 144 weeks.

Official Title
-----------------
An Open-Label Treatment Protocol With UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy for an Advanced Stage Mucopolysaccharidosis Type 7 (MPS 7) Patient

Conditions
-----------------
Mucopolysaccharidosis Type 7

Intervention / Treatment
-----------------
* Drug: UX003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1 specific patient Confirmed diagnosis of MPS 7 based on leukocyte or fibroblast glucuronidase enzyme assay or genetic testing confirming diagnosis. Written informed consent of parent(s) or legal guardian(s)
Sexes Eligible for Study
-----------------
Male

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: UX003|Open Label|

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
-----------------
Mucopolysaccharidosis Type 7, Sly syndrome, UX003, Enzyme Replacement Therapy, rare disease, Lysosomal Storage Disease, metabolic disorder
A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Device: K101 nail solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients aged 18 years or older 25%-75% of the target nail altered as a result of onychomycosis Signed written informed consent Exclusion criteria Proximal subungual onychomycosis Patient who has been previously randomized to treatment in the phase III study K70-2 investigating K101 Other conditions known to cause abnormal nail appearance Use of topical (1 month before screening) and/or systemic (3 months before screening) antifungal medication. Participation in another clinical study with an investigational drug or device during the previous 4 weeks before enrolment. Known allergy to any of the tested treatment products

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: K101 nail solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients experiencing at least some improvement of the target nail (scoring 2 or more according to Global Assessment Scale) after 8 weeks treatment. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Discoloured and deformed nails resulting from onychomycosis
Study of Metformin Pharmacogenetics in Twins

Study Overview
=================
Brief Summary
-----------------
The trough concentration of metformin will be examined in monozygotic and dizygotic twins. Current twin study will determine the total weight of genetics on the trough concentration of metformin.

Official Title
-----------------
The Relation Between Heritability and the Trough Concentration of Metformin in Plasma Under Steady-state in Twins

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-40 years Both twins has to be included Dizygotic twin pairs has to be same sex Informed consent given Healthy condition Exclusion Criteria: Chronical/daily alcohol abuse Hypersensitivity to metformin Ingestion of drugs containing topiramate or x-ray contrast fluids For women: Positive pregnancy test/breastfeeding at the beginning of the trial. No use of safe anticonceptives

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br>6 days treatment with metformin | Drug: Metformin<br>* 6 days treatment with metformin to steady-state<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heritability | The trough concentrations of metformin in twin pairs will be used to determine the effect of heritability on metformin trough concentrations. This will give insight to the weight that genetic factors have on metformin pharmacokinetics at steady-state. | After 6 days of metformin treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single nucleotide polymorphisms (SNPs) | The effect of SNPs on trough metformin concentration | After 6 days treatment with metformin |
Magnesium Food Frequency Questionnaire

Study Overview
=================
Brief Summary
-----------------
The study aims to develop a quick tool to assess magnesium intakes.

Detailed Description
-----------------
The study aims to develop a quick tool to assess magnesium intakes. Participants will be asked to record a complete dietary intake for 14 consecutive days, the magnesium food frequency questionnaire along with a calcium food frequency questionnaire, and a brief participant data form. Data from the 14 day consecutive food diary will be correlated with the food frequency questionnaire.

Official Title
-----------------
Validation of a Newly Developed Food Frequency Questionnaire to Assess Magnesium Intakes

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-75 years of age Fluent in spoken and written English Exclusion Criteria: Unable to report continuous food diary for 14 days Medical conditions/medications/supplements affecting metabolism and/or magnesium or calcium status

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnesium Status | Intake (mg/day) | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium Status | Intake (mg/day) | 14 days |
Cryotherapy in the Treatment of Desmoid Tumors

Study Overview
=================
Brief Summary
-----------------
Desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. Therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose chemotherapy. Since this neoplasm remains benign, our study aims to avoid chemotherapy in patients usually young through the use of a minimally invasive treatment such as cryotherapy.

Official Title
-----------------
Cryotherapy in the Treatment of Desmoid Tumors

Conditions
-----------------
Desmoid

Intervention / Treatment
-----------------
* Procedure: Cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologic diagnosis of desmoid tumors age > 18 years abdominal and extra-abdominal desmoid tumors Exclusion Criteria: contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic/vascular structures retroperitoneal desmoid tumors age < 18 years

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br> | Procedure: Cryotherapy<br>* The procedure involves general or peripheral anesthesia and percutaneous treatment under CT control with probes capable of forming ice spheres of up to 3 cm that will be used in sufficient number to treat the neoplasm completely.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response to treatment | assessment of tumor response to treatment will be performed using the solid tumor response criteria | At baseline (time 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
desmoid tumor; cryotherapy
Individualized Neurodevelopmental Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to evaluate this therapeutic intervention by expressing functional level with valid quantitative data.

Detailed Description
-----------------
The intervention lasted 6 weeks. There were 3 sessions per week. At each session there was a part of standard physical therapy program and there was also a part with emphasis on dynamic balance exercises.

Official Title
-----------------
Individualized Neurodevelopmental Treatment

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Behavioral: standard physical therapy program with emphasis on dynamic balance exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: spastic tetraplegia Exclusion Criteria: vision problems

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 9 Years

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: standard physical therapy program with emphasis on dynamic balance exercises|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |