linjc16/ctgov huggingface dataset:
Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

Study Overview
=================
Brief Summary
-----------------
Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of allergy in family

Official Title
-----------------
Double Blind, Randomised Study on the Effect of Prebiotics on Incidence of Atopic Manifestations in Infants

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Other: galactooligosaccharide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nonbreastfed eutrophic infants of corresponding gestational age presence of a positive family allergic anamnesis in parents or siblings (atopic eczema, allergic rhinitis or bronchial asthma) Exclusion Criteria: children with serious disease, breastfed children children fed another formula then the ones used

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 8 Weeks

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Galactooligosaccharides<br>addition of 0,5g galactooligosaccharides to HA (hypoallergenic) starter formula | Other: galactooligosaccharide<br>* addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides<br>* Other names: prebiotics;|
| No Intervention: Only HA formula<br>only standard HA starter formula | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORAD (SCORing Atopic Dermatitis score) assessment of atopy | objective evaluation of atopic symptoms | at 6 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometric parameters (height, weight) |  | at 6 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interventional, doubleblind, randomised, pediatric, prebiotic, atopic, dermatitis, infant
Longitudinal Twin Study - Cohort Study of Blood Pressure

Study Overview
=================
Brief Summary
-----------------
To analyze the genetic and environmental contributions of juvenile hemodynamic determinants of blood pressure, including cardiac output and systemic vascular pressure, to adult cardiovascular risk.

Detailed Description
-----------------
BACKGROUND: Identifying individuals at a young age who are at risk for future development of hypertension in adult life is a public health issue of great importance. The imperfect nature of blood pressure tracking throughout childhood and adolescence, and the fact that the genes which determine blood pressure in childhood may not be the same ones which operate in adulthood make it clear that improved predicting models are needed. The twin-parent study design allowed testing more subtle genetic and environmental hypotheses than was possible with nuclear families or twins alone. The longitudinal component permitted an analysis of developmental changes in the genetic expression of the hemodynamic determinants of blood pressure. The inclusion of unlike sex twins permitted an analysis of the consistency of genetic and environmental effects across the sexes. DESIGN NARRATIVE: The longitudinal comparison of the cardiovascular responses of adolescent twins and their parents was initialed in 1983. Three cohorts of twin families were enrolled, each cohort beginning 18 months apart. Both monozygotic and dizygotic twins were included. Variables measured included demographics, family history, personality, blood pressure, anthropometry, stage of puberty, dynamic exercise, isometric exercise, psychological stress, echocardiography, genotyping, and lipid profiles. Each cohort revisited every 18 months. A fourth cohort of 330 preadolescent twin pairs stratified by sex and zygosity was recruited from an established population-based twin registry. The hemodynamic determinants of blood pressure were assessed by non-invasive measurements of cardiac function including echocardiography and response to isometric and dynamic exercise. Zygosity was determined by questionnaire and confirmed by dermatoglyphic analysis and blood group tests. Anthropometric and hemodynamic measurements in the parents were compared to those in the children. The study included up to five sets of longitudinal measurements, thereby permitting an evaluation of whether the same or different genes operated at different ages encompassing pre-puberty, puberty, and post-puberty.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Cycling Dual-task in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Taking into account the process of functional and cognitive evolution that patients with Parkinson's disease experience throughout the evolution of the pathology, the objective of this study is to evaluate the effect of a dual-task program combining cognitive tasks and forced cycling on the functional and cognitive capacity of these patients.

Official Title
-----------------
Effects of a Cycling Dual-task Intervention on Cognition and Functionality in Parkinson's Disease: a Pilot Randomized Clinical Trial

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Cycling exercise
* Other: Cognitive tasks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson disease Hoehn and Yahr 1 and 2 Exclusion Criteria: Hoehn and Yahr >2
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 |
| --- | --- |
| Experimental: Cycling combined with cognitive tasks<br> | Other: Cycling exercise<br>* 20 minutes of cycling (90 rpm).<br>Other: Cognitive tasks<br>* 20 minutes of cognitive tasks based on the different domains of the UPDRS scale.<br>|
| Active Comparator: Cycling<br> | Other: Cycling exercise<br>* 20 minutes of cycling (90 rpm).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go | Dynamic balance | Change from Baseline Timed Up and Go at 7 weeks | 
| Sit to Stand test | Lower limbs strength | Change from Baseline Sit to Stan Test at 7 weeks | 
| Movement Disorder Society - Unified Parkinson's Disease Rating Scale | Parkinson's Disease rating | Change from Baseline Unified Parkinson's Disease Rating Scale at 7 weeks (0-159, better lower values) | 
| Parkinson's Disease Questionnaire - 39 | Quality of life | Change from Baseline Parkinson's Disease Questionnaire - 39 at 7 weeks (0-100, better lower values) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trail Making Test A & B | Attention, visual screening ability and processing speed | Change from Baseline Trail Making Test A & B at 7 weeks | 
| Stroop test | Ability to inhibit cognitive interference | Change from Baseline Stroop Test at 7 weeks |
Usefulness of Near-focus With Narrow-band Imaging

Study Overview
=================
Brief Summary
-----------------
Near-focus with narrow-band imaging is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with indio carmin spray, commonly used tool to determine tumor margin. The subject are patients who underwent endoscopic submucosal dissection for gastric neoplasms. Participants are randomized into near-focus with narrow-band imaging and indigo carmin groups. First, marking is performed at the tumor margins determined by each modality. The distance from the marking dots to the tumor margin is measured histopathologically in the resected specimens. Finally, the investigators will compare the accuracy between two groups based on the distance from marking dots to tumor margin measured by histopathologic examination.

Official Title
-----------------
Usefulness of Near-focus With Narrow-band Imaging for Determining Gastric Tumor Margin

Conditions
-----------------
Gastric Tumors

Intervention / Treatment
-----------------
* Device: Near focus with narrow band imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who undergo endoscopic submucosal dissection for gastric tumors (early gastric carcinoma or gastric adenoma) Exclusion Criteria: fail to en bloc resection

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Near focus with narrow band imaging<br>Near focus with narrow band imaging is used for marking the tumor margin. | Device: Near focus with narrow band imaging<br> <br> |
| No Intervention: Indigo carmin<br>After indigo carmine was sprayed over the lesion, marking is performed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm) | Marking was diagnosed as accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm | 1 week after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
near focus with narrow band imaging, tumor margin, indigocarmine chromoendoscopy
A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts.

Detailed Description
-----------------
This double blind, randomized controlled trial will evaluate effectiveness of two digital interventions among 391 participants. Study participation will start when participants sign consent. Participants and research assessors will be blinded to treatment assignment.

Official Title
-----------------
A Randomized, Double Blind Controlled Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic for Adult Patients With Suicidal Ideation and/or Suicide Attempts

Conditions
-----------------
Suicide, Attempted, Suicidal Ideation

Intervention / Treatment
-----------------
* Device: OTX-202
* Device: OTX-000


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages ≥18 years old Patients recently hospitalized. Owns a smartphone. Willing and able to complete enrollment procedures. Able to understand the nature of the study. Able and willing to provide at least two verifiable contacts. Exclusion Criteria: Patients who have untreated psychosis or active psychosis Patients who appear to be impaired by the use of alcohol or other substance(s) Patients who sign, or have signed, an informed consent form to participate in any clinical research Patients who upon clinical examination are cognitively impaired Patients with a medical condition that may compromise, interfere, limit, effect or reduce the subject's ability to complete

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental App + Treatment as Usual<br>This intervention will be for the treatment group | Device: OTX-202<br>* Experimental Pscyhoeducation and Intervention App<br>|
| Experimental: Other App + Treatment as Usual<br>This intervention will be for the control group | Device: OTX-000<br>* Other Pscyhoeducation App<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Columbia-Suicide Severity Rating Scale(C-SSRS) | The C-SSRS will be used to assess change in suicide behaviors at 8 separate time points from screening period to Week 104. | Screening, Week 4, Week 8, Week 12, Week 24, Week 52, Week 78, Week 104 |
Placebo Effects on Blood Pressure Induced by Expectancy Manipulation

Study Overview
=================
Brief Summary
-----------------
The objective of the present study was to examine the effects of a single placebo intervention on blood pressure and to investigate autonomic and psychological mediating mechanisms.

Official Title
-----------------
Effects of Placebos and Verbal Suggestions on Blood Pressure - Randomized Controlled Trial

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Drug: Placebo globuli
* Drug: Histaminum hydrochloricum globuli


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent Exclusion Criteria: not meeting inclusion criteria hypotension or hypertension treated or untreated hypertension or hypotension Severe systemic disorders (tumors, tbc, diabetes, asthma etc) diseases that influence the cardiovascular or gastrointestinal system intake of drugs affecting blood pressure and/or autonomic nervous system pregnancy and lactation phase body mass index >= 32 cardiovascular risk factors (diabetes, smoking) drug or alcohol abuse insufficient compliance participation in another trial within the last three months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Histaminum hydrochloricum globuli<br>To allow double-blind administration of the placebo pills going along with verbal suggestions of a blood-pressure-lowering effect | Drug: Histaminum hydrochloricum globuli<br> <br> |
| Experimental: Placebo globuli<br> | Drug: Placebo globuli<br>* placebo globuli administered together with verbal suggestions of a hypotensive drug effect<br>|
| No Intervention: No treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure (systolic, diastolic) |  | minutes 1 to 30 after intervention |
A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)

Study Overview
=================
Brief Summary
-----------------
A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of <115 mg/dL

Official Title
-----------------
A Multicenter, Open-Label Extension Study Of High-Risk Hyperlipidemic Patients Treated With An Atorvastatin Starting Dose Adapted To Their Baseline LDL-C Level

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of base study Dyslipidemia and at high risk of CHD Exclusion Criteria: Impaired liver function Gastrointestinal disease that could limit drug absorption

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Arm A<br> | Drug: Atorvastatin<br>* Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly |  | Week 52 | 
| LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels |  | Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study | 
| Percent change from baseline of base study in LDL-C, HDL-C, non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, and triglycerides in patients who were statin-naive at baseline of base study |  | Baseline and Weeks 17, 34, and 52 | 
| Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study |  | Week 52 | 
| Adverse events and laboratory test changes |  | Weeks 17, 34, and 52 | 
| Achievement of LDL-C target |  | Weeks 17 and 34 | 
| Achievement of LDL-C target by diabetic patients |  | Week 52 |
Pre and Postoperative Gait Analysis of Randomized Patient to 2 Different Cement Fixation Methods

Study Overview
=================
Brief Summary
-----------------
The primary goal of Total Hip Replacement (THR) surgery in the treatment of hip osteoarthritis is to reduce pain and restore hip function in order to increase patient mobility and quality of life. Two different cement fixation methods are used in order to insert THR implants. This will be done before and after surgery in 2 groups randomized to either of 2 cement fixation methods. Gait analysis preoperative and 2 year after surgery.

Detailed Description
-----------------
The primary goal of Total Hip Replacement (THR) surgery in the treatment of hip osteoarthritis is to reduce pain and restore hip function in order to increase patient mobility and quality of life. Patients with radiological signs of osteoarthritis of the hip, hip pain and functional disability may be treated with insertion of a THA. Two different fixation methods are used in order to insert THR implants. Cemented fixation using bone cement, polymethyl methacrylate (PMMA) is the most commonly used fixation method in Sweden. A new bone cement, Refobacin®, already marketed in Germany is planned to be introduced in Sweden in late 2018. The hospital is also equipped with a modern gait laboratory were the functional gait performance can be evaluated. This will be done before and after surgery in 2 groups randomized to either of 2 cement fixation methods. The subjects will undergo gait analysis befor and 2 year after surgery.

Official Title
-----------------
Pre and Postoperative Gait Analysis of Randomized Patients to 2 Different Cement Fixation Methods

Conditions
-----------------
Gait Analysis, Hip Arthritis, Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Other: Gait analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hip arthritis Exclusion Criteria: no hip arthritis
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative<br>Gait analysis kinematics and kinetics | Other: Gait analysis<br>* Gait analysis<br>* Other names: Kinematics and kinetics;|
| Experimental: Postoperative<br>Gait analysis kinematics and kinetics | Other: Gait analysis<br>* Gait analysis<br>* Other names: Kinematics and kinetics;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematics | Hip angels in 3 planes | Preop | 
| Kinematics | Hip angels in 3 planes | Postop 2 year |