linjc16/ctgov huggingface dataset:
CopeSmart: Using Mobile Technology to Promote Positive Mental Health in Young People

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effectiveness of a mental health mobile app (CopeSmart) in promoting positive mental health through emotional self-awareness in adolescents. Participants will be recruited from second-level schools in Ireland. Schools will be randomly assigned to the intervention or control condition. Participants in the intervention condition will use CopeSmart for a four week period. Those in the control condition will not use any mental health app.

Official Title
-----------------
CopeSmart: Using Mobile Technology to Promote Positive Mental Health in Young People

Conditions
-----------------
General Mental Health and Well-Being

Intervention / Treatment
-----------------
* Device: CopeSmart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be between 14 and 19 years Must be enrolled in second-level education Must have access to an iPhone, iTouch or Android mobile device Must obtain signed parental consent to participate Exclusion Criteria: - No parental consent

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 19 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CopeSmart<br> | Device: CopeSmart<br>* Participants will use the CopeSmart app at least once per day for four weeks<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in levels of emotional self-awareness measured by the Emotional Self-Awareness Scale |  | Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in frequency of use of positive coping strategies measured by the Coping Strategies Inventory |  | Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up) | 
| Changes in levels of well-being measured by the WHO-5 Well-Being Index |  | Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up) | 
| Changes in help-seeking behaviour measured by the General Help-Seeking Questionnaire |  | Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up) | 
| Changes in levels of emotional distress measured by the Depression, Anxiety and Stress Scale |  | Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emotional Self-Awareness, Positive Coping, Help-Seeking
Effect of a Topical Ketamine on Acute and Chronic Pain, Dose Finding

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effect of addition of different doses of Ketamine locally in acute and chronic post-mastectomy pain after breast cancer surgery and on the probability of developing chronic post-mastectomy pain.

Official Title
-----------------
Effect of a Topical Ketamine on Acute and Chronic Post-mastectomy Pain, Dose Finding - Clinical Study

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: group (A)
* Drug: group (B)
* Drug: group (c)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - American society of heart association class I-II female patients aged 18-60 years scheduled for modified radical mastectomy with axillary dissection for breast carcinoma Exclusion Criteria: known allergy to the study drugs significant cardiac- respiratory- renal or hepatic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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 |
| --- | --- |
| Active Comparator: Group (A)<br>patients will receive 1mg / kg of Ketamine diluted by 20 ml saline (0.9 % ) | Drug: group (A)<br>* patients will receive 1mg / kg of Ketamine diluted by 20 ml saline (0.9 % ) and irrigated onto surgical field after hemostats and before skin closure.<br>|
| Active Comparator: Group (B)<br>patients will receive 2 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) a | Drug: group (B)<br>* patients will receive 2 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) and irrigated onto surgical field after hemostasis and before skin closure.<br>|
| Active Comparator: Group (C)<br>patients will receive 3 mg / kg of Ketamine diluted by 20 ml saline (0.9 %) | Drug: group (c)<br>* patients will receive 3 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) and irrigated onto surgical field after hemostasis and before skin closure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the total amount of morphine consumption | total amount of rescue analgesia | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | pain intensity measured by Visual analogue scale | 48 hours |
Human Milk Fortifier - Growth Evaluation

Study Overview
=================
Brief Summary
-----------------
It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.

Official Title
-----------------
Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier

Conditions
-----------------
Premature Birth

Intervention / Treatment
-----------------
* Dietary Supplement: Human milk fortifier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth weight ≤1500 g AND/OR gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof) Male or female Tolerating an enteral intake of human milk, donor milk or a combination at ≥100 mL/kg/d for ≥ 24 h Subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d. Written informed consent has been obtained from the legal representative(s). Exclusion Criteria: Infants with current systemic disease Infants with a history of systemic disease Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery. Small size for gestational age (SGA) - body weight ≦ 5th percentile for that gestational age. Infants diagnosed with any inherent metabolic disease. Infants diagnosed with any chromosomic disease. Receiving any commercial formula supplementation to breast milk. Receiving steroids at the time of enrollment. Participation in another nutritional clinical trial that may affect outcomes of this study.

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New human milk fortifier<br>New human milk fortifier | Dietary Supplement: Human milk fortifier<br> <br> |
| Active Comparator: Currently marketed fortifier<br>Currently marketed fortifier | Dietary Supplement: Human milk fortifier<br> <br> |
| Experimental: New human milk fortifier with new Ca source<br>a subgroup of patients will receive the new milk fortifier containing a new source of calcium. | Dietary Supplement: Human milk fortifier<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day. |  | 21 days |
Correlation Between Chronic Neck Pain and Shoulder Proprioception Among Patients With Cervical Radiculopathy

Study Overview
=================
Brief Summary
-----------------
Is there correlation between cervical radiculopathy and shoulder proprioception or not?

Official Title
-----------------
Correlation Between Chronic Neck Pain and Shoulder Proprioception Among Patient With Cervical Radiculopathy

Conditions
-----------------
Cervical Radiculopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic neck pain with unilateral cervical radiculopathy. Exclusion Criteria: has impingement syndrome ,history of instability and any systemic disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- | --- |
| Shoulder Proprioception among cervical radiculopathy patients | Percision of repositioning shoulder with closed eyes in patient with chronic neck pain and cervical radiculopathy | 15 minute |
COmpliance and Efficacy in Mono and Combination Tablet Study ATacand/Atacand Plus

Study Overview
=================
Brief Summary
-----------------
To evaluate compliance and patients' satisfaction in mono and combination treatment of Candesartan cilexetil (Atacand)/ Candesartan cilexetil 16mg, hydrochlorothiazide 12.5mg (Atacand plus) in hypertension.

Official Title
-----------------
A Prospective, Non-interventional, Observational, Multi-center Trial to Evaluate Compliance and Efficacy in Mono and Combination Treatment of Candesartan Cilexetil(Atacand)/ Candesartan Cilexetil 16mg, Hydrochlorothiazide 12.5mg(Atacand Plus) in Hypertension

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have consented to participation/data release in this study Patients diagnosed with hypertension and prescribed with atacand/atacand plus by the physician based on clinical decision Exclusion Criteria: Secondary hypertension requiring therapy other than antihypertensive medication Patients not prescribed with atacand/atacand plus based on safety reasons or any other reason as determined by the physician Women in pregnancy or lactation Patients enrolled in any other studies

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Atacand/Atacand plus, COMBAT, Compliance, Naturalistic, Observational
Safety and Efficacy Study of RTS,S AS02A/AS01B Vaccine to Prevent Malaria

Study Overview
=================
Brief Summary
-----------------
This is a double blinded study where 2 test vaccines will be evaluated to see if they protect persons who have never had malaria against malaria infection when bitten by mosquitoes.

Official Title
-----------------
Dbl-Blind, Rand Phase 1/2a Human Challenge Study, to Eval Safety, Reactogenicity, Immunogenicity and Preliminary Efficacy After Sporozoite Challenge/Rechallenge of Vaccines Containing RTS,S

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Biological: RTS,S with AS02A/AS01B adjuvant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be in good general health Be able to participate for 4-15 months Exclusion Criteria: Pregnant or planning pregnancy History of malaria or exposure to malaria in past 12 months Received an investigational malaria vaccine Past history of allergic reaction to previous immunization Positive blood tests for HIV and specific types of hepatitis

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: RTS,S with AS02A/AS01B adjuvant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and reactogenicity of the candidate vaccine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the humoral immune response to the candidate vaccine |  |  | 
| To assess the efficacy of the candidate vaccine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malaria
The Optimal Timing of a Second Autologous Peripheral Blood Stem Cell Transplantation in Patients (<61 Years) With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
Autologous peripheral blood stem cell (PBSC) transplantation is now considered standard therapy in patients (< 65 ans) with multiple myeloma. The Intergroupe Francophone du Myelome conducted a randomised trial of the treatment of multiple myeloma with high dose chemotherapy followed by either one or two successive autologous stem cell transplantation. The probabilities of event-free-survival and overall survival were doubled with a double transplant. The benefits were greatest among patients who had not had a very good partial response to the first transplant. The aim of this multicenter randomised trial in previously untreated patients with multiple myelome (stage II, III DS)is to assess the optimal timing of a second autologous stem-cell transplant.After a first-line therapy with thalidomide-dexamethasone followed by a PBSC collection, patients are randomly assigned to receive two autologous PBSC transplants (arm A)or one autologous PBSC transplant followed by a consolidation therapy with thalidomide-dexamethasone (arm B). Patients included in the arm B will receive a second transplant in case of disease progression on consolidation therapy, or in case of relapse in responders.

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Procedure: autologous PBSC transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients less than 61 years of age Durie Salmon stage II or III written and informed consent Exclusion Criteria: Prior treatment for myeloma ECOG performance score of 4 Positive HIV test Chronic respiratory disease (DLco < 60%) Systolic ejection fraction < 50% Pregnant or nursing women

Ages Eligible for Study
-----------------
Maximum Age: 61 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

| Intervention/Treatment |
| --- |
|Procedure: autologous PBSC transplant|optimal timining of a second autologous transplant|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (from randomistion) of the 2 groups at 5 years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free-survival |  |  |
HEARD (Long Term) Study - Histology of the Esophagus in Acid-Related Disease

Study Overview
=================
Brief Summary
-----------------
Determine if different levels of acid-suppression with esomeprazole for 6 months on chosen histological markers of esophageal epithelial acid-related disease in patients with upper GI symptoms.

Official Title
-----------------
An Open-Label, Parallel-Group, Multi-Centre Study to Determine the Effect of Treatment With Esomeprazole for Six Months on Histological Markers of Esophageal Epithelial Acid-Related Disease in Patients With Upper GI Symptoms.

Conditions
-----------------
Gastroesophageal Reflux, Heartburn, Dyspepsia

Intervention / Treatment
-----------------
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent 18 years or older history of upper GI symptoms Exclusion Criteria: Peptic ulcer disease upper gastrointestinal surgery malignancy

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline after 6 months in the level of ki-67 expression and histological markers of esophageal epithelial acid-related disease after acid-suppressive therapy with esomeprazole |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in immunohistochemical markers of esophageal epithelial acid-related disease after 6 months treatment with different levels of acid suppression with esomeprazole |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunohistochemical, erosive esophagitis, Acid reflux disease
Health Effects of oraL Protein Supplements in HD (The HELPS-HD Trial)

Study Overview
=================
Brief Summary
-----------------
To conduct a pragmatic randomized clinical trial in which the researchers will determine the mortality impact of a protocol whereby all hemodialysis patients receive an oral, protein-based nutritional supplement during the dialysis procedure as compared to the existing nutritional protocol whereby only hemodialysis patients with serum albumin below 3.5 g/dL and incident hemodialysis patients during the first months of care receive an oral, intradialytic protein-based nutritional supplement during the dialysis procedure.

Official Title
-----------------
Health Effects of oraL Protein Supplements in HD (The HELPS-HD Trial) An Open-Label Cluster Randomized Pragmatic Trial Evaluating the Effectiveness of Oral Intradialytic Nutritional Supplements on Mortality in Hemodialysis Patients

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Nutritional Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receipt of in-center hemodialysis in a facility participating in the trial Able to consume oral nutritional supplements Age ≥18 years Exclusion Criteria: Tube feed or intravenous feed dependent Unable to feed oneself or request help with feeding if a supplement is provided Known allergy to ingredient(s) of the supplement

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual Care Protocol<br>Facility randomized to follow the usual care nutritional supplement protocol | Dietary Supplement: Nutritional Supplement<br>* Selection of which supplement to give to the patients will be left to the dialysis unit's governing body as this study is not interested in a specific supplement's effect on nutrient restoration and subsequent outcomes but rather on oral replacement of amino acids regardless of the agent used.<br>|
| Other: Intensive Protocol<br>Facility randomized to follow the intensive nutritional supplement protocol | Dietary Supplement: Nutritional Supplement<br>* Selection of which supplement to give to the patients will be left to the dialysis unit's governing body as this study is not interested in a specific supplement's effect on nutrient restoration and subsequent outcomes but rather on oral replacement of amino acids regardless of the agent used.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | end of study - approximately 3 years |