linjc16/ctgov huggingface dataset:
Does Administration of Probiotics During Infancy Increase the Caries Risk of a Child

Study Overview
=================
Brief Summary
-----------------
Aim: to examine caries occurrence in children who ten years ago received a mixture of probiotics during infancy. Hypothesis: the administration of probiotics during infancy has no effect on future dental health.

Official Title
-----------------
Early Administration of Bifidobacterium Lactis BB-12 and the Caries Occurence of Children a 4 Years of Age

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics in infant milk formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child participated in the probiotic milk intervention study in early 2000 Child lives now within 100 km from Turku Exclusion Criteria: Child has a chronic illness affecting dental health Child lives now outside 100 km from Turku

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotics in milk formula<br>B. lactis BB-12 and L. rhamnosus GG delivered in milk formula during the first year of infancy | Dietary Supplement: Probiotics in infant milk formula<br>* Probiotic infgant milk formula administered during the forst year of life<br>* Other names: B.lactis BB12 and L.rhamnosus GG in milk formula;|
| Placebo Comparator: Control milk formula<br>The children received milk formula with no probiotics | Dietary Supplement: Probiotics in infant milk formula<br>* Probiotic infgant milk formula administered during the forst year of life<br>* Other names: B.lactis BB12 and L.rhamnosus GG in milk formula;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries occurence |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral microbial colonization |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotics, Caries, Oral flora
A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;

Official Title
-----------------
A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates

Conditions
-----------------
Cow Milk Allergy

Intervention / Treatment
-----------------
* Dietary Supplement: Amino acid based formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: less than 18 months old with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive Skin prick test (>=6mm) or specific immunoglobulin E >= 5 kilo-unit/L or combination still symptomatic while fed an extensively hydrolysed formula Exclusion Criteria: Exclusively breast fed infants non allergic digestive enteropathy

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 18 Months

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: New Thickened Amino acid based formula<br> | Dietary Supplement: Amino acid based formula<br> <br> |
| Active Comparator: Amino acid based formula<br> | Dietary Supplement: Amino acid based formula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of withdrawal for intolerance |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypersensitivity, Milk Hypersensitivity, Immune System Diseases, Food Hypersensitivity
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.

Official Title
-----------------
A Prospective, Open Label Protocol to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male and females aged 18 to 75 Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression Exclusion criteria: Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney. Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose). Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline. Other inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EC MPS<br> | Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Month evaluation |  |  | 
| patient and graft survival |  |  | 
| acute rejection (suspected or biopsy confirmed) |  |  | 
| graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate), |  |  | 
| infections, adverse events, serious adverse events. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplantation, enteric-coated mycophenolate sodium
Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to define if the auditory stimulation during stepping verticalization sessions with Erigo is able to modify the cerebral electric activity or improve consciousness in patients affected by vegetative state or minimally conscious state.

Conditions
-----------------
Consciousness Disorders

Intervention / Treatment
-----------------
* Other: Erigo + Music
* Other: Erigo + Metronome
* Other: Erigo + Silence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vegetative State or Minimally Conscious State diagnosis >3 months from acute brain injury Exclusion Criteria: No clinical stability Sepsis Orthopaedic contraindications for verticalization Deep Vein Thrombosis weight >130 Kg height >210 cm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music<br>Erigo + Music: During each stepping verticalization session the patient receives auditory stimulation (earphones) with previously preferred music | Other: Erigo + Music<br>* The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with Erigo (3/week for 5 consecutive weeks) and musical stimulation.<br>|
| Active Comparator: Metronome<br>Erigo + Metronome: During each stepping verticalization session the patient receives auditory stimulation (earphones) with a metronome (rhythmic with the stepping movement) | Other: Erigo + Metronome<br>* The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with Erigo (3/week for 5 consecutive weeks) and metronome stimulation.<br>|
| Active Comparator: Silence<br>Erigo + Silence: During each stepping verticalization session the patient does note receive any auditory stimulation. | Other: Erigo + Silence<br>* The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with Erigo (3/week for 5 consecutive weeks), without auditory stimulation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Coma Recovery Scale revised score |  | 0 and 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Levels of Cognitive Functioning score |  | 0 and 35 days | 
| change in Disability Rating Scale score |  | 0 and 35 days | 
| change in quantitative EEG parameters |  | 0 and 35 days | 
| change in Glasgow Coma Scale score |  | 0 and 35 days |
Insulin Glulisine in Healthy Lean and Obese Subjects

Study Overview
=================
Brief Summary
-----------------
Primary objective To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin glulisine across healthy subjects in 4 different BMI-classes (lean, overweight, moderately obese, severely obese), using the euglycemic clamp technique with the Biostator™. Secondary objective To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous administration of insulin glulisine in comparison to insulin lispro and to investigate the safety and tolerability after subcutaneous administration of insulin glulisine in comparison to insulin lispro.

Official Title
-----------------
Pharmacodynamic and Pharmacokinetic Properties of Insulin Glulisine (Apidra) in Comparison to Insulin Lispro (Humalog) in Healthy Lean and Obese Subjects

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Insulin Glulisine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Normal HbA1c Women have to either be postmenopausal, surgically sterilized, or not pregnant and using adequate contraception. Exclusion criteria : Systemic concomitant medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin Glulisine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the serum insulin glulisine concentration and insulin lispro concentration |  | During the Study Conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure blood glucose |  | During the study conduct | 
| To measure glucose infusion rate |  | During the study conduct | 
| To measure the serum C-peptide |  | During the study conduct | 
| Adverse events collection |  | from the inform consent signed up to the end of the study |
Errors of Refraction Among Primary School Children

Study Overview
=================
Brief Summary
-----------------
This study will include primary school children to evalute their refraction and follow those who will wear glasses to detect their compliance. Visual acuity will be measured using autorefractometer after cycloplegic eye drops 3 times and glasses will be prescribed for those who are needed. Follow up of the students to detect their compliance of wearing correction.

Official Title
-----------------
Errors of Refraction: Prevalence and Compliance of Wearing Correction Among Primary School Children

Conditions
-----------------
Error, Refractive

Intervention / Treatment
-----------------
* Diagnostic Test: Visual acuity measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary school student less than 12 years. No sensory defect in those children. Exclusion Criteria: Corneal opacity. Abnormal fundus lesion.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Visual acuity measurement|Visual acuity will be measured using autorefractometer after cycloplegic eye drops 3 times and glasses will be prescribed for those who are needed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity improvement | Measurement of visual acuity after wearing of glasses | 3 months |
Feasibility Study of the NEW NORMA-SENSE

Study Overview
=================
Brief Summary
-----------------
In-vitro study Collect data regarding the color appearance on the new developed indicator strips (NEW NORMA-SENSE), in contact with vaginal secretion with elevated pH Measure the buffering capacity of vaginal secretion from non-symptomatic and symptomatic subjects Detect these indicator strips' performance, in contact with urine

Detailed Description
-----------------
This in-vitro study was designed to collect data regarding the color appearance on the new developed indicator strips (NEW NORMA-SENSE) when coming in contact, in-vitro, with vaginal secretion with elevated pH, and to measure the buffering capacity of vaginal secretion from non-symptomatic subjects and symptomatic subjects, and to detect these indicator strips' performance when come in contact with urine.

Official Title
-----------------
Feasibility Study of the NEW NORMA-SENSE Indicator Strip and Vaginal Secretion Buffer Capacity Measurement - IN-VITRO Study.

Conditions
-----------------
Vaginal Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women, aged between 18 and 45, with or without symptoms of vaginal infection. Subjects are ready to sign the informed consent form. Exclusion Criteria: Subjects are unable or unwilling to cooperate with the study procedures. Subjects are currently participating in another clinical study that may directly or indirectly affect the results of this study. Subjects that suffer from vaginal bleeding or menstruate. Subjects that have had sexual relations within the last 12 hours. Subjects that applied local antiseptic, antibiotic or vaginal treatment within the last 3 days. Subjects that applied vaginal douching within 12 hours prior to the visit at the clinic.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaginal infection, color appearance, new developed indicator strips (NEW NORMA-SENSE), in-vitro, vaginal secretion, elevated pH
Coenzyme q 10 and Fertility Outcome in Women With Clomiphene Resistant PCOS

Study Overview
=================
Brief Summary
-----------------
The study evaluates the effect of coenzyme q 10 on ovulation and subsequent pregnancy in women with polycystic ovarian syndrome. Half of the participants will receive coq10 and ovulation induction with clomiphene and other half would receive a placebo with clomiphene.

Official Title
-----------------
Combined Coenzyme Q10 and Clomiphene Citrate for Ovulation Induction in Clomiphene-citrate-resistant Polycystic Ovary Syndrome

Conditions
-----------------
Coenzyme q10

Intervention / Treatment
-----------------
* Drug: Coenzyme Q10
* Drug: clomiphene citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of polycystic ovarian syndrome PCOS based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS (2003). All women were previously treated with 100 mg of CC daily for 5 days per cycle, for two to three cycles with persistent anovulation or ovulate with very thin endometrium <5 mm at the time of hCG administration Exclusion Criteria: Non-consenting. known autoimmune disorders prior treatment of endometriosis or surgery to reproductive tract prior history of pelvic inflammatory disease those with tubal factors and uterine factors as assessed on history and confirmed by normal hysterosalpingogram. Thyroid disorder as assessed by history examination and TSH level Patients with raised FSH

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clomiphene<br>clomiphene citrate 150 mg once a day for 5 days | Drug: clomiphene citrate<br>* ovulation induction drug<br>* Other names: clomid;|
| Experimental: clomiphene and coenzyme q10<br>clomiphene citrate 150 mg once a day for 5 days and coenzyme q 10 120 mg each day | Drug: Coenzyme Q10<br>* antioxidant used to decrease oxidative stress and improve fertility prospects<br>* Other names: celeron sr;Drug: clomiphene citrate<br>* ovulation induction drug<br>* Other names: clomid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of ovulating women | transvaginal ultrasound as the disappearance of the leading follicle, presence of follicular fluid in the Douglas pouch and midluteal progesterone >5 pg/ml. | 1-2 months | 
| number of pregnancies | ultrasound visualization of gestational sac with pulsating fetal pole | 1-2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovulation induction, coenzyme q10, pregnancy rate
Treatment Pattern of NOACs (Non-vitamin K Oral Anticoagulants) in Outpatient Users in Colombian Databases

Study Overview
=================
Brief Summary
-----------------
This population-based descriptive study will characterize first-time users of three NOACs (rivaroxaban, dabigatran and apixaban) in prevention of stroke in non-valvular atrial fibrillation (SPAF) patients and will assess the patterns of drug utilization in routine general practice in Colombia

Official Title
-----------------
Treatment Pattern of NOACs (Non-vitamin K Oral Anticoagulants) in Outpatient Users in Colombian Databases - TREND Colombia

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Data Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First prescription of NOACs (rivaroxaban, dabigatran and apixaban) in the outpatient setting. Non valvular Atrial Fibrillation (NVAF) Patients aged ≥18 years at least one year of enrollment in the Audifarma database one year since first encounter with healthcare provider will be included in the study Exclusion Criteria: Patients with any record of index drug prescription prior to the enrolment period. Patients who qualify as members of more than one cohort study on the same day

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 |
| --- | --- |
| SPAF patients in Colombia_Rivaroxaban<br>First time users of rivaroxaban in the Audifarma database | Other: Data Collection<br>* Data will be extracted from July 2009 to the last available database extraction<br>|
| SPAF patients in Colombia_Dabigatran<br>First time users of dabigatran in the Audifarma database | Other: Data Collection<br>* Data will be extracted from July 2009 to the last available database extraction<br>|
| SPAF patients in Colombia_Apixaban<br>First time users of apixaban in the Audifarma database | Other: Data Collection<br>* Data will be extracted from July 2009 to the last available database extraction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age |  | At Baseline | 
| Sex |  | At Baseline | 
| Co-morbidity |  | At Baseline | 
| Healthcare utilization | Primary Care Physicians visits, Outpatient visits and Hospital admissions | Up to 2 years | 
| Proportion of Naive to non-naive patient |  | At Baseline | 
| Dose at first prescription |  | Up to 6 years | 
| Duration of treatment |  | Up to 6 years | 
| Discontinuation |  | Up to 6 years | 
| Switch to another study drug |  | Up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time trends of usage of study medications |  | Up to 6 years |