linjc16/ctgov huggingface dataset:
Mental Health and Resilience in Emerging Adulthood

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine differences in selected psychiatric/psychological variables between a sample of unemployed young adults who have dropped out of high school and a sample of college students.

Official Title
-----------------
Mental Health and Resilience in Emerging Adulthood

Conditions
-----------------
Depression, Anxiety, Personality Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18-25 years old who have dropped out of school and who are currently unemployed Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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 |
| --- | --- |
| People who have dropped out of school<br> | |
| College students (control group)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of axis-1 disorders in the sample. | Participants will be subject to an assessment with the MINI International Neuropsychiatric Interview, resulting in an overview of axis-1 psychiatric disorders in the sample. | Within 6 months of enrolment |
Ultrasound Predictors of Difficult Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
This prospective observational study aims to investigate about the efficacy of spine ultrasound in predicting difficult spinal anesthesia

Official Title
-----------------
The Use of Ultrasound to Predict a Difficult Spinal Anesthesia: a Prospective Single-blind Observational Study

Conditions
-----------------
Anesthesia, Procedural Complication

Intervention / Treatment
-----------------
* Diagnostic Test: Spinal Ultrasound
* Procedure: Spinal Anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing spinal anesthesia for elective surgery ASA physical status score < 4 Exclusion Criteria: Contraindications to regional anesthesia ASA physical status score ≥ 4 Patient's refusal or inability to sing the informed consent Previous spine surgery affecting the intervertebral space chosen for spinal anesthesia

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Spinal Ultrasound|Spinal Ultrasound is performed by an observer who records ultrasound characteristics of the intervertebral space chosen by the anesthetist who will practice spinal anesthesia|
|Procedure: Spinal Anesthesia|Spinal anesthesia is performed by an anesthetist after the observer recorded ultrasound characteristics of the intervertebral space chosen by the anesthetist, who is blinded to the ultrasound evaluation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound View | Ultrasound visibility of Dura Mater complexes on the intervertebral space chosen for spinal anesthesia | 10 minutes | 
| Difficulty in performing spinal anesthesia | Difficult spinal anesthesia includes: failure, procedure lasting more than 400 seconds from the insertion of the needle to the deliquoration; a number of needle replacements greater than 10; a change of the clinician practicing spinal anesthesia. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure Rate | Failed Spinal Anesthesia | 20 minutes | 
| Duration | Spinal anesthesia duration (expressed in seconds) from the insertion of the needle to the deliquoration | 20 minutes | 
| Spinal needle replacements | Number of needle replacements | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Anesthesia, Ultrasound
Irbesartan in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of this multicenter, doubleblind, randomized study was to investigate the renoprotective effect of irbesartan treatment in patients with type 2 diabetes and microalbuminuria (a precursor of diabetic kidney disease). 590 patients were randomized to a median 24 months of treatment with 300 mg irbesartan once daily, 150 mg irbesartan once daily or placebo. Time to development of overt nephropathy, defined by persistent proteinuria, was the primary outcome measure.

Official Title
-----------------
The Irbesartan in Patients With Type 2 Diabetes and Microalbuminuria (IRMA 2)

Conditions
-----------------
Microalbuminuria, Type 2 Diabetes, Hypertension

Intervention / Treatment
-----------------
* Drug: Irbesartan treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes. Hypertension. Persistent microalbuminuria. Serum creatinine concentration of no more than 1.5 mg per deciliter (133 µmol per liter) for men and no more than 1.1 mg per deciliter (97 µmol per liter) for women. - Exclusion Criteria: Nondiabetic kidney disease. Cancer. Life-threatening disease with death expected to occur within two years. Indication for angiotensin-converting- enzyme (ACE) inhibitors or angiotensin-II-receptor antagonists. -

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Irbesartan treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of overt nephropathy |  |  |
Prevention of Cow's Milk Allergy in Children

Study Overview
=================
Brief Summary
-----------------
Impact of fermented milk in prevention of cow's milk allergy in new born and infants

Official Title
-----------------
Use of Fermented Milk in Prevention of Cow's Milk Allergy in New Born and Infant

Conditions
-----------------
Milk Hypersensitivity

Intervention / Treatment
-----------------
* Other: Fermented milk
* Other: Standard milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mother before the 5th month of pregnancy mother agreeing to stop consumption of yogurts and fermented milks during the 3rd quarter of pregnancy mother agreeing to receive a calcium supplementation during the 3rd quarter of pregnancy atopic mother or father and at least another atopic member (sister or brother) parents having given written informed consent adhesion to eviction regimen for mother and child parents agreeing with a regular follow-up (3 visits and monthly phone call with the dietician) Exclusion Criteria: mother in an exclusion period from another study parents refusing to sign the informed consent infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator known or suspected immunodeficiency in the family
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: 1<br>Fermented milk | Other: Fermented milk<br>* Formula used for non breastfed children or in complement of breastfeeding<br>|
| Active Comparator: 2<br>Standard milk | Other: Standard milk<br>* Formula used for non breastfed children or in complement of breastfeeding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensibilisation and cow's milk allergy |  | 4, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitization or allergy to other allergens |  | 4, 12 and 24 months | 
| Atopic diseases (atopic dermatitis, asthma) |  | 4, 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergy, cow's milk, sensibilisation, fermented milk, infant formula
Assessing the Impact of a Mode of Vitamin D Supplementation (Sequential Dose vs Daily Dose) on the Incidence of Hypercalciuria in Subjets Aged From 2 to 18 Years

Study Overview
=================
Brief Summary
-----------------
Recommendations for vitamin D supplementation for subjets between 2 and 18 years offer strong sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3 months. Data from the literature show a further increase in the incidence of oxalo-calcium stones in children and adolescents associated with hypercalciuria with training Randall plates, essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and urinary calcium excretion, these data lead to the question of increased sensitivity in some children with vitamin D, sensitivity could explain these situations with hypercalciuria increase the gallstone risk. This increased sensitivity to vitamin D may unmask particularly if inputs of high doses of vitamin responsible then a transient hypercalciuria with development of microcrystals.

Official Title
-----------------
Evaluation de l'Impact d'un Mode de supplémentation en Vitamine D (Dose séquentielle vs Dose Quotidienne) Sur l'Incidence de l'Hypercalciurie Chez Des Sujets Des départements du Gard et de l'Hérault agés de 2 à 18 Ans. Etude contrôlée randomisée en 2 Groupes parallèles

Conditions
-----------------
Transient Hypercalciuria

Intervention / Treatment
-----------------
* Drug: Cholecalciferol sequential dose
* Drug: Cholecalciferol daily dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 2 to 17 years included Obtaining informed consent of the parents signed Participants aged 18 years included

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholecalciferol sequential dose<br>cholecalciferol : 100 000 Unit International (UI), sequential dose (2 mL) | Drug: Cholecalciferol sequential dose<br>* sequential dose administration of the treatment<br>* Other names: Vitamin D;|
| Experimental: Cholecalciferol daily dose<br>cholecalciferol : 1000 UI, daily dose during 28 days (0.1 ml by day) | Drug: Cholecalciferol daily dose<br>* daily dose administration of the treatment<br>* Other names: Vitamin D;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from calcium level in urines at day 7, day 14 and day 28 |  | day 7, day 14 and day 28 |
Fenoldopam and Acute Renal Failure

Study Overview
=================
Brief Summary
-----------------
Patients undergoing cardiac surgery could develop postoperative acute renal failure requiring renal replacement therapy. Fenoldopam, already used for patients with hypertensive emergencies, could improve renal function in critically ill patients with or at risk for acute renal failure.

Official Title
-----------------
Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.

Conditions
-----------------
Acute Renal Failure

Intervention / Treatment
-----------------
* Drug: fenoldopam
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients who underwent cardiac surgery have Risk of Acute Renal Failure (R of RIFLE score) Exclusion Criteria: glaucoma already on renal replacement therapy study drug in the past 30 days inclusion in other protocols

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fenoldopam<br>Fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days | Drug: fenoldopam<br>* fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days<br>* Other names: corlopam;|
| Placebo Comparator: Placebo<br>Placebo (normosaline), continuous perfusion | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients requiring Renal Replacement Therapy |  | participants will be followed for the duration of intensive care unit stay, an expected average of one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of dead patients. |  | Participants will be followed for 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fenoldopam, acute renal failure, renal replacement therapy, mortality, cardiac surgery, cardiac anesthesia, intensive care unit
Anthropometric Measurements and Balance in Children With Diabetes Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Type 1 diabetes mellitus is the most common chronic metabolic disorder in children. Diabetic children who take proper nutrition and good care attain normal growth status. Factors affecting growth in diabetic patients include gender, age at diagnosis, duration of disease, glycemic control, and puberty status. Moreover, diabetes mellitus has negative impact on vestibular system, affect proprioception and lower limb muscle fatigue resulting in reduced balance.

Detailed Description
-----------------
Limited literature is available regarding the relation between anthropometric measurements and balance in children with diabetes mellitus. Therefore, the current study will be conducted to investigate the relation between anthropometric measurements (weight, height and body mass index) and balance in children with diabetes mellitus.

Official Title
-----------------
Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Other: children with Diabetes Mellitus, Type 1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as controlled T1DM. Age ranges from 7 to 11 years. From both sexes. Duration of the disease 3 to < 5 years. Same socioeconomic level. Exclusion Criteria: Other hormonal diseases (hypothyroidism or hyperthyroidism). Hereditary sensory and autonomic neuropathy Significant visual disorders. Subjects participating in regular sports activities. History of fracture or surgery in the lower extremities in the past 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 11 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: children with Diabetes Mellitus, Type 1|assessment of Relation between anthropometric measurements and balance in children with type 1 diabetes|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| balance | HUMAC balance system will be used to assess balance | baseline assessment | 
| weight anthropometric measurement | the anthropometric measurement will be conducted using universal weight scale | baseline assessment | 
| height anthropometric measurement | the anthropometric measurement will be conducted using universal height scale | baseline assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, anthropometric measurements, balance, Diabetes Mellitus, Type 1
Uterine Elastography: a Potential Predictor of Embryo Transfer Success

Study Overview
=================
Brief Summary
-----------------
To determine if the mean elasticity value (measured in kilopascals, kPa) of a patient's endometrium, myometrium and cervix in a sonographically normal appearing uterus predict frozen embryo transfer (FET) success and long term reproductive outcomes when measured the day prior to FET.

Official Title
-----------------
Uterine Elastography: a Potential Predictor of Embryo Transfer Success

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Diagnostic Test: Uterine Elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients, 18yo-45yo, presenting for ultrasound the day prior to embryo transfer Patients planning to undergo single embryo transfer (SET) of a euploid embryo by Preimplantation genetic testing for aneuploidy (PGT-A) Uterine evaluation prior to transfer (saline sonogram or hysteroscopy) within 1 year Egg recipients Exclusion Criteria: Gestational carriers BMI > 35 Diagnosis of a uterine anomaly History of uterine surgery, excluding polypectomy, c-section, D&C Communicating hydrosalpinx Transfer of an embryo of unknown ploidy status or embryos of undetermined safety Surgically retrieved sperm Embryos that were cryopreserved on day 7 of development Poor quality embryos defined by modified Gardner grading criteria used in the embryology lab Sonographically abnormal appearing uteri, including distortions from leiomyomas and thin endometrium

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women undergoing euploid, single frozen embryo transfer<br>Women age 18yo-45yo undergoing euploid, single, frozen embryo transfer with sonographically normal appearing uterus without uterine factor infertility | Diagnostic Test: Uterine Elastography<br>* Shear wave elastography data will be obtained at the transvaginal ultrasound visit the day prior to frozen embryo transfer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Implantation Rate | number of fetal heart beats at time of discharge ultrasound | 6 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemical Pregnancy | Positive serum bHCG level | 8-10 days after embryo transfer | 
| Clinical Pregnancy | presence of gestational sac on ultrasound | 2-4 weeks after embryo transfer | 
| Clinical Pregnancy Loss | loss of gestational sac, yolk sac, fetal pole, fetal heart beat on ultrasound after being present | 2-40 weeks after embryo transfer |
Ultrasound-Guided Erector Spinae Plan Block in Patients Undergoing ESWL

Study Overview
=================
Brief Summary
-----------------
Extracorporeal shock wave lithotripsy (ESWL) is widely used in the treatment of urinary tract stones and is generally applied to outpatients. To achieve fragmentation in ESWL, shock waves must be applied with sufficient power and time. Providing effective analgesia during this procedure is crucial to the success of the procedure. Erector Spinae Plan Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in urinary system surgery. This study aimed to investigate the efficacy of ESPB in patients undergoing ESWL.

Official Title
-----------------
The Analgesic Efficacy of Ultrasound-Guided Erector Spinae Plan Block in Patients Undergoing ESWL

Conditions
-----------------
Urinary System Stones, Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 ml
* Drug: 5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-II patients undergoing Extracorporeal Shockwave Lithotripsy Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group ESPB<br>Ultrasound-guided erector spinae plane block with 10 ml %0.5 bupivacaine and 10 ml %2 lidocaine | Drug: Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 ml<br>* Erector spinae plane block, 30 min before the ESWL procedure.<br>|
| Active Comparator: Group NSAII<br>lidocaine 5% gel and 800 mg ibuprofen intravenously | Drug: 5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously<br>* 5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously, 30 min before the ESWL procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Opioid consumption during procedure | Intraoperative 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Score | Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) | Intraoperative 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extracorporeal Shockwave Lithotripsy, Erector Spinae Plane Block