linjc16/ctgov huggingface dataset:
A Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis

Study Overview
=================
Brief Summary
-----------------
Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when administered in adequate amounts, confer health benefit to the host.Based on this previous knowledge on the beneficial effects of probiotics during pro-inflammatory conditions of the gastrointestinal tract, investigators hypothesized that oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).Investigators conducted a prospective, multicenter, randomized and controlled trial to assess whether oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).

Official Title
-----------------
A Prospective Multicenter Randomized Controlled Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis

Conditions
-----------------
Probiotics, Hirschsprung's Disease Associated Enterocolitis

Intervention / Treatment
-----------------
* Drug: Bifico


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria consists of all patients suffering from HD at an age of less than 13 years old, and HD is confirmed by postoperative pathological examination, barium enema and anorectal manometry. Exclusion Criteria: Age> 13 years old Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or can not thrive. Patients are complicated with congenital gastrointestinal malformations (such as anal stenosis, intestinal atresia stenosis), metabolic and endocrine diseases caused by organic constipation and functional constipation in children. Children are complicated with liver, kidney dysfunction, blood disorders, immune deficiency diseases and significant ECG abnormalities. Children have taken oral antibiotics, microecological modulator, yogurt, other gastrointestinal motility drugs which can affect the gut flora. Drug allergies, or allergic diseases.. Poor compliance with oral probiotics treatment.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br> | Drug: Bifico<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probiotics Prevent Hirschsprung's Disease Associated Entercolitis |  | two years |
Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)

Study Overview
=================
Brief Summary
-----------------
Cow's milk allergy may be involved in the evolution of sleep apnea in infants. The study will assess the effects of specifies diet changes (i.e. non-milk based formula) on the infant. Specifically , infants will be investigated by sleep studies in order to test this hypothesis.

Official Title
-----------------
Cow's Milk Allergy in Infants With Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Non milk or soy based formula
* Dietary Supplement: milk based formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Polysomnographically diagnosed OSA Age is 2-24 months Clinical suspicion of milk allergy due to findings in the medical history or physical exam Exclusion Criteria: Congenital defects in the pulmonary and gastrointestinal systems Family history of genetic diseases or familial syndromes Infantile asthma.

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 24 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Non milk or soy based formula<br>25 infants , non milk or soy based formula . | Dietary Supplement: Non milk or soy based formula<br>* Babies will be given a non milk or soy base formula for 12 weeks<br>|
| Active Comparator: 2<br>Intervention with milk based formula will be given to 25 infants. | Dietary Supplement: milk based formula<br>* Babies will be given a milk based formula for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change). |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea syndrome, The study examines the response of infants diagnosed with obstructive sleep apnea syndrome to diet changes
Place of Flixovate® in the Treatment Pathway and Its Conditions of Use in Infants Aged From 3 to 12 Months Between 2010 and 2012 by French GPs and Private Paediatricians

Study Overview
=================
Brief Summary
-----------------
this study has been request by french health authorities to evaluate the use of flixovate in infants and its place in the treatment pathway. this study has 2 main pbjectives: 1/ Evaluation of changes in the prescription share of Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012. 2/Description of the conditions of use of Flixovate® in infants aged less than 12 months (infant profile, dosage form, dosage, treatment duration, prior, concomitant and subsequent treatments etc.).

Official Title
-----------------
Place of Flixovate® in the Treatment Pathway and Its Conditions of Use in Infants Aged From 3 to 12 Months Between 2010 and 2012 by French GPs and Private Paediatricians

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Analysis of changes in share of prescriptions: Infants who received at least one prescription of topical steroids between 1st January 2010 and 31st December 2012. Infants aged 3 to 12 months on the day of prescription of topical steroids. Description of the conditions of use and patient profiles: Infants who received at least one prescription of topical steroids between 1st January 2010 and 31st December 2012. Infants aged 3 to 12 months on the day of prescription of topical steroids. Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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 |
| --- | --- | --- |
| Description of the conditions of use of Flixovate® in infants aged less than 12 months | data collected and analysed: Profile of prescribers (age, sex, geographic location), Profile of infants (age, age group, gender, Z-score, medical history), Conditions (diagnoses corresponding to prescriptions of Flixovate®, dosage, mean duration of treatment and duration in classes, previous treatment, concomitant medications, treatments prescribed after discontinuation of Flixovate®. (emollients and other topical steroids). | baseline | 
| - Evaluation of changes in the prescription share of Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012. | data collected and analysed: Profile of prescribers (age, gender, geographical location). Number of prescriptions of Flixovate® and other topical steroids by class, INN and brand name | baseline, one year, 2 years, 3 years |
To Study the Characteristics of Different Types of Vertigo in Patients Attending the Ear Nose & Throat (ENT) Clinics.

Study Overview
=================
Brief Summary
-----------------
The VERTIGO study is likely to help determine characteristics of different types of vertigo in patients presenting in the Ear Nose & Throat (ENT) clinics with complaints of dizziness. Moreover, it will also help to develop an understanding about the current management practices of this condition at local level.

Official Title
-----------------
To Study the Characteristics of Different Types of Vertigo in Patients Attending the ENT Clinics.

Conditions
-----------------
Vertigo

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients 18 years of age and older Patients with vestibular vertigo of known or unknown origin Patients who are willing and able to provide written informed consent Exclusion Criteria: Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion based on clinical judgment Patient with psychiatric disorders, significant neurological disorder or spinal cord damage that would make the evaluation difficult for the investigator Patients who are not willing to give informed consent Patients with a known history of hypersensitivity to betahistine Patients with a history of pheochromocytoma

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 |
| --- | --- |
| Dizziness<br>Patients with Dizziness | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics (Different Types) of dizziness | It will be determined that a patient with dizziness is suffering from what type of Vertigo i.e. Benign Paroxysmal Positional Vertigo, Menier's Disease, Vestibular Neuritis, Labyrinthitis or any other. As these are clinical types of Vertigo these cannot be measured in units | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QoL) of patients at baselines | Dizziness Handicap Inventory will be used | 6 months | 
| Management of vertigo currently in practice | As per practice of the physician/Investigator. Management of Vertigo is either by certain maneuvers such as Epley's and Simont or by medications. For the maneuvers, no unit can be defined. The information for medication which will be collected will be Name (preferably the generic name), Dose, Units (form of the medicine), Route and Frequency. | 6 months | 
| QoL of patients post treatment | Dizziness Handicap Inventory will be used | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vertigo, Dizziness
Opioid-Free Study in Arthroscopic Rotator Cuff Repair

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and test an opioid-free pain control protocol for patients undergoing arthroscopic rotator cuff repair.

Official Title
-----------------
Opioid Free Arthroscopic Rotator Cuff Repair: A Prospective Observational Trial

Conditions
-----------------
Rotator Cuff Tears

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients over the age of 18 clinically indicated for an Arthroscopic Rotator Cuff Repair (ARCR) Exclusion Criteria: Patients with irreparable rotator cuff tears allergic or sensitivity to the study medication intolerance to pain protocol history of gastrointestinal issues renal disease any evidence of glenohumeral arthritis

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 |
| --- | --- |
| Arthroscopic Rotator Cuff Repair<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to fulfill oxycodone prescription | data collected to the time from surgery until the patient chooses to fulfill a prescription for opioid medication following surgery | within first 3 days of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain (Visual Analog Scale) | patient-reported pain as measured on a scale from 0-10. Zero means no pain and 10 being worst pain imaginable | Post-operative day 3 | 
| Patient satisfaction | Patient will be asked on a 5 point likert scale to rate their satisfaction with their post-operative pain regime | Post-operative day 3 |
Virtual Reality Laparoscopy Training

Study Overview
=================
Brief Summary
-----------------
The use of virtual reality simulation training in obstetrics and gynecology has not been widely studied. The investigators hypothesized that residents randomized to the trainer would not perform differently when compared with those who are not randomized. Residents in Obstetrics and gynecology are randomized to a 4 month training course on our simulator. They are objectively evaluated performing various laparoscopy tasks prior to and after the course.

Official Title
-----------------
Prospective Randomized Trial of Virtual Reality Simulator Training in an Obstetrics and Gynecology Residency

Conditions
-----------------
Differences in OSATS Scores

Intervention / Treatment
-----------------
* Other: Trainer Curriculum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident in OB/Gyn at TriHealth Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Other


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trainer Curriculum<br> | Other: Trainer Curriculum<br> <br> |
| No Intervention: No Curriculum<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| observed structured assessment of technical skills (OSATS) Score | The residents are timed in seconds on various laparoscopy tasks. They are also rated by an objective blinded observer in several performance categories and given a score by the observer. These times and scores are recorded upon entry into the study, after randomization to intervention or no intervention. | 0 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| observed structured assessment of technical skills (OSATS) score | The residents are timed in seconds on various laparoscopy tasks. They are also rated by an objective blinded observer in several performance categories and given a score by the observer. These times and scores are recorded 4 months after entry into the study. | 4 Months |
Internal Limiting Membrane Flap in the Management of Retinal Detachment Due to Paracentral Retinal Breaks

Study Overview
=================
Brief Summary
-----------------
To describe the technique and outcomes of using either inverted or free internal limiting membrane flap in the management of retinal detachment due to paracentral retinal breaks.

Detailed Description
-----------------
This retrospective observational case series includes nine patients received surgery for retinal detachment due to paracentral retinal breaks developed either from primary rhegmatogenous orgin, or secondary iatrogenic retinal breaks after prior membrane peeling or during surgery for tractional retinal detachment. Either inverted or free internal limiting membrane flaps were inserted in the identified breaks, followed by air fluid exchange and gas tamponade. Visual acuity and structural changes were evaluated.

Official Title
-----------------
Internal Limiting Membrane Flap in the Management of Retinal Detachment Due to Paracentral Retinal Breaks

Conditions
-----------------
Retinal Detachment, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with retinal detachment and posterior paracentral retinal breaks located within the equator from January 2017 to January 2018 Exclusion Criteria: Patient with macular hole Patient with other ocular diseases including ocular hypertension, optic nerve atrophy, glaucoma or chronic uveitis
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 |
| --- | --- | --- |
| re-attachment rate of retinal detachment | re-attachment of retina through examination including fundoscopic exam and optical coherent tomography exam | within 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | visual acuity in logMAR | within 3 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinal Detachment; internal limiting membrane flap; retinal paracentral breaks
Monoamine Transporter Function and Autonomic Regulation During Psychodynamic Psychotherapy

Study Overview
=================
Brief Summary
-----------------
Outcome of psychodynamic psychotherapy measured by [123I] nor-B-CIT SPET imaging Background Psychodynamic psychotherapy is a widely practised form of psychotherapy in the treatment of depression. There is evidence that serotonin transporter (SERT) densities are altered in depression. Preliminary observations have suggested that SERT function may recover in connection with dynamic psychotherapy. The objective was to determine whether SERT densities change in relation to clinical recovery during psychodynamic psychotherapy.

Detailed Description
-----------------
N=26 Method Twenty six drug-naïve currently depressed (moderate/severe) patients with no previous treatment were recruited for the study. The baseline study included a group of 18 healthy controls. The patients were randomised into psychotherapy and waiting-list control groups. For controls, psychotherapy was started after a 6-month waiting period. [123I] nor-B-CIT SPET imaging was performed at baseline and after 12 months of psychotherapy. For the controls, additional imaging was performed after the 6-month waiting period.

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: depression Exclusion Criteria: antidepressive medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| 1<br>Case-group | |
| 2<br>Control-group | |

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
-----------------
Psychotherapy, depression
Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy

Study Overview
=================
Brief Summary
-----------------
Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs AEDs alone. Serum magnesium, seizure control and Intelligent quotation (IQ) will be done at base line and after 6 months of treatment.

Detailed Description
-----------------
The Aim of this work was to study the effect of Magnesium as add on therapy on clinical seizure control in drug resistant idiopathic epilepsy and IQ.

Official Title
-----------------
Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy: A Pilot Study

Conditions
-----------------
Drug Resistant Epilepsy

Intervention / Treatment
-----------------
* Dietary Supplement: Magnesium
* Drug: Placebo - Concentrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with drug resistant idiopathic epilepsy Exclusion Criteria: Structural, Metabolic, Infectious and Unknown etiology epilepsy Any neurological disease other than epilepsy Any nutritional disorder Any other systemic diseases (including Renal disease, Cardiac arrhythmia) Drug intake other than antiepileptic drugs (AED)

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium add-on<br>20 children with drug resistant epilepsy will receive oral magnesium sulfate 6 ml per day which equivalent to 400 mg elemental magnesium (Yuen & Sander, 2012) for 6 months and their regular antiepileptic drugs. | Dietary Supplement: Magnesium<br>* Oral magnesium<br>|
| Placebo Comparator: Antiepileptic drugs only<br>20 children with drug resistant epilepsy will receive their regular antiepileptic drugs and placebo for 6 months. | Drug: Placebo - Concentrate<br>* Placebo will be given<br>|
| No Intervention: Healthy controls<br>To asses serum magnesium level for comparison with the intervention group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure control | Change from base line seizure frequency, severity (Chalfont scale) at 6 months. | 6 months | 
| IQ improvement | Change from base line IQ (Wechsler Intelligence Scale-Revised for Children and Adults) | 6-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, IQ, Idiopathic epilepsy, Magnesium supplementation, Seizure control, Chalfont score