linjc16/ctgov huggingface dataset:
A Smartphone Application for Screening of Developmental Disorders in Children

Study Overview
=================
Brief Summary
-----------------
The detection of developmental disorders in the child is often late because the parents do not have the information necessary to consult at the first clinical signs. For example, the diagnosis of autism spectrum disorders is made at the age of 5, so earlier diagnoses are possible earlier or even in the 1st year with appropriate questionnaires. An application (Malo) has been developed to allow through regular questionnaires from 1 month to 3 years old to assess the child's development by his parents in the form of a digital health record assessing several areas at regular intervals (monthly the 1st year then every 3 to 12 months): sensory, psychomotor development, sleep, height and weight, cognitive and addictions (especially to screens). The questions will be adapted to the age of the child. An alert suggesting to consult the general practitioner or the pediatrician will be generated according to an algorithm validated by a committee of experts. Based on a study model on health data already carried out as part of the triage application for patients suspected of COVID 19 coronavirus disease.fr with 14 million users in 6 months having improved the relevance of calls to the 15 (8 times fewer unnecessary calls) and general practitioners. This study will assess parental interest in this application.

Official Title
-----------------
A Smartphone Application for Screening of Developmental Disorders in Children: a Prospective Feasibility Study

Conditions
-----------------
Development, Child

Intervention / Treatment
-----------------
* Device: web-application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent of a child or more under 3 years of age (1 month to 3 years) Exclusion Criteria: Parent of a child who has already been diagnosed with a developmental disorder, known physical or mental disability

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 3 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Users<br>Users of the web-application | Device: web-application<br>* web application for monitoring children's development<br>* Other names: MALO;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| usefulness | number of users who find the application useful | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alert | Description of alerts triggered by algorithms | 6 months | 
| Consultation | Number of relevant consultations (or teleconsultations) after an alert | 6 months | 
| postpartum depression | Number of women in postpartum depression | 6 months |
Validation of a Prediction Score for Recurrent C. Difficile Infection: Implementation for Treatment Algorithm Strategies

Study Overview
=================
Brief Summary
-----------------
The objective of the present study is to derive a high-risk R-ICD prediction rule and a prospective implementation of this prediction rule.

Detailed Description
-----------------
For objectives 1 and 2, a retrospective study of the microbiology database will be carried out and the medical records will be consulted to collect the variables included in Annex 2. The other prediction rules to be compared are those of Cobo et al., Reigadas et al and Gerding et al. We will review a total of 215 patients according to the calculation of the sample size (see section) A prospective study will also be carried out in which the positive patients for C. difficile determined by the Microbiology Service of the General University Hospital Gregorio Marañón will be included. The medical records of the selected cases will be reviewed. All patients included in the prospective study (Objective 3) will receive the information sheet and consent sheet that they must sign for this study (Annex 1). These patients will be followed and the variables included in Annex 2 will be collected.

Official Title
-----------------
Validation of a Prediction Score for Recurrent C. Difficile Infection: Implementation for Treatment Algorithm Strategies

Conditions
-----------------
Clostridium Difficile Infection

Intervention / Treatment
-----------------
* Behavioral: Retrospective
* Behavioral: Prospective


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For the retrospective cohort, those patients with a positive sample for ICD will be randomly selected from the microbiology database. For the prospective cohort: after the routine identification of a case of DCI by the microbiology laboratory, those new cases will be included in the study. Exclusion Criteria: Children under 18 years or patients with <3 faeces not trained in the last 24 hours will not be included.

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 |
| --- | --- |
| Retrospective group<br> | Behavioral: Retrospective<br>* Those patients with a positive sample for ICD will be randomly selected from the microbiology database.<br>|
| Prospective group<br> | Behavioral: Prospective<br>* After the routine identification of a case of DCI by the microbiology laboratory, those new cases will be included in the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Create Score | Create a high risk of recurrence score by reviewing a retrospective cohort of patients with DCI. | 31 december 2020 |
Study Evaluating Rapamune in Patients After Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions

Official Title
-----------------
An Open Label Post Marketing Surveillance Assessment to Evaluate the Effectiveness and Safety of Rapamune in Patients After Kidney Transplantation Receiving a Rapamune Containing Regime

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

Intervention / Treatment
-----------------
* Drug: sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having received a renal allograft from a cadaveric or living donor with low or moderate risk of developing acute rejection episodes. Exclusion Criteria: Contraindications according to Summary of the Product Characteristics (SmPC).
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>sirolimus | Drug: sirolimus<br>* Tablet, dosage is determined by trough level<br>|

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
-----------------
Kidney transplants
Observational Study With InnoLet® in Daily Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this study is to review the efficacy and safety of insulin treatment with InnoLet® in daily clinical practice.

Official Title
-----------------
A Prospective, Open, Uncontrolled, Observational Study With Innolet in Daily Clinical Situations According to the Product Labelling, Without Any Study Specific Investigations

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin human


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus (Type 1 or type 2) Need insulin treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Insulin human<br> | Drug: insulin human<br>* Insulin human delivered with the InnoLet® device was prescribed according to product labelling to subjects in need of insulin treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events: Serious and non-serious |  |  |
A Study to Assess the Concentration of Budesonide in Breast Milk From Asthmatic Women

Study Overview
=================
Brief Summary
-----------------
The purpose to measure the concentration of budesonide in breast milk of asthmatic mothers on their normal maintenance treatment with budesonide (Pulmicort Turbuhaler), and to estimate the exposure of budesonide to infants.

Official Title
-----------------
An Open Single Centre Study to Assess the Concentration of Budesonide in Breast Milk From Asthmatic Women on Maintenance Treatment w/Pulmicort ® Turbuhaler ® at the Dose Levels 200/400 µg Bid

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Pulmicort (budesonide) Turbuhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be willing and able to comply with study procedures and provide informed consent. Be breast-feeding women, aged 18 to 45 years inclusive, and having infants aged 1 to 6 months. Be asthmatics that have been on maintenance treatment with Pulmicort Turbuhaler 200 or 400 µg bid for at least 3 months prior to visit Exclusion Criteria: Clinically relevant abnormalities in physical examination, laboratory assessments, blood pressure or pulse as judged by the investigator. Clinically relevant disease and/or abnormalities, which in the opinion of the investigator, may either put the patient or infant at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study. A suspected/manifested infection of HIV, hepatitis B or C or other infection according to WHO Risk classification 2-4
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pulmicort (budesonide) Turbuhaler|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concentration of budesonide in breast milk from asthmatic women |  |  | 
| on maintenance treatment with Pulmicort Turbuhaler |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of budesonide to the infant from breast milk concentrations |  |  |
Non-interventional Study to Evaluate Arimidex in Postmenopausal Women With Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate Arimidex 6 month therapy as an adjuvant treatment in postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.

Official Title
-----------------
ARIMIDEX Study ( Non-interventional Study to Evaluate Arimidex in Adjuvant Therapy in Partial or Complete Response or Stabilized Disease After First Line Chemotherapy in Postmenopausal Women With Advanced Breast Cancer)

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

Intervention / Treatment
-----------------
* Drug: anastrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients to be included in the program are that ones according to the indications specified in the Romanian anastrozole (Arimidex) approved SmPC (attached to the protocol)and who are already treated with anastrozole for at least 1 month before inclusion in this program/non-interventional study. Exclusion Criteria: Patients not to be included in the programme: patients who have a known hypersensitivity to anastrozole (Arimidex®) or any of its excipients.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

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

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
-----------------
Advanced breast cancer, Advanced breast cancer in postmenopausal women
Effect of Cervical Vagal Blockade on Cough Incidence in Non-intubated Uniportal Video-assisted Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
Currently, there is a trend toward non-intubated anesthesia methods for video-assisted thoracic surgery in our hospital. During the surgery, intrathoracic vagus nerve blockade is suggested for inhibit cough reflex in previous paper. However, right and left side of vagus nerves both deep near the aorta or trachea respectively. To achieving the procedure may induce cough reflex by lobar traction even result vital organ damage. This study aims to apply alternative vagus nerve blockade at neck level via ultrasound guidance and test if the procedure real reduce cough reflex then previous method. We also follow up the patient's vital sign, vocal cord and diaphragm movement, horner syndrome and hoarseness to evaluating if cervical vagal blockade has the potential risk involve other surrounding nerves

Official Title
-----------------
Effect of Cervical Vagal Blockade on Cough Incidence in Non-intubated Uniportal Video-assisted Thoracoscopic Surgery

Conditions
-----------------
Video-assisted Thoracoscopic Surgery

Intervention / Treatment
-----------------
* Procedure: Cervical Vagal Blockade
* Procedure: Without Blockade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults younger than 80 years old are scheduled for one-port video assisted thoracic surgery Exclusion Criteria: Anticipated difficult airway, Respiratory insufficiency,Vocal cord palsy,diaphragm palsy parkinsonism,previous stroke,tachycardia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical Vagal Blockade<br> | Procedure: Cervical Vagal Blockade<br>* Cervical Vagal Blockade with 0.5 % ropivacaine 2.5 ml and 2% xylocaine 2.5 ml<br>|
| Placebo Comparator: Without Blockade<br> | Procedure: Without Blockade<br>* Without Blockade<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Cervical Vagal Blockade on Cough Incidence | number of coughing episodes | During the VATS procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vagus nerve block
Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.

Official Title
-----------------
A Clinical Trial for the Assessment of Safety and Efficacy of the UltraSOUND Mediated InTerVentional Treatment of Resistant Hypertension

Conditions
-----------------
Uncontrolled Hypertension

Intervention / Treatment
-----------------
* Device: Ultrasound-based Renal Denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uncontrolled hypertension (defined as SBP ≥ 140 mmHg during 24Hr Ambulatory BP monitoring) Current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic) Renal artery diameter ≥5mm by digital angiography Accessibility of renal vasculature Exclusion Criteria: Estimated GFR < 45 Type 1 Diabetes Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal denervation<br>Subjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications. | Device: Ultrasound-based Renal Denervation<br> <br> * Other names: Sound TX System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse events | All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in office blood pressure measurement |  | 30 days, 3 months, 6 months, 9 months, 12 months | 
| Change from baseline in ambulatory 24-hour blood pressure measurement |  | 6 months, 12 months | 
| Change from baseline in renal artery dimensions | Change in renal artery dimensions as measured by renal angiography, CT, or MRI | 30 days | 
| Change from baseline in creatinine |  | 6 months | 
| Adverse events and device complications |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, uncontrolled hypertension, resistant hypertension
Effect of Dural Release on Women With Back and Neck Pain After Obstetrics and Gynecological Surgery

Study Overview
=================
Brief Summary
-----------------
Something must be done in order to release the tension within the dura mater before any lasting correction of the spine can be effected. Each of the cranial nerves is wrapped in a sheath of dura mater. As they exit the cranial vault they are described by Gray's Anatomy as having a dural cuff.

Official Title
-----------------
Effect of Dural Release on Women With Back and Neck Pain After Obstetrics and Gynecological Surgery

Conditions
-----------------
Back Pain

Intervention / Treatment
-----------------
* Other: cranioscaral treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age of the participants will be ranged from 20 to 40 years. Their body mass index will be ranged from 20 to 25 kg/m2. They will have regular menstrual cycle. They will not receive any hormonal therapy or taking any regular drugs. Exclusion Criteria: Bone disease. Discogenic state with radiculopathy or not. Systemic disease of musculoskeletal system. Any sensory problems. Previous vertebral fractures. Major spinal structural abnormality.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group (group A):<br>15 women take cranioscaral treatment | Other: cranioscaral treatment<br>* dural release<br>|
| control group (group B):<br>shame group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index | BMI in kg/m^2 | 3 months | 
| Satisfaction assessed by the VAS | Degrees of menstrual pain will be assessed using a VAS, which was a method of representing subjects' pain on a 10 cm linear scale. Score of 0 meant 'no pain' and 10 meant 'worst pain'. Tomeasure specific symptoms | 3 months | 
| a pressure-pain threshold | algometer Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability | 3 months |