linjc16/ctgov huggingface dataset:
Identification and Characterization of Genetic Variants in Hereditary Angioedema

Study Overview
=================
Brief Summary
-----------------
This project aims to analyse in an unbiased way the existence of genetic variants that contribute to explaining and predicting the differences in clinical expression between patients with HAE.

Official Title
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Identification and Functional Characterization of Genetic Variants Associated With Specific Clinical Phenotypes in Hereditary Angioedema Due to C1 Inhibitor Deficiency: An Unbiased Approach

Conditions
-----------------
Hereditary Angioedema With C1 Esterase Inhibitor Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (≥ 18 years old) with HAE-C1INH diagnosis (confirmed by mutation in SERPING1 gen or immunochemical study showing a decrease in C1INH function <50% in two determinations together with a family history (symptomatic patients' group) Patients ≥ 22 years old with C1INH hereditary deficiency (confirmed by mutation of SERPING1 gene or immunochemical study showing a decrease in C1INH function <50% in two determinations together with a family history) and who have not developed symptoms consistent with HAE-C1INH Signed informed consent. Exclusion Criteria: No confirmed C1INH deficiency. Inability to sign the informed consent. Presence of recurrent angioedema with histaminergic characteristics (response to treatment with antihistamines, glucocorticoids and/or epinephrine)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic patients<br>Adult patients (≥ 18 years old) with hereditary angioedema with C1INH deficiency (HAE-C1INH) from different regions of Spain will be included. Patients included in the study will be divided into two groups: a) symptomatic, which will be those who present symptoms compatible with HAE-C1INH and who have a confirmed diagnosis | |
| Asymptomatic patients<br>Asymptomatic patients, which will be those with a C1INH deficiency and who have not developed symptoms of HAE. Asymptomatic patients must be at least 22 years old and meet the same criteria than those symptomatic, except for the presence of symptoms consistent with HAE-C1INH | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Set of validated disease-modifying genetic variants in Spanish patients with HAE-C1INH | To identify and characterize novel genetic variants associated with the incomplete penetrance and variable clinical expressivity observed in HAE-C1INH patients. | Day 1 |
Long Term Follow up in Pediatric Supracondylar Humeral Fracture

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to learn about long term outcomes in Supracondylar Humeral Fracture in children after surgery. The main questions it aims to answer are: how good is the elbow function what are the post-operative complication what is the time before return to sport what is the aesthetic prejudice of the scar for the patient Participants will answer questionnaries and send photographs of their elbows to the examinator

Detailed Description
-----------------
Elbow fractures represent 5% of total fracture in children. Supracondylar humeral fractures compound half of them. As distal humerus is responsible for only 20% of humeral growth, bone remodelage her is less important compared to other sites in children.. Many different attitudes are possible : orthopedic reduction, open reduction, percutaneous pinning ... No methode as clearly demontrated a superiority. Percutaneous pinning as been widely used the last years though We haven't find any study evaluating long term outcomes regarding functionnal and aesthetic outcomes in supracondylar humeral fracture treated by percutaneous pinning.

Official Title
-----------------
Long Term Follow up in Pediatric Supracondylar Humeral Fracture After Surgical Treatment

Conditions
-----------------
Supracondylar Humerus Fracture, Elbow Fracture

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Children operated for a supracondylar humeral fracture in university hospital of Grenoble from July 2011 to December 2019 Exclusion Criteria: Opposition from patient or parents to participate Children who did not effectively suffered a supracondylar humeral fracture

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome after supracondylar humeral fracture | Pediatric-Adolescent Shoulder and Elbow Survey (PEDI ASES), rate from 0 to 84, 0 is poor and 84 is excellent | 1 day | 
| functional outcome after supracondylar humeral fracture | FLYNN'S CRITERIA | 1 day | 
| functional outcome after supracondylar humeral fracture | range of motion mesured in degrees | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative complication | identify number and type of complication | 1 day | 
| time before return to sport | time in days before return to sport | 1 day | 
| aesthetical prejudice | The Patient and Observer Scar Assement Scale (POSAS), rate from 7 to 70, 7 is excellent and 70 is poor | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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long term follow up
Micro- and Macro-Circulation in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major morbidities (stroke, acute kidney injury, prolonged intubation, mediastinitis, surgical reopening, death). The state of sublingual microcirculation, of peripheral microcirculation and cardiovascular control will be assessed in 100 patients undergoing cardiac surgery during general anesthesia before the intervention and at the end of the intervention at the arrival in post-surgery ICU by means of signal processing techniques. The extracted markers will be used to assess a statistical prediction model of major morbidities.

Official Title
-----------------
Micro- and Macro-Circulation in Cardiac Surgery Patients

Conditions
-----------------
Cardiac Surgery, Coronary Artery Bypass Graft, Surgical Aortic Valve Replacement

Intervention / Treatment
-----------------
* Diagnostic Test: Acquisition of cardiovascular signals and microcirculation sidestream darkfield images


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 yrs indication for a cardiac surgery intervention spontaneous sinus rhythm informed consent Exclusion Criteria: know autonomic nervous systems pathologies or dysfunctions pregnancy

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: Acquisition of cardiovascular signals and microcirculation sidestream darkfield images|ECG, arterial pressure and peripheral flow velocity via a percutaneous laser doppler will be acquired together with images of the sublingual microcirculation detected with sidestream darkfield images microscope|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of major morbidities by means of the variability of cardiovascular and hemodynamics markers | Statistical model assessment; time series variability analysis | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autonomic nervous system, heart rate variability, cardiac surgery, major morbidities
Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA

Study Overview
=================
Brief Summary
-----------------
To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA.

Official Title
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A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA

Conditions
-----------------
Intestinal Malabsorption

Intervention / Treatment
-----------------
* Drug: ELGN-2112
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female preterm infant born less than 26 weeks GA or Intra-Uterine Growth Restricted infants born between 26+0 to 31+6 GA. Birth weight ≥ 450g Singleton or twin birth Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 5 Days

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ELGN-2112 Human insulin [rDNA]<br> | Drug: ELGN-2112<br>* To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* A placebo formulation consisting of the same inactive ingredients as ELGN-2112.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA | Safety will be assessed by capturing of adverse events (AEs) during the treatment period. | Five days from birth until 42 days | 
| Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born IUGR infants<3rd percentile* born at 26-32 weeks GA. | Safety will be assessed by capturing of adverse events (AEs) during the treatment period. | Five days from birth until 42 days |
The Socket Shield Technique, a Prospective Cohort Study of 20 Patients

Study Overview
=================
Brief Summary
-----------------
23 implants with socket shield were followed for 18 months. buccal bone thickness and survival rates registered.

Detailed Description
-----------------
Aims: This study aims to collect data on implant survival, bone volume maintenance, and complications associated with the socket shield technique. Materials & methods: The study involved the placement of 23 implants using the socket shield technique in 20 patients. AstraTech EV implants were used, and no bone substitutes or connective tissue grafts were applied. Patients were monitored for 18 months, recording implant survival, volumetric bone analysis on CBCT scans, interproximal bone levels, bone sounding, pink esthetic scores, and complications. Prosthetic procedures were also described, including temporary and final restorations.

Official Title
-----------------
The Socket Shield Technique: Stability of the Buccal Peri-implant Bone After Partial Root Removal - a Prospective Cohort Study of 20 Patients, With 18 Months Follow-up

Conditions
-----------------
Peri-implant Health

Intervention / Treatment
-----------------
* Device: oral implant placement with socket shield technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Hopeless teeth suitable for immediate implant placement Only single-rooted teeth in the maxilla Intact buccal and palatal bone plate Intact buccal root portion Any periodontal phenotype (thin, thick) Exclusion Criteria: • Horizontal root fracture below bone level Smoking Systemic pathology influencing bone healing Active periodontal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: oral implant placement with socket shield technique<br>cohort of 20 patients in need of tooth replacement with oral implant | Device: oral implant placement with socket shield technique<br>* tooth is split in socket shield configuration, implant is immediately placed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| buccal bone thickness | thickness as measured on cbct scan | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative survival rate | implant survival | 18 months |
Multi-Cancer Early Detection (MCED) of Firefighters

Study Overview
=================
Brief Summary
-----------------
This study is an an observational prospective cohort research study to explore the performance of new blood and urine tests for the early detection of cancer among firefighters.

Official Title
-----------------
Multi-Cancer Early Detection (MCED) of Firefighters

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: MCED


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Currently employed as a firefighter, full-time or part-time Taking part in Vincere's First Responder Cancer Screening Program Able to donate blood and urine sample Able to provide informed consent to participate in the study Exclusion Criteria: Deemed medically unfit for sample donation Personal history of cancer in the last 5 years (with the exception of non-melanoma skin cancer)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Firefighters who receive multi-cancer early detection (MCED) test<br> | Other: MCED<br>* multi-cancer early detection (MCED) test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, positive and negative predictive performance values (PPV and NPV) to detect cancer using Elypta's MCED test, as measured in plasma, in urine, and in plasma and urine combined |  | Up to 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Multi-Cancer Early Detection, MCED
Metacognitive Awareness, Pediatric Nursing, Students, Academic Achievement

Study Overview
=================
Brief Summary
-----------------
Metacognitive Awareness Pediatric Nursing Students Achievement

Detailed Description
-----------------
The study was carried out at Faculty of Nursing Damanhour University Egypt. The Faculty of Nursing has nine different scientific nursing departments including pediatric nursing department. Pediatric nursing is one of the main courses was taught for the students enrolled in the third year in each term in the third scholastic year. Each term is consisting of 15 weeks. The clinical training (rotation) is given 12 hours /week. The present study subjects comprised of 150 students. The sample size was determined by using EPI Info 7 program using the following information: Population size = 500 (total no. of pediatric nursing students during the 2nd term of the academic year 2022 -2023), expected frequency =50%, acceptable error= 10%, confidence coefficient = 99%, which revealed a simple size = 125.

Official Title
-----------------
Association Between Metacognitive Awareness of Pediatric Nursing Students and Their Academic Achievement: A Correletional Study

Conditions
-----------------
Achievement

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Pediatric nursing students Third year 19-23 years Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 23 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pediatric Nursing Achievement tool | It was developed by the researchers guided by the Pediatric Nursing notes that was developed by the Pediatric Nursing Staff of the Faculty of Nursing Damanhour University (2020) | three months | 
| Metacognitive Awareness Inventory | It consisted of 52 items divided into two broad parts; the first part: Knowledge about cognition (17 items). The second part: Regulation of cognition (35 items) | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
1 - Metacognitive Awareness, 2 - Pediatric Nursing, 3 - Students Achievement
Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study

Study Overview
=================
Brief Summary
-----------------
Patients affected by breast cancer undergo radiotherapy with bare chest and can therefore live the moments in which they undress in front of the radiation therapy technologists (RTTs) in charge of their treatment as an extremely embarrassing one. Furthermore, for some of these patients the relationship with their bodies has indeed changed since surgery (i.e. mutilations, scars), particularly for specific age or socio-economic groups. In this context, sub-standard care in maintaining modesty during breast cancer radiotherapy has been reported in literature, even if poorly studied. Aim of this multicentric observational study is to describe how modesty is perceived by patients undergoing radiotherapy for breast cancer.

Official Title
-----------------
Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study

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

Intervention / Treatment
-----------------
* Behavioral: Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients undergoing adjuvant radiotherapy for breast cancer Able to understand and sign informed consent Exclusion criteria Patients with inadequate linguistic abilities and inability to express informed consent Patients denying informed consent Patients receiving palliative treatments Patients affected by major psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Breast cancer patients undergoing radiotherapy in adjuvant setting<br> | Behavioral: Test<br>* A specific self-test composed by 16 questions , will be administered to BC patients undergoing adjuvant RT.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary aim of this study is to identify patients perception of modesty during RT for breast cancer through the use of a dedicated 16 items questionnaire validated in a Delphi consensus for the purposes of this study |  | 1-5 weeks |
Spinal Manipulation With Laser Therapy Versus Dry Needling in Chronic Lower Backache

Study Overview
=================
Brief Summary
-----------------
To determine the effectiveness of spinal manipulation with laser therapy versus dry needling for pain, disability and fear of movement in chronic low backache

Official Title
-----------------
Spinal Manipulation With Laser Therapy Versus Dry Needling in Chronic Lower Backache: Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Diagnostic Test: Spinal Manipulation With Laser Therapy
* Diagnostic Test: Dry Needling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those patients will be included in the study who have chronic low back pain (12 week duration). both genders aged 18-60 years low back pain Exclusion Criteria: Those patients will be excluded in the study who have needle phobia, any infection, cancer, dermal changings, heart transplant, pregnancy, rheumatic fever(25)fracture, cauda equina syndrome, arrhythmia, sensory deficiency, mental illness, surgery, osteoporosis, low term use of steroid

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Manipulation With Laser Therapy<br> | Diagnostic Test: Spinal Manipulation With Laser Therapy<br>* Spinal Manipulation With Laser Therapy in Chronic Lower Backache<br>|
| Other: Dry Needling<br> | Diagnostic Test: Dry Needling<br>* Dry Needling in Chronic Lower Backache<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index scale |  | 6 Months |