linjc16/ctgov huggingface dataset:
Double Flap Technique for Macular Hole

Study Overview
=================
Brief Summary
-----------------
Double flapping technique to close the macular hole.

Detailed Description
-----------------
Recently, it is agreed to close the macular hole with the retinal innermost layer; which is called internal limiting membrane (ILM), in most cases, the hole closes. But, sometimes the ILM single flap might displace resulting in a persistent hole. Therefore, the investigators tried to make two flaps utilizing ILM, and sometimes certain patients have a very thin membrane over the retina; it is called epiretinal membrane (ERM). The investigators use the double flapping technique by utilizing ERM; therefore, the ILM remains and can be used if the hole resists closing with the first surgical interventions. Here, the investigators did not use any new materials with unknown side effects on the human retina. Although the flap technique is well known; however, investigators are making a double flap to decrease the chance of persisting macular holes. The visual recovery will be appeared in the post-operative period, whether it is the same, better, or worse.

Official Title
-----------------
Double Flap Technique Utilizing ERM and ILM for Macular Hole

Conditions
-----------------
Macular Holes

Intervention / Treatment
-----------------
* Other: Surgical intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full thickness macular hole Exclusion Criteria: Partial-thickness macular hole Vitreomacular traction
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: Double flap technique to secure macular hole closure.<br>Single ILM flap technique is already performing worldwide; however, sometimes it is associated with flap displacement. To overcome this issue, the double flap technique was tried. | Other: Surgical intervention<br>* Pars Plana Vitrectomy for Macular Hole Closure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular coherence tomography | The closure of the hole can be assessed clearly | The fourth week post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Double Flaps
Ability of Muscle Imaging and Motor Function Measure (MFM) to Detect Changes in Disease Progression in Ambulant Spinal Muscular Atrophy Patients Compared to Healthy Volunteers.

Study Overview
=================
Brief Summary
-----------------
This non-drug, single center, 24-week, longitudinal study in ambulant spinal muscular atrophy (SMA) patients and in age- and gender-matched healthy volunteers will assess the detection of disease progression by magnetic resonance imaging (MRI) and the Muscle Function Measure (MFM) test. Each participant will be evaluated in three testing sessions: at baseline, at Week 12 and at Week 24. Both patients and volunteers will undergo MRI scans. Patients will additionally undergo testing of motor function and have blood samples taken for Survival of the Motor Neuron (SMN) genes, proteins and mRNA analysis.

Official Title
-----------------
A SINGLE CENTER, LONGITUDINAL, NON-DRUG STUDY TO ASSESS THE ABILITY OF MUSCLE IMAGING AND OF MOTOR FUNCTION MEASURE (MFM) TO DETECT CHANGES IN DISEASE PROGRESSION IN AMBULANT SPINAL MUSCULAR ATROPHY (SMA) PATIENTS AS COMPARED TO AGE-MATCHED HEALTHY CONTROLS

Conditions
-----------------
Healthy Volunteer, Muscular Atrophy, Spinal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects, aged >/= 10 years at screening For SMA patients: Confirmed clinical diagnosis of 5q-autosomal recessive SMA, ambulant at time of screening, and prefereably without spinal cord fixation Exclusion Criteria: Previous (3 months or less) or concomitant participation in any other therapeutic trial Known or suspected cancer Other chronic disease or inadequate renal, liver, or heart function Contraindications for MRI scans, including but not limited to: claustrophobia, pacemaker, artifical heart valves, cochlear implants, presence of foreign metal objects in the body, intracranial vascular clips, etc. Any contraindications to MRI found on a standard radiography scan.

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| Age- and gender-matched controls<br> | |
| Patients with spinal muscular atrophy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in quantitative muscle MRI based on fat content and T2 values |  | At baseline, Week 12 and Week 24 | 
| Disease progression, assessed through the Motor Function Measure test |  | At baseline, Week 12 and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression, assessed with the 6-minute Walk Test. |  | At baseline, Week 12 and Week 24 | 
| Levels of Survival of Motor Neuron (SMN) RNA |  | At baseline and Week 24 | 
| Levels of SMN proteins |  | At baseline and Week 24 |
Thrombophilia and Thyroid Autoimmunity in Implantation Failure and Recurrent Miscarriage

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate the incidence of both, inherited and adquired thrombophilia, and thyroid autoinmunity in unknown infertility (UI), implantation failure (IF) and recurrent miscarriage (RM). To focus on these particular disorders and to rule out another potential confounding variables, 4 particular groups of women were created. Only young women (< 38 years old), patients whose previous preimplantation genetic screening (PGS) cycles displayed an acceptable rate of aneploidies, and women without organic uterine abnormality, autoimmune disease or endocrine disorder were included in the study.

Conditions
-----------------
Thrombophilia, Thyroid Autoimmunity

Intervention / Treatment
-----------------
* Procedure: blood analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The control group included 32 oocyte donors, 18-35 years old, white caucasian, with normal karyotype, no miscarriages, and previous healthy live born infants without pregnancy complications. The UI group consisted of 31 couples with > 1 year infertility , < 38 years of age, normal ovarian function, normal hysterosalpingography and transvaginal ultrasound scan of the uterus and ovaries, normal karyotype in both parents, and normozoospermia. The IF group included 26 couples with 3.9±1.1 IVF failures with embryo transfer of at least 2 good quality embryos. They were < 38 years old, white caucasian, and had normal uterus by vaginal ultrasound and/or hysterosalpingography/ hysteroscopy. Moreover, endocrine disorders or autoimmune diseases were ruled out, a normal karyotype was found in both parents. The male had a sperm concentration > 5 mill/ml.They also had a PGS cycle with ≥ 60% of normal embryos. The group of women with RM (n = 30) had 3.2±1.3 (range: 2-9) previous miscarriages. They were < 38 years old, white caucasian, with normal uterus by vaginal ultrasound and/or hysterosalpingography/ hysteroscopy. Also, no endocrine anomalies or autoimmune diseases were found, and both parents had normal karyotype. Sperm concentration was > 5 mill/ml. Only 6 women had 2 miscarriages (20%) and the remaining 24 women at least 3. They also had a PGS cycle with ≥ 60% of normal embryos.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Teneligliptin-Glimepiride DDI Study

Study Overview
=================
Brief Summary
-----------------
An open label, one sequence study to investigate the pharmacokinetic drug interaction between Teneligliptin and Glimepiride in healthy male subjects

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

Intervention / Treatment
-----------------
* Drug: Teneligliptin+Glimepiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male adult aged 20 to 45 years Body weight ≥ 50kg, and BMI between 18 and 29 kg/m2 at screening Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose. Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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: single arm<br> | Drug: Teneligliptin+Glimepiride<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) |  | 24hr | 
| Area under the plasma concentration versus time curve (AUC) |  | 24hr |
SD, IL-13 Production Rate in IPF

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate how QAX576 affects levels of interleukin 13 (IL-13) in patients with idiopathic pulmonary fibrosis (IPF).

Official Title
-----------------
A Open-label, Multicenter Study, With a Single Intravenous Dose of QAX576 to Determine IL-13 Production in Patients With Idiopathic Pulmonary Fibrosis

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: QAX576


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between the ages of 40 and 80 years with a confirmed diagnosis of idiopathic pulmonary fibrosis Both men and women must be on non-childbearing potential. Additional information regarding this requirement is available at screening. Capability to meet certain lung function tests at screening Non-smokers No participation in another clinical study within 4 weeks of study start. Exclusion Criteria: Certain medical conditions may exclude candidates from participation. Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start Past medical personal or close family history of clinically significant ECG abnormalities Connective tissue disorders Active infection or history of systemic parasitic infection Known hypersensitivity to the drug. History of immunocompromise, including a positive HIV test result. History of drug or alcohol abuse within 12 months of study start Any condition that may compromise patient safety

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>QAX576 | Drug: QAX576<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -To investigate the possibility that some IPF patients experience increased IL-13 production. Blood samples to be collected pre-dose and weekly after dosing. -To investigate the hypothesis that QAX576 will neutralize IL-13 in patients with IPF |  | Week 1,2,3 and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -To evaluate the changes in biomarkers in blood over time in patients with IPF. Serum samples will be obtained at pre-dose and 2 weeks post-dose. |  | Week 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic Pulmonary Fibrosis
Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome

Study Overview
=================
Brief Summary
-----------------
This study compares pre- and postoperative (at 6 month) quality of life and pathomorphology of the pelvis (by MRI defecation) after a STARR procedure for outlet obstruction. Trial with surgical intervention

Official Title
-----------------
Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome

Conditions
-----------------
Surgery, Constipation

Intervention / Treatment
-----------------
* Procedure: STARR Operation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All patients at our institution treated with the STARR operation Exclusion criteria: Age under 18, Chronic or acute inflammatory disease of the bowel or rectum

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: STARR Operation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathomorphological changes of the pelvis (by MRI): intussuception, rectocele, defecation angles |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery (STARR operation)
AN INTELLIGENT MODEL FOR THE OPERATIVE BLOCK

Study Overview
=================
Brief Summary
-----------------
Perioperative medicine is characterized by a very delicate path; it is composed, in fact, of a series of highly specialized clinical measures managed by various professionals (surgeons, anesthetists, intensivists, nurses, etc.), who work together to ensure the best quality of all phases of the path (preoperative , intra and postoperative). On the other hand, it is necessary to underline the huge resources needed to provide surgical services. Organizational optimization, based on specific analyzes, could lead to a more careful management of resources in this area, avoiding waste due to early closure of the operating room or unexpected extension of the same. In recent years, precisely to respond to the need to analyze large quantities of information, the use of artificial intelligence techniques, and in particular of machine learning, is becoming increasingly popular, a branch of artificial intelligence that aims, through the use of algorithms and statistical model, to infer new knowledge in a way automatic. Such technologies appear to possess excellent analytical skills both in the clinical and, above all, organizational fields. The data that are emerging in the literature on this issue, although still the first in this regard, seem to confirm this hypothesis.

Official Title
-----------------
NEW MODEL OF ORGANIZATION OF AN OPERATIVE BLOCK (BLOC-OP)

Conditions
-----------------
Artificial Intelligence in Operating Room

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing surgery who sign the informed consent form will be included. Exclusion Criteria: refusal of the patient to the study in question.

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 |
| --- | --- |
| Surgical Patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Time Prediction | Prediction of time spend in oprating room | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome evaluation | ICU admission | 1 year | 
| Outcome evaluation | Rate of surgical procedures cancellation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Machine Learning, Perioperative Medicine, Artificial Intelligence, Operating Room
Different Intravitreal Injection Techniques and Pain Level

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether certain intravitreal injection techniques cause less pain than others and would therefore be beneficial for the patient's well being.

Official Title
-----------------
Effect of Different Injection Techniques on Pain Level in Intravitreal Injections

Conditions
-----------------
Injection Site Discomfort

Intervention / Treatment
-----------------
* Other: Technique of injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving intravitreal anti vascular endothelial growth factor (VEGF) injections Informed consent Exclusion Criteria: Dementia or any other reason for cognitive deterioration Technical limitations not allowing injecting by the protocol

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Slow angled injection<br>Slow and angled insertion of the needle through the sclera | Other: Technique of injection<br> <br> |
| Active Comparator: Slow straight injection<br>Slow and straight insertion of the needle through the sclera | Other: Technique of injection<br> <br> |
| Active Comparator: Fast angled injection<br>fast and angled insertion of the needle through the sclera | Other: Technique of injection<br> <br> |
| Active Comparator: Fast straight injection<br>fast and straight insertion of the needle through the sclera | Other: Technique of injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during the injection as measured by the Pain numeric rating scale |  | Up to 2 minutes after the injection |
Para Aortic Lymphadenectomy : Always ?

Study Overview
=================
Brief Summary
-----------------
Cervical cancer affects more than 3000 new cases per year in France. The treatment of stage IB3 to IVA cervical cancer is based on concomitant radio-chemotherapy. The irradiation volumes are based, according to current recommendations, on imaging examinations and / or on the results of a laparoscopic Para-aortic lymphadenectomy (PAL). There is some risk of false negatif with the PET/CT. For this reason, most of the time, PAL is offered when there is no pathological paraaortic lymph node on PET/CT. The investigators suppose that this staging surgery could be avoid when no pathological pelvic nodes are identified on PET/CT. The investigators use a retrospective study, to analyse histological report of systematic PAL, comparing to results of pre-operative PET/CT.

Official Title
-----------------
Assesment of Paraaortic Lymphadenectomy in Locally Advanced Cervical Cancer, When no Pathologic Pelvic Lymph Node on PET/CT: Retrospective Study.

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Procedure: Para Aortic Lymphadenectomy (PAL) by laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Patients with : locally advanced cervical cancer, who undergone PAL with pre operative PET CT, between January 2015 and december 2019 Exclusion criteria: - patients aged under 18

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 |
| --- | --- |
| Patients with locally advanced cervical cancer<br>Patients with locally advanced cervical cancer, who had undergone a PAL | Procedure: Para Aortic Lymphadenectomy (PAL) by laparoscopy<br>* Para Aortic Lymphadenectomy (PAL) by laparoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes. | negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes. The intraoperative 3D optical scan gives the tumor localization obtained by radioguided occult lesion localization thanks to pen marking left by the surgeon. The comparison is done by superimposing both acquisitions. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity of PAL | morbidity of PAL | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Locally advanced cervical cancer, more than IB3 stage FIGO 2018, Para aortic lymphadenectomy, Laparoscopy, PET/CT