linjc16/ctgov huggingface dataset:
Blade Finger Technique for Safe Laparoscopic Entery

Study Overview
=================
Brief Summary
-----------------
blade-finger technique is a new technique for laparoscopic access which is safe

Detailed Description
-----------------
after optaining irb approval and patients consented, they were divided into 3 groups to whom one of the techniques of laparoscopic entery was applied and there was a comparison between these groups

Official Title
-----------------
A Prospective Randomized Controlled Trial on Safe Laparoscopic Access and Ports Insertion Using the Blade-Finger Technique

Conditions
-----------------
Laparoscopic Surgery, Operative Surgical Procedure, Insufflation, Safety Issues

Intervention / Treatment
-----------------
* Procedure: finger-blade technique
* Procedure: Hasson's technique
* Procedure: veress needle technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients more than 18 year-old. underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to May, 2022. Exclusion Criteria: Patients with one or more previous abdominal surgery (upper, lower or upper and lower midline scars). Patients with distended abdomen due to bowel obstruction. Patients with uncorrected coagulopathy.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group a<br>the group we used our new blade-finger technique | Procedure: finger-blade technique<br>* laparoscopic access technique for group a<br>* Other names: laparoscopic access technique;|
| Experimental: group b<br>the group we used Hasson's technique | Procedure: Hasson's technique<br>* laparoscopic access technique for group b<br>* Other names: laparoscopic access technique;|
| Experimental: group c<br>the group we used veress needle technique | Procedure: veress needle technique<br>* laparoscopic access technique for group c<br>* Other names: laparoscopic access technique for group c;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time needed to access the peritoneal cavity | the time of the procedure of access | the first 15 minutes of operation | 
| numbers of trials till the good peritoneal access achieved | number of trials till succeeded peritoneal access | the first 15 minutes of operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of complications | bleeding, bowel injury | the first 15 minutes of operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
veress needle, Hasson's technique, laparoscopic access, blade-finger technique
A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial and multi-centered study with a 2-arm design. The treatment group will receive topical skin adhesive for skin closure of their wound and the control will receive sutures. Subjects will be assessed at follow-up visits. Patients are required to maintain a diary postpartum.

Official Title
-----------------
A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth

Conditions
-----------------
Episiotomy, Perineal Tear

Intervention / Treatment
-----------------
* Device: High Viscosity DERMABOND


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years of age. Patient has an episiotomy incision or perineal tear resulting from a vaginal delivery. Patient agrees to participate in the follow-up schedule of assessments and completion of a daily diary. Patient has signed the informed consent form. Exclusion Criteria: Patient has peripheral vascular disease. Patient has insulin dependent diabetes mellitus. Patient has a blood clotting disorder that requires therapy. Patient has a personal or family history of keloid formation or hypertrophy. Patient has a known allergy to cyanoacrylates or formaldehyde. Patient has impaired wound healing by history. Patient is a chronic steroid user.

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: High Viscosity DERMABOND|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth |  |  | 
| The incidence of perineal skin opening requiring re-closure post-partum |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence and extent of clinically relevant skin openings |  |  | 
| Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area |  |  | 
| Perineal skin closure cosmesis |  |  | 
| Patient satisfaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childbirth
Prevelance of Molar Incisor Hypomineralization Among a Group of Egyptian Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out the prevalence of molar incisor hypomineralization among a group of Egyptian children

Detailed Description
-----------------
Molar incisor hypomineralization is frequent in many population throughout the world and a wide variation of molar incisior hypomineralization 2.4_40% has been reported.To the best of our knowledge,there is no Sufficient information regarding the prevalence of molar incisor hypomineralization in Egyptian children therefore the aim of this study is to assess the prevalence of molar incisor hypomineralization among a group of Egyptian children.

Official Title
-----------------
Prevelance of Molar Incisors Hypomineralization Among a Group of Egyptian Children

Conditions
-----------------
Child Development Disorder

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient seeks dental care in paediatric dentistry and dental public health department in Cairo university positive patient acceptance for participation in the study children with at least one of four permanent molars erupted or partially erupted Exclusion Criteria: uncooperative children children with appliance children with systemic diseases
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|Clinical examination|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Molar incisor hypomineralization | Presence of Molar incisor hypomineralization or not through clinical examination (binary) | 10min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Molar incisor hypomineralization | Clinical examination using modified index based on EAPD criteria | 15min |
Elucidating the Molecular and Biochemical Basis of the Human AhR-mutation Disease

Study Overview
=================
Brief Summary
-----------------
In a previous study, we have identified a consanguineous family from Northern Israel with three children affected by idiopathic infantile nystagmus (IIN) and foveal hypoplasia, which follow an autosomal recessive mode of inheritance of AhR gene. in this study we will determine whether the disease phenotype is the consequence of a decrease in or absence of AHR-induced AHH activity

Detailed Description
-----------------
In a previous study, we have identified a consanguineous family from Northern Israel with three children affected by idiopathic infantile nystagmus (IIN) and foveal hypoplasia, which follow an autosomal recessive mode of inheritance of AhR gene. in this study we will: To determine whether the disease phenotype is the consequence of a decrease in or absence of AHR-induced AHH activity. To this end, basal and ligand-mediated AHH enzyme activity will be compared in heterozygotic and homozygotic family members versus healthy volunteers. To examine steady state protein levels of the AHR protein in cells of homo- and heterozygotic patients versus those of healthy volunteers. If no mutant protein is detected, we will determine the effect of the mutation on mRNA stability. To analyze steady state levels of related partner proteins (such as ANRT) and proteins levels of transcriptional targets (AHH) in heterozygotic and homozygotic family members versus healthy volunteers. To investigate the ability of the mutant allele to induce transcriptional activation in an engineered yeast test system. We will use a yeast strain engineered to contain human AHR and AHR nuclear translocator together with a reporter gene to investigate whether the mutation interferes with transcription activation.

Official Title
-----------------
Elucidating the Molecular and Biochemical Basis of the Human AhR-mutation Disease

Conditions
-----------------
Mutation, Point

Intervention / Treatment
-----------------
* Diagnostic Test: Blood for protein activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with mutation in AhR gene Exclusion Criteria: None
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 |
| --- | --- |
| Study group<br>Patients with mutation in AhR gene - presumed low Blood for protein activity | Diagnostic Test: Blood for protein activity<br>* Blood for protein activity<br>|
| Control<br>Patients without mutation in AhR gene - presumed normal Blood for protein activity | Diagnostic Test: Blood for protein activity<br>* Blood for protein activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low protein activity | Low protein activity | 1 year |
Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes

Study Overview
=================
Brief Summary
-----------------
This study explored the prevalence of DDEs in a chronic pain population with cLBP and associated healthcare utilization and costs using a healthcare claims database.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic low back pain Exclusion Criteria: pregnancy

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

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
retrospective chronic low back pain
Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
Hypocalcemia is one of the most frequent complications of total thyroidectomy, a procedure used for benign as well as malignant conditions of the thyroid gland. Postoperative hypocalcemia is usually caused by hypoparathyroidism. Vitamin D is implicated in calcium metabolism as it increases intestinal calcium transport and regulates parathormone production. Aim of the present study is to evaluate preoperative vitamin D levels as a prognostic factor for postoperative hypocalcemia and hypoparathyroidism.

Official Title
-----------------
Preoperative Vitamin D Levels as a Prognostic Factor for Postoperative Hypocalcemia and Hypoparathyroidism After Total Thyroidectomy

Conditions
-----------------
Hypocalcemia, Hypoparathyroidism, Vitamin D Deficiency, Thyroidectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is over 18 years old Patient scheduled for total thyroidectomy Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures Exclusion Criteria: Primary hyperparathyroidism Primary hypoparathyroidism Chronic Renal Failure Hypoalbuminemia Neck irradiation Systematic Diseases (e.g., infections) Thyroid or parathyroid cancer Osteoporosis Drugs that influence calcium metabolism (vitamin D analogues, oral calcium supplements, biphosphonates, teriparatide, thiazide diuretics)

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 |
| --- | --- |
| Total Thyroidectomy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of preoperative vitamin D levels on postoperative hypocalcemia after total thyroidectomy. |  | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of preoperative vitamin D levels on parathyroid function after total thyroidectomy. |  | 24 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypocalcemia, Hypoparathyroidism, Vitamin D deficiency, Total thyroidectomy, calcium, PTH
Acute Effects of Acupuncture in the Response of the Median Neurodynamic Test

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether the application of acupuncture alters the mechanical (range of elbow extension motion) and physiological (eg, intensity and onset of discomfort, tingling feeling and/or feeling of tension or restriction of movement) responses of the neurodynamic test of nerve median in asymptomatic individuals

Detailed Description
-----------------
To understand the potential of acupuncture therapy in pain syndromes that involve changes of the mechanics and physiology of the peripheral nervous system

Official Title
-----------------
Acute Effects of Acupuncture in the Response of the Median Neurodynamic Test: a Randomised, Double-blind, Non-inferiority Trial

Conditions
-----------------
Other Lesions of Median Nerve

Intervention / Treatment
-----------------
* Other: Acupuncture therapy (leopard spot needling technique)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years-old normal mobility in the joints of the upper quadrant Exclusion Criteria: pathology that may impair nerve function (eg, diabetes) complaints over the past 3 months in the upper quadrant significant deformities in the upper quadrant

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: new acupoint<br>Subjets in this arm receive acupuncture therapy in a new acupoint (leopard spot needling technique) | Other: Acupuncture therapy (leopard spot needling technique)<br>* Comparison of the effects of a new or extraordinary acupoint versus a classical acupoint<br>|
| Active Comparator: classical acupoint<br>Subjects in this arm receive acupuncture therapy in a classical acupoint in the pericardial conduit (leopard spot needling technique) | Other: Acupuncture therapy (leopard spot needling technique)<br>* Comparison of the effects of a new or extraordinary acupoint versus a classical acupoint<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elbow extension range of motion | Elbow extension range of motion during the median nerve neurodynamic test is measured by means of a smartphone (iPhone 4; app Compass (native); iOS 7.1.1) | immediately after the application of acupuncture | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupoints, Acupuncture therapy, Median nerve, Biomechanics
Open Versus Laparoscopic Appendectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective randomized trial is to compare the feasibility of open with laparoscopic appendectomy in suspected acute appendicitis. The investigators especially focused on the postoperative recovery and long-term complications.

Official Title
-----------------
Open Versus Laparoscopic Appendectomy in Suspected Acute Appendicitis - a Prospective Randomised Clinical Trial With With 10-Year Follow-up

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Procedure: open appendectomy
* Procedure: laparoscopic appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 15 years suspected acute appendicitis suitability for laparoscopy Exclusion Criteria: patients refusal to participate lack of a laparoscopic surgeon

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Active Comparator: open appendectomy<br> | Procedure: open appendectomy<br> <br> |
| Active Comparator: laparoscopic appendectomy<br> | Procedure: laparoscopic appendectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication; wound problem or other primary complication |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute appendicitis
Expanded Access for ATB200/AT2221 for the Treatment of IOPD

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants designed to provide access to ATB200/AT2221.

Detailed Description
-----------------
This program is being offered on a patient by patient basis.

Official Title
-----------------
Expanded Use Of Recombinant Human Acid Alpha-Glucosidase/N-butyl-deoxynojirimycin (ATB200/AT2221) For Patients With Infantile-Onset Pompe Disease

Conditions
-----------------
Pompe Disease Infantile-Onset

Intervention / Treatment
-----------------
* Biological: ATB200
* Drug: AT2221


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is male or female and 0 to < 18 years old. Patient has a diagnosis of Pompe disease, based on documentation of GAA genotyping demonstrating variants associated with IOPD. Patient does not currently qualify for or is unable to enroll (eg, due to location, etc) in any commercial drug-sponsored ongoing clinical trial. Patient is currently being treated with an approved ERT and is declining (eg, worsening in motor function, respiratory function/parameters, cardiac function, etc) based on treating physician's clinical judgement. The patient's legal guardian or representative has given informed consent (and assent when age appropriate for regional requirements) to treatment prior to administering ATB200/AT2221 in a manner consistent with all national requirements. If of reproductive potential and sexually active, female subjects agree to use a highly effective method of contraception throughout the duration of the treatment and for up to 90 days after their last dose of ATB200/AT2221. Exclusion Criteria: Patient has a hypersensitivity to any of the excipients in ATB200, alglucosidase alfa, or AT2221 Patient has a medical or any other extenuating condition or circumstance that may, in the opinion of the investigator and/or Amicus, pose an undue safety risk to the patient. Concomitant use of miglitol (eg, Glyset), non-AT2221 form of miglustat (eg, Zavesca), acarbose (eg, Precose or Glucobay), voglibose (eg, Volix, Vocarb,or Volibo)

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 17 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: ATB200|Participants received ATB200 co-administered with AT2221 capsule (Miglustat)|
|Drug: AT2221|Participants received ATB200 co-administered with AT2221 capsule (Miglustat)|

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
-----------------
expanded access, compassionate use