linjc16/ctgov huggingface dataset:
The Effect of Caudal Volumes on the Anatomical Spread of Caudals in Children

Study Overview
=================
Brief Summary
-----------------
Radiological study into the anatomical spread of caudal local anaesthetic in children age 1-7

Conditions
-----------------
Asa 1 and 2 Patients for Elective Surgery Requiring Caudal as Part of Their Care

Intervention / Treatment
-----------------
* Drug: caudal volume 1
* Biological: caudal volume 2
* Drug: caudal volume 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asa 1 and 2 patients Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: caudal volume 1|nan|
|Biological: caudal volume 2|nan|
|Drug: caudal volume 3|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The radiographic height of the block post injection |  |  |
Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix

Study Overview
=================
Brief Summary
-----------------
OBJECTIVE: to compare endocervical brushing with endocervical curettage with respect to diagnostic and patient discomfort. METHOD: women referred to colposcopy because of abnormal Papanicolaou tests will be randomized to endocervical sampling with either a metal curette (endocervical curettage -ECC) or and endocervical brush. All samples will be submitted for histological study.

Conditions
-----------------
Cervical Dysplasia

Intervention / Treatment
-----------------
* Procedure: Curette v/s endocervical brush


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: French-speaking 21 years or older Attending our colposcopy clinic Need for endocervical evaluation Full autonomy or capacity to understand the procedures Exclusion Criteria: Pregnancy Absence of uterus History of DES exposure in utero

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Curette v/s endocervical brush|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specimen adequacy | Cytological and histological interpretation of the endocervical brush specimens will then be performed, while for the endocervical currete specimens only histological interpretation will be done. The adequacy of the specimens will be based on the quantity of endocervical cells present (< or ≥ 20 endocervical cells), the quantity of histological material (< or ≥ 3 epithelial stripes) and the quality of histological material (absence or presence of lamina propia). | 09/2011 - 05/2012 (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient discomfort | To evaluate the degree of patient discomfort, patients will be requested to complete a questionnaire once the exam has been completed. The main acceptance variables will be degree of helplessness, pain (on visual analog scales), willingness to undergo the test again, and overall satisfaction. Once the exam has been completed, the doctor performing the sampling will answer a questionnaire indicating his/her perception of the exam (patient's pain, technical difficulty performing the exam, doctors acceptability of the exam). | 09/2011 to 05/2012 (8 months) |
Description of the Safety and Functionality of a Rectoscope (P201630551)

Study Overview
=================
Brief Summary
-----------------
Most patients with rectal cancer receive neoadjuvant therapy. This usually causes a decrease in tumor size. In approximately 20% of patients who receive neoadjuvant therapy, the tumor disappears completely (complete pathological response), showing as a scar on the rectal mucosa, not noticeable from the rectal serosa, from outside the rectum, difficulting the identification of the tumor location by the surgeon. Rectoscope (p201630551) allows the surgeon to view the illuminated rectum from the patient's abdomen, determining the appropriate point of section of the rectum.

Official Title
-----------------
Description of the Safety and Functionality of a Rectoscope (P201630551) That Allows the Identification of the Distal Section Margin in Oncological Rectal Surgery

Conditions
-----------------
Oncological Rectal Surgery

Intervention / Treatment
-----------------
* Device: Rectoscope (P201630551)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women over 18 years old. Patients with rectal cancer (15 cm or less from the anal margin), whether or not they have received neoadjuvant treatment, in whom cancer surgery is to be performed through the anterior (abdominal) route, whether laparoscopic or not. Patients who accept their participation in this study, after explaining the study details. Patients who sign the informed consent. Exclusion Criteria: Patients who are going to undergo an abdominoperineal amputation or transanal surgery for rectal cancer. Patients who do not accept their participation in this study.

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Oncology patients candidate for rectal surgery (tumors located up to 15 cm from the anal margin) and meet inclusion criteria. Rectoscope (P201630551) allows the identification of the distal section margin. | Device: Rectoscope (P201630551)<br>* Rectoscope (P201630551) allows the identification of the distal section margin in oncological rectal surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events related to use of the device. | Safety. Clavien-Dindo classification will be used. | at immediate postoperative period | 
| Evaluation of functionality | Categorical variable. 3 options: the device has worked without problems the device has worked, but with problems the device could not carry out its function. | at surgery |
Preoperative Epidural Labor Analgesia and Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
Parturients who undergo emergency Cesarean section (C-sec) after experiencing labor pain are likely to develop pain-induced central sensitization. The investigators hypothesized that those without epidural labor analgesia undergoing subsequent emergency C-sec would experience more severe postoperative pain or require more analgesia after C-sec compared to those with epidural labor analgesia. Thus, the investigators conducted this retrospective study by grouping parturients undergoing emergency C-sec after experiencing labor pain into two groups (epidural labor group and no epidural labor group) and those undergoing elective C-sec aimed to compare the effect of epidural labor analgesia on postoperative pain severity and analgesic consumption.

Official Title
-----------------
The Influence of Preoperative Epidural Labor Analgesia on Postoperative Pain in Parturients Undergoing Cesarean Section: a Retrospective Analysis

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Procedure: Epidural labor analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cesarean section(C-sec) under spinal anesthesia Exclusion Criteria: Patients without accurate medical records Failure of epidural analgesia

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Epidural (ED) emergent C-sec<br> | Procedure: Epidural labor analgesia<br>* Epidural catheter was inserted for labor analgesia using an 18-gauge Tuohy needle and a 20 gauge epidural catheter. In our institute, for epidural labor analgesia, 10 ml bolus of 0.075% levobupivacaine mixed with fentanyl 2 μg/ml was administered and same regimen was continuously infused by patient-controlled epidural analgesia (infusion rate : 10 ml/hr, bolus : 4 ml, lockout time: 30 min).<br>|
| Non-ED emergent C-sec<br> | |
| Non-ED elective C-sec<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of numerical rating scale for postoperative pain |  | At postoperative 6h, 24h, 48h, and 72h. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of postoperative analgesic consumption |  | At postoperative 6h, 24h, 48h, and 72h. |
French Attitude Registry in Case of ICD Lead Replacement

Study Overview
=================
Brief Summary
-----------------
The average survival rate of a defibrillation lead is 91 to 99% at 2 years, 85-95% at 5 years and 60-72% at 8 years. We must also manage alerts for defibrillation probes with a higher complication rate than average. We will therefore be increasingly confronted with faulty sensors or at risk to be replaced. There are no standardized approach for replacing defibrillation lead. A record made in the United States showed significant differences according to the teams strategy in case of failure of defibrillation lead in particular with regard to the decision to explant or abandon the probe. The risk of extracting a defibrillation lead are well known with a major complication rate of 1.6 to 1.95%. Regarding the risk of complications related to the abandonment of a probe we have less data. For some there is no risk to abandon a defibrillation lead. But others reported a complication rate of 5.5% related to pacing discontinued. Main objective: Collect the attitude of different centers and different operators when replacing a failed defibrillation lead or at risk. Explantation or abandonment of the sensor replaced.

Official Title
-----------------
French Attitude Registry in Case of ICD Lead Replacement

Conditions
-----------------
Defibrillator, Explantation of Probe

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient to receive a replacement defibrillation lead not motivated by an infection and having been informed. Patient who agreed to participate in the study Patients aged 18 years and over No Exclusion Criteria

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 |
| --- | --- |
| Patients with a defibrillator<br>The study population is that of patients with a defibrillator to have a change of probe. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explanted probes | Percentage of explanted probes among implanted ones | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of explantation | Percentage of events during and after explantation of probe | 2 years |
Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma

Official Title
-----------------
A Phase II, Multi-centre, Open-Label, Parallel Group, Randomised Study To Compare the Efficacy of AZD6244 vs Temozolomide in Patients With Unresectable AJCC Stage 3 or 4 Malignant Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: AZD6244
* Drug: Temozolomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with late stage malignant melanoma Aged 18 or over Female patients must be post-menopausal or with negative urine pregnancy test if pre-menopausal Exclusion Criteria: Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable) Participation in any other trial with an investigational product within the previous 30 days

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Temozolomide | Drug: Temozolomide<br>* oral<br>|
| Experimental: 2<br>AZD6244 | Drug: AZD6244<br>* Oral liquid or Capsule<br>* Other names: ARRY-142886;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma by assessing progression free survival (PFS) |  | From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest) | 
| Time to death |  | From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest) | 
| Objective Response Rate |  | RECIST data collected as per institutional standard practise | 
| Duration of response |  | RECIST data collected as per institutional standard practise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the safety and tolerability of AZD6244 |  | Assessed at all visits | 
| Investigation of the pharmacokinetics of AZD6244 |  | Day 1 & 8 (for patients on AZD6244) | 
| Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive |  | From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanoma, Phase II, AZD6244, temozolomide
Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Treatment of SCI

Study Overview
=================
Brief Summary
-----------------
This study is expanded access to an Investigational New Drug (IND) for an individual patient with spinal cord injury (SCI) at cervical spine 5-6 (C 5-6) designed to provide access to autologous adipose-derived mesenchymal stem cells (HB-adMSCs)

Detailed Description
-----------------
This is an expanded access single-dose study with the primary goal of treatment submitted at the request of an individual patient with complete C5-6 spinal cord injury (SCI) resulting in quadriplegia who does not qualify for any current clinical trials and for whom there are no other FDA approved fully restorative treatments. The overall objective of this study is to evaluate patient's response, adverse events and serious adverse events (AE/SAEs), and cell expansion characteristics of a single intravenous (IV) infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in a subject with complete SCI resulting in quadriplegia.

Official Title
-----------------
Individual Patient Expanded Access IND (Investigational New Drug) of Autologous HB-adMSCs for the Treatment of Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injury at C5-C7 Level

Intervention / Treatment
-----------------
* Biological: HB-adMSCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cognitively intact, capable of giving informed consent Clinical diagnosis of a non-penetrating traumatic SCI Asia Impairment Scale grade of A, B, or C Exclusion Criteria: Prior history of: Brain injury Recent or ongoing infection Clinically significant cardiovascular, lung, renal, hepatic or endocrine disease, Neurodegenerative disorders Cancer Immunosuppression as defined by WBC<3,000 cells/ml at baseline screening, HIV+ Chemical or ETOH dependency Having a contraindication to MRI scans Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSC administration Participation in other interventional research studies Unwillingness to return for follow-up visits

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HB-adMSCs|single infusion of HB-adMSCs|

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
-----------------
SCI, stem cells, quadriplegia, spinal cord injury, paralysis, MSCs
Serum Adiponectin as an Early Marker for Renal Impairment in Patients With Non-alcoholic Fatty Liver Disease.

Study Overview
=================
Brief Summary
-----------------
Early detection of renal impairment in patients with non-alcoholic fatty liver disease and its correlation with serum Adiponectin level.

Detailed Description
-----------------
Detection of serum Adiponectin by ELISA technique using (EIA-3418) KIT, DRG international inc., USA

Official Title
-----------------
Early Detection of Renal Impairment in Patients With Non-alcoholic Fatty Liver Disease by Measuring Serum Adiponectin Level.

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Diagnostic Test: serum Adiponectin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with fatty liver aged from 18 to 60 yrs either diabetic or not . Patient with normal echogenic kidney in ultrasound and eGFR more than 60 mL/min/1.73m2. The Control group are completely healthy subjects without any systemic or liver and kidney affection Exclusion Criteria: Patients less than 18 yrs & more than 60 yrs . All patients having any other causes of renal and hepatic disease rather than Diabetes and having any other systemic problem.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cases<br>non-alcoholic fatty liver patients | Diagnostic Test: serum Adiponectin<br>* serum adiponectin as early marker for renal impairment. Adiponectin is a recently identified adipose tissue-derived protein (adipocytokine) with important metabolic ,antiinflammatory, anti-atherogenic, and reactive oxygen species protective actions.<br>|
| control<br>healthy persons | Diagnostic Test: serum Adiponectin<br>* serum adiponectin as early marker for renal impairment. Adiponectin is a recently identified adipose tissue-derived protein (adipocytokine) with important metabolic ,antiinflammatory, anti-atherogenic, and reactive oxygen species protective actions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate serum Adiponectin level with renal impairment in non-alcoholic fatty liver disease. | measure level of serum Adiponectin in non-alcoholic fatty liver patients to detect early renal impairment. | baseline |
Response of Topical Capsaicin in Alopecia Areata

Study Overview
=================
Brief Summary
-----------------
It has been postulated that Alopecia Areata (AA) is, at least in part, a neurologically mediated disease. Research supporting this theory includes the finding that nerves surrounding the hair follicles are collapsed. We want to take this research a step further and show that not only are these perifollicular nerves collapsed, but that their function is also impaired.

Detailed Description
-----------------
To assess the function of perifollicular scalp nerves in AA we will look at the response of these nerves to the topical medication capsaicin. Under normal circumstances topical capsaicin is known to target nerves in the peripheral nervous system causing short-term release of the neuropeptide Substance P (SP) as well as long-term transient depletion of SP. We expect the AA patients will respond abnormally to topical capsaicin treatment.

Official Title
-----------------
Perifollicular Nerves in Alopecia Areata: Response to Topical Capsaicin

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Drug: Capsaicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have alopecia totalis or universalis. Be in good health. Not be taking any medications including topical medications Be 18 years or older. Be willing to apply study medication or vehicle as directed, comply with instructions and commit to follow-up visits. Not have had hair chemically treated (including colored hair, permed hair, etc) within the month prior to the study. Exclusion Criteria: Absence of extensive alopecia areata. People not in good health. People taking medications. Allergies to capsaicin. Presence of irritated or visibly inflamed scalp. Having had hair chemically treated (including colored hair, permed hair, etc.) within the month prior to study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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 |
| --- |
|Drug: Capsaicin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Topical capsaicin will quantitatively decrease the amount of Substance P in the scalp of AA patients. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The scalps of AA patients may be less sensitive to stimuli. |  |  |