linjc16/ctgov huggingface dataset:
Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy

Study Overview
=================
Brief Summary
-----------------
The aim was to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute postoperative pain and in reduction of analgesics consumption on demand and their side effects in patients after ambulatory knee arthroscopy

Official Title
-----------------
Auricular Acupuncture Versus Placebo (Sham Acupuncture) for Postoperative Pain Relief After Ambulatory Knee Arthroscopy - a Randomized Controlled Trial

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Auricular acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an American Society of Anesthesiologists physical status of I to II scheduled for ambulatory knee arthroscopy under general anesthesia. Surgery time does not exceed 60 minutes. Patients without previous opioid and/or psychiatric medication. Patients ranged 16-65 years old. Patients able to use Visual Analogue Scale-100 for pain intensity measurement. Patients who have given informed consent. Exclusion Criteria: Pregnant or nursing females. Recidivist alcoholics and/or patients with history of psychiatric disease. Local or systemic infection. Age < 16 and > 65 years. Surgery time more than 60 minutes. Inability to use Visual Analogue Scale-100. Patients consumed opioid medication before surgery. Patients with prosthetic or damaged cardiac valves (s. Potential risks) Patients who are unable to understand the consent form.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Procedure: Auricular acupuncture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative ibuprofen requirement after the surgery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity assessed by patients on VAS-100 ; total piritramide requirement in anesthesia recovery room; incidence of analgesia-related side effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute pain, postoperative pain, auricular acupuncture
A Method to Determine the Size of Laryngeal Mask Airway (LMA)

Study Overview
=================
Brief Summary
-----------------
After institutional ethics board approval and written informed consent from parents, 197 children scheduled for routine genitourinary operation and in whom a LMA was indicated for anesthesia were included in the study. The size of the LMA was determined by choosing the size that was best matched with the auricle of the children. The results were compared with the standard method recommended by the manufacturer's weight-related guidelines. The patients were classified in different groups depending on the PLMA sizes determined by both methods. A kappa coefficient evaluated the agreement between both techniques.

Official Title
-----------------
A Simple Method to Determine the Size of the ProSeal LMA (PLMA) in Children

Conditions
-----------------
Ear Based ProSeal LMA

Intervention / Treatment
-----------------
* Device: Ear-sized based


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I/II scheduled for genitourinary operation LMA was indicated for anesthesia Exclusion Criteria: surgery lasting more than 3 h overweight or underweight patients gastroesophageal reflux risk of aspiration airway infection in the last six weeks decreased pulmonary or chest wall compliance.

Ages Eligible for Study
-----------------
Maximum Age: 15 Years

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ear-sized based and weight based formula<br>the sizes of the PLMA determined with the ear-based compared with the sizes according to the manufacturer's weight-based formula | Device: Ear-sized based<br>* the sizes of the PLMA determined with the ear-based formula were compared with the sizes according to the manufacturer's weight-based formula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the sizes of the PLMA determined with the ear-based formula | we were to determine whether the size of the auricle could be used as a proxy for the appropriate size of the PLMA | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
child, ear based, Proseal LMA
Prospective Pediatric Vesicoureteral Reflux Surgery Database

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to provide a clearer understanding of quality and outcomes for three types of surgical procedures performed at Connecticut Children's for treatment of vesicoureteral reflux. In order to consistently gather data over time, the investigators propose to establish database for surgical intervention for vesicoureteral reflux. Specific Aim 1: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to increase internal understanding of these procedures. Specific Aim2: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to perform more valuable clinical analysis for publication.

Official Title
-----------------
Prospective Pediatric Vesicoureteral Reflux Surgery Database

Conditions
-----------------
Vesicoureteral Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's. Exclusion Criteria: Subject not scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.

Ages Eligible for Study
-----------------
Maximum 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<br>Patients receiving a surgical procedure for vesicoureteral reflux at Connecticut Children's Medical Center. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of vesicoureteral reflux | Resolution of vesicoureteral reflux | Date of surgical intervention (day 1) to resolution of vesicoureteral reflux or additional surgical interventions for correction of vesicoureteral reflux, whichever comes first, or until enrollee's 18th birthday. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deflux, pediatric urology, vesicoureteral reflux, ureteral reimplant
Effectiveness and Safety of Firmagon®

Study Overview
=================
Brief Summary
-----------------
Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma. The period until Prostate Specific Antigen (PSA) progression during the Firmagon® therapy is to be documented and related to the testosterone values measured in the course of therapy (if available). Other clinical parameters, the patients' quality of life and the direct and indirect costs incurred by the medical care for the advanced hormone-dependent prostate carcinoma and its consequences will be evaluated. In this context the medical outcome and the life quality are defined as effectiveness and benefit value parameters. Both the effectiveness under daily life circumstances and economic variables of the therapy can thus be shown and compared within an analysis of costs vs. benefits or costs vs. effectiveness.

Official Title
-----------------
Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma

Conditions
-----------------
Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma

Intervention / Treatment
-----------------
* Other: Firmagon given by prescription according to SPC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: therapeutic need according to SPC written informed consent Exclusion Criteria: - contraindications according to SPC

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with Advanced Hormone-dependent Prostate Carcinoma treated with Firmagon according to SPC | Other: Firmagon given by prescription according to SPC<br>* Non-interventional,observational Firmagon given by prescription according to SPC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of the PSA progression-free survival |  | open (until therapy end or stop) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. testosterone levels |  | open (until therapy end or stop) | 
| 2. number of ADRs and SUSARs |  | open (until therapy end or stop) | 
| 3. quality of life |  | open (until therapy end or stop) |
Blood Pressure Reactivity After Resistance Exercise in Older Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine and compare the effects of two sessions of resistance exercise in blood pressure reactivity to a mental stress test in older hypertensive women.

Official Title
-----------------
BLOOD PRESSURE REACTIVITY TO MENTAL STRESS IS ATTENUATED FOLLOWING RESISTANCE EXERCISE IN ELDERLY HYPERTENSIVE WOMEN

Conditions
-----------------
Resistance Exercise Pressor and Neural Responses in Older Women

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:older hypertensive women - Exclusion Criteria:subjects taking hormonal therapy; those with a history of metabolic, neurologic, or cardiovascular diseases other than HTN, those with a history of cardiovascular events; subjects with physical limitations; those with non-treated HTN; obesity (BMI ≥ 30.0); and subjects taking adrenergic inhibitors or non-dihydropyridinic calcium channel blockers. -

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Performance of two resistance exercise sessions | Other: Exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure reactivity to mental stress |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistance Training, Psychological Stress, Aging, Hypertension, Autonomic Nervous System
COaching and Prehabilitation: Faisability Study in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
This faisability study aims to evaluate the adhesion of the patient to a multidisciplinary program (adapted physical activity, coaching and nutrition)

Official Title
-----------------
Feasibility Study of Tripartite Prehabilitation of Patients With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndromes During Intensive Chemotherapy Before Allogenic Haematopoietic Stem Cell Transplantation: the COHABILIT Protocol

Conditions
-----------------
Myelodysplastic Syndromes, Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Procedure: Coaching and Habilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acute myeloid leukemia or high-risk myelodysplastic syndrome Age between 18 and 70 years Eligible for an intensive chemotherapy Eligible for allograft Able to answer a questionnaire Exclusion Criteria: Diagnosis of acute promyelocytic Leukemia Palliative treatment Contraindication to moderate physical activity Performans status 4, unless it is related to the disease Patient who does not understand French Patient unable to use a smartphone Patient deprived of liberty or placed under the authority of a tutor, Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation program<br>Program based on nutritional support, physical activity program and coaching. Home-based monitoring will be done thanks to connected watches (step counter pedometer) and a connected body fat weight scale | Procedure: Coaching and Habilitation<br>* nutritional support, adapted physical activity and coaching<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility to the adapted multidisciplinary program | proportion of patients who will complete more than 50% of the APA/coaching sessions prescribed | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prehabilitation, coaching, nutritional support, physical activity, allogeneic stem cells transplantation
Antibody Response in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.

Study Overview
=================
Brief Summary
-----------------
This is prospective cohort study aimed to compare antibody response against SARS-CoV-2 in dialysis patients and non-dialysis-dependent volunteers. The research hypothesis is that dynamic of IgG antibodies against SARS-CoV-2 will differ in two groups. To determine whether there is a statistically significant interaction between factors group and time on the titer of IgG antibodies against SARS-CoV-2, a two-way repeated measures ANOVA will be used.

Detailed Description
-----------------
In both groups level of IgG antibodies against SARS-CoV-2 will be measured at the Day 1 (10 weeks from the date of first symptoms), Weeks 8 and 16 from the Day 1.

Official Title
-----------------
A Comparison of Antibody Response Against SARS-CoV-2 in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.

Conditions
-----------------
Dialysis, Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older SARS-CoV-2 infection within 10 weeks prior enrollment, confirmed by PCR or strongly suspected on computed tomography Providing informed consent Exclusion Criteria: Refusal to provide informed consent

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 |
| --- | --- |
| Dialysis<br>Patients with CKD stage 5, treated with maintenance hemodialysis | |
| Healthy<br>Volunteers who are not dialysis-dependent | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-SARS-COV-2 IgG level |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of people with detectable Anti-SARS-COV-2 IgG in study groups |  | Day 1, weeks 8, 16 | 
| Anti-SARS-COV-2 IgG level |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IgG, antibodies, CKD, hemodialysis
Dermacyd Silver Floral (Lactic Acid) - Compatibility - Stay on Floral

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFL.

Official Title
-----------------
Study for Dermatological Evaluation of Topic Compatibility. Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd PH_DESILSTY_FL (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: LACTIC ACID(ND)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Phototype Skin I,II, III e IV Integral skin test in the region Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; Exclusion criteria: Lactation or pregnancy Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection Disease which can cause immunosuppresion, such as diabetes, HIV Use of Antihistamines 30 days before selection Personnel history of atopy History of sensitivity or irritation for topic products Cutaneous active disease (local and/or general) which can modify the study results Use of new drugs and/or cosmetics during the study Cutaneous reactive Previous participation in studies using the same product in test Volunteer which has immunodeficiency congenital or acquired Relevant history or confirmation of alcohol or other drugs abuse Intolerance detected or suspected for some component of the sample tested Medecin or sponsor employees or their close family The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermacyd Silver Floral (Lactic Acid)<br>Lactic Acid sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample | Drug: LACTIC ACID(ND)<br>* Treatment duration: 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale |  | from the treatment start to the end of the study (treatment duration 6 weeks) |
Comparative Microarray Analysis in Primary Cutaneous Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). This study will be an exploratory analysis by miRNA expression profiling using microarrays.

Detailed Description
-----------------
Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). With regards to a rapidly growing number of newly discovered miRNA sequences, the availability of up-to-date miRNA expression profiles for primary cutaneous malignant melanoma (PCMM), cutaneous malignant melanoma metastases (CMMM) and benign melanocytic naevi (BMN) is limited. Patients with PCMM, CMMM and BMN are included in the study to perform an exploratory analysis by miRNA expression profiling using microarrays. Expression levels of miRNA candidates will be validated by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).

Official Title
-----------------
Comparative Microarray Analysis of microRNA Expression Profiles in Primary Cutaneous Malignant Melanoma, Cutaneous Malignant Melanoma Metastases and Benign Melanocytic Naevi

Conditions
-----------------
Cutaneous Malignant Melanoma

Intervention / Treatment
-----------------
* Procedure: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Cutaneous Malignant Melanoma Cutaneous Malignant Melanoma Metastases Benign Melanocytic Naevi Exclusion Criteria: - Other Skin Cancer than Primary Cutaneous Malignant Melanoma

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Cutaneous Malignant Melanoma<br> | Procedure: Biopsy<br>* Biopsy<br>|
| Cutaneous Malignant Melanoma Metastases<br> | Procedure: Biopsy<br>* Biopsy<br>|
| Benign Melanocytic Nevi<br> | Procedure: Biopsy<br>* Biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |