linjc16/ctgov huggingface dataset:
Training Nurses in Basic Hypnoanalgesia Techniques

Study Overview
=================
Brief Summary
-----------------
Demonstrate that a 4-day training session will allow nurses to master basic hypnoanalgesia techniques, and this new tool will translate into a reduction of procedural distress and pain in their patients, thereby opening the way to larger clinical trials in various pediatric settings.

Official Title
-----------------
Training Nurses in Basic Hypnoanalgesia Techniques to Reduce Procedural Distress and Pain in Children: a Pilot Study

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

Intervention / Treatment
-----------------
* Procedure: training in hypnoanalgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children followed in the hematology-oncology outpatient clinic at least 4 times per year good understanding in French use of topic anesthesia or distraction object allowed, as long as used at all venipuncture measured sessions Exclusion Criteria: prior use of hypnoanalgesia patients coming for emergency or non-scheduled appointment patients with acute pain on their scheduled appointment to the clinic acute psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: training in hypnoanalgesia<br>training nurses in hypnoanalgesia to perform painful procedure in children | Procedure: training in hypnoanalgesia<br>* training nurses in hypnoanalgesia techniques to perform painful procedures in children followed in the outpatient hematology oncology clinic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Practice performance of pediatric nurses after a 4-day training in hypnonalgesia techniques. Practice performance will be evaluated by two external evaluators on videotapes using a standardized scale. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main secondary outcome measure : self-reported distress (fear) on VAS (visual analog scale). |  | 12 months | 
| Distress evaluated with the Faces, Legs, Activity, Cry, Consolability scale by two external evaluators on video recordings. |  | 12 months |
Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to examine ghrelin, amylin, glucagon and glucagon-like peptide (GLP)-1 responses to a test meal in lean and obese individuals.

Detailed Description
-----------------
The primary hypothesis is that obese adolescents have a disturbed balance of hormones associated with appetite regulation with less suppression of ghrelin and attenuated stimulation of GLP-1 secretion in response to meal intake compared to lean normal weight controls. A second aim of the study was to test which gastrointestinal peptides are most associated with insulin resistance.

Official Title
-----------------
Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents

Conditions
-----------------
Endocrine System Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: test meal (500 kcal)
* Dietary Supplement: test meal (500 kcal)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: caucasian youth pubertal Tanner stage x, y, or z Exclusion Criteria: fasting plasma glucose > 7.0 mmol/L significant illness taking medications

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Test meal (500 kcal)_normal weight<br>ham sandwich chocolate cream orange juice | Dietary Supplement: test meal (500 kcal)<br>* whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)<br>|
| Active Comparator: Test meal (500 kcal)_obese weight<br>ham sandwich chocolate cream orange juice | Dietary Supplement: test meal (500 kcal)<br>* whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of gastrointestinal peptide secretion in normal weight and obese adolescents | Relation of GLP-1 release to insulin secretion in normal weight and obese adolescents | 2 hours blood sampling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between gastrointestinal peptides and insulin release | Dynamics of gastrointestinal peptide secretion including Tmax and Cmax | 2 hours blood sampling |
Trial to Examine the Effect of Natural Anti- Obesity Agent (Phaseolus Vulgaris) Among Women of Lahore

Study Overview
=================
Brief Summary
-----------------
This double-blind randomized placebo-controlled trial will test the hypothesis that administration of Phaseolus Vulgaris supplementation to women in Lahore, Pakistan, who are overweight will induce the weight loss (Primary outcome) and changes in body composition (Waist circumference) secondary outcome.

Official Title
-----------------
A Randomized Double Blind Study to Examine the Effect of Natural Anti-obesity Agent Among Women of Lahore

Conditions
-----------------
Overweight and Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Phaseolus Vulgaris
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ranges from 25-40 Consistently stable body weight for at least 6 months Good general health No ongoing drug treatment for weight reduction Commitment to avoid any changes in lifestyle throughout the test period Age between 18-45 years Women resident of Lahore Exclusion Criteria: Pregnant or breast-feeding females People with Type 2 diabetes People with any other chronic diseases Weight reduction treatment during the 6 months prior to the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phaseolus Vulgaris<br>Three oral doses of 1000 mg Phaseolus Vulgaris daily for 3 months | Dietary Supplement: Phaseolus Vulgaris<br>* Weight loss<br>|
| Placebo Comparator: Placebo<br>Three oral doses of Placebo daily for 3 months | Dietary Supplement: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | change in body weight | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss
Genome-wide Association Study

Study Overview
=================
Brief Summary
-----------------
To explore biomarkers predictive of clinical response to Taxane/5-FU/platinum based chemotherapy in esophageal squamous cell carcinoma. To identify negative predictive markers to 5-FU/platinum/Taxane. To elucidate signal transduction pathway attributable to 5-FU/platinum/Taxane resistance. To analyze correlation between the quantity of circulating tumor cells and circulating endothelial cell precursors and treatment response to Taxane/5-FU/platinum based chemotherapy.

Official Title
-----------------
Genome-wide Association Study to Predict Treatment Response for Chemotherapy in Esophageal Squamous Cell Carcinoma

Conditions
-----------------
Esophageal Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological confirmed esophageal squamous cell carcinoma Patients treated with Taxane or 5-FU or platinum based chemotherapy. provision of a signed written informed consent. Exclusion Criteria: patients not signed written informed consent. patient unacceptable for study in the judgement of the investigator.

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 treated with Taxane/5-FU/platinum based chemo.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers predictive | Biomarkers predictive of clinical response to Taxane or 5-fluorouracil or platinum based chemotherapy. | 24months |
Effect of the Subconscious on Mohs Micrographic Surgery

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine if relaxation therapy improves patient satisfaction with Mohs micrographic surgery.

Detailed Description
-----------------
Patients are instructed in relaxation techniques. The goal of this study is to determine how relaxation techniques affect the patient's Mohs micrographic surgery experience.

Official Title
-----------------
Effect of the Subconscious on Mohs Micrographic Surgery

Conditions
-----------------
Basal Cell Carcinoma, Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Behavioral: relaxation therapy 1
* Behavioral: relaxation therapy 2
* Behavioral: relaxation therapy 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 25 and older Subjects are undergoing micrographic Mohs surgery for facial basal and squamous cell carcinoma. The subjects are in good health. The subjects have willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. Exclusion Criteria: Subjects who have wound healing problems. Subjects who have had prior Mohs surgery. Subjects who are smokers. Subjects who are currently using anticoagulation therapy Subjects who have a history of bleeding disorders. Subjects who are unable to understand the protocol or to give informed consent Subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders, cognitive disorders, depression with psychotic features, dissociative disorders. Subjects who are taking medications that may affect healing such as prednisone, or any immunosuppressants. Subjects who are immunocompromised. Subjects who have Diabetes Mellitus or any other condition determined by the PI to affect healing.

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>relaxation tape 1 | Behavioral: relaxation therapy 1<br>* relaxation therapy 1<br>|
| Experimental: II<br>relaxation tape 2 | Behavioral: relaxation therapy 2<br>* relaxation therapy 2<br>|
| Placebo Comparator: III<br>relaxation tape 3 | Behavioral: relaxation therapy 3<br>* relaxation therapy 3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient anxiety |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar appearance |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mohs Surgery
Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid

Study Overview
=================
Brief Summary
-----------------
Melasma is an acquired discoloration of the skin characterized by brown patches. Chemical peels using agents such as Jessner's solution and trichloroacetic acid (TCA) are commonly used to treat melasma. A chemical peel involves applying the peeling agent to the skin for a short period. The skin will peel similar to a sunburn, and moisturizers are applied to the skin. Although both agents are well-accepted, there have been no good comparisons of the two agents. The purpose of this study is determine if there is a difference in the effectiveness of these two agents.

Official Title
-----------------
Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid: A Comparison of Clinical Efficacy

Conditions
-----------------
Melasma

Intervention / Treatment
-----------------
* Procedure: Jessner's solution chemical peel
* Procedure: Trichloroacetic acid chemical peel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults > 18 years old Clinical diagnosis of melasma Mental capacity to give informed consent Exclusion Criteria: Pregnancy H/o allergy to Jessner's solution, tricholoracetetic acid, tretinoin, or hydroquinone Active dermatitis Presence of cutaneous infection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chemical Peel<br>Split face treatment paradigm | Procedure: Jessner's solution chemical peel<br> <br> Procedure: Trichloroacetic acid chemical peel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy by clinician's evaluation | Hyperpigmenation Global Score | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy by subject's evaluation | Hyperpigmentation Global Score | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melasma, Jessner's solution, Trichloroacetic acid (TCA)
Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

Study Overview
=================
Brief Summary
-----------------
Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles. Approximately 40% of all patients with infections caused by S. Pyogenes develop a streptococcal toxic-shock syndrome. In these cases the mortality rates exceed 40% in spite of adequate treatment with antimicrobials. Due to the rapid progress, the extensive damage on soft tissues and high risk of death, the microbes are called flesh-eating bacteria. The present study is a spin-off of the larger EU funded INFECT study, looking at the experiences of patient and family to understand the impact on every day life. The present prospective mixed methods study has the potential to provide important knowledge regarding the occurrence of early signs and symptoms of NSTI, quality of life 6 and 24 months after diagnosis, and how the care and treatment can be optimized and organized in a person/patient and family centered way. The study also aims at validate the SF 36 questionnaire for this group of patients.

Official Title
-----------------
Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

Conditions
-----------------
Necrotizing Fasciitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with necrotizing fasciitis and their significant others Age above 18 yrs Exclusion Criteria: Persons with dementia or severe psychiatric illness Persons that do not master the Scandinavian language

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 and their significant others<br>Patients affected by necrotizing fasciitis and their significant others | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quantitative - health related quality of life Qualitative - patient experience | 6 months | 
| Quality of life | Quantitative - health related quality of life Qualitative - patient experience | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of significant others | Quantitative - health related quality of life Qualitative - experience of significant others | 6 months | 
| Quality of life of significant others | Quantitative - health related quality of life Qualitative - experience of significant others | 24 months |
Surgical Prep in Hand Surgery

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to identify the common bacterial flora on the hand and evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation. The null hypothesis is that there is no difference in the efficacy of Chloraprep, Duraprep, and betadine in pre-operative skin preparation in clean, elective hand surgery cases.

Official Title
-----------------
Efficacy of Surgical Preparation Solutions in Hand Surgery

Conditions
-----------------
Surgical Scrubbing, Disinfection

Intervention / Treatment
-----------------
* Other: Skin culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the following procedures (carpal tunnel release, trigger finger release, cyst excision, 1st dorsal compartment release) Exclusion Criteria: prisoners pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Chloraprep<br> | Other: Skin culture<br>* Culture swab used to culture skin adjacent to incision<br>|
| Duraprep<br> | Other: Skin culture<br>* Culture swab used to culture skin adjacent to incision<br>|
| Betadine only<br> | Other: Skin culture<br>* Culture swab used to culture skin adjacent to incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of positive cultures |  | after skin prep solution has dried |
Cataract Lens Hardness Based on Phaco Tip Resistance

Study Overview
=================
Brief Summary
-----------------
Phacoemulsificaton tip elongation depends upon voltage once resonant frequency of piezoelectric crystals has been reached. Purpose of the study is to record voltage data of 20 consecutive cataract surgeries in order to evaluate correlation between voltage and LOCS classification of lens nuclei using a system that deploys a feedback mechanism capable of keeping invariant elongation regardless of enountered resistence

Detailed Description
-----------------
The R-Evolution (Optikon 2000 Rome, Italy) phaco machine is equipped with a patented system named minimal stress that used the direct piezoelectric effect from the resonant ceramics that drive the phacoemulsificator tip to assess in real time and adjust phaco tip elongation that continuously varies according to encountered resistance. After priming in balanced salt solution, phaco tip elongation and the amount of potential difference (voltage) needed to obtain a ginev elongation in balanced solution is assessed. Once the phaco tip is used during surgery, the resistence offered by the crystalline lens material to the phaco tip reduces actual elongaton which in turn reduces the voltage produced by the directo piezometric effect. The machine uses voltage produced by actual elongation to adjust the diving voltage and therefore can ensure accurate pahco tip elongation under any condition of lens material resistance. Purpose of the study is to record driving voltage and its variations and evaluate if there is a correlation between phaco tip resistence and drving voltage. This is evaluated both in vitro activating the phaco tip in increasingly dense glycerol solutions and in real life phaco surgery recording the voltage requested by phaco tip resistence and correlating it to the classification of lens opacity (LOCS III system) clinically used to grade cataract hardness.

Official Title
-----------------
Evaluation of Cataract Lens Hardness Based on Phacoemulsificator Tip Resistance

Conditions
-----------------
Cataract Senile

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of nuclear or cortical cataract Exclusion Criteria: previous ocular trauma, previous ocular surgery, connective tissue disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cataract lens hardness according to LOCS III classification system | lens opacity and estimated nucleous hardness according to international LOCS classification | at enrolling | 
| average voltage | voltage necessary to emulsify cataratct nuclous | at the time of surgery | 
| peak voltage | maximum voltage necessary to emulsify cataract nucleous | at the time of surgery |