linjc16/ctgov huggingface dataset:
Relevance of Sensitization to Fenugreek in Children

Study Overview
=================
Brief Summary
-----------------
The prevalence of allergy to legumes is inscreasing, especially in children and for some of these legumes, little is known and there are not included in the list of priority allergen. The overall goal of this study is to improve knowledge about fenugreek allergy. The principal aim is to evaluate the prevalence of allergy to fenugreek confirmed by a positive oral food challenge in children sensitized to fenugreek. The secondary objectives are to describe the case of allergy to fenugreek (co-allergies, severity, age..), to evaluate diagnostic values of skin prick-tests and specific IgE and to compare the molecular profile of specific IgE to peanut between sensitization to fenugreek without allergy and sensitization with a confirmed allergy

Official Title
-----------------
Relevance of Sensitization to Fenugreek in Children

Conditions
-----------------
Allergy to Fenugreek

Intervention / Treatment
-----------------
* Diagnostic Test: Oral Food Challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children for whom an oral food challenge to fenugreek has been performed between the 1st January 2017 and the 15th April 2022 and for whom skin prick test and/or specific IgE to fenugreek are avalaible Exclusion Criteria: patient over 18 years old undeterminate oral food challenge

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Oral Food Challenge|diagnostic values of skin prick test and specific IgE for allergy confirmed by oral food challenge (routine, not an intervention)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral food challenge to fenugreek | Astier's score 0 to 4 (0=negative, 1 and 2=mild to moderate reaction, 3 and 4 = severe reaction) | 2017-2022 | 
| skin prick-test to fenugreek | skin prick test positive if wheal size superior to 3mm | 2017-2022 | 
| specific IgE to fenugreek | specific IgE positive if value superior to 0.35kU/L | 2017-2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of allergy | reactogenic dose (from 1 to 1000mg of fenugreek) | 2017-2022 | 
| molecular profile for peanut allergy | IgE values for rAra h1, h2, h3, h6, h8, h9 | 2017-2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergy, children, legumes, sensitization, diagnostic
Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis

Study Overview
=================
Brief Summary
-----------------
When performing shaving of a rectal endometriotic nodule, the surgeon can use the macroscopic appearance of the nodule and the tactile feedback provided by the laparoscopic instruments to decide the area of the bowel that needs to be excised. Theoretically, compared with segmental bowel resection, the shaving technique may expose the patients to a higher risk of persistence of intestinal endometriosis. The objective of this ultrasonographic study was to assess the risk of rectal endometriosis persistence following laparoscopic shaving of rectovaginal nodules.

Official Title
-----------------
Persistence of Rectal Endometriosis After Laparoscopic Shaving of Rectovaginal Endometriosis Infiltrating the Rectum

Conditions
-----------------
Endometriosis, Rectum

Intervention / Treatment
-----------------
* Diagnostic Test: Transvaginal ultrasound
* Behavioral: 5-point Likert scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients underwent laparoscopic shaving of rectovaginal endometriosis infiltrating the rectum Exclusion Criteria: patients underwent previous bowel surgery (except appendectomy); patients experienced postoperative complications (such as pelvic abscess, rectovaginal fistula, ureteral injuries)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women who underwent shaving for rectal endometriosis<br> | Diagnostic Test: Transvaginal ultrasound<br>* Transvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis<br>Behavioral: 5-point Likert scale<br>* Subjective scale to evaluate satisfaction to previous surgical treatment for rectal endometriosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with rectal recurrence of endometriosis | Evaluated by ultrasound | 3 months after the surgical approach | 
| Number of patients with rectal recurrence of endometriosis | Evaluated by ultrasound | 6 months after the surgical approach | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of patients to the previous surgical treatment | Evaluated by five-point Likert scale | 3 months after the surgical approach | 
| Volume of nodules in patients with rectal recurrence of endometriosis | Evaluated by ultrasound | 3 months after the surgical approach | 
| Satisfaction of patients to the previous surgical treatment | Evaluated by five-point Likert scale | 6 months after the surgical approach | 
| Volume of nodules in patients with rectal recurrence of endometriosis | Evaluated by ultrasound | 6 months after the surgical approach |
Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics

Study Overview
=================
Brief Summary
-----------------
We have designed this study to measure the effect of normal flora supplementation, using available probiotics, on the incidence of Clostridium difficile-associated diarrhea in a population of general inpatients who are receiving antibiotics.

Detailed Description
-----------------
General medical-surgical patients in a community hospital who are receiving antibiotics, and who agree to participate, will be given one of two different probiotics, or placebo. Data will be gathered during their hospitalization, and at one and three months following hospital discharge. We expect to see a lower incidence of Clostridium difficile-associated diarrhea in the probiotic groups when compared to the placebo group. We will also be looking for differences between the effects of the two probiotics, which differ in strain types and number of colony forming units per dose.

Official Title
-----------------
Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics

Conditions
-----------------
Development of Clostridium Difficile Associated Diarrhea

Intervention / Treatment
-----------------
* Dietary Supplement: Theralac probiotic
* Dietary Supplement: Culturelle probiotic
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any hospitalized patient who is age 19 or older and receiving antibiotics. - Exclusion Criteria: Feeding tube in place Pregnancy Milk or soy allergy Sensitivity to lactose Immunocompromised defined as: Absolute neutrophil count (ANC) ≤ 500 cells/mm3 HIV Cancer patient receiving chemotherapy or radiation therapy Immune deficiency Post organ transplant Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization. -

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Theralac probiotic<br> | Dietary Supplement: Theralac probiotic<br> <br> |
| Active Comparator: Culturelle probiotic<br> | Dietary Supplement: Culturelle probiotic<br> <br> |
| Placebo Comparator: Placebo<br> | Other: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Clostridium difficile associated diarrhea in patients receiving antibiotics |  | Up to six months |
Ramosetron Pre-treatment for PONV and QT Prolongation

Study Overview
=================
Brief Summary
-----------------
Ramosetron is commonly used to prevent postoperative nausea and vomiting (PONV) in the Eastern Asia. The prolongation of QTc interval is a main side effect. In this study, the pre-treatment time of ramosetron to decrease PONV, and QTc prolongation is compared.

Detailed Description
-----------------
This prospective study evaluate 42 female patients who underwent laparoscopic gynecologic surgery under general anesthesia. Group I (n=21) receive 0.6mg of ramosetron at anesthesia induction. Group R (n=21) received the same at the end of surgery. PONV is evaluated at arrival to post-anesthetic care unit (PACU), before induction, discharge from PACU, 24-, 48-, and 72- after discharge from PACU. The QTc interval is checked before anesthesia, at arrival to PACU, and 24-h after discharge from PACU. Forty two subjects are needed with an α value of 0.05, a power of 0.8, and effect size difference of 0.9.

Official Title
-----------------
Comparison of Ramosetron Pre-treatment Time for Postoperative Nausea and Vomiting (PONV) and QTc Prolongation

Conditions
-----------------
PONV, Prolonged QTc Interval

Intervention / Treatment
-----------------
* Drug: Ramosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent laparoscopic gynecologic surgery Exclusion Criteria: preoperative bradyarrhythmia in ECG

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ramosetron iv at induction (I)<br>0.6mg of ramosetron is given to the patients intravenously at anesthesia induction | Drug: Ramosetron<br>* Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery<br>* Other names: ramosetron pre-treatment;|
| Active Comparator: ramosetron iv at recovery (R)<br>0.6mg of ramosetron is given to the patients intravenously at end of surgery | Drug: Ramosetron<br>* Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery<br>* Other names: ramosetron pre-treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc interval change | Difference of QTc interval from preoperative value | within 10 min after arrival at PACU, and 24 hour after discharge from PACU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ramosetron
OAB and the Microbiome

Study Overview
=================
Brief Summary
-----------------
To determine differences in the urinary microbiomes, identified by polymerase change reaction (PCR) (UTIP™), of female patients with urgency and frequency syndrome with or without pelvic pain (Group A) compared to female controls without symptoms of lower urinary tract symptoms (LUTS) (Group B).

Official Title
-----------------
Trends in the Microbiome Profiles of Women With Urgency and Frequency Syndrome, With or Without Pelvic Pain?

Conditions
-----------------
Overactive Bladder, Urgency-frequency Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 y/o-90 y/o Able to consent Group A only: Urgency and Frequency Syndrome or OAB only. UDI-6 answer of moderately to quite a bit on questions 1 or 2. Group B only: Urinary Distress Inventory 6 (UDI-6) answer not at all or somewhat for questions 1 or 2. Exclusion Criteria: Pregnant Pelvic radiation Urinary retention (>200 ml) Renal calculi Recurrent urinary tract infection (UTI) (2 in 6 months), or Current UTI Immunosuppressed or radiation history Neurologic disorder

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female patients with overactive bladder (OAB)<br>Patients with urgency and frequency syndrome with or without pelvic pain (Group A) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient. | |
| Female control patients without LUTS<br>Patients without LUTS (Group B) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Lactobacillus in samples. | Evaluation of urine and perineal samples by PCR. | Day 1 | 
| Proportion of patients negative for repeat sequencing. | Evaluation of urine and perineal samples by PCR. | Day 1 | 
| Proportion of patients with change in UDI-6 score | UDI 6 question 1 and 2 has a total score from 0-6 with a high score indicating more distress. Proportion of patients with a decrease in score from baseline will be reported for this outcome. | Up to 4 weeks |
A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091

Study Overview
=================
Brief Summary
-----------------
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-109 in healthy male subjects.

Detailed Description
-----------------
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-109 compared with AD-1091 in healthy male subjects.

Official Title
-----------------
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study Under Fed State to Evaluate the Safety and Pharmacokinetics of AD-109 in Healthy Male Volunteers

Conditions
-----------------
Embolism and Thrombosis

Intervention / Treatment
-----------------
* Drug: Rivaroxaban 18mg Oral Tablet
* Drug: Rivaroxaban 20 MG Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit The Age equal to or greater than 19 in healthy male volunteers at the time of screening visit Exclusion Criteria: Patients with Medical history increasing the risk of bleeding

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A-Rivaroxaban<br>Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109) | Drug: Rivaroxaban 18mg Oral Tablet<br>* AD-109 (Rivaroxaban 18mg) Oral Tablet<br>Drug: Rivaroxaban 20 MG Oral Tablet<br>* AD-1091 (Rivaroxaban 20mg) Oral Tablet<br>|
| Experimental: Arm B-Rivaroxaban<br>Period 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091 | Drug: Rivaroxaban 18mg Oral Tablet<br>* AD-109 (Rivaroxaban 18mg) Oral Tablet<br>Drug: Rivaroxaban 20 MG Oral Tablet<br>* AD-1091 (Rivaroxaban 20mg) Oral Tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Cmax of Rivaroxaban | pre-dose to 34 hours | 
| Area Under the Curve in time plot (AUCt) | AUCt of Rivaroxaban | pre-dose to 34 hours |
Docosahexaenoic Acid on Breath Holding Spells in Children

Study Overview
=================
Brief Summary
-----------------
DHA on Breath Holding Spells

Detailed Description
-----------------
Effect of DHA on Breath Holding Spells

Official Title
-----------------
Effect of Docosahexaenoic Acid on Breath Holding Spells in Children: A Randomized Controlled Trial

Conditions
-----------------
Breath Holding Attack

Intervention / Treatment
-----------------
* Drug: DHA
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with newly diagnosed sprlls Exclusion Criteria Other treatment as iron and piracetam

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 5 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docosahexaenoic Acid<br>Docosahexaenoic acid | Drug: DHA<br>* Docosahexaenoic acid<br>* Other names: Docosahexaenoic acid;|
| Placebo Comparator: Placebo drug<br>Placebo | Drug: Placebo<br>* Placebo<br>* Other names: Placebo oral tablet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of the spells | Number of attacks | 6 months |
Effect of Escitalopram vs. Reboxetine on Gastro-intestinal Sensitivity of Patients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
Patients with major depressive disorder (MDD) commonly have many gastrointestinal complaints. Gastrointestinal pain is classified into 2 categories: visceral and somatic pain. The main aim of this study is to compare somatic and visceral sensitivity between healthy people and pateints with MDD. These two sensitivities will be assessed by the 2 following tests: standardized rectal distension and Transdermal transcutaneous electric nerve stimulation. Thereafter, patients with MDD will be randomly allocated to escitalopram or reboxetine. After 6 weeks of treatment, somatic and visceral sensitivity will be reassessed.

Official Title
-----------------
Effect of Escitalopram vs. Reboxetine on Somatic and Visceral Sensitivity of Patients With Major Depressive Disorder: a Randomized, Double Blind Clinical Trial

Conditions
-----------------
Major Depression, Pain, Abdominal Pain

Intervention / Treatment
-----------------
* Drug: escitalopram
* Drug: Reboxetine
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MDD according with DSM-IV-TR Hamilton depression scale > 21 Exclusion Criteria: history of gastrointestinal illness history of escitalopram, citalopram or reboxetine allergy. history of escitalopram, citalopram or reboxetine resistant depression. other axis I psychiatric disorder. a punctuation > 2 on the suicide item of the Ham-D. history of ECT during the past 6 months. pharmacological failure of the present depressive episode. pregnancy or nursing. treatment with drugs that may interact with study medication.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>subjects with MDD randomized to Escitalopram | Drug: escitalopram<br>* escitalopram 10 mg/d for 6 weeks<br>* Other names: reboxetine;|
| Active Comparator: 2<br>MDD patients receiving reboxetine | Drug: Reboxetine<br>* Reboxetine 8 mg/d for 6 weeks<br>|
| Other: 3<br>Healthy volonteers | Other: No intervention<br>* This group of healthy volonteers will receive no drug and will be a healthy comparator.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rectal distension Transcutaneous Electrical Neuro-Stimulation |  | 1-7 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
major depression, pain, escitalopram, reboxetine, visceral sensitivity, somatic sensitivity