cyrilzakka/clinical-trials huggingface dataset:
A Random Clinical Trial (RCT) of the Impact of Electrocoagulation on Ovarian Reserve

Laparoscopic ovarian cystectomy is widely used for the removal of benign ovarian cysts but damage to ovarian reserve caused by electrocoagulation has recently been questioned.

The purpose of this study is to investigate the impact of bipolar and ultrasonic scalpel electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.

Laparoscopic ovarian cystectomy is currently considered the treatment of choice in women with benign ovarian cyst and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad caused by electrocoagulation has recently been questioned. Many evidences support that the removal of ovarian cysts is associated with an injury to ovarian reserve. On the contrary, some retrospective studies did not show adverse outcomes compared with the control group (tubal infertility) . There is a lack of good clinical and scientific evidence such as randomized controlled study to report definitively the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.

Eligibility Criteria:
Inclusion Criteria:

* age 18-40 years
* ultrasound diagnosis as unilateral ovarian cyst and the average size between 5cm and 10cm
* no clinical and sonographic suspicion of ovarian cancer
* regular menstrual cycles defined as cycle length between 25 and 35 days in the 6 months before surgery
* sonographic normal contralateral ovary
* agreement to be enrolled in the study.

Exclusion Criteria:

* prior ovarian surgery or known endocrine disease
* surgical necessity to perform adnexectomy
* intraoperative diagnosis of an abnormal contralateral ovary
* post operative pathologic diagnosis was not benign ovarian cyst
* oral contraceptive use before surgery.
Propolis in Reducing Dentin Hypersensitivity

Objective: This randomized, double-blind, parallel, placebo-controlled clinical trial aims to evaluate the effect of propolis with two distinct concentrations (10% and 15%), and the impact on volunteers' quality of life.

Materials and methods: Volunteers meeting the inclusion and exclusion criteria will be randomized and allocated into three groups: Group 1- placebo - toothpaste without active ingredient, Group 2- toothpaste with 10% propolis and Group 3. - toothpaste with 15% propolis. Number of teeth will be used as sample unit, totaling 22 teeth per group. Volunteers will receive oral hygiene instruction with guidance to brush their teeth three times a day with toothpaste corresponding to the groups in which they will be allocated for 30 days. The evaluation of dentin hypersensitivity will be performed with three (3) evaluation times: baseline (immediately before the beginning of treatment), 15 and 30 days, through tactile and evaporative stimuli, using the visual analog scale (VAS). The self-reported evaluation of the volunteers will be done through a questionnaire before the beginning and after one month with the completion of the research to determine the impact of treatment on their quality of life. The data regarding HD in VAS, if present normal distribution, will be used Two-way analysis of variance (ANOVA) with Tukey's post hoc for comparison between treatments. However, if the data show anormal distribution, Friedman to compare the different times in the same group (intra group), and Kruskal Wallis to make the comparison between groups (inter group). To evaluate the QEHD ordinal data, Wilcoxon and Mann-Whitney tests will be used. Bioestat 5.3 (Belém, Pará, Brazil) will be used, considering an alpha level of 5%.


Eligibility Criteria:
Inclusion Criteria:

* Two to four hypersensitive teeth with a response ≥ 04 on the visual analogue scale (VAS) from 0 to 10, where 0 represents no pain and 10 extreme pain, during the application of tactile (explorer probe) and evaporative (jet air);
* Dentinal exposure on the posterior teeth, due to the presence of a shallow non-carious lesion up to 02 mm in depth, according to the Smith \& Knight index (measured with a millimeter probe), and / or class I gingival recession according to Miller classification.

Exclusion Criteria:

* Restorations; tooth decay and/or periodontal pockets; dental pulpitis; enamel cracks or fractures on sensitive teeth;
* Continuous treatment with anti-inflammatory drugs and/or analgesics or desensitizing treatment induced three months prior to research recruitment data;
* Pregnancy or lactation;
* Systemic diseases;
* Fixed orthodontic appliances;
* Occlusal instability.
Evaluation of Multisite Sampling to Detect C. Trachomatis or N. Gonorrheae Compared With Vaginal Sampling in Women at Risk for Sexually Transmitted Infections

Screening for STIs in MSM is based on multisite samples: urine, anal and oral for PCR targeting C. trachomatis, N. gonorrhoeae, M. genitalium and T. vaginalis, whereas only vaginal self-sampling is recommended in women.

Recent publications and observations suggest that a substantial number of STIs are under diagnosed with the current recommendations.

The main objective of the study is to assess the number and percentage of additional C. trachomatis and N. gonorrhoeae infections diagnosed by a multiple sampling strategy in women, particularly when the vaginal sampling is negative The secondary objective will assess the acceptability of anal and oropharyngeal self-sampling relative to vaginal self-sampling in women.

1500 women will be included in 5 different screening STIs centers in France based of the prevalence of STIs in this population (10% C. trachomatis) and the hypothesis that this new strategy allows to detect 20% more underdiagnosed STIs The sequential recruitment will concern women attending at one of the 5 STIs screening centers, whether they are symptomatic or not. If they agree to participate in the study, the patients will take the samples themselves from the 3 sites (vaginal, anal and oral self-sampling) using standard swabs (brand). The sample will immediately be placed in the transport medium in each of the 3 Sigma VCM tubes labeled by the patient, depending on the collection site. The study nurse will register the inclusion of patients, identify the tubes, collect information and send them to the local laboratory for the PCR to be performed. The study will be continued until the number of patients to be included for each of the centers is obtained. The anonymized data will be entered on an Excel database. The results of the PCRs will be collected a posteriori by the IDEs to populate the database. The PCR result will be given both qualitatively (positive/negative) and CT value for C. trachomatis and N. gonorrhoeae infections.

Eligibility Criteria:
Inclusion Criteria:

* Women coming for STI screening at a Cegidd
* Asymptomatic or not
* Women aged at least 18 years
* Having given her consent to participate

Exclusion Criteria:

* Patient having received antibiotic treatment covering C.trachomatis and N.gonorrheae in the month preceding the screening
* Patient under guardianship or curatorship
* Patient under legal protection
* Pregnant or breastfeeding woman
Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer

Background Obesity and overweight are well known risk factors for breast cancer and also are associated with higher recurrence and mortality rates.

Main goal of this study is to evaluate the efficacy of metformin plus chemotherapy in terms of pathologic complete response in comparison with placebo plus the same chemotherapy regimen Design: Randomized, double blind, clinical trial. This study will be performed at National Cancer Institute of Mexico City, at breast cancer unit.

Patients with ER+ or PR+, HER2 negative, breast cancer are candidates to participate.

After completion of chemotherapy all patients will have a breast surgery to assess pathologic response.

Complete pathologic response is defined as the abscence of malignant cells in breast tissue and lymph nodes. The presence of DCIS is considered as pCR

Definitions Luminal A: tumors ER + PR + HER2 Negative and Ki67 \<14% Luminal B: tumors ER +/-, PR +/-, HER2 negative and Ki67 \>15% Complete pathologic response is defined as the abscence of malignant cells in breast tissue and lymph nodes. The presence of DCIS is considered as pCR

Eligibility Criteria:
Inclusion Criteria:

* Women older than 18 years old and younger than 70 years old

  * Invasive breast cancer confirmed by core biopsy, any histology
  * Tumor ≥2 cm and/or lymph node positive (proven by FNA)(T2-4b, N0-3, M0)
  * Must have ER/PR positive and HER2 negative
  * Must have full staging and extent disease and clinically and radiographically tumor measure
  * Without previous treatment for breast cancer (including surgery, hormonotherapy or chemotherapy)
* Normal liver, kidney and blood tests
* Performance Status ECOG 0-2 o Karnofsky ≥70%
* Fasten glucose levels \<125 mg/dl
* Signed consent

Exclusion Criteria:

* Previous use of metformin for any indication
* Presence of Diabetes Mellitus
A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults

The goal of this study is to compare real-world effectiveness of the mRNA-1273 vaccine versus the BNT162b2 vaccine on medically attended COVID-19 and COVID-19 hospitalizations among fully vaccinated immunocompromise participants.

This observational retrospective comparative effectiveness cohort study will use the HealthVerity aggregated medical and pharmacy claims database. HealthVerity data elements include provider-submitted claims, adjudicated insurance claims, and pharmacy billing manager claims submissions. Hospitalizations are included in the data at a summary level.

Eligibility Criteria:
Inclusion Criteria:

* Fully vaccinated with a currently US authorized COVID-19 vaccine:
* 2 doses of mRNA-1273 (minimum 14 days between doses)
* 2 doses of BNT1262b2 (minimum 14 days between doses)
* Continuous enrollment in medical \& pharmacy plan for at least 365 days prior to index/Cohort entry date (CED)
* Identified as immunocompromised via at least 1 of the following criteria at index/CED
* Evidence of blood or stem cell transplant in 2 years prior to index/CED
* Any history of organ transplant and taking immunosuppressive therapy within the 60 days prior to index/CED
* Evidence of active cancer treatment in the 180 days prior to index/CED with an active cancer diagnosis in the 365 days prior to treatment
* Any prior history of a primary immunodeficiency disorder (for example, for conditions such as DiGeorge syndrome and Wiskott-Aldrich syndrome)
* Any history of an HIV diagnosis code prior to index/CED
* A fill for an immunosuppressive therapy in the 60 days prior to index/CED

Exclusion Criteria:

* Prior COVID-19 infection (any history prior to index/CED through day 13 post-completion of vaccine regimen) identified via the following diagnosis codes on an inpatient or outpatient claim:
* U07.1: "COVID-19, virus identified"
* J12.82: "Pneumonia due to COVID-19"
* Z86.16: "Personal history of COVID-19"
* The following diagnosis codes were utilized early in the pandemic. Exclusion will be applied March 1, 2020 through day 13 post-completion of vaccine regimen:
* J12.89: "Other viral pneumonia"
* J20.8: "Acute bronchitis due to other specified organisms"
* J40: "Bronchitis, not specified as acute or chronic"
* J22: "Unspecified acute lower respiratory infection"
* J98.8: "Other specified respiratory disorders"
* J80: "Acute respiratory distress syndrome"
* Prior receipt of a heterologous COVID-19 vaccine (relative to the COVID-19 vaccine identified at index/CED) in the 365 days prior to index/CED through 13 days post-completion of vaccine regimen
* Receipt of an additional dose of homologous COVID-19 vaccine between index/CED and 13 days post-completion of vaccine regimen
* Missing or unknown gender on index/CED
Effect of Butyrogenic Fibers in IBS Patients

Despite there being no clearcut advantages, one of the most common recommendations in IBS management is to increase the amount of dietary fibres. In some IBS patients fibres have a deleterious effect on pain and bloating. It has been shown that butyrate can increase colonic sensitivity in rats. Our purpose is to study whether butyrogenic fibres can modify rectal sensitivity and symptoms in IBS and healthy control through a modification of colonic flora.

Despite there being no clearcut advantages, one of the most common recommendations in IBS management is to increase the amount of dietary fibres. In some IBS patients fibres have a deleterious effect on pain and bloating. It has been shown that butyrate can increase colonic sensitivity in rats. Our purpose is to study whether butyrogenic fibres can modify rectal sensitivity and symptoms in IBS and healthy control through a modification of colonic flora.

Eligibility Criteria:
Inclusion Criteria:

* Female aged 18-60 years
* Normal volunteers and patients with IBS assessed by Rome II criteria
* Effective contraception
* Affiliated to National Health Service
* Having received oral and written information about the study
* Having provided her written informed consent

Exclusion Criteria:

* Significant clinical or biological abnormality
* Organic gastrointestinal disease
* Subjects having lower than 15g/day or higher than 20g/day fibres intake
* Antibiotic treatment during the month preceding the pre inclusion day
* Antispasmodics, antidiarrheics, laxatives, and prokinetics during the week preceding the pre inclusion day and during all the study period.
* Digestive surgery tract except appendectomy and cholecystectomy
* Alcohol abuse
* Drug addiction
* Major psychiatric disorder
Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay

The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of infection. Swab samples will be collected from acute and chronic wounds of different etiologies and these will be analysed for bacteria types and markers of infection.


Eligibility Criteria:
Inclusion Criteria:

* Subject has presented to participating study site with a wound(s) suspected to be infected, as determined by the Investigator and/ or study staff - defined as one that through clinical judgment has questionable infection status, and /or shows three or more of the NERDS or STONES signs of infection);
* Subject has presented to participating study site with a wound(s) suspected not to be infected, as determined by the Investigator and/ or study staff - defined as one that does not show three or more of the NERDS or STONES signs of infection.
* Subject is 18 years of age or older.
* Subject agrees to complete all aspects of the study and provides Informed Consent

Exclusion Criteria:

* Subject is less than 18 years of age.
* Target wound contains a malignancy
* Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
* Subject is confirmed to be positive for HIV or hepatitis.
* Subject is unable or unwilling to provide informed consent.
* Subjects deemed inappropriate for the study by the site's Principal Investigator.
The Early Warning System for the Diabetic Encephalopathy

Diabetes( mainly type II diabetes )lead to the central nervous system (CNS) function impairment, especially the mild cognitive impairment that increased the risk of progression to dementia.The primary objectives are defined according to a hierarchical design: i) to tailor and apply multi-parametric, functional MRI techniques to identify cerebral abnormalities (cerebral biomarkers) in type 2 diabetes mellitus and prodromal diabetes mellitus ; ii) to assess whether these cerebral biomarkers are associated with cognitive decrements;iii) to follow up with the putative prediabetic condition patients to verify whether they can transform into diabetes.

Diabetes ( mainly type II diabetes ) lead to the central nervous system (CNS) function impairment, especially the mild cognitive impairment (MCI) that increased the risk of progression to dementia. It was regarded that neurodegeneration contributes to the diabetic MCI, however, recent research suggested that CNS microvascular alterations are the mechanism for early diabetic MCI. But there still lacks an early warning system for the CNS micro-structure alterations during early diabetes. Latest neuroimaging techniques enable the measurement of brain blood flow, local neural activity，and the nuclei deposition of iron to reflect CNS micro-structure alterations. But these techniques are complicated and can not fully reflect the alterations with one single technique.We previous observed that 44.4% of diabetic patients demonstrate MCI and established the comprehensive protocols of measuring brain blood flow, local neural activity and the nuclei deposition of iron simultaneously based on the multimodal MRI technique so as to reflect the microstructure alterations reliably and validly. Therefore, we intend to integrate psychological measurement and clinical biochemical examination, and to establish the early warning system for the central nervous system micro-structure alterations during early diabetes based on the multi-modal MRI technique. The reliability and validity of this system will be tested in the diabetic rat model. The early warning system will likely assist in screening patients with diabetic microstructure alterations, to perform early intervention so as to prevent or delay the progression from diabetic MCI to dementia.

Eligibility Criteria:
Inclusion Criteria:

* without dementia
* Inform Consent Form
* Education time more than 6 years
* blood glucose matches the group standard

Exclusion Criteria:

* Pregnant woman
* suffer from serious brain disease
* Magnetic resonance contraindications
* lack of compliance
* image quality is too poor to deal with
Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration. In addition, the correlation between the infant's development and the mother's emotional state will be analyzed.

Medical records of the children will be used for information in four categories: prenatal, birth, development,and demographic information. Parents will be contacted and interviewed regarding the child's development. In addition, they will complete the following questionnaires: PPQ-II Perinatal PTSD Questionnaire- modified, PTGI -The Posttraumatic Growth Inventory,Parental Stress Index- Short Form- PSI-SF, and Life Events questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Preterm Infant
* Very low birth weight or extremely low birth weight

Exclusion Criteria:

* Missing information regarding birth week and weight
A Study Of Diflucan In Children With Ringworm Of The Scalp

The purpose of this study is to evaluate the safety and efficacy of fluconazole for the treatment of tinea capitis in pediatric patients aged 3 to 12 years.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (aged 3-12 years)
* Clinical diagnosis of tinea capitis
* Direct microscopy (KOH) positive for fungal elements within or outside hair shaft

Exclusion Criteria:

* Negative baseline KOH
* Liver disease
Saliva and Plasma Endocannabinoids Concentrations According to Feeding Status and Body Mass Index

Up till now, the evaluation of the endocannabinoid system (ECS) in humans needs invasive procedures. The investigators managed in the lab to determine the levels of endocannabinoids in a small number of subjects. The aim of the study is to confirm that salivary is a useful tool to evaluate the activity of the ECS both in normal weight and obese subjects that are characterised by a hyperactivity of the system. Therefore, the first objective of the study is to compare the fasting level of salivary anandamide between 12 obese patients and 12 normal weight subjects.

The prevalence of obesity keeps increasing in industrialized countries. However, efficient treatments of this chronic disease are still lacking. A better understanding of the systems that regulate energy balance and eating behavior is mandatory to better understand the disease and find appropriate treatments. The endocannabinoid system (ECS) which comprises cannabinoid receptors, such as CB1 and CB2, endogenous ligands (named endocannabinoids) and specific biosynthetic and degradative pathways is a key system in the regulation of energy balance and obesity. Obesity is characterised by an hyperactivity of the system both in animal and humans. Moreover, the activity of the ECS is influenced by feeding status although only one study has only been performed in humans. The investigation of the ECS in humans needs invasive procedure (blood sampling or adipose or liver biopsy). The aim of our study is to evaluate a new tool for the ECS evaluation in humans i e the determinations of saliva concentration of endocannabinoids both in normal weight and obese subjects before and after food intake. Blood and saliva sampling will be performed after an overnight fast, one hour before, just before and one hour after a lunch in12 normal weight subjects and 12 obese characterised with anthropometric (Weight, height, BMI (Body Mass Index), waist circumference, blood pressure) and metabolic (glycaemia, insulin, lipid profile, liver profile) evaluations. The endocannabinoids concentrations will be measured with mass spectrometry in blood and saliva and gut hormones (PYY (peptide YY) and ghrelin) will be measured in plasma.

Eligibility Criteria:
Inclusion Criteria:

Obese patients :

* Age between 18 and 65 yrs
* BMI (Body Mass Index) \> 30 kg/m²
* Signed inform Consent before any investigation related to the study
* No smoker

Normal weight subjects :

* Age between 18 and 65 yrs
* BMI between 18 and 25 kg/m²
* Signed inform Consent before any investigation related to the study
* No smoker

Exclusion Criteria:

* treatments that could interfere with the endocannabinoid system (anxiolytics, anticonvulsivants, antidepressants drugs)
* pregnancy, breast feeding