linjc16/ctgov huggingface dataset:
Predicting Changes in Core Muscles During Female Sexual Dysfunction: A Comprehensive Analysis Using Machine and Deep Learning

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Predicting changes in core muscles during female sexual dysfunction by A Comprehensive Analysis Using Machine and Deep Learning Female sexual dysfunction (FSD) is a common condition that affects womenof all ages. It is characterized by a range of symptoms, including decreased libido, difficulty achieving orgasm, and pain during intercourse. One potential cause of FSD is muscular weakness or changes in the core muscles. These muscles play an important role in sexual function, and changes in their strength or activation patterns can lead to FSD. Additionally, the development of a machine learning model for this purpose could pave the way for future studies exploring the use of artificial intelligence in the diagnosis and treatment of other musculoskeletal disorder and female health issues.

Official Title
-----------------
Predicting Changes in Core Muscles During Female Sexual Dysfunction: A Comprehensive Analysis Using Machine and Deep Learning

Conditions
-----------------
Female Sexual Dysfunction

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a number of parities ≤ three normal vaginal deliveries Exclusion Criteria: History of a recto-vaginal or vesico-vaginal fistula, undiagnosed uterine bleeding urinary tract infection, diabetes, intrauterine device sexual disorder

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female sexual dysfunction group<br> | Other: no intervention<br>* no intervention<br>|
| Normal females<br> | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm excursion | Ultrasound imaging curvilinear transducer | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force of contraction of pelvic floor muscles | ultrasound imaging, convex transducer was used at a frequency of 5 MHz for evaluating. Voluntary PFM contractions' force (strength) of all patients. It has a good inter-rater reliability for measuring PFM force (ICC, 0.81, 0.7123) respectively, as well as a good intra-rater reliability (ICC,0.98, 0.9841) respectively | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Core Muscles, machine learning,female sexual dysfunction, KNN
Rapid Autopsy Protocol for Patients With Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This is pilot study to establish a rapid autopsy program in Small Cell Lung Cancer (SCLC) at the Indiana University Simon Comprehensive Cancer Center and outline the components necessary for tumor tissue collection.

Detailed Description
-----------------
The goal of this project to establish a rapid autopsy program in SCLC at the IUSCCC and outline the key components necessary for tumor tissue acquisition. This proposal is a collaboration between scientists, lung cancer physicians, pathologists, and the IUSCCC Translational Research Core. Tumor tissue collected will be used for protein and gene analysis and RNA, whole exome sequencing in addition to the establishment of SCLC. This research is part of a discovery project in which biological and molecular markers of SCLC will be identified.

Official Title
-----------------
Rapid (Warm) Autopsy Protocol for Patients With Small Cell Lung Cancer

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Biospecimen Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old at the time of informed consent Written informed consent and HIPAA authorization for release of personal health information. Active SCLC diagnosis.

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 |
| --- | --- |
| Active SCLC Diagnosis<br> | Procedure: Biospecimen Collection<br>* Lung, liver, skin, subcutaneous metastases, and blood specimens may be collected via rapid autopsy within 10 hours of expiration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining the Feasibility of the Creation of a Rapid Autopsy Program at IUSCCC for SCLC through enrollment and sample collections |  | 5 years | 
| Utilization of Tissue to Better Understand the Complex Biology of SCLC | Utilize tissue obtained from rapid autopsies to generate novel patient derived xenograft models and tumor cell lines, in addition to RNA, whole exome and whole genome sequencing, protein extraction to better understand the complex biology of SCLC and set up an infrastructure to develop relevant clinical models that will allow the development of better therapies. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer, Small Cell Lung Cancer, Future Research
Colonic Polyp Size Measurement With Artificial Intelligence

Study Overview
=================
Brief Summary
-----------------
Primary objective of the study is to evaluate if the novel virtual polyp sizing tool accuracy in determining the size class of polyps among diminutive (0-5 mm), small (6-9 mm) and large (10 mm and above).

Official Title
-----------------
MEasuring the Accuracy of an Artificial Intelligence Tool That Establishes Polyp Size in Real-time

Conditions
-----------------
Colon Polyp, Artificial Intelligence

Intervention / Treatment
-----------------
* Device: Colonic Polyp Measurement Assessment Via Artificial Intelligence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients aged 18 years or older undergoing colonoscopy Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation. Exclusion criteria: Patients with known contra-indications to colonoscopy Patients who perform an emergency colonoscopy.

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

| Intervention/Treatment |
| --- |
|Device: Colonic Polyp Measurement Assessment Via Artificial Intelligence|In this study, we collect colonoscopy video clips of polyps and, among the related clinical information, their estimated size using the gold standard technique, and we use them offline to evaluate the measurement performances of the novel virtual polyp sizing tool|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy for categorical distribution of polyp size | 1. Accuracy of the novel virtual polyp sizing tool in the determination of polyp size class among diminutive (0-5 mm), small (6-9 mm) and large (10 mm and above) as compared to the size estimated in-vivo by performing endoscopists with the help of a side-by-side forceps of known size | at study completion (this outcome is not an outcome measured from Time A to Time B but an outcome measured in one time point for all the colonoscopies performed in the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy for continous determination of polyp size | 1. Polyp size in mm as determined by the novel virtual polyp sizing tool as compared to the size estimated in-vivo by performing endoscopists with the help of a side-by-side forceps of known size | at study completion (this outcome is not an outcome measured from Time A to Time B but an outcome measured in one time point for all the colonoscopies performed in the study. |
School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
Determination of FH status by genetic testing in school age children who have demonstrated elevated cholesterol on baseline screening.

Official Title
-----------------
School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia

Conditions
-----------------
Familial Hyperlipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elevated cholesterol on baseline screening to use as means of identifying those with an FH variant Exclusion Criteria: normal cholesterol

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 10 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia | Percentage of school children who have elevated cholesterol related to FH variant | Evaluation of family members over a defined 5 year period |
Enhancing Surgical Safety in Developing Nations: Investigating Antibiotics' Role in Hand Surgeries.

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare the use of antibiotics with no use in people undergoing soft tissue hand surgery in developing countries. The main question it aims to answer is: • Is an antibiotic necessary for this type of surgery in this population? Researchers will compare a group of patients who receives antibiotics during the surgical procedure with a group who receives no antibiotics to see if infection rates are the same.

Official Title
-----------------
Antibiotic Prophylaxis in Clean Soft Tissue Hand Surgery Among a Population in a Developing Country: A Randomized, Parallel, Triple-Blind, Placebo-Controlled Clinical Trial

Conditions
-----------------
Soft Tissue Injuries

Intervention / Treatment
-----------------
* Drug: Antibiotic
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: individuals with clean soft tissue conditions of the upper limb requiring surgery Exclusion Criteria: abandonment of treatment ASA > 3

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: antibiotic prophylaxis<br> | Drug: Antibiotic<br>* the individual will receive 1 dose of antibiotic during anesthetic induction<br>|
| Placebo Comparator: placebo<br> | Other: placebo<br>* the individual will receive 10 ml of saline during anesthetic induction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical wound infection | CDC protocol for surgical wound infection surveillance | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antibiotic prophylaxis, hand surgery, orthopedic surgery, postoperative care, surgical wound infection, developing country
Microbiome Effect of Omadacycline on Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to assess microbiome changes associated with omadacycline vs. comparators (moxifloxacin or oral vancomycin). Using a phase I study design, healthy volunteers aged 18-40 years will be given a 10-day course of either omadacycline 450 mg days 1 and 2 followed by 300 mg PO once daily, moxifloxacin 400 mg once daily, or oral vancomycin 125 mg given four times daily. Stool will be collected at baseline, daily during therapy, and at two follow-up time periods (days 13-14 and days 30-32). DNA will be extracted from stool and used for qPCR biomass and microbial metagenomic experiments. Results from the study will provide definitive data on the microbiome effects of omadacycline versus comparator antibiotics.

Official Title
-----------------
Microbiome Effect of Omadacycline on Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Omadacycline
* Drug: Vancomycin Pill
* Drug: Moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
All volunteers will be considered healthy based on medical history, none will have a history of cardiovascular, gastrointestinal, hepatic, or renal disease. Subjects will not have taken an antibiotic for at least three months prior to enrollment. Patients will not have taken a probiotic for at least a month prior to enrollment and during the entire study period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omadacycline<br>Subjects will receive 3 tablets on day 1 and day 2 (450 mg) followed by 2 tablets (300 mg) for days 3 through 10. | Drug: Omadacycline<br>* 10-day course<br>|
| Active Comparator: Vancomycin (oral)<br>Vancomycin 125 mg capsules will be taken four times daily for a total of 10 days. | Drug: Vancomycin Pill<br>* 10-day course<br>|
| Active Comparator: Moxifloxacin<br>Moxifloxacin 400 mg tablets will be taken once per day for a total of 10 days. | Drug: Moxifloxacin<br>* 10-day course<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome changes | Metagenomic changes (16S rRNA) and qPCR for individual bacterial species | During dosing and 30 day follow up period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
omadacycline, microbiome, healthy volunteer
Surgical Emergencies Gradation and Postoperative Outcome

Study Overview
=================
Brief Summary
-----------------
Reducing surgical waiting time has been shown to be associated with a reduction in postoperative morbidity and mortality in this type of surgery. The use of a gradation of surgical emergencies makes it possible to prioritise them in an objective, consensual manner and to carry them out within a theoretical expected waiting time relative to the degree of urgency. The investigators hypothesise that exceeding the theoretical expected waiting time relative to the degree of urgency defined by the gradation of surgical emergencies is associated with an increase in postoperative morbidity and mortality in emergency surgery. The objective is to assess the impact on post-operative morbidity and mortality of waiting times exceeding the theoretical expected time by grading the surgical emergencies of patients undergoing emergency surgery.

Official Title
-----------------
Effect of Implementation of a Surgical Emergencies Gradation on Postoperative Outcome in Emergency Operating Theatre Patients of the Amiens-Picardy University Hospital

Conditions
-----------------
Emergency Surgery, Mortality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years old. Non-cardiac emergency surgery. Exclusion Criteria: Minor patients Emergency cardiac surgery Patients under guardianship or curators Pregnant women Patients who object to their personal data being used in research

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Post-operative complications |  | 1 year | 
| Mortality at 1 year |  | 1 year | 
| Length of stay in intensive care unit |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emergency surgery, gradation, Complication, mortality
An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
An open label, single-arm clinical study evaluating the safety and efficacy of ICI201 infusion in relapsed/refractory multiple myeloma

Official Title
-----------------
An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma

Conditions
-----------------
Relapsed/Refractory Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: ICI201


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma. 2. Subjects must have previously received at least 3 anti-myeloma regimens. Subjects must have documented disease progression (according to IMWG criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD). 3. Measurable disease as defined by the protocol 4. ECOG score is 0 or 1. 5. Expected survival time ≥12 weeks. 6. GPRC5D positive expression in bone marrow plasma cells Exclusion Criteria: 1. Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs. 2. Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection. 3. Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses < 10mg/ day). 4. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg). 5. Patients who have recieved GPRC5D-targeted therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICI201<br> | Drug: ICI201<br>* ICI201 CAR-T cell injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicity (DLT) | Dose limiting toxicity (DLT) | Time Frame: 28 days post ICI201 administration | 
| Incidence and severity of all adverse events related to study drug | Incidence and severity of all adverse events related to study drug | Time Frame: 2 years post ICI201 administration |
Influence of Air Pollution on SPondyloarthritis Flare-ups and Resistance to Treatment

Study Overview
=================
Brief Summary
-----------------
The relationship between exposure to air pollution and spondyloarthritis (SpA) has been poorly studied. Based on data from the literature on other inflammatory pathologies such as rheumatoid arthritis, we hypothesize that there is a relationship between exposure to air pollution and the risk of presenting a flare-up in SpA patients following and living in Franche-Comté (France). Primary objective:The potential relationship between exposure to air pollution (nitrogen dioxide, fine particles with a diameter of less than 10 or 2.5 microns and Ozone) and the onset of a spondyloarthritis flare-up will be explored in patients with this pathology.

Official Title
-----------------
Influence of Air Pollution on SPondyloarthritis Flare-ups and Resistance to Treatment

Conditions
-----------------
Spondyloarthritis, Axial

Intervention / Treatment
-----------------
* Other: Assessment of exposure to air pollution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Axial Spondyloarthritis (radiographic or non-radiographic) according to Assessment of SpondyloArthritis international Society (ASAS) criteria Patient having received a consultation / hospitalization during the period 2019-2022 Patient enrolled in the MISTIC cohort Having lived in Franche-Comté during the 2019-2022 period. Exclusion Criteria: Other chronic inflammatory rheumatism (rheumatoid arthritis according to ACR 2010 criteria or psoriatic arthritis according to ClASsification criteria for Psoriatic ARthritis criteria) No inflammatory rheumatic disease

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 diagnosis of Axial Spondyloarthritis<br>Patients with a diagnosis of Axial Spondyloarthritis, received in rheumatology consultation/hospitalization over the period 2019-2022 and living in Franche-Comté over the same period | Other: Assessment of exposure to air pollution<br>* For each patient, exposure to air pollution will be assessed over a period immediately prior to any flare-up and over four periods at a distance from the flare-up.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a SpA flare-up | The occurrence of a SpA flare-up measured by disease activity, defined according to the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and/or ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score - C reactive protein) scores (BASDAI score ≥4/10 and/or ASDAS-CRP score ≥2.1) according to ASAS group | 6 to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Air pollution