linjc16/ctgov huggingface dataset:
Sponsor-Initiated OCS Heart Perfusion Registry

Study Overview
=================
Brief Summary
-----------------
OHP-II Registry is a sponsor-initiated, multi-center, observational post-approval registry.

Detailed Description
-----------------
The objective of this sponsor-initiated OHP-II Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and document the performance of the OCS device in the real-world setting. All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry. Up to 5,000 subjects will be enrolled. All interested U.S. Heart transplant centers that use the OCS Heart System for donor heart perfusion will constitute the OHP-II Registry participating centers.

Official Title
-----------------
Sponsor-Initiated OCS Heart Perfusion (OHP-II) Registry

Conditions
-----------------
Heart Transplant

Intervention / Treatment
-----------------
* Device: OCS Heart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: N/A Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OCS Heart Transplant Recipients<br>All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry. Up to 5,000 subjects will be enrolled. | Device: OCS Heart<br>* The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival | Patient survival at one-year post-heart transplant. | One year post-heart transplant |
User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL

Study Overview
=================
Brief Summary
-----------------
Prospective collection of data from medical records, multicenter, post-market clinical follow-up study.

Official Title
-----------------
User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Device: Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously bilaterally implanted with TECNIS Odyssey IOL, following cataract extraction; Enrollment at least 21 days after second eye surgery; Clear intraocular media in each eye; Signed informed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries; Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures; Ability to understand, read, and write in English Exclusion Criteria: Concurrent participation in an interventional clinical trial during the time from which the data will be collected; Use of systemic or ocular medication that may affect vision Prior corneal refractive surgery in each eye (i.e., LASIK, PRK, SMILE, RK, CK); NOTE: Limbal relaxing incisions (LRI) are permissible as planned at the time of surgery (intraoperatively) but not postoperatively until after completion of the study visits; Ongoing adverse events that might impact study measurements, as determined by the investigator; Acute or chronic disease or condition, ocular trauma, or surgery that may confound study measurements (e.g., clinically significant macular degeneration, glaucoma, cystoid macular edema, proliferative diabetic retinopathy, keratoconus, etc.); Amblyopia, strabismus, nystagmus in each eye
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intervention|No study treatments will be administered during this study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuities | Visual Acuity will be collected via observed case data in units of logMAR. | 1-month postoperative |
Nd:YAG Laser and Radiofrequency in Treatment of Fingernail Psoriasis

Study Overview
=================
Brief Summary
-----------------
Compare the effect of Radiofrequency to long pulsed Nd:YAG 1064 nm laser in treatment of fingernail psoriasis.

Official Title
-----------------
Comparative Study Between Long Pulsed Nd:YAG Laser and Radiofrequency in Treatment of Fingernail Psoriasis

Conditions
-----------------
Nail Psoriasis

Intervention / Treatment
-----------------
* Device: Radiofrequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nail Psoriasis Exclusion Criteria: Manual workers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency<br>Device | Device: Radiofrequency<br>* Device emitting electric waves generating heat<br>|
| Active Comparator: Nd Yag Laser<br>Device | Device: Radiofrequency<br>* Device emitting electric waves generating heat<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Targeted Nail Psoriasis Severity Index (tNAPSI) score |  | 12 weeks |
Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements

Study Overview
=================
Brief Summary
-----------------
Tranexamic acid in debridement surgery of burns on the volume of bleeding in transfusion requirements

Detailed Description
-----------------
A randomized, double-blind, prospective trial was conducted to establish the effect of intraoperative tranexamic acid in the early surgical debridement of severe burns. The study was carried out between the months of January 2022 and December 2023.

Official Title
-----------------
Efficacy of Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements at Centro Medico de Occidente'

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Drug: Tranexamic acid
* Other: 0.9% isotonic saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First-time patients undergo surgical debridement of their burns. A burn percentage of 10-30% of burned body surface area Patients over 18 years of age Patients under 40 IMSS beneficiaries Exclusion Criteria: Burned patients with previous surgical debridement. Patients with co-morbids. Patients with a history of drug hypersensitivity. Patients with kidney disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Randomized, double-blind, prospective trial to establish the effect of intraoperative tranexamic acid in early surgical debridement of severe burns. The study was carried out between the months of January 2022 to December 2022.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tranexamic acid<br>A total of 20 patients were included: 9 patients in the tranexamic acid group | Drug: Tranexamic acid<br>* 10mg/kg intravenous single dose<br>|
| Placebo Comparator: placebo<br>A total of 20 patients were included: 11 patients in the control group using 0.9% isotonic saline solution. | Other: 0.9% isotonic saline solution<br>* 100 ml intravenous single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the group with tranexamic acid with the group with saline solution. | The differences between the groups at the beginning of the study were evaluated with the Student's t test for continuous variables, and the proportions were compared with the Chi2 or Fisher test. | The time frame: the total time of the study is during the first day, only one dose will be given, and they will be compared at 24 hours. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burns
Genetic Markers and Biomarkers in Patients With Intellectual Disabilities of Genetic Origin

Study Overview
=================
Brief Summary
-----------------
Analyze genetic and biological markers in patients with Intellectual Deficiencies (ID) of genetic origin in order to better understand the mechanisms of modified genes, cellular mechanisms, pathways involved in different disorders , complications and pathologies associated with ID of genetic origin.

Detailed Description
-----------------
Blood and skin samples will be taken from patients coming at the outpatients clinic of the Institut Jérôme Lejeune and who consent to participate to the study. Search and identification of markers will be then done from the collected samples.

Official Title
-----------------
Search for Genetic Markers and Biomarkers to Follow Patients With Intellectual Disabilities of Genetic Origin and to Understand Its Origin and Associated Comorbidities

Conditions
-----------------
Down Syndrome, Intellectual Disability

Intervention / Treatment
-----------------
* Other: Biological samplings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient diagnosed with an intellectual disability of genetic origin Patient of all ages coming for consultation at the Institut Jérôme Lejeune Patient whose parents or legal representative have received and understood the information document and signed the informed consent for a sample for the research project. Patient affiliated to a social security scheme Exclusion Criteria: Parents unable to find out about the constraints related to the study Refusal of informed patient participation Pregnant, parturient and nursing mothers Persons deprived of their liberty by judicial or administrative decision
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Down syndrome or other Intellectual deficiency of genetic origin<br>Patients with Down syndrome or with other intellectual deficiency of genetic origin followed at the outpatients clinic of the Institut Jérôme Lejeune. | Other: Biological samplings<br>* Blood and/or skin samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of biomarkers in blood | Analysis of biomarkers from blood samples taken during the visit | 10 years | 
| Identification of biomarkers from skin samples | Analysis of biomarkers from skin samples taken during the visit | 10 years |
Urinary Retention Following taTME VS laTME Total Mesorectal Excision for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
A comprehensive study with prospectively collected data. These patients were assigned to either the taTME group or the laTME group according to the surgery procedure received

Detailed Description
-----------------
Transanal total mesorectal excision has emerged as a potential solution to certain limitations associated with laparoscopic total mesorectal excision in rectal cancer patients. Differences in surgical approaches have raised questions regarding their impact on the risk of postoperative urinary retention, with limited data available from large scale study.

Official Title
-----------------
Urinary Retention Following Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: transanal total mesorectal excision
* Procedure: Laparoscopic Total Mesorectal Excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range from 18 to 65 years, Diagnosed with rectal cancer at clinical tumor node metastasis stages II or III. Palpable tumor determined by digital rectal examination or proctoscopy The distal border of the tumor located within 12 cm from the anal verge Exclusion Criteria: Patients presenting clear indications of pelvic side wall involvement or distant metastasis Uncontrolled hypertension or cardiovascular disease Patients with synchronous colon cancer History of other malignancies within the past 5 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: laTME<br>Laparoscopic Total Mesorectal Excision | Procedure: Laparoscopic Total Mesorectal Excision<br>* Laparoscopic Total Mesorectal Excision<br>|
| Other: taTME<br>a transanal bottom-up approach was employed for the Total Mesorectal Excision procedure | Procedure: transanal total mesorectal excision<br>* a transanal bottom-up approach was employed for the TME procedure<br>Procedure: Laparoscopic Total Mesorectal Excision<br>* Laparoscopic Total Mesorectal Excision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary retention | urinary retention rate | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary retention
Altered Respiratory Compliance Under Invasive Mechanical Ventilation in SARS-CoV-2 & Development of Respiratory Sequels

Study Overview
=================
Brief Summary
-----------------
The goal is to study the association between the value of the compliance of the respiratory system at the first day of the initiation of invasive mechanical ventilation and the presence of respiratory sequelae at a distance from the COVID-19 infection with the hypothesis that patients who have presented an alteration of the compliance of the respiratory system are at greater risk of developing respiratory sequelae. Studying the altered compliance of the respiratory system in ARDS secondary to COVID-19 and its relationship to the development of respiratory sequelae would help us to improve the management of patients with COVID-19.

Official Title
-----------------
Altered Respiratory Compliance Under Invasive Mechanical Ventilation in SARS-CoV-2 & Development of Respiratory Sequels

Conditions
-----------------
ARDS Due to Disease Caused by SARS Co-V-2, Respiratory Compliance, Sequels of COVID

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized in intensive care medicine between 01/03/2030 and 01/09/2022 (with invasive mechanical ventilation for at least 48 hours for a SARS-CoV-2 infection documented by RT-PCR) who were followed in pulmonary outpatient medicine at least 3 months after their hospitalization in intensive care medicine and before 01/12/2022 and who had respiratory sequelae during this period. Hospitalized in intensive care medicine between 01/03/2020 and 01/12/2021 (with invasive mechanical ventilation for at least 48 hours for SARS-CoV-2 infection documented by RT-PCR) who were followed up in pulmonary outpatient medicine but did not have respiratory sequelae between 01/06/2020 and 01/12/2022. Exclusion Criteria: Documented underlying respiratory pathology. Pneumothorax within the first 10 days. Patient requiring extracorporeal circulatory support. Refusal to participate Persons referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code: Pregnant woman, parturient or breastfeeding mother / Minor (not emancipated) / Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice) / Adult unable to express his consent Persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1. Respiratory system compliance data not available on the computer software

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 |
| --- | --- | --- |
| Presence of respiratory sequelae | Presence of respiratory sequelae (FVC <80% or DLCO <70% or radiologic sequelae attributable to SARS-CoV-2) at M3 or M6 or M12 | 1 year |
Clinical Study on Third-line Treatment of Advanced Duodenal Adenocarcinoma by Fuquinitinib Combined With Sindillimab

Study Overview
=================
Brief Summary
-----------------
This research project is a single-center, retrospective clinical exploration study. It aims to retrospectively analyze data from 20 patients with advanced duodenal adenocarcinoma who received third-line treatment with furquinelone combined with sintilimab, in order to determine the clinical efficacy and safety of this combination therapy in advanced duodenal cancer.

Official Title
-----------------
Clinical Study on Third-line Treatment of Advanced Duodenal Adenocarcinoma by Fuquinitinib Combined With Sindillimab

Conditions
-----------------
Third-line Treatment, Dvanced Duodenal Adenocarcinoma, Furquinelone Combined With Sintilimab

Intervention / Treatment
-----------------
* Drug: furquimatinib and sintilimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for inclusion: Age between 18 and 80 years (inclusive); Imaging findings consistent with unresectable local advanced, recurrent or metastatic duodenal adenocarcinoma; Histologically confirmed unresectable local advanced, recurrent or metastatic duodenal adenocarcinoma; ECOG performance status 0-2; At least one measurable or evaluable lesion according to RECIST v1.1; Third-line or above treatment with the combination of sintilimab and furquimatinib. Exclusion Criteria: - Patients meeting any of the following criteria will be excluded: Patients with incomplete clinical data or laboratory examination that affects statistical analysis; Patients who have had other malignant tumors in the past 5 years; Patients who have had arterial thrombotic diseases such as angina, myocardial infarction, and transient ischemic attack in the past 6 months; Patients who have received other types of anti-tumor or experimental treatment; Pregnant or lactating women; Patients with other diseases or abnormal mental status that may affect the patient's treatment; Patients who have received other types of immune therapy, anti-angiogenic drugs, or small-molecule tyrosine kinase inhibitors.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: furquimatinib and sintilimab|furquimatinib and sintilimab|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy endpoint: Objective Response Rate (ORR) |  | 2 years |
The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women

Study Overview
=================
Brief Summary
-----------------
A single-blind, randomized, and probiotic-treatment including adult women with vaginitis and/or HPV positive. After oral probiotics, all participants will be followd-up cervical swabs and vaginal microbiome alteration till the end of the study.

Official Title
-----------------
The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women

Conditions
-----------------
Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome

Intervention / Treatment
-----------------
* Dietary Supplement: probiotic:Lactobacillus crispatus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as vaginal viginitis willing to sign permit willing to regular follow up Exclusion Criteria: Pregnant Virgin Severe cervix pathology CINII or CIN III Confirmed cervical cancer under long term antibiotics due to other physical condition

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: probiotic intervention<br>probiotic group with daily treatment | Dietary Supplement: probiotic:Lactobacillus crispatus<br>* We seek to observe that probiotic supplement(arm A) can improve vagina microbiome distribution by comapred to placebo group(arm B) in our study.<br>|
| Placebo Comparator: placebo<br>placebo-controlled with daily treatment | Dietary Supplement: probiotic:Lactobacillus crispatus<br>* We seek to observe that probiotic supplement(arm A) can improve vagina microbiome distribution by comapred to placebo group(arm B) in our study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement alteration of vaginal microbiome | 16s rRNA | 3 months |