linjc16/ctgov huggingface dataset:
Safety of Low PEEP Maneuvers During ARDS Management

Study Overview
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Brief Summary
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Acute Respiratory distress syndrome (ARDS) is a severe condition in which protective ventilation is a critical point in its management. Positive end expiratory pressure (PEEP) setting can be challenging for clinicians and high PEEP has been associated with better outcome in moderate and severe ARDS. Recently, recruitment to inflation ratio and airway closure have been investigated in order to help PEEP adjustment. However, ventilatory maneuvers are performed with a low level of PEEP and therefore expose to derecruitment and oxygen desaturation. So far, the risk of oxygen desaturation has not been investigated and risk factors are unknown. The aim of this study is to evaluate the prevalence of oxygen desaturation during ventilatory maneuvers at low level of PEEP in patients with moderate or severe ARDS

Official Title
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Safety of Low PEEP Maneuvers During ARDS Management

Conditions
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Acute Respiratory Distress Syndrome, Positive End Expiratory Pressure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age : > 18 yo inclusion criteria: ARDS, Mechanical ventilation, low PEEP maneuvers Exclusion Criteria: refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years

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

Accepts Healthy Volunteers
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No

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of oxygen desaturation |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Acute Respiratory distress syndrome, Positive end expiratory pressure
Natural Frozen Embryo Transfer (FET) vs Substituted Frozen Embryo Transfer (FET)

Study Overview
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Brief Summary
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In frozen embryo transfer substituted cycles, patients are treated with progesterone and estrogen in an attempt to mimic the natural cycle and a transfer is planned whenever the endometrium is ready. In contrast, in frozen embryo transfer natural cycle patients are not taking any hormones, only triggered with hCG (human chorionic gonadotropin) when a dominant follicle is ready or they wait for the disappearance of the dominant follicle to plan the transfer date. Some doctors and centres shift towards using the substituted protocol in an attempt to make scheduling easier with less frequent ultrasounds. This study will aim to compare clinical and biochemical pregnancy rates in patients who underwent frozen embryo transfers in natural cycles vs substituted cycles at the centre.

Official Title
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Embryo Transfer in Natural vs Substituted Cycle and the Scheduling Pattern of IVF

Conditions
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Fertility Disorders

Intervention / Treatment
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* Other: Frozen embryo transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age < 40 years old Women having undergone either a frozen embryo transfer in natural cycle or substituted cycle IVF and FET cycles done at Clinique OVO Exclusion Criteria: egg or embryo recipient History of recurrent miscarriages, defined as ≥ 3 consecutive losses Patients that needed Viagra, Plasma-Rich Platelet (PRP) or other modalities to improve their endometrial thickness Uterine abnormalities Abnormal hormonal profiles FET Stimulated cycles History of recurrent implantation failure defined as failed ≥ 2 euploid embryos transfer or ≥ 3 blastocysts

Ages Eligible for Study
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Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Frozen embryo transfer substituted cycle<br>In a substituted cycle, estrogen and progesterone are given and a transfer is planned when the endometrium is ready | Other: Frozen embryo transfer<br>* A frozen embryo transfer involves thawing a fertilized embryo and transferring it in the uterus in order to obtain a pregnancy<br>|
| Frozen embryo transfer natural cycle<br>In a natural cycle no hormones are given and a transfer is planned when there is a dominant follicle apparent at the ultrasound | Other: Frozen embryo transfer<br>* A frozen embryo transfer involves thawing a fertilized embryo and transferring it in the uterus in order to obtain a pregnancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the clinical pregnancy rate of embryo transfer in natural vs substituted cycles | clinical pregnancy is the presence of fetal heartbeat at the viability ultrasound | 6 to 8 weeks after Frozen Embryo Transfer |
Oral Microbioma and Oral Malignant Disease

Study Overview
=================
Brief Summary
-----------------
This case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease.

Official Title
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Association Between Oral Microbioma With Developing of Oral (Pre)Malignant Disease.

Conditions
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Oral Cancer, Oral Squamous Cell Carcinoma, Premalignant Lesion

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years in case of oral malignancy or premalignant disease, ≥40 years in case of no malignant disease Patients are (partially) dentate (≥20 teeth) Patients who have given written informed consent to participate in this study Exclusion Criteria: Patients with a history of radiotherapy in head and neck region Patients with a history of chemotherapy, immunotherapy or immunomodulating drugs Patients with a previous malginancy in head and neck region Edentulous patients (with or without implants) Patients with removable (partial) dentures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with no oral malignant disease<br> | |
| Patients with oral premalignant disease<br> | |
| Patients with oral malignant disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between oral microbioma and (pre)malignant disease. | Prevalence of clusters of different oral pathogens will be displayed for patients with malignant disease, premalignant disease and no oral malignancy. Taxonomic representation of statistically and biologically consistent differences between patients with malignant disease, premalignant disease and no oral malignant disease will be displayed. | Through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the difference in oral microbioma between young (>40 years) patients with oral SCC and older (>40 years) patients with oral squamous cell carcinoma. | Prevalence of different oral pathogens will be displayed for patients of both age groups. | Through study completion, an average of 3 years | 
| To desribe the difference in oral microbioma and stage of disease upon presentation. | Prevalence of different oral pathogens will be displayed for patientgroups with different tumor stages. | Through study completion, an average of 3 years |
CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study

Study Overview
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Brief Summary
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The main purpose of this study is to measure the amyloid burden, defined as extracellular volume (ECV) assessed by Magnetic Resonance Imaging (MRI) over time in a subset of up to 150 participants enrolled in ION-682884-CS2 (NCT04136171).

Detailed Description
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This pilot study will determine the efficacy of ION-682284 in reducing the amyloid deposit on the heart tissue compared to placebo.

Official Title
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The CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study

Conditions
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Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Intervention / Treatment
-----------------
* Diagnostic Test: Cardiac MRI


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: To participate in the ION-682884-CS2MRI sub-study, participants must meet all inclusion criteria of the study protocol ION-682884-CS2 (NCT04136171). Exclusion Criteria Contraindication or sensitivity to MRI contrast agents Orthopnea of sufficient severity to preclude supine scanning at screening. Weight or body girth exceeds the limits of the cardiac MRI machine specifications. Contraindication to cardiac MRI scanning, as assessed by local MRI safety questionnaire/checklist.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Experimental: ION-682884-CS2 MRI Scan Sub-set<br>Participants enrolled in the parent study ION-682884-CS2 (NCT04136171) to receive either eplontersen or placebo and who consented to participate in this sub-study will undergo cardiac MRI at Baseline, Weeks 25, 49, 97 and 140. | Diagnostic Test: Cardiac MRI<br>* MRI Scans as specified in the corresponding arm group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment Groups |  | From Baseline up to Week 140 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TTR, Amyloidosis, Cardiomyopathy
Impact of Postoperative Medical Equipment Removal/Insertion on Parental Anxiety in Pediatric Cardiac Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
A lot of observationnal studies describe parental stressors in PICU/PCICU, but none studied, prospectively, the links between medical equipment removal/insertion and anxiety modulation. The primary objective is to identify the impact of medical equipment removal/insertion on the STAI-Y score (anxiety) The secondary objective is to identify the parental anxiety determinant (via VAS).

Detailed Description
-----------------
A lot of observationnal studies describe parental stressors in Paediatric Intensive care Unit, but none studied, prospectively, the links between medical equipment removal or insertion and anxiety modulation. The primary objective is to identify the impact of medical equipment removal or insertion on the STAI-Y score (anxiety) The secondary objective is to identify the parental anxiety determinant (via Visual Analog Stress Scale. Parents will fill out questionnaire upon arrival in the Intensive care unit when reaching the bedside of their hospitalized child right after the elective cardiac surgery. Then after each equipment removal or insertion they will be asked to fill out again the same questionaire.

Official Title
-----------------
Impact of Postoperative Medical Equipment Removal/Insertion on Parental Anxiety in Pediatric Cardiac Intensive Care Unit

Conditions
-----------------
Parents, Anxiety Postoperative

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: parents/legal tutor of minor patient (congenital cardiopathy) with elective hospitalization in PCICU for surgical procedures Exclusion Criteria: Parents no french speaking child hospitalized for Cardiac Catheterization child hospitalized for Berlin Heart insertion child hospitalized for heart transplantation
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parents<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State Trait Anxiety Index - Y version | Anxiety declarative scale from 20 to 80 maximum and higher anxiety | at the arrival in the intensive care unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogic Scale | VAS from 0 to a maximum of 100 mm evaluating: their child confort ; the clinical information's clarity ; their possibility to participate to the care ; the impact on their parental role perceptions ; their trust in caregivers ; their satisfaction concernaing the caregivers attention ; their child clinical condition impacting their (and caregivers) presence in child hospitalization room. | at the arrival in the intensive care unit |
89Zr-labeled NY009 PET Imaging in Patients

Study Overview
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Brief Summary
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This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY009 PET Imaging in patients

Official Title
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89Zr-labeled NY009 PET Imaging in Patients

Conditions
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Cancer

Intervention / Treatment
-----------------
* Drug: 89Zr-NY009


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients voluntarily signed informed consent; Age 18-75, male or female; Patients diagnosed with cancer confirmed by histopathology or cytology; At least one measurable solid lesion has been examined according RECIST1.1 standard; ECOG score 0 2. Exclusion Criteria: Recovery from major trauma (including surgery) within 4 weeks prior to study treatment; Patients with systemic or locally severe infections, or other serious coexisting diseases; Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines; Patients with autoimmune diseases, including rheumatoid arthritis; Inadequate control of arrhythmias, including atrial fibrillation; Uncontrolled hypertension; Patients with allergies or allergies to any component of the imaging agent or antibody; Patients who cannot undergo PET/CT imaging scan; Syphilis, HBV, HCV, or HIV positive subjects; Male and female subjects of reproductive age cannot take effective contraceptive measures; Pregnant or lactating women; Patients with a history of mental illness or related conditions; Other subjects considered unsuitable by researchers.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 89Zr-NY009<br> | Drug: 89Zr-NY009<br>* Patients will receive a tracer (5-10mg, IV) dose of 89Zr (2-3mCi) labelled NY009<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of tissue distribution of 89Zr-NY009 | Biodistribution of 89Zr-NY009 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 89Zr-PET scans will be reported. | 7 days |
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.

Detailed Description
-----------------
Stem cell treatment has shown efficacy for PCOS in both human and animal studies. We are also reporting completer resolution of polycystic ovary syndrome (PCOS) in a young woman after a single intravenous injection of umbilical cord derived mesenchymal stem cells (UCDSC). We hypothesized that intravenous infusion of UCDSC can reduce or eliminate PCOS. Patients will receive roughly 2 million umbilical cord derived mesenchymal stem cells per kg of body weight. Hormone levels and ultrasound will be checked 3,6 and 12 months after treatment.

Official Title
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Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome, PCOS

Intervention / Treatment
-----------------
* Biological: AlloRx


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Ultrasound documented poly cystic ovary syndrome Exclusion Criteria: Active infection, Active cancer, Chronic multisystem organ failure, Pregnancy, Clinically significant abnormalities on pre-treatment laboratory evaluation, Medical condition that would (based on the opinion of the investigator) compromise patient's safety, Continued drug abuse, Previous organ transplant, Hypersensitivity to sulfur, Inability to supply proper informed consent

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

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

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: Treatment Group (AlloRx)<br>Intravenous infusion | Biological: AlloRx<br>* Cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse Events | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Global Improvement Score (GI) | Ranging from 0 to 100% | Four year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome, Stem Cell, Stem Cells, Mesenchymal Stem Cells, Umbilical Cord Derived Mesenchymal Stem Cells
Outcome of Laparoscopic Appendicectomy Versus Open Appendicectomy in Sudanese Patients

Study Overview
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Brief Summary
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Background: Laparoscopic appendectomy as a minimal invasive procedure had low morbidity and mortality. It affords a direct diagnosis of the problem, allows determination of the appropriate treatment. Open appendectomy is global treatment of acute appendicitis can be done by many incisions, and associated with considerable complications. Materials and Methods: This is a cross sectional descriptive hospital-based study to study the outcome of laparoscopic appendectomy versus open appendectomy at Elmak Nimer University Hospital over the study period. All patients in the study period who underwent appendectomy was included, data is collected through standard structured data collection sheet and analyzed by using SPSS v24.0.

Official Title
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Outcome of Laparoscopic Appendicectomy Versus Open Appendicectomy in Sudanese Patients: Cross-sectional Study

Conditions
-----------------
General Surgery

Intervention / Treatment
-----------------
* Procedure: Laproscopic Appendicectomy
* Procedure: Open Appendicectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients in the study period who underwent appendectomy were included. Exclusion Criteria: Patientspresented with complicated appendicitis Acute appendicitis with comorbiditites Pregnant ladies Patients of stump appendicitis . Patient with inadequate data

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic Appendicectomy<br> | Procedure: Laproscopic Appendicectomy<br>* A type of surgery done without a large incision. Instead, from 1 to 3 tiny cuts are made. A long, thin tube called a laparoscope is put into one of the incisions. It has a tiny video camera and surgical tools.<br>* Other names: Regular surgical site dressing;|
| Open Appendicectomy<br> | Procedure: Open Appendicectomy<br>* A cut or incision about 2 to 4 inches long is made in the lower right-hand side of your belly or abdomen. The appendix is taken out through the incision.<br>* Other names: Regular surgical site dressing;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of post-operative complications | the rate of postoperative complications, such as surgical site infections, intra-abdominal abscess formation, and other adverse events. The comparison would help assess the efficacy and safety of each surgical approach in the context of appendectomies. | Jan 2019 - Jan 2021 |