linjc16/ctgov huggingface dataset:
Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension

Study Overview
=================
Brief Summary
-----------------
Background: Pregnancy-induced hypertension (PIH) is responsible for most perinatal and fetal mortality. Few programs are patient-centered during pregnancy, increasing the risks of misinformation and misconceptions among pregnant women and, as a result, malpractices. Objective: This study aims to develop and validate a form to assess the knowledge and attitudes of pregnant women about PIH.

Detailed Description
-----------------
Many observational studies explored the awareness of pregnant women of PIH, but no structured tool is available to assess such awareness. During the past two years, education campaigns were postponed and primary care was prioritized. To allow better-informed decisions and targeted actions, this pilot study aims to develop and validate a short form to assess the knowledge and attitudes of pregnant women about pregnancy-induced hypertension. The long-term objective of this study is to provide a practical tool for pregnant women.

Official Title
-----------------
Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension: A Cross-sectional Study Among Pregnant Women in Lebanon

Conditions
-----------------
Pregnancy Related, Hypertension in Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants were asked to participate in the study with no criteria based on race, ethnicity, or gestational age. Exclusion Criteria: Those with a history of hypertension or pre-eclampsia were excluded.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Survey|A short 25-item tool was developed and can be applied in clinics to assess the awareness of pregnancy hypertension.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Awareness of hypertensive disorders of pregnancy by developing a 25-item questionnaire | Thirty-six statements were initially provided to which women had to answer either ''yes'', ''No'' or ''I don't Know''. Out of these statements, 25 were retained due to positive inter-item correlation (15 knowledge statements and 10 behavior statements), and the other statements were eliminated one by one after testing for reliability and computing the effect of each statement on the internal consistency. | 6 months |
An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer

Detailed Description
-----------------
The 1,132 patients with resectable or borderline resectable PDAC who underwent surgery between 2007 and 2021 were retrospectively reviewed. Patients with resectable PDAC without contact of major vessels (R-no contact) (n=651), with contact of portal vein or superior mesenteric vein (PV/SMV) ≤180° (R-contact) (n=306), and borderline resectable PDAC without arterial involvement (BR-V) (n=175) were analyzed.

Official Title
-----------------
An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer According to Tumor-vessel Relationship and CA 19-9 Levels

Conditions
-----------------
Pancreatic Cancer, Neoadjuvant

Intervention / Treatment
-----------------
* Drug: Neoadjuvant treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC) Between January 2007 and June 2021 at Seoul National University Hospital Exclusion Criteria: Patients who had borderline resectable PDAC with arterial invasion Patients who received chemotherapy as initial treatment and did not undergo surgery Incomplete follow-up data for analysis
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| resectable PDAC with no contact to major vessels (R-no contact)<br> | Drug: Neoadjuvant treatment<br>* Intravenous gemcitabine-based combination regimens or FOLFIRINOX were included in NAC.<br>|
| resectable PDAC with contact PV/SMV of ≤180° (R-contact)<br> | Drug: Neoadjuvant treatment<br>* Intravenous gemcitabine-based combination regimens or FOLFIRINOX were included in NAC.<br>|
| borderline resectable PDAC with PV/SMV contact >180° and without arterial involvement (BR-V)<br> | Drug: Neoadjuvant treatment<br>* Intravenous gemcitabine-based combination regimens or FOLFIRINOX were included in NAC.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | the time from diagnosis to death from any cause or the date of the last visit | From the date when biopsy results came out until the date of death from any cause or the date of the last visit, whichever came first, assessed up to 60 months |
Optimizing Counceling on Feeding Options of Babies From Mothers Living With HIV

Study Overview
=================
Brief Summary
-----------------
Semi structured interviews will be performed to determine attitudes and experiences of people living with HIV and health care providers on counseling on feeding options of babies from mothers living with HIV in order to optimize counseling in the future

Official Title
-----------------
From Guidelines to Clinical Care: What is Needed for Optimizing Counceling on Feeding Options of Babies From Mothers Living With HIV?

Conditions
-----------------
Hiv

Intervention / Treatment
-----------------
* Behavioral: Semistructured interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health care provider involved in care for people living with HIV in Duth HIV treatment facility or Person living with HIV + age 18-45 + prior pregnancy/desire to have children Exclusion Criteria: Insufficient command of Dutch or English language (oral)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Health care providers involved in care for people living with hiv<br>Semi-structured interviews with health care providers | Behavioral: Semistructured interview<br>* Semistructured interview and validated quality of life assesment using EQ5-DL<br>|
| Other: People living with HIV with prior pregnancy or desire to have children<br>Semi-structured interviews with people living with HIV with prior pregnancy or desire to have children | Behavioral: Semistructured interview<br>* Semistructured interview and validated quality of life assesment using EQ5-DL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experiences and attitudes on subject | Experiences and attitudes on subject | Explore during semistructured interview during 1 to 2 hours |
PRecision Ecmo in CardIogenic Shock Evaluation

Study Overview
=================
Brief Summary
-----------------
Venoarterial (VA) ECMO is a form of life support for patients with severe cardiogenic shock and cardiac arrest. Although it can be lifesaving, currently many patients still die or have long term disability, such as weakness, shortness of breath and cognitive impairments, and it remains extremely expensive. It is important that new ways of identifying which patients will gain the most benefit from ECMO are found, while also avoiding costly futile use when it there is no benefit. The PRECISE Study is an Australian-led, nation-wide observational study that will investigate whether biomarkers can better guide decisions around to whom and how ECMO is delivered. The study will involve the collection of a small amount of blood (which would normally be discarded) at up to 4 different time points, including just prior to ECMO initiation, and also at days 1, 3, and 7 of ECMO support. These results will then be linked to a national registry which includes the important patient centred outcomes, such as disability at 6 months. This study will lead to the better support of a highly vulnerable population, and improve the efficiency of one of the most complex and costly interventions available.

Official Title
-----------------
PRecision Ecmo in CardIogenic Shock Evaluation

Conditions
-----------------
Cardiogenic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will be commencing on VA ECMO (for cardiogenic shock or ECPR) 18 years old or older Patients who will be enrolled in the EXCEL Registry (HREC Project 534/18) Exclusion Criteria: Patients who are already on ECMO, or where There are inadequate resources to complete the study

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 |
| --- | --- |
| Adult patients commencing on VA-ECMO<br>The study population is adult patients on VA-ECMO for cardiogenic shock or cardiac arrest that are or will be enrolled in the national ECMO registry (EXCEL). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability-free survival at day 180 | Measured with the World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0) | Day 180 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECPR, ECMO, cardiogenic shock, critical illness, intensive care
Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)

Study Overview
=================
Brief Summary
-----------------
Plastic particles are a ubiquitous pollutant in the living environment and food chain, so far, plenty of studies have reported the internal exposure of microplastics and nanoplastics in human tissues and enclosed body fluids. Neurosurgery is the only department that can open the skull. In addition to blood and cerebrospinal fluid, there are brain tissue and tumors in the presence of lesions. Whether any of these microplastics and nanoplastics are present remains a mystery. This prospective observational study will harvest biological samples of neurosurgery patients. The objective of this research is to be able to detect microplastics and nanoplastics on blood and operation samples of neurosurgery patients.

Official Title
-----------------
Presence of Microplastics and Nanoplastics in Neurosurgery Patients

Conditions
-----------------
Carotid Artery Stenosis, Glioma, Intracranial Aneurysm, Intracranial Hemorrhages, Brain Tumor

Intervention / Treatment
-----------------
* Diagnostic Test: biological samples analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years Any type of neurosurgery Exclusion Criteria: ·refusal of the patient to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: biological samples analysis|biological samples analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microplastics | Detection of microplastics in human brain tissue and the blood undergoing neurosurgery | baseline, intraoperative | 
| nanoplastics | Detection of nanoplastics in human brain tissue and the blood undergoing neurosurgery | baseline, intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microplastics, nanoplastics, Intracranial Aneurysm, brain tumor, Carotid Artery Stenosis
Opportunistic Salpingectomy in Non-gynecological Surgeries

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate patient's compliance for opportunistic salpingectomy (OS) and procedure feasibility in non gynecological abdominal surgeries

Detailed Description
-----------------
Patients who are candidate for non-gynecological abdominal surgery, are offered OS. If agree, a general surgeon perform the procedure during the planned abdominal surgery

Official Title
-----------------
Opportunistic Salpingectomy in Non-gynecological Surgeries - a Pilot Study

Conditions
-----------------
Ovarian Cancer Prevention

Intervention / Treatment
-----------------
* Procedure: salpingectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who were candidates for non-gynecological abdominal surgery Aged 45 or older, or aged 40 or older with a desire for bilateral salpingectomy Exclusion Criteria: Pregnant women Candidates for urgent surgery

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-gynecologic surgery<br>Female candidates for non-gynecologic abdominal surgery | Procedure: salpingectomy<br>* surgical removal of the fallopian tubes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients willing for salpingectomy | The number of patients that will agree for salpingectomy | day of enrollment | 
| patients undergoing salpingectomy | The number of patients that will undergo salpingectomy | from enrollment and up to 6 weeks | 
| length of salpingectomy | the length (in minutes) of salpingectomy | within surgery | 
| surgical complications | complications during or after salpingectomy | up to 30 days from surgery |
Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to evaluate the efficacy of employing cefepime (CFM) versus ampicillin/sulbactam (AMS) in lowering the rate of post-cesarean surgical site infections.

Detailed Description
-----------------
A prospective randomized clinical study conducted in the department of obstetrics and gynecology of Beni-Suef University Hospital . A total of 213 women were assessed for eligibility, 13 of which were excluded. A total of 200 pregnant women who were eligible for elective cesarean sections (CS). The overall median duration of postoperative followed up was from 10 days to one month to determine the surgical site infection (SSI).

Official Title
-----------------
The Impact of Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

Conditions
-----------------
Cesarean Section; Infection

Intervention / Treatment
-----------------
* Drug: Cefepime 1000 MG
* Drug: Ampicillin-sulbactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women within age group more than18 years. Pregnant women with elective cesarean delivery. Previous and primary cesarean delivery. Exclusion Criteria: Severe hepatic disease women Emergent cesarean deliveries. Women with medical disorders as pre-gestational diabetes, anemia, hypertension, or preeclampsia. Women who had a skin infection adjacent to the operative site.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cefepime Group<br>Pregnant women (n=100) received IV cefepime (CEF) (maxipime®1000mg) 30 minutes before cesarean delivery (CD) and 12 hours after CD | Drug: Cefepime 1000 MG<br>* Cefepime is a fourth-generation cephalosporin antibiotic<br>* Other names: maxipime;|
| Active Comparator: Ampicillin/Sulbactam<br>Pregnant women (n=100) received IV Ampicillin/Sulbactam (AMS) (Unictam® 1500 mg) 30 minutes before CD and 12 hours after CD | Drug: Ampicillin-sulbactam<br>* Broad-Spectrum Antibiotic<br>* Other names: unictam;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical site infection | pain, redness, swelling, warm skin around the wound, yellow or green discharge | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical site infection, Cefepime
Paula Method Versus Chewing Gum for Postoperative Recovery After Caesarean Section

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare the effectiveness of gum chewing vs Paula exercises in patients after cesarean delivery. The main question it aims to answer is: does the Paula method hasten the time to recovery of bowel function compared to gum chewing after cesarean delivery. Participants will be asked to either chew gum or to do Paula exercises. The time to restoration of bowel function after the surgery will be measured.

Official Title
-----------------
Comparing Effectiveness of Paula Method Versus Chewing Gum for Postoperative Recovery of Gastrointestinal Function in Patients After Elective Caesarean Section

Conditions
-----------------
Cesarean Delivery Affecting Fetus, Post Operative Bowel Function

Intervention / Treatment
-----------------
* Behavioral: Paula exercises
* Behavioral: Gum chewing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women after an elective caesarean delivery Age 18+ Ability to read and write in Hebrew Exclusion Criteria: Diagnosis of chronic gastrointestinal diseases Inability to chew gum Use of laxatives.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paula<br>The patients will perform Paula exercises after cesarean delivery. | Behavioral: Paula exercises<br>* The patients will perform Paula exercises after the cesarean delivery<br>|
| Active Comparator: Gum chewing<br>The patients will chew gum after the cesarean delivery. | Behavioral: Gum chewing<br>* The patients will be given chewing gum and will be asked to chew it after the cesarean delivery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first flatus or bowel movements | The patients will note the time of the first passing gas and the first bowel movement after the cesarean delivery. | Up to one week from delivery |
SpermQT Prospective Observational Trial

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to validate the ability of the Epigenetic Sperm Quality Test (SpermQT) to assess a man's sperm quality and corresponding success of infertility treatments.

Detailed Description
-----------------
This prospective study will consist of analyzing a man's semen sample to determine the patient's SpermQT score and following the success of each fertility treatment to produce a pregnancy and live birth. Physicians and patients will be blinded to SpermQT results.

Official Title
-----------------
SpermQT Prospective Observational Trial

Conditions
-----------------
Male Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subjects have been recommended to pursue IUI, or they have recently completed an IUI (regardless of outcome) Male partner is under 45 years of age Female partner is under 38 years of age The total motile sperm count from the raw semen analysis must be greater than or equal to 10 million Exclusion Criteria: The female or male partner have a BMI equal to or greater than 40 The male partner has undergone male testosterone replacement therapy in the last 6 months Either the female or male partner have a history of recurrent pregnancy loss, defined as 2 or more consecutive clinical/ultrasound pregnancy losses There are any known factors contributing to female factor infertility, such as but not limited to: Severe Endometriosis (stage 3 or higher, endometrioma on ovaries) Multiple uterine fibroids 5cm or larger Severe Asherman's Syndrome Severe Mullerian anomaly Lack of tubal patency in at least one fallopian tubes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI) | Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of IUI in each bracket of SpermQT score (Poor, Normal, and Excellent) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that have and have not achieved pregnancy during subsequent rounds of intrauterine insemination (IUI) and in vitro fertilization (IVF) | Number of patients that have and have not achieved pregnancy during subsequent rounds of IUI and with IVF in each bracket of SpermQT score (Poor, Normal, and Excellent) | 18 months | 
| Number of patients that have and have not achieved a live birth | Number of patients that have and have not achieved a live birth in each bracket of SpermQT score (Poor, Normal, and Excellent) | 18 months | 

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