linjc16/ctgov huggingface dataset:
Cornual Pregnancy: Results of a Single-center Retrospective Experience and Systematic Review on Reproductive Outcomes

Study Overview
=================
Brief Summary
-----------------
To present our experience in the diagnosis and management of cornual pregnancy. A systematic review was also conducted to investigate reproductive outcomes after treatment.

Official Title
-----------------
Cornual Pregnancy: Results of a Single-center Retrospective Experience and Systematic Review on Reproductive Outcomes

Conditions
-----------------
Ectopic Pregnancy

Intervention / Treatment
-----------------
* Procedure: laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18 years; patients with a diagnosis of cornual pregnancies. Exclusion Criteria: All patients whose medical records did not contain the data deemed necessary for study analysis or who did not consent to the publication and use of their data; Other type of ectopic pregnancies.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: laparoscopy|Conservative or surgery treatment for cornual pregnancies|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | defined as the presence of a gestational sac on transvaginal ultrasound or other definitive clinical signs | 2 years | 
| ongoing pregnancy rate | defined as a pregnancy beyond 24 weeks of gestation | 2 years | 
| miscarriage rate | defined as fetal loss before the 20th week of gestation | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methotrexate, cornual pregnancy, ectopic pregnancy, laparoscopy, fertility
A Greek-designed ERAS Protocol in Elective Craniotomy

Study Overview
=================
Brief Summary
-----------------
The implementation of ERAS protocol in elective cranial neurosurgical cases in a tertiary hospital.

Detailed Description
-----------------
In this study, the investigators have integrated the most current data from literature aiming to investigate the effectiveness of a contemporary ERAS protocol for elective cranial neurosurgical cases in a tertiary hospital. The hypothesis is that the implementation of such protocol will shorten the postoperative length of stay, minimize the complication rates, and improve the overall clinical status of patients undergoing elective craniotomy compared to the standard perioperative care

Official Title
-----------------
A Greek-designed Enhanced Recovery After Surgery (ERAS) Protocol in Elective Cranial Neurosurgical Procedures: An Observational Study

Conditions
-----------------
ERAS, Craniotomy

Intervention / Treatment
-----------------
* Other: ERAS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically suitable for elective craniotomy ASA-PS I-III Exclusion Criteria: traumatic lesions pathology requiring emergent surgery preoperative loss of consciousness severe co-morbidities that may affect postoperative recovery (e.g. paralysis, autoimmune diseases, myocardial or severe infarction, heart, liver or lung malfunction, severe mental illness etc.) recurrent tumor

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 |
| --- | --- |
| ERAS<br> | Other: ERAS<br>* Implementation of ERAS protocol in elective craniotomy patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay | The days the patient stays in hospital | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain intensity as measured by Visual Analogue Scale (VAS) | Postoperative Day 1 to discharge, an average of 7 days | 
| Mental status | Mental status as measured by Glasgow Coma Scale (GCS) Minimum value : 3 Maximum value : 15 Higher scores mean a better outcome | 1 day at discharge | 
| Patient's satisfaction | Patient's satisfaction as measured by a Likert Scale | 1 day at discharge and 1 month postoperatively | 
| Anxiety and Depression | Anxiety and Depression level as measured by Hospital Anxiety and Depression Scale (HADS) | Preoperatively, second postoperative day and one month postoperatively | 
| Personality Index | Personality Index as measured by TIPI | Preoperatively, second postoperative day and one month postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERAS, Craniotomy, Perioperative management
Outcome of Transanal Specimen Extraction Surgery for Elderly Colorectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of a cohort of elderly CRC patients (aged ≥ 65 years) underwent transanal-NOSES between August 2008 and February 2022 was constructed. Data were obtained from China NOSES Database (CNDB). The primary outcomes included time to first flatus, postoperative hospital stays, 30-day postoperative complication and hospital mortality. The secondary outcomes were overall survival (OS) and disease-free survival (DFS).

Official Title
-----------------
Outcome of Transanal Specimen Extraction Surgery for Elderly Colorectal Cancer Patients: a National Database Study in China of 1395 Cases

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed as T1-4N0-2M0 colorectal cancer pathologically patients underwent transanal-NOSES patients aged 65 years or older Exclusion Criteria: patients with multiple primary colorectal cancer patients with total colectomy patients without complete data

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Overall survival | Time of death from any cause after survival | 4-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
survival
A Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles

Study Overview
=================
Brief Summary
-----------------
Multicentre, single arm phase III trial to assess the pearl index of LVDS. The trial lasts 13 cycles.The assessments include (but are not limited to) recording demographic data, pregnancy tests, gynaecological examinations, laboratory tests and a quality of life questionnaire. Adolescents will undergo DXA scans to measure bone mineral density (at selected sites only). The women will be provided with an e-diary app for their smartphone, to record IP use and vaginal bleeding.

Official Title
-----------------
A Multicentre, Single Arm Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Combination Product: LVDS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At Visit 1a, subjects must meet ALL of the following criteria: Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women. Women who either have never used hormonal contraceptives before consent/assent (naïve users), or have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent and a full menstrual cycle during the drug-free period (previous users) or directly switch from another hormonal contraceptive (switchers). Only for subjects who were not pregnant and did not use hormonal contraception during the last 6 months before consent/assent: Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months. Exclusion Criteria: Pregnancy or wish of pregnancy. Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary. History of infertility. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a. Unexplained amenorrhoea. Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LVDS<br> | Combination Product: LVDS<br>* Levonorgestrel Vaginal Delivery System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pearl Index |  | 1 year |
Enhanced vs Conventional Recovery After Breast Surgery

Study Overview
=================
Brief Summary
-----------------
the investigators hypothesize that with the use of enhanced recovery of surgery (ERAS), the postoperative hospital stay after breast surgeries is reduced and also postoperative complications are decreased.

Detailed Description
-----------------
Group A NON-ERAS pathway All patients received best of care practice, with standardization of preoperative and postoperative care. Group B ERAS pathway

Official Title
-----------------
Enhanced Recovery vs Conventional Recovery After Anesthesia for Patients Undergoing Breast Surgery

Conditions
-----------------
Patient Satisfaction

Intervention / Treatment
-----------------
* Other: NON-ERAS pathway
* Other: ERAS pathway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Age: 20-60 years. Adequate cognitive state (able to understand and collaborate) American society of anesthesia (ASA) I, II Exclusion Criteria: Patients who are: Uncooperative. Having allergy to any of the study drugs. Known abuse of alcohol or medication. Having Local infection at the site of injection or systemic infection. Pregnancy. With coagulation disorders. Any complicated patients
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>NON-ERAS pathway All patients received best of care practice, with standardization of preoperative and postoperative care | Other: NON-ERAS pathway<br>* All patients received best of care practice, with standardization of preoperative and postoperative care<br>|
| Active Comparator: Group B<br>ERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions . | Other: ERAS pathway<br>* ERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study aims to explore the effectiveness and safety of the enhanced recovery after surgery (ERAS) protocol vs. traditional perioperative care programs for modified radical mastectomy. | visual analogue scale VAS Score (a scale from 0 to 10 where 0 is interpreted as no pain, 1- 4 mild pain, 5-6 moderate pain, 7-10 severe pain) will be recorded 15 min after extubation (as soon as the patient will be alert enough to report pain)' every 1hour for the first 8hours' then every 3hours for the remaining 24 hours. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of first ambulation | hours | 48 hours |
Feasibility Study: Educational Genetic Test Video

Study Overview
=================
Brief Summary
-----------------
Assess whether introducing an educational video regarding the benefits, risks, and limitations of genetic testing affects prostate cancer patients' decisional conflict regarding receiving germline genetic testing.

Official Title
-----------------
Pilot Feasibility Study: Educational Genetic Test Video

Conditions
-----------------
Prostate Cancer, Education

Intervention / Treatment
-----------------
* Behavioral: Educational Video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer patients who have been prescribed germline genetic testing by their provider Understand written and spoken English Have not received germline genetic testing for hereditary cancer risk in the past Exclusion Criteria: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant individuals Prisoners

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Video<br>Educational video about germline genetic testing, which is 7 minutes long | Behavioral: Educational Video<br>* Educational video regarding the benefits, risks, and limitations of genetic testing for hereditary cancer risk.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the value of presenting patients an educational video regarding the benefits risks, and limitations of genetic testing for hereditary cancer risk. | Determine proof-of concept by the results of a patient survey to assess the effect that the video has on decisional conflict. The survey administered post intervention uses a modified decisional conflict scale in a pre then post format. This is a 5 point Likert scale where 1 equals no, 2= probably no, 3= unsure, 4= probably yes, and 5=yes. This format asks participants to imagine their thoughts on the subject before having watched the video, then to clarify their thoughts on the same subjects now that they have watched the video. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genetic testing education
Targeted Perfusion Based Haemodynamic Management in Critically Ill Patients Using Urethral Perfusion

Study Overview
=================
Brief Summary
-----------------
To assess the safety and feasibility of the IKORUS device in critically ill patients and to gather exploratory data on haemodynamic coherence

Official Title
-----------------
Targeted Perfusion Based Haemodynamic Management in Critically Ill Patients Using Urethral Perfusion - a Pilot Study

Conditions
-----------------
Critically Ill

Intervention / Treatment
-----------------
* Drug: 250 ML NaCl 4.5 MG/ML Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult >/= 18 years of age Within 24 h of ICU admission Predicted length of ICU stay at least 5 days Receiving >0.1 mcg/kg/min of noradrenaline at time of study enrolment Exclusion Criteria: Palliative treatment intent Contra indication to urethral catheterisation or complication during previous urethral catheter insertion Contraindication to fluid or vasopressor challenges in the opinion of the attending clinician

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Patients will receive fluid and vasopressor challenges and the macro and microvascular responses will be recorded using the IKORUS monitor alongside conventional haemodynamic monitoring | Drug: 250 ML NaCl 4.5 MG/ML Injection<br>* Bolus 250 ml crystalloid. Usually 0.9% saline or compound sodium lactate solution at discretion of attending clinician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change to Urethral Perfusion Index |  | 5 minutes after fluid challenge administration |
NAC vs Placebo on Opioid Use for Hysterectomy

Study Overview
=================
Brief Summary
-----------------
This study will enroll females who are ages 18 and older undergoing a laparoscopic or robotic, partial or full hysterectomy. Participants will be randomized to receive IV n-acetylcysteine or placebo during the first 60 minutes of their procedure. At various time points after the procedure patients will be asked to report their pain scores, and any pain medication taken.

Official Title
-----------------
A Trial Evaluating the Impact of N-acetylcysteine on Opioid Use in Patients Undergoing a Hysterectomy Procedure

Conditions
-----------------
Hysterectomy

Intervention / Treatment
-----------------
* Drug: IV N-acetylcysteine
* Drug: IV Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Undergoing elective laparoscopic or robotic, full, or partial hysterectomy procedure 18 years of age and older Exclusion Less than 40kg in weight Unable to provide written, informed consent History of an adverse or anaphylactoid reaction to acetylcysteine Active asthma, wheezing, or using inhaled bronchodilators Non-English speaking Insulin dependent diabetes if D5W is required Blood clotting disorders

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: IV Placebo<br>Patients will receive: Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure. | Drug: IV Placebo<br>* Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.<br>* Other names: Placebo;|
| Active Comparator: IV N-acetylcysteine<br>Patients will receive: N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure. | Drug: IV N-acetylcysteine<br>* N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure<br>* Other names: NAC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption 0-72 hours post-study medication | 72-hour post-medication opioid consumption. | 0-72 hours after study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Using a Visual Analog Scale from 0-100, patients will report pain scores from 0-72 hours post-medication. A lower pain score means a better outcome. | Study medication start to 72 hours post-study medication | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hysterectomy
Structured Training on Oncology Nurses' Performance Related Port A Cath Device

Study Overview
=================
Brief Summary
-----------------
evaluate the effect of structured simulation-based training on oncology nurses' performance regarding port A cath device.

Detailed Description
-----------------
All oncology nurses who are expected to deal with port a-cath device will be recruited in the study pre test will introduced first, then simulated based training will be placed related to port a-cath device care after that , post test will be done immediately and 3 months later to measure nurses knowledge and practice level

Official Title
-----------------
Effect of a Structured Simulation-based Training on Oncology Nurses' Performance Regarding Port A Cath Device.

Conditions
-----------------
Port a Cath

Intervention / Treatment
-----------------
* Behavioral: simulation-based training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oncology nurses who are providing direct care for patients with port a-cath device Exclusion Criteria: Participants who will not be able to complete the questionnaire
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: pre- and post-test
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurses<br>A simulation-based training will be done for all nurses | Behavioral: simulation-based training<br>* the training will include a theoretical & practical parts<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in oncology nurses' knowledge and practice regarding port a-cath device care | The researchers will provide a structured questionnaire based on reviewing related literatures called Port a-Cath Nurses Knowledge questionnaire, it will consist of closed-ended questions to assess Nurses Knowledge And they will assess Nurses Practice level by using the preprepared Port a-Cath Nurses observational checklist. They will be used three times: before, immediately after training and 3 months post training | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
simulated training, oncology nurses, port a cath device