linjc16/ctgov huggingface dataset:
Long-term Effect of The Mother Infant Transaction Program (MITP)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if a cost and time effective intervention in a previous RCT for preterm infants and their parents can reduce the parents experience of concern and stress, and improve the childrens development in various aspects at three years of corrected age. Hypothesis 1: The preterm born children of parents who were enrolled in the earlier RCT have a higher developmental level then preterm children of parents who received the usual treatment. Hypothesis 2: Parents who who were enrolled in the earlier RCT will have a lower level of stress and concern then parents who received treatment as usual.

Detailed Description
-----------------
A previous RCT by Ravn (NCT00245843) investigated if the MITP could sensitize the mothers toward the babies signals and thereby increase the quality of joint attention. The study followed the children for 1 year. This study is a follow-up to the above mentioned RCT. It investigates whether the effect of the RCT is present at three years corrected age. The research questions are: Can a psychoeducative program like the MITP influence the childrens' development in various aspects? How did the MITP influence the parents experience of concern and stress three years later? Were there any differences by the groups? a) Preterm intervention group b)Preterm control group c) Full term control group The questionnaires to be used in this observational study are: Ages and Stages

Official Title
-----------------
Long-term Effect of The Mother Infant Transaction Program (MITP)

Conditions
-----------------
Premature Births

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All parents of children who participated in Ravn's RCT and who said yes to be asked for participation in an eventually later study will be asked.

Ages Eligible for Study
-----------------
Minimum Age: 35 Months
Maximum Age: 37 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MITP exposure or not<br>Mothers of children born preterm and term. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child development |  | 36 months | 
| Parenting stress |  | Child age 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature babies, Social interaction, Psychoeducative intervention, Mother Infant Transaction Program, Three years follow-up, Late preterm, Cognitive development, Social development, Emotional development, Motor development, Children born preterm and their parents
HRD and Resistance to PAPPi in EOC Patients

Study Overview
=================
Brief Summary
-----------------
The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients has been investigated in previous studies (NCT04190667 and NCT04651920). This study is to investigate the correlation between HRD and the resistance to poly(ADP-ribose) polymerase inhibitors (PARPi) in a Chinese cohort confirmed of epithelial ovarian cancer. The mutated genes, HRD score model and their relationship with the prognosis is the primary endpoint in this study. All enrolled patients will accept PARPi as maintenance therapy after the complete or partial remission of targeted lesions. A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

Official Title
-----------------
Correlation Between Homologous Recombination Deficiency Status and Resistance to PARP Inhibitors in Chinese Epithelial Ovarian Cancer Patients

Conditions
-----------------
Epithelial Ovarian Cancer, Homologous Recombination Deficiency, Homologous Recombination Repair Gene Mutation, Poly(ADP-ribose) Polymerase Inhibitor, Drug Resistance, Progression-free Survival, Overall Survival

Intervention / Treatment
-----------------
* Genetic: Testing of homologous recombination deficiency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older Pathological confirmation of epithelial ovarian cancer With available tumor tissues Given consents to participate the study With detailed follow-up outcomes Exclusion Criteria: Not meeting all of the inclusion criteria Declining to accept PARPi as maintenance therapy after the major treatment for cancer

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Testing of homologous recombination deficiency|A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival after the start of PARPi | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival after the start of PARPi | One year | 
| Severe adverse events | Severe adverse events after the start of PARPi | One year |
Internal Carotid Artery Blood Flow in Robot-Assisted Laparoscopic Prostatectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the change of the internal carotid artery blood flow according to the steep trendelenburg position and pneumoperitoneum in patients undergoing robot-assisted laparoscopic prostatectomy.

Official Title
-----------------
Change of Internal Carotid Artery Blood Flow During Pneumoperitoneum With Steep Trendelenburg Position in Robot-Assisted Laparoscopic Prostatectomy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer and who are 20 years or older and under 80 years Patients who agree to voluntarily participate in this study Patients with ASA class 1-2 Exclusion Criteria: History of diagnosis of cerebrovascular disease Patients who refused to participate in clinical studies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Position|Pneumoperitoneum with Steep Trendelenburg position|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in internal carotid artery blood flow | Difference between the internal carotid artery blood flow measured at 10 minutes after anesthetic induction during supine position and the internal carotid artery blood flow measured at 10 minutes after pneumoperitoneum with steep Trendelenburg position | At 10 minutes after pneumoperitoneum with steep Trendelenburg position | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internal carotid artery blood flow | Internal carotid artery blood flow before anesthetic induction | Baseline (Before anesthetic induction) | 
| Internal carotid artery blood flow | Internal carotid artery blood flow at 10 minutes after anesthetic induction | At 10 minutes after anesthetic induction | 
| Internal carotid artery blood flow | Internal carotid artery blood flow at 10 minutes after pneumoperitoneum and Trendelenburg position | At 10 minutes after pneumoperitoneum and Trendelenburg position | 
| Internal carotid artery blood flow | Internal carotid artery blood flow at 30 minutes after pneumoperitoneum and Trendelenburg position | At 30 minutes after pneumoperitoneum and Trendelenburg position | 
| Internal carotid artery blood flow | Internal carotid artery blood flow during supine position at skin closure | Procedure (At skin closure) |
Tissue Collection Protocol for Gastroesophageal Cancers

Study Overview
=================
Brief Summary
-----------------
This proposed collection of primary tumor cells lines will benefit esophageal cancer research within the University Health Network. This collection of gastro-esophageal tumor samples will be used to grow primary tumor cell lines, which will provide researchers with ready samples of various gastro-esophageal cancers. This will help to address the issue of access to these cell lines due to the limited number of patients with gastro-esophageal tumors, and high rates of contamination. Samples will be collected during surgery or Esophagogastroduodenoscopy(EGD). The surgeon will resect a sample for the research coordinator and/or fellow who will collect the sample and take it back to the lab for processing. Samples collected will be in excess of standard samples that are sent for pathology. The surgeon will make sure that excess samples will not affect pathological diagnosis

Official Title
-----------------
Tissue Collection for Gastro-esophageal Cancer Primary Cell Line Establishment

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Other: Tissue Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with esophagogastric cancer and/or GERD +/- Barrett's esophagus who will undergo surgery and/or EGD as standard of care. Exclusion Criteria: Patients who are not well enough to undergo surgery or EGD as standard of care.

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 |
| --- | --- |
| TIssue Collection<br>Only one arm will be used to collect tissue from Esophageal Adenocarcinoma | Other: Tissue Collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectively culture, proliferate, and store primary gastro-esophageal cell lines in order to create a bank of primary esophageal / gastric cancers for research purposes |  | 3 years |
Pharmacokinetic Study of Synera™ in Neonates and Infants

Study Overview
=================
Brief Summary
-----------------
This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.

Official Title
-----------------
A Pharmacokinetic Study of Synera™ (Lidocaine 70 mg and Tetracaine 70 mg Topical Patch) to Evaluate the Systemic Exposure to Lidocaine and Tetracaine in Neonates and Infants

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: lidocaine 70mg and tetracaine 70mg topical patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be an infant of 1 to 4 months of age and weigh at least 2.5 kg or a neonate of 0 to 4 weeks postnatal age with a gestation period of at least 37 weeks, and weigh at least 1.8 kg. Subject is scheduled to have a medically indicated minor superficial procedure for which topical local anesthesia would provide a benefit. Subject has or will have an indwelling vascular access catheter for blood sampling at the time of the procedure visit. The indwelling vascular access catheter placement must be necessary for medical reasons other than the purposes of this study. The additional blood draws for the purposes of this study do not pose more than a minor risk to the health and welfare of the subject. Exclusion Criteria: Subject has known allergies or sensitivities to any component of Synera. Subject has clinically significant laboratory abnormalities. Subject has known multiple allergies that could indicate hypersensitive skin. Subject has known active atopic dermatitis at or near the patch application site.

Ages Eligible for Study
-----------------
Maximum Age: 4 Months

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

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

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

| Intervention/Treatment |
| --- |
|Drug: lidocaine 70mg and tetracaine 70mg topical patch|One Synera Patch applied for 30 minutes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera |  | 30 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitor the nature and frequency of adverse events |  | 30 Hours |
Assessment of Quality of Life in Disorders of the Pelvic Floor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the touch-screen version of the PFDI-20, PFIQ-7, PISQ 12 and SF-36 french questionnaires to their paper versions. The investigators hypothesize that the percentage of completely filled questionnaires will be higher in the touch-screen version.

Official Title
-----------------
Assessment of Quality of Life in Disorders of the Pelvic Floor

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Other: Paper questionnaire
* Other: Touch screen questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patient has pelvic organ prolapse the patient requires a surgical intervention within the next 4 to 8 weeks the patient understands and reads french the patient is affiliated with a social security system the patient has given consent Exclusion Criteria: the patient refuses to participate the patient is under guardianship

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference group<br>This group will fill out paper questionnaires. | Other: Paper questionnaire<br> <br> |
| Experimental: Experimental group<br>This group will fill out touch-screen questionnaires. | Other: Touch screen questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence / absence of a completely filled out questionnaire |  | 6 months post-op |
Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women During Pregnancy

Study Overview
=================
Brief Summary
-----------------
This study was to construct and develop an application (APP) based on social-cognitive theory for overweight and obese women during pregnancy.

Detailed Description
-----------------
Our program used and evaluated the mHealth program, which has pregnant women using APP and wearable devices to help prevent excessive gestational weight gain, and it continued to promote physical activity for overweight and obese pregnant women.

Official Title
-----------------
Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women --Develop Applications With Wearable Devices

Conditions
-----------------
Gestational Weight Gain, Physical Activity

Intervention / Treatment
-----------------
* Other: experimental group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women--who have had, for 8-12 weeks, a pre-pregnancy body mass index of more than 25 kg/m2 Exclusion Criteria: high risk pregnancy, such as pre-clampsia, pregnancy induced hypertension, preterm contraction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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
Interventional Model Description: randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experiemental group<br>Experimental group was the mHealth app to improved their gestational weight gain and physical activity during pregnancy. | Other: experimental group<br>* provide mHealth program, which has pregnant women using wearable device and app<br>|
| No Intervention: control group<br>standard prenatal care and without mHealth app | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manage gestational weight gain | control excessive gestational weight gain | 4-6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase physical activity level | increase the scores of pregnancy of physical activity questionnaire | 4-6 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, obese, pregnant women
Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
Primary objective: Description of ultrasound abnormalities seen in native septic arthritis of the knee during each visit. Primary endpoint: Describe the ultrasound abnormalities observed on Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee.

Detailed Description
-----------------
Secondary Objectives: Search for poor prognostic factors in native septic arthritis of the knee. To look for an association between initial sonographic factors and the use of joint lavage. Look for associations between sonographic signs and clinico-radio-biologic factors at each visit (D10, 6 weeks, 3 months and 6 months)

Official Title
-----------------
Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee

Conditions
-----------------
Ultrasound Therapy; Complications, Septic Arthritis, Knee Arthritis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of legal age Bacteriologically proven native septic arthritis Meets the definition of septic arthritis: Bacteriological documentation of joint puncture fluid-Native articulation Free subject, without guardianship or trusteeship, or subordination Non-opposition of the patient after clear and fair information about the study Exclusion Criteria: Presence of material in the affected joint Arthritis with Mycobacterium Tuberculosis. Associated endocarditis Patients benefiting from a reinforced protection, namely: minors, pregnant and/or breast-feeding women, persons deprived of liberty by a judicial or administrative decision, adults under legal protection

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 |
| --- | --- |
| native septic arthritis of the knee<br>Describe the ultrasound abnormalities observed at D0, D10 or before surgery, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee: thickness and vascularity of the synovial membrane, existence and measurement of joint effusion existence of articular partitioning, erosions and adjacent soft tissue involvement (muscle abscess, cellulitis) | Device: ultrasound<br>* Describe the sonographic abnormalities observed at Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| description of the ultrasound abnormalities seen in native septic arthritis of the knee | Describe the ultrasonographic abnormalities seen in native septic arthritis of the knee | Day0, Day 10 or before surgery, 6week, 3months, 6months |