linjc16/ctgov huggingface dataset:
New Pre-Surgical Scoring System for Uterine Septum

Study Overview
=================
Brief Summary
-----------------
Comparing surgical outcomes of Hysteroscopic metroplasty for uterine septum when using the standard ESGE or ASRM classifications vs the novel scoring system dubbed Shawki Septum Scoring System. Outcomes based primarily on completion of the septal correction (no residual parts) and avoiding complications, the most significant of which are uterine perforation.

Official Title
-----------------
Uterine Septum: Novel Pre-surgical Scoring System to Aid and Standardise Hysteroscopic Metroplasty

Conditions
-----------------
Septate Uterus

Intervention / Treatment
-----------------
* Diagnostic Test: Shawki Septum Scoring System
* Diagnostic Test: ESHRE ASRM Classification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uterine Septum diagnosed by 3D ultrasound Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hysteroscopic Metroplasty using ESHRE ASRM Classification<br> | Diagnostic Test: ESHRE ASRM Classification<br>* Utilising the current classification before performing hysteroscopic metroplasty<br>|
| Active Comparator: Hysteroscopic Metroplasty using Shawki Septum Scoring System<br> | Diagnostic Test: Shawki Septum Scoring System<br>* Utilising the novel scoring system to facilitate feasibility and safety of hysteroscopic metroplasty for uterine septum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Complete Septum Correction | No residual septum on 3D ultrasound | 1 month | 
| Percentage of patients who had an intra-operative Uterine perforation | Diminishing the risk of intra-operative perforation of the fundus | during the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hysterscopy, Congenital Uterine Anomaly, Uterine Septum, Septet Uterus, Novel Scoring System, Shawki Septum Scoring System
Discovering Factors in Head and Neck Cancer Patients' Clinical Study Experiences

Study Overview
=================
Brief Summary
-----------------
Enrollment in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups. This trial will evaluate the safety and efficacy of head and neck cancer treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future head and neck cancer studies.

Official Title
-----------------
An Observational Medical Trial Assessing Patterns in Experiences of Participants of Head and Neck Cancer Clinical Trials

Conditions
-----------------
Head and Neck Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years of age Patient is able and willing to comply with the treatment/follow-up schedule and requirements Patient must provide written informed consent Exclusion Criteria: Participants who are vulnerable to any intervention Women who are pregnant, intend to become pregnant, or are lactating Inability to perform regular electronic reporting

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who decide to enroll in a clinical study. |  | 3 months | 
| Number of study participants who remain in clinical trial until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
head and neck cancer
Clinical Stories and Psychological Experiences of Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to collect and analyze information from the multidimensional assessment of cancer patients (medical, psychological, psychometric, biological, etc.) treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The collection of information will allow to investigate the possible presence of correlations between psychological aspects and clinical medical conditions of the person during the course/treatment of cancer. In the course of the study, the possible presence of previous stressful and/or traumatic events, and the presence of psychological, post-traumatic and/or dissociative symptoms during treatment will be explored. Any correlations between medical conditions and psychological, emotional and behavioral characteristics will also be explored. Finally, it will be possible to investigate the effectiveness of psychological interventions that are carried out according to clinical practice.

Official Title
-----------------
ONCO_STORIES. Stress, Trauma, Origins, Psychological Responses, Interpersonal Relationships and Experiences in the Clinical History of Cancer Patients

Conditions
-----------------
Tumor

Intervention / Treatment
-----------------
* Other: Self Report Questionaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals between 18 and 99 years old; Individuals with a diagnosis of current oncologic disease and in active oncologic treatment at the hospital where the study is conducted; Individuals with a history of oncologic disease who have completed oncologic treatment or in follow-up at the hospital where the study is conducted; Exclusion Criteria: Non-signing of informed consent; Non-signing of consent/assent by patient/legal guardian; Patients with cognitive impairment or legal disqualification; Clinical/medical or psychological condition that does not allow completion of self-report questionnaires;

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

| Intervention/Treatment |
| --- |
|Other: Self Report Questionaires|Collection and analysis of information from patient self-report assessments and integration with clinical information from assessments performed routinely during cancer treatment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and analyze information from the multidimensional assessment of cancer patients | Descriptive and statistical analysis of data collected on the clinical and psychological conditions of the cancer patient through routine assessments and self-report questionnaires. | 1 hour |
Travoprost Intraocular Implant in Conjunction With Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria and who undergo successful cataract extraction with implantation of a posterior chamber intraocular lens (PC-IOL) will receive a travoprost intraocular implant and followed up for 12 months.

Official Title
-----------------
Multicenter, Open-label, Single-arm Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With Cataract Surgery

Conditions
-----------------
Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: iDose TR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically significant age-related cataract eligible for phacoemulsification in the study eye open-angle glaucoma or ocular hypertension in the study eye successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber IOL Exclusion Criteria: unmedicated (washed out) IOP of >36 mmHg in the study eye hypersensitivity to travoprost or any other components of the travoprost intraocular implant vertical cup/disc ratio > 0.8 in the study eye best spectacle corrected visual acuity of worse than 20/80 in the fellow eye any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

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

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

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: iDose TR<br>Travoprost Intraocular Implant administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery | Drug: iDose TR<br>* anchored intracameral implant containing travoprost<br>* Other names: travoprost intraocular implant;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean diurnal IOP | Mean diurnal IOP at the Month 3 Visit minus the mean diurnal IOP at the Baseline Visit | 3 months |
GENE EXPRESSION PROFILING IN A VALIDATION COHORT OF LOCALLY ADVANCED AND RECURRENT/METASTATIC SALIVARY GLAND CANCERS

Study Overview
=================
Brief Summary
-----------------
The INDAGA-UK trial is a retrospective, multi-centre observational study in participants with locally advanced and recurrent salivary gland to investigate t its molecular profiling, and to explore new prognostic and druggable markers. We will analyse samples and data from patients diagnosed with salivary gland cancer from 2013 - 2023. Subject and sample identification will occur over a 12-month period. Samples and data will be analysed over the next 12 months prior to study end.

Official Title
-----------------
GENE EXPRESSION PROFILING IN A VALIDATION COHORT OF LOCALLY ADVANCED AND RECURRENT/METASTATIC SALIVARY GLAND CANCERS: THE INDAGA-UK TRIAL

Conditions
-----------------
Salivary Gland Cancer

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged over 18 Histological diagnosis of salivary gland cancer (SGCs) Availability of archival tissue (acceptable after 2013 up to present) Ability to give informed consent (if applicable)* for retrieving histological specimen and preform molecular analysis *De-identified archival tissue from deceased patients will be collected as part of the study once REC approval is in place, if the patient was alive when the samples were taken and they are not part of the NHS opt out scheme. Exclusion Criteria: Different H&N cancer of other histology Thyroid cancers

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 |
| --- | --- |
| Cohort 1<br> | Other: Observation<br>* Observational study, no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Description of the molecular and genomic profile of locally advanced and recurrent-metastatic SGCs. | • Description of the molecular and genomic profile of locally advanced and recurrent-metastatic SGCs. | Time Frame: Through study completion, expected duration of 10 years |
Eplerenone, Aflibercept and Topical Nepafenac Serous Foveal Deta Chment in Central Serous Chorioretinopathy

Study Overview
=================
Brief Summary
-----------------
describing the influence of; combined Eplerenone, intravitreal Aflibercept, and topical Nepafenac; on serous foveal detachment in eyes with CSCR

Detailed Description
-----------------
Retrospective Review of records of eyes with Central serous chorioretinopathy (CSCR) that have been treated in the period between 2015 and 2021 After checking inclusion and exclusion criteria; we will enroll all cases that have been treated by the combination of eplerenone, intravitreal aflibercept and topical nepafenac. Investigators collected and recorded the following data: Age Gender Systemic hypertension (present or not) Smoking (Yes / No) Best corrected visual acuity (BCVA) (baseline, final) Central macular thickness (CMT) (baseline, final) Serous detachment Height (SDH) (baseline, final) Duration of Follow-up ( in months)

Official Title
-----------------
Influence of Combined Eplerenone , Intravitreal Aflibercept and Topical Nepafenac Therapy on Serous Foveal Detachment in Central Serous Chorioretinopathy (CSCR)

Conditions
-----------------
Central Serous Chorioretinopathy

Intervention / Treatment
-----------------
* Other: Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CSCR eyes treated by combination of Eplerenone, Aflibercept and Nepafenac. Exclusion Criteria: • CSCR treated by other modalities CSCR treated by just 1 or 2 components of :Eplerenone, Aflibercept and Nepafenac

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy|Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in central macular thickness (CMT ) in microns | reduction in CMT after therapy | (baseline, 6 months) | 
| Change in serous detachment height (SDH) in microns | reduction in SDH after therapy | (baseline, 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BCVA | number of lines of improvement in BCVA after therapy | (baseline, 6 months) | 
| Duration of Follow-up ( in months) | Duration of Follow-up ( in months) | (baseline, 6 months) | 
| Complications (Eplerenone, Aflibercept, and nepafenac) | present or absent | (baseline, 6 months) |
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.

Official Title
-----------------
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

Conditions
-----------------
Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Biological: Brexucabtagene Autoleucel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have commercially manufactured brexucabtagene autoleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential) Deemed medically fit and stable to receive the product per the investigator's evaluation Repeat leukapheresis is not feasible per the investigator's assessment Be diagnosed with 1 of the approved labeled indications for brexucabtagene autoleucel that is intended for release In the Investigator's opinion, there is no satisfactory alternative therapy available to the individual Exclusion Criteria: History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as brexucabtagene autoleucel Uncontrolled active infection or inflammation per physician assessment Primary central nervous system (CNS) lymphoma

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Brexucabtagene Autoleucel|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Emotional Bodymaps in Pediatric Pain Patients and Their Parents.

Study Overview
=================
Brief Summary
-----------------
The aims of this study are to find out how pain may alter the experience of emotions in the body in pediatric pain patients and how how their parent feel the emotions in their bodies. We are also interested how this possible effect is mediated by the duration and location of pain, mood changes or with the experience of bullying.

Official Title
-----------------
Emotional Bodymaps in Pediatric Pain Patients and Their Parents.

Conditions
-----------------
Pediatric Pain

Intervention / Treatment
-----------------
* Behavioral: interdiciplinary treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fluency in finnish language Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 Years

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 |
| --- | --- |
| Pediatric pain patients and their parents<br>patients and their parents | Behavioral: interdiciplinary treatment<br>* Normal interdiciplinary treatment path<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emotional bodymaps | sensations of emotion in ones body | 10months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain PROMIS | pain interference and intensity | 10 months | 
| psychological flexibility | measure of psychological flexibility | 10 months |
Low-dose Tolvaptan for Inpatient Hyponatraemia.

Study Overview
=================
Brief Summary
-----------------
This is a retrospective cohort study to assess the safety and efficacy of low first dose of Tolvaptan and low or standard second dose of Tolvaptan in patients with moderate to severe hyponatraemia associated with SIADH not responding to conservative means of hyponatraemia management. Patients are treated as part of standard clinical care. There is growing evidence that treating patients with SAIDH induced hyponatraemia using a low dose of Tolvaptan with 7.5mg (below licensed lowest 15mg daily dose). This is the largest study to date and seeks to validate the efficacy and safety or this lower than approved dose of Tolvaptan in patietns who only need a first dose but also in patients who need a second low or srandard dose of Tolvaptan.

Official Title
-----------------
Efficacy and Safety of Low-dose Tolvaptan in Treatment of Inpatient Hyponatraemia.

Conditions
-----------------
Hyponatremia, SIADH

Intervention / Treatment
-----------------
* Drug: Tolvaptan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presenting to Accident & Emergency department or seen as inpatients with moderate to severe hyponatraemia (sNa: <125mmol) associated with SIADH and not responding to conservative measures of hyponatraemia management. Patients of all genders aged 18-90 y.o Exclusion Criteria: Pregnant women and patients aged < 18y.o Hyponatraemia not associated with SIADH

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First dose tolvapatan<br> | Drug: Tolvaptan<br>* Oral ingestion of low dose Tolvaptan (7.5mg daily) for management of inpatient hyponatraemia for 1st dose Tolvaptan group. Oral ingestion of low dose Tolvaptan (7.5mg daily) or standard dose Tolvaptan (15mg daily) for 2nd dose Tolvaptan group.<br>|
| Second dose tolvaptan<br> | Drug: Tolvaptan<br>* Oral ingestion of low dose Tolvaptan (7.5mg daily) for management of inpatient hyponatraemia for 1st dose Tolvaptan group. Oral ingestion of low dose Tolvaptan (7.5mg daily) or standard dose Tolvaptan (15mg daily) for 2nd dose Tolvaptan group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to low dose tolvaptan | Evaluate the efficacy of tolvaptan 7.5mg daily to improve sodium concentration during inpatient hyponatraemia | Within 30 hours from tolvaptan intake | 
| Safety of low dose tolvaptan | Evaluate the magnitude of sodium increase after an initial 7.5mg Tolvaptan dose | Within 30 hours from tolvaptan intake | 

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