linjc16/ctgov huggingface dataset:
Quality of Life of Eye Amputated Patients in Denmark

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate eye amputated patients health related quality of life, perceived stress, self-rated health, labour marked participation and socio-economic position. The investigators hypothesis is that quality of life, perceived stress and self- rated health of many eye amputated patients are drastically changed. Eye amputation has a marked negative influence on labour marked participation and socio-economic position of the patients.

Official Title
-----------------
Quality of Life of Eye Amputated Patients in Denmark

Conditions
-----------------
Eye Cancer, Painful Blind Eye, Panophthalmia, Traumas

Intervention / Treatment
-----------------
* Procedure: eye amputation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria were operation for evisceration, enucleation, orbital exenteration or secondary implantation of an orbital implant during the period 1996-2003. 267 patients were in 2005 invited to a clinical investigation and of those 173 accepted. Included in this study were patients who came to the clinical investigation, who accepted to receive questionnaires and were alive in 2008. Exclusion Criteria: Dead Below 18 years Left the country Living at Greenland or the Faeroe Islands

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 |
| --- | --- |
| eye amputated<br>lost an eye | Procedure: eye amputation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life |  |  |
A STUDY TO EVALUATE THE EFFICACY OF CJH1 (CLR4001) IN PARKINSON'S DISEASE

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the ability of CJH1 to increase the sensitivity of dopamine receptors and thereby reduce symptoms of Parkinson's Disease.

Official Title
-----------------
A STUDY TO EVALUATE THE EFFICACY OF CJH1 [CLR4001] IN THE TREATMENT OF PARKINSON'S DISEASE

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: CJH1 (CLR4001)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's with Parkinson's disease Exclusion Criteria: Contraindications to study medication

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with CJH1<br> | Drug: CJH1 (CLR4001)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced signs and symptoms of Parkinson's disease | Reduced signs and symptoms of Parkinson's disease | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Novel Treatment Parkinson's disease
Investigation of the Relationship Between Pelvic Floor Awareness and Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
There is no study in the literature examining the knowledge level and urinary symptoms of active athletes about the pelvic floor. The aim of this study is to determine the relationship between PTC awareness and incontinence in young athletes who engage in long-term and high-intensity activities that increase the risk of SUI.

Official Title
-----------------
Investigation of the Relationship Between Pelvic Floor Awareness and Urinary Incontinence in Young Athletes

Conditions
-----------------
Pelvic Floor, Urinary Incontinence, Young Athletes

Intervention / Treatment
-----------------
* Diagnostic Test: Pelvic Floor Health Knowledge Quiz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-25 years old Young athletes Exclusion Criteria: Having a neurological disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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 |
| --- | --- |
| continent<br>able to hold urine during sports | Diagnostic Test: Pelvic Floor Health Knowledge Quiz<br>* It is a questionnaire to measure the knowledge level of the participants about pelvic floor health.<br>* Other names: Incontinence Impact Questionnaire-7;|
| incontinent<br>leaking urine during sports | Diagnostic Test: Pelvic Floor Health Knowledge Quiz<br>* It is a questionnaire to measure the knowledge level of the participants about pelvic floor health.<br>* Other names: Incontinence Impact Questionnaire-7;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Physical Activity Questionnaire- Short Form | The physical activity level is determined by recording the light, moderate and vigorous activities and sitting time of the person in the last 1 week. | baseline | 
| Pelvic Floor Health Knowledge Quiz | It is a questionnaire to measure the knowledge level of the participants about pelvic floor health. | baseline | 
| International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) | It is a questionnaire containing six questions to find out the frequency of urinary incontinence, during which activities it occurs, and how much the person is affected by this condition. | baseline | 
| Incontinence Impact Questionnaire-7 | It is a questionnaire consisting of 7 questions used in the evaluation of daily life effects due to incontinence. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pelvic floor, awareness, knowledge, urinary incontinence, athletes
CANPOS: Predictive Biomarkers of Tumor Progression in Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
CANPOS is a non-interventional study aiming at evaluate at the time of initial surgery the value of new serum markers to predict the occurrence of metastases in patients with early-stage non-small cell lung cancer. This would represent a rational to develop personalized follow-up and prevention strategies

Official Title
-----------------
CANPOS: Predictive Biomarkers of Tumor Progression in Non-small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Biological: Serum and plasma samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a diagnosis or suspected for a diagnosis of lung cancer, non-small cell lung cancer age over 18 years patient naïve of any oncology treatment (excluding surgery alone) within the past 5 years patient who signed the informed consent by the study protocol Exclusion criteria were: any ongoing treatment for cancer any history of cancer within 5 years before the diagnosis of lung cancer any psychological, sociological or geographical conditions that would not allow the study follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Patients with a non-small cell lung cancer<br>Serum and plasma samples (at time of diagnosis, after surgery, and at time of progression to evaluate the value of new serum markers to predict the occurrence of metastases). | Biological: Serum and plasma samples<br>* Serum and plasma are collected at time of diagnosis, after surgery, and at time of progression to evaluate the value of new serum markers to predict the occurrence of metastases.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Serum levels of osteoprotegerin | The serum levels of osteoprotegerin, as assessed by standard ELISA methods, will be measured to to evaluate at the time of initial surgery, the value of new serum markers to predict the occurrence of metastases in patients with early-stage non-small cell lung cancer. | At the time of initial surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer, Biomarkers, Bone, Metastases
Genetic Inclusion by Virtual Evaluation

Study Overview
=================
Brief Summary
-----------------
This study aims to transform the current clinical practice paradigm by leveraging an internally designed web-based model of delivery of care called Consultagene to provide remote evaluation and genomic sequencing for improving genetic health of less resourced children with rare disorders living along the Texas-Mexico border.

Detailed Description
-----------------
Inadequate access to genetics evaluation and genomic testing in the Hispanic minorities living along the Texas-Mexico has marginalized the most vulnerable pediatric group. In this study, we will (1) implement a virtual web-based service, called Consultagene for simplifying patient pathways and deliver virtual genetics evaluation in Rio Grande Valley (RGV) (2) provide rapid genetic diagnoses through whole genome sequencing and interpretation of diagnostic studies for medical decision-making and improving health outcomes for the minorities, and (3) build genomic competency of front-line healthcare providers through education and machine learning to expedite referral of pediatric patients with suspected rare diseases for shortening diagnostic odyssey.

Official Title
-----------------
Virtual Platforms for Genetics Evaluation in the Medically Underserved

Conditions
-----------------
Birth Defects, Multiple Congenital Anomaly, Neurodevelopmental Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: Whole genome sequencing (WGS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients with undiagnosed rare genetic diseases residing in the Rio Grande Valley in Texas Exclusion Criteria: Children with known genetic diseases

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

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

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

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 |
| --- | --- |
| Other: WGS arm<br>All 100 patients recruited will undergo WGS | Diagnostic Test: Whole genome sequencing (WGS)<br>* WGS will identify copy number variations (CNVs), single nucleotide variants (SNVs), as well as triplet repeat disorders in children with rare diseases<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to diagnosis |  | 12 months |
Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia

Study Overview
=================
Brief Summary
-----------------
An open-label, multi-center, Phase Ib study to determine the safety and pharmacokinetics of intravenous and oral APX001 in patients undergoing chemotherapy for Acute Myeloid Leukemia with neutropenia. A total of 20 patients will be enrolled in this study. 10 patients in Cohort I, intravenous drug dosing and 10 patients will be enrolled in Cohort II, oral drug dosing. All patients will receive chemotherapy for their AML according to local clinical standard of care as well as antifungal prophylaxis. APX001 will be administered for 14 consecutive days, beginning on Study Day 3 after onset of chemotherapy

Official Title
-----------------
An Open Label, Multi-Center Study to Determine the Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia With Neutropenia

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: APX001 with Standard of Care anti-fungal agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Provision of written consent Ages 18-75 inclusive, male or female Diagnosis of Acute Myeloid Leukemia Patients entering first induction treatment chemotherapy Expected to be neutropenic (<500 ANC/ul) for >/= 10 days Key Exclusion Criteria: Patients who received systemic antifungal therapy for proven or probable fungal infections within the last 12 months Current fever (> 38 degrees Celsius) Concomitant use of rifampin, rifabutin, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine and carbamazepine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Interventional Model Description: The first 10 patients enrolled will be administered IV APX001. The second 10 patients enrolled will be administered oral APX001
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APX001 with Standard of Care Anti-fungal agent<br> | Drug: APX001 with Standard of Care anti-fungal agent<br>* safety assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment-related adverse events as assessed and reported by CTCAE v4.0 |  | One to forty-four days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) |  | One to forty-four days | 
| Peak Plasma Concentration (Cmax) |  | One to forty-four days |
Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy

Study Overview
=================
Brief Summary
-----------------
Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in laparoscopic right colectomy reduces post-operative bowel canalisation time and length of stay in comparison with extracorporeal mechanical anastomosis.

Official Title
-----------------
Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy. A Prospective Randomized Controlled Clinical Trial

Conditions
-----------------
Neoplastic or Benign Disease of Right Colon, Elective Laparoscopic Surgery

Intervention / Treatment
-----------------
* Procedure: Laparoscopic right colectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or more Benign o neoplastic disease of right colon Elective laparoscopic surgery Exclusion Criteria: Emergency surgery Adhesion or infiltration of near organs Severe heart disease ( New York Heart Association class > 3 ) Severe respiratory disease ( arterial PO2 < 70 torr ) Severe Liver disease (Child-Pugh class C) Ongoing infections Number of plasmatic neutrophil < a 2.0 x 10 9/L Other contraindications to laparoscopy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracorpopreal anastomosis<br>Intracorporeal mechanical anastomosis | Procedure: Laparoscopic right colectomy<br>* Laparoscopic right colectomy with mechanical ileo-colon anastomosis L-L<br>|
| Active Comparator: Extracorporeal anastomosis<br>Extracorporeal mechanical anastomosis | Procedure: Laparoscopic right colectomy<br>* Laparoscopic right colectomy with mechanical ileo-colon anastomosis L-L<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative canalisation time and length of stay | Comparison of post-operative bowel movement time (fist flastus and first dejection) and overall length of stay between the two study groups | Post-operative stay (about 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of post-operative ileum and complications. Valuation of global costs | Comparison of post-operative short and long-term complications (in particular post-operative ileum) between the two study groups. Valuation of global costs differences. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic surgery, Right colectomy, Mechanical anastomosis, Post-operative ileum
Dose-Ranging Study of an Ophthalamic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataract

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of three doses of C-KAD Ophthalmic Solution in patients with loss of visual function due to age-related nuclear cataract

Official Title
-----------------
A Randomized, Placebo-Controlled, Single-Masked, Dose-Ranging Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataracts

Conditions
-----------------
Nuclear Cataract

Intervention / Treatment
-----------------
* Drug: LiquiTears
* Drug: C-KAD Ophthalmic Solution
* Drug: C-KAD Ophthalmic Solution
* Drug: C-KAD Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of nuclear sclerosis cataract BCDVA within the range of 20/40 and 20/80 Exclusion Criteria: Any other clinical condition in the eye that may compromise vision Presence or history of glaucoma Presence or history of diabetes Use of eyedrops Use of steroids

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1.3% (low dose)<br> | Drug: C-KAD Ophthalmic Solution<br>* 4 drops applied daily for 360 days<br>|
| Active Comparator: 2% (medium dose)<br> | Drug: C-KAD Ophthalmic Solution<br>* 4 drops applied daily for 360 days<br>|
| Active Comparator: 2.6% (high dose)<br> | Drug: C-KAD Ophthalmic Solution<br>* 4 drops applied daily for 360 days<br>|
| Placebo Comparator: Placebo<br> | Drug: LiquiTears<br>* 4 drops applied daily for 360 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity by ETDRS |  | 360 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract Study, Ophthalmic Study, Agerelated cataract, Nuclear Cataract, Low grade nuclear cataracts
Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization

Study Overview
=================
Brief Summary
-----------------
Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study

Detailed Description
-----------------
Following completion of the Phase 2, multicenter, randomized, active-controlled study of the safety and tolerability of two formulations of CD101 compared to fluconazole for the treatment of moderate to severe episodes of acute vulvovaginal candidiasis (NCT07299432), subjects without a recurrence of VVC will be followed up to an additional 90 days +/- 14 days to assess candida colonization and recurrence of VVC.

Official Title
-----------------
A Non-Interventional Extension Study to Investigate Vulvovaginal Candidiasis Recurrence and Candida Colonization Following a Phase 2 Randomized, Active-Controlled Study of Two Formulations of CD101 Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis

Conditions
-----------------
Candidiasis, Vulvovaginal, Yeast Infection, Mycoses, Moniliasis, Vulvovaginal, Vaginitis, Monilial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in and completed the primary study through the Day 28 visit. Received at least one dose of study drug in the primary study Able to give written informed consent prior to completion of the primary study Exclusion Criteria: Received systemic or topical vaginal non-study antifungal therapy at any time during the primary study Diagnosed with bacterial vaginosis, trichomonas, gonorrhea, chlamydia, or active herpes at any point during the primary study The Principal Investigator considers that the subject should not participate in the study

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

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

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 |
| --- | --- | --- |
| Time to recurrence of clinical signs/symptoms of VVC | Time to recurrence of clinical signs/symptoms of VVC | Up to Day 90 +/- 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of candida colonization | Rate of candida colonization | Up to Day 90 +/- 14 days | 
| Rate of recurrence of clinical signs/symptoms of VVC | Rate of recurrence of clinical signs/symptoms of VVC | Up to Day 90 +/- 14 days | 
| Time to recurrence of culture confirmed VVC | Time to recurrence of culture confirmed VVC | Up to Day 90 +/- 14 days | 
| Rates of recurrence of culture confirmed VVC | Rates of recurrence of culture confirmed VVC | Up to Day 90 +/- 14 days |