linjc16/ctgov huggingface dataset:
Anxiety on the First Day of Chemotherapy

Study Overview
=================
Brief Summary
-----------------
investigating chemotherapy anxieties

Detailed Description
-----------------
Breast cancer is the most common type of cancer in women in the world, and it is the first in cancer-related deaths in women all over the world. In the treatment of breast cancer, in addition to surgery, patients with advanced stage or high risk of recurrence receive neoadjuvant and adjuvant chemotherapy treatments. This period starts with 3 months and extends according to the treatment protocols it will receive. Since the first diagnosis of breast cancer, it has psychological effects such as intense stress, decrease in quality of life and anxiety as well as physical effects on patients. The time spent in the waiting room while patients are examined and receiving treatment before chemotherapy inevitably has an effect on their anxiety. In this study; It was aimed to investigate the effects of environmental factors in waiting rooms on patients' anxiety.

Official Title
-----------------
The Effect of Art Design in the Chemotherapy Waiting Room on the Anxiety of Patients Who Will Receive Chemotherapy for the First Time

Conditions
-----------------
Breast Cancer, Anxiety

Intervention / Treatment
-----------------
* Other: waiting room enriched with music, paintings and artificial plants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to receive chemotherapy for breast cancer for the first time give consent for the study Exclusion Criteria: not approving to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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 |
| --- | --- |
| No Intervention: standard waiting room<br>standard chemoterapy waiting room | |
| Experimental: waiting room enriched with art objects<br>waiting room enriched with music, paintings and artificial plants | Other: waiting room enriched with music, paintings and artificial plants<br>* waiting room enriched with music, paintings and artificial plants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety and stress measurements | The State-Trait Anxiety Inventory (STAI) - Measuring anxiety with the Hospital Anxiety and Depression Scale (HADS) | 60-120 minutes |
Expanded Access to ANG1005 for Individual Patients

Study Overview
=================
Brief Summary
-----------------
This is an expanded access study with ANG1005 treatment for two individual patients from Protocol ANG1005-CLN-03 with WHO Grade III Anaplastic Astrocytoma and WHO Grade III Anaplastic Oligodendroglioma and one individual patient from Protocol ANG1005-CLN-04 with Recurrent Brain Metastases and Leptomeningeal Carcinomatosis.

Official Title
-----------------
Expanded Access to ANG1005 for an Individual Patient With Recurrent WHO Grade III Anaplastic Astrocytoma; Expanded Access to ANG1005 for an Individual Patient With Recurrent WHO Grade III Anaplastic Oligodendroglioma; Expanded Access to ANG1005 for an Individual Breast Cancer Patient With Recurrent Brain Metastases and Leptomeningeal Carcinomatosis.

Conditions
-----------------
Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Breast Cancer With Recurrent Brain Metastases, Leptomeningeal Carcinomatosis

Intervention / Treatment
-----------------
* Drug: ANG1005


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neurologically stable Karnofsky performance status (KPS) ≥ 80 Adequate laboratory results Exclusion Criteria: Radiotherapy within 3 months. Evidence of significant intracranial hemorrhage NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy Inadequate bone marrow reserve Any evidence of severe or uncontrolled disease

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ANG1005|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Toilet Training and Adults With Learning Disabilities

Study Overview
=================
Brief Summary
-----------------
Incontinence is common in adults with learning disabilities (LDs). Behavioural toilet training in conjunction with toilet alarms is recommended for people with LDs, but there is a paucity of research, thus evidence-based practise, on behavioural toilet training for adults with LDs. The aim of this study is to assess the toileting needs and issues of 30 adults with LDs with incontinence, and determine whether a 12-week individualised positive behavioural support training intervention, with the use of toilet alarms, promotes continence.

Detailed Description
-----------------
Adults with learning disabilities with incontinence are being invited to participate in a 12-week personalised, positive toilet training plan, following assessment of their toileting needs. Primary outcome measures will be: number of incidences of incontinence, and number of instances of successful voiding in a toilet. Toilet alarms will be used to encourage prompted voiding in a toilet.

Official Title
-----------------
Toileting Assessment and Toilet Training for Adults With Learning Disabilities With Incontinence

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Device: Toilet alarm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adults with learning disabilities with incontince across all levels of learning disabilities (mild to profound) Exclusion Criteria: Cannot sit on a toilet for up to 3 minutes

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A feasibility sample of 30 adults with learning disabilities with incontinence
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>30 adults with learning disabilities with incontinence will be offered a 12-week personalised toilet training plan, which promotes prompted voiding in a toilet | Device: Toilet alarm<br>* A Malem toilet alarm (wristworn, discretely in underwear, or bed mat) will be used to promote prompred voiding in a toilet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of instances of incontinence | The intervention should promote less instances of incontinence | 12 weeks | 
| Number of instances of successful voiding in a toilet | The intervention should promote more instances of successful voiding in a toilet | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Incontinence, Learning disabilities
DPBRN Persistent Pain and Root Canal Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to document by survey the occurence of tooth pain present 3 months and 6 months after root canal therapy in the patients recruited for the DPBRN Peri-operative tooth pain study. This study will access the feasibility of obtaining 3 month and 6 month follow-up data on the patient enrolled in the DPBRN Peri-operative tooth pain study.

Official Title
-----------------
Persistent Pain and Root Canal Therapy

Conditions
-----------------
Root Canal Therapy, Persistent Tooth Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19-70 years old Permanent adult tooth requiring its first non-surgical root canal therapy patients with more than 1 tooth requiring root canal therapy are eligible, but only the first root canal procedure will be included to avoid problems of correlation within patients Exclusion Criteria: evidence of prior root canal therapy, including iatrogenic, but not disease-induced pulp access of the tooth being considered patients with obvious cognitive impairments (e.g., past stroke with communication deficits, dementia,mental disability) patients unable to return for 6 month follow-up

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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 |
| --- | --- |
| Persistent Tooth Pain<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-operative pain, root canal therapy, feasibility, post-surgical persistent pain
Degarelix in the Treatment of Endometriosis Recurrence

Study Overview
=================
Brief Summary
-----------------
The long acting GnRH antagonist degarelix will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.

Detailed Description
-----------------
Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing recurrence after surgery at least in 20-50% after 5 years of follow-up. The long acting GnRH antagonist degarelix, which do not have the flare-up effect at the opposite of GnRH agonist and strongly suppress LH secretion and thecal cell activity may show a better effects on endometrial implants than GnRH agonist.

Official Title
-----------------
Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: degarelix
* Drug: goserelin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women affected by endometriosis showing recurrence of pain symptoms previous surgery for endometriosis Exclusion Criteria: presence of other systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Degarelix<br>180 women will be treated with degarelix 80mg in one administration | Drug: degarelix<br>* 180 women will be treated with degarlix 80 mg, in only one administration covering three months<br>* Other names: firmagon;|
| Active Comparator: Goserelin<br>180 women will be treated with goserelin 3.6mg monthly for three months | Drug: goserelin<br>* 180 women will be treated with decapeptyl 3.6 every month for three months<br>* Other names: decapeptyl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free time | time without pain symptoms due to the disease recurrence | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of disappearance pain | time needed during treatment to improve the pain symptoms | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis, long acting GnRH antagonist, Degarelix, Recurrence, Pelvic Pain
Development of Gourmet Healthy Cooking Workshop for Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Subjects that participate in the practical workshop will improve their metabolic indexes, control their weight and improve their quality of life, in contrast to the participants that will take part in the nutritional consulting sessions

Detailed Description
-----------------
Participants will be randomly assigned to a dietary consultation-only control group or to a gourmet medical cooking workshop. The workshop will consist of 6 lessons with the following lessons: introduction, caloric density of food, fats, vegetable and fruits, Whole grains and legumes, Healthy desserts . All the lessons will start with half an hour theoretical introduction, followed by a 2.5 hours hands on session under supervision of a medical chef. The study population will include women receiving adjuvant chemotherapy for breast cancer. 72 patients will be recruited and will be randomly divided into two groups: an intervention group of 36 will commence the workshop during 2007 and a control group of 36 who will take part in dietitian consulting sessions only.

Official Title
-----------------
Development of Gourmet Healthy Cooking Workshop for Cancer Patients

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: gourmet cooking workshop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adjuvant chemotherapy
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: gourmet cooking workshop|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: We expect to see change in the following outcomes: the patient's metabolic state, the patient's weight, body composite, patient's quality of life. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight, gourmet healthy cooking, quality of life, adjuvant chemotherapy, breast cancer
Immune Response of Haemodialysis Patients Post Covid-19 Vaccination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess immune response of end stage renal failure patients after Covid 19 vaccination

Official Title
-----------------
The Malaysian Study On Hemodialysis Patients SARS-COV-2 Vaccination Immune Response: A Prospective Observational Cohort Study

Conditions
-----------------
Immune Response Post Covid 19 Vaccination

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ESRF patient on hemodialysis who are eligible for the goverment Covid 19 vaccination programme 18 years old and above consented to join the study Exclusion Criteria: patient who refused to be vaccinated patient who deemed unsuitable for Covid vaccination

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 |
| --- | --- | --- |
| Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level | Study the antibody synthesis induced by vaccination, among end stage renal failure patients, and the change in its level at 1 month, at 6 months and at 1 year after complete vaccination. | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level after 1st inoculation of the vaccine (incomplete vaccination) | Study the antibody synthesis and the change in its level after 1st inoculation of the vaccine | one month |
Check of Optical Features and Accuracy of the Zeiss ZO Lens After Selection and Calculation With OKULIX

Study Overview
=================
Brief Summary
-----------------
It is planned to implant the intraocular lenses XL Stabi ZO and Invent ZO into the eyes of patients for whom a cataract operation is medically indicated. The lenses are marketed and CE certified. Their implantation is clinical routine. In the trial the accuracy of prediction of target refraction and the difference between calculated and measured contrast vision will be examined for both lens types.

Official Title
-----------------
Check of Optical Features and Accuracy of the Zeiss ZO Lens of the Company Carl Zeiss Meditec After Selection and Calculation With OKULIX

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Invent ZO
* Device: XL Stabi ZO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for cataract operation Written informed consent of patient after information Exclusion Criteria: Immobility Limited capacity of understanding Diseases that hamper a follow-up examination Astigmatism >2.0 D Patients with ocular diseases who may be expected to show a vision of less than 0.63 (decimal) two months after cataract surgery with implantation of intraocular lens Complications during surgery, especially complications with positioning of the intraocular lens and with capsulorhexis

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ZO<br>XL Stabi ZO or Invent ZO | Device: Invent ZO<br>* monofocal aspheric IOL for implantation into capsular bag<br>Device: XL Stabi ZO<br>* monofocal aspheric IOL for implantation into capsular bag<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of prediction of target refraction |  | postop. | 
| Difference between calculated and measured contrast vision. |  | postop. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Improvement of adjustment accuracy of intraocular lenses and imaging quality
Incidence of Cardiovascular Diseases in Patients With Hypopituitarims

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was therefore two-fold: 1) to make a retrospective comparison of incidence of non-fatal stroke and cardiac events between a large cohort of patients with confirmed GHD on replacement therapy (including GH) and a control cohort from the general population; 2) to compare the prevalence of DM and cardioprotective medication between the cohorts at the time of questionnaire distribution with adjustment for possible confounders and effect modifiers.

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed GH deficiency Exclusion Criteria: Not confirmed GH deficiency
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac disease, cerebrovascular disease, GH deficiency, diabetes mellitus, hypertension, GH therapy, GH deficiency and hypopituitarims
Effectiveness of Adhesive Containing MDPB

Study Overview
=================
Brief Summary
-----------------
9 general practices in the Netherlands were provided with two composite resin adhesives, each for a period of 9 months. One contained MDPB (Adhesive P), and the other one was used as a control (Adhesive S). Patient's age, SES, and caries risk, as well as tooth type/number, reason for restoration placement, used restorative material and bonding agent, and affected surfaces were recorded. All interventions carried out on these teeth in the next 6 years were extracted from the electronic patient records, along with their date, type, reason, and surfaces. Two dependent variables were defined: general failure, and failure due to secondary caries. All data handling and statistical analyses were carried out in R 4.0.5.

Official Title
-----------------
Effectiveness of Adhesive Containing MDPB: a Practice-based Clinical Trial

Conditions
-----------------
Secondary Caries

Intervention / Treatment
-----------------
* Drug: Clearfil Protect Bond
* Drug: Clearfil SE Bond


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Needing at least one dental restoration Exclusion Criteria: Opted out of data collection

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Protect Bond<br>Restoration placed using Clearfil Protect Bond adhesive (Kuraray Noritake, Osaka, Japan) , which contains the antibacterial monomer MDPB (12-Methacryloyloxydodecylpyridiniumbromide) | Drug: Clearfil Protect Bond<br>* An adhesive is used routinely when placing resin composite restorations. This group receives a commercially available adhesive containing an antibacterial monomer (MDPB)<br>* Other names: 12-Methacryloyloxydodecylpyridiniumbromide;|
| SE Bond<br>Restoration placed using Clearfil SEBond adhesive (Kuraray Noritake, Osaka, Japan) | Drug: Clearfil SE Bond<br>* An adhesive is used routinely when placing resin composite restorations. This group receives a commercially available adhesive.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration survival | Time in years restoration has survived without needing dental re-intervention | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure through caries | Incidence of secondary caries leading to replacement of the restoration | up to 5 years |