linjc16/ctgov huggingface dataset:
Oxytocin Buffers Stress Response in Individuals With Impaired Coping Abilities

Study Overview
=================
Brief Summary
-----------------
This study investigated, if people with impaired coping abilities benefit from intranasal oxytocin application.

Official Title
-----------------
Oxytocin Buffers Cortisol Responses to Stress in Individuals With Impaired Coping Abilities

Conditions
-----------------
Coping Skills, Oxytocin, Stress

Intervention / Treatment
-----------------
* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male Exclusion Criteria: psychological disorders drug abuse cigarette smoking coronary diseases nervous system diseases

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>Intranasal Oxytocin, 24 IU | Drug: Oxytocin<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Cortisol |  |  |
Clinic Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether 18F-Al-NOTA-MATBBN is safety and effective for cancer diagnosis.

Detailed Description
-----------------
Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.

Official Title
-----------------
Phase 1 Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics

Conditions
-----------------
Breast Neoplasms, Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: 18F-Al-NOTA-MATBBN PET/CT
* Device: PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers or patients with age more than 18 yeas; The patients have been diagnosed with cancer or suspected with cancer; It must fulfill the ethical requirements and subjects have signed an informed consent. Exclusion Criteria: Pregnancy or nursing mothers; Having drugs or alcohol dependence; Hypersensitive to the active or inactive ingredients of the study drug; Having attended other drug clinical trials within three months; Cardiac functional insufficiency; Hepatic and renal function insufficiency; Hypertensive patients with serious complications; Endangering the safety of life.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Experimental: 18F-Al-NOTA-MATBBN PET/CT<br>Imaging with 18F-Al-NOTA-MATBBN PET/CT | Drug: 18F-Al-NOTA-MATBBN PET/CT<br>* 18F-Al-NOTA-MATBBN(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min.<br>Device: PET/CT<br>* Imaging with 18F-Al-NOTA-MATBBN PET/CT.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value of 18F-Al-NOTA-MATBBN in malignant lesions | The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in malignant lesions will be measured. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collection | Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Neoplasms,Prostatic Neoplasms
Evaluation of the Subjectively Perceived Pelvic Floor Function in Patients With Gynecological Tumors and Breast Cancer Under Systemic Tumor Therapy Using a Validated Questionnaire

Study Overview
=================
Brief Summary
-----------------
The multimodal therapy of gynecological malignancies and breast cancer often leads to an impairment of the pelvic floor function. This has a major impact on the quality of life of cancer patients. The aim of the study is to record and analyze the potential subjective impairment of the bladder, bowel and sexual function under systemic tumor therapy as well as possible influencing factors by means of validated disease-specific questionnaires. to find possible starting points for the prevention and treatment of the symptoms.

Official Title
-----------------
PANTHERA-Studie Pelvic Floor Disorders in Patients Under ANtineoplastic THERApy

Conditions
-----------------
Pelvic Floor Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breastcancer under tumor therapy Gynecological carcinoma under tumor therapy Exclusion Criteria: none

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint | The primary endpoint and basis for the sample size calculation is the incidence of clinically relevant deteriorations in the total score of pelvic floor function. Bladder function, bowel function, sedimentation problems and sexual function, QoL are recorded using scores using the validated German pelvic floor questionnaire | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint | Type of tumor (breast cancer, ovarian cancer, cervical cancer, endometrial cancer, vulvar cancer), TNM stage, body weight, height, age, type of tumor therapy, number of previous therapies (chemoline), parity, mode of delivery, nicotine abuse, medication, previous surgery. | 12 months |
Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand safety (e.g., occurrence of adverse drug reactions [ADRs]) and efficacy data on the long-term use of Vyndaqel Capsules (hereinafter referred to as Vyndaqel) in all patients who received this drug under actual use conditions after its marketing.

Detailed Description
-----------------
Both prospective and retrospective is acceptable All the patients whom an investigator prescribes Vyndaqel should be registered

Official Title
-----------------
VYNDAQEL DRUG USE INVESTIGATION (REGULATORY POST MARKETING COMMITMENT PLAN)

Conditions
-----------------
Transthyretin Familial Amyloid Poluneuropathy

Intervention / Treatment
-----------------
* Drug: Vyndaqel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subjects of this surveillance are all patients who received Vyndaqel. Exclusion Criteria: Patients not receive Vyndaqel.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vyndaqel<br> | Drug: Vyndaqel<br>* 20mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse drug reaction in this study |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on the following scale; NIS, QOL-DN, mBMI |  | 3 years |
EYLEA Age-Related Macular Degeneration (AMD) Post-marketing Surveillance in Japan

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received EYLEA for Age-Related Macular Degeneration (AMD). The objective of this study is to assess safety and effectiveness of EYLEA using in real clinical practice. A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.

Official Title
-----------------
Special Drug Use Investigation of EYLEA for AMD

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received EYLEA for AMD Exclusion Criteria: Patients who have already received EYLEA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Patients treated with EYLEA under practical manner for AMD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA |  | Up to 3 years | 
| Number of participants with serious adverse events (SAEs) and ocular adverse events(AEs) (especially AEs due to ITV injection procedure) from the first ITV injection of EYLEA |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with ADRs, SAEs and ocular AEs ( especially AEs due to ITV injection procedure) in subpopulations of patients background characteristics and status of EYLEA treatments from the first ITV injection of EYLEA |  | Up to 3 years | 
| Mean changes in visual acuity |  | Baseline and 6, 24 or 36 months | 
| Proportion of patients who maintained visual acuity(corresponding to <15 letters of Early Treatment Diabetic Retinopathy Study(ETDRS) from baseline) and improved visual acuity(corresponding to >0 letter of ETDRS from baseline) |  | Up to 3 years | 
| Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments |  | Baseline and 6, 24 or 36 months | 
| Number and intervals of ITV injection of EYLEA |  | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EYLEA, Age-Related Macular Degeneration
Bariatric Surgery and COVID-19

Study Overview
=================
Brief Summary
-----------------
The National Bariatric Surgical Registry (NBSR) is a prospectively collected database for all patients undergoing elective bariatric surgery in the UK. It was used to identify patients that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020). Characteristics of this group were compared with a pre-pandemic cohort (one year from 1st September 2018).

Official Title
-----------------
Bariatric Surgery Provision in Response to the COVID-19 Pandemic: Retrospective Cohort Study of a National Registry

Conditions
-----------------
COVID-19, Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Other: COVID-19 pandemic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients listed on National Bariatric Surgical Registry (NBSR) that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) or prior to the pandemic (one year from 1st September 2018) - Exclusion Criteria: - Where a variable was 'not recorded' this point was excluded from analysis. For age, gender, procedure type and provider the records were 100% complete, for BMI at time of surgery there was 5% missing data and for other variables the missing value rate was 2% or lower.
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 |
| --- | --- |
| Pre-pandemic<br>Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018). | |
| Pandemic<br>Patients that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) | Other: COVID-19 pandemic<br>* Pandemic group underwent surgery during the COVID-19 pandemic. Pre-pandemic group underwent surgery prior to the pandemic.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revisions | Number of patients undergoing revisional bariatric surgery | 1 year | 
| Private | Number of patients undergoing elective bariatric surgery in the private sector | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completed Laparoscopically | Number of cases completed laparoscopically for patients undergoing elective bariatric surgery in the NHS | 1 year | 
| Length of Stay | Length of stay for NHS patients undergoing bariatric surgery in days | 1 year | 
| Surgical Complications | Number of surgical complications in patients undergoing elective bariatric surgery in the NHS | 1 year | 
| Presence of Second Consultant | Presence of second consultant in elective bariatric cases undertaken in the NHS | 1 year |
The Impact of COVID-19 Pandemic on Thyroid Surgery in Italy: Results From a Nation-wide Multicentric Study

Study Overview
=================
Brief Summary
-----------------
Italy has been on the frontline of the COVID-19 pandemic, caused by the coronavirus SARS-CoV-2, the need to focus resources to deal with the pandemic led to a disruption of routine surgical care, as well as activity for oncologic and chronic disease. The aim of this study was to evaluate the impact of COVID-19 pandemic on surgical activity of the Italian Units of Endocrine Surgery belonging to the SIUEC (Italian Society of Endocrine Surgery), the most important national scientific society of endocrine surgery.The aim of this study was to evaluate the impact of COVID-19 pandemic on surgical activity of the Italian Units of Endocrine Surgery belonging to the SIUEC (Italian Society of Endocrine Surgery), the most important national scientific society of endocrine surgery.

Official Title
-----------------
The Impact of COVID-19 Pandemic on Thyroid Surgery in Italy: Results From a Nation-wide Multicentric Study

Conditions
-----------------
Thyroid Disease

Intervention / Treatment
-----------------
* Procedure: Thyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients that had undergone thyroidectomy during COVID-19 pandemic (from the 9th March to the 31st August 2020), defined as case group, or during the same period of the previous year (from the 9th Match to the 31st August 2019), defined as control group. Exclusion Criteria: incomplete data
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 - COVID group<br>Patients that underwent surgery during COVID-19 pandemic | Procedure: Thyroidectomy<br>* Thyroidectomy<br>|
| Group 2 - control group<br>Patients that underwent surgery during 2019 | Procedure: Thyroidectomy<br>* Thyroidectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the overall reduction of surgical activity for thyroid disease |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify if the number of thyroid cancers operated during COVID-19 pandemic was significant different from the number of patients operated during the same period of the previous year |  | 1 year | 
| Quantify the number of aggressive tumors operated during COVID-19 pandemic and the same period of the previous year | Comparison between the number of patients operated during COVID-19 pandemic with aggressive thyroid carcinoma (with lymph node metastasis, and/or extrathyroidal extension, and/or multifocality) with patients with aggressive thyroid carcinoma operated during the same period of the previous year | 1 year |
Functional and Molecular Characterisation of Oesophageal Distal Epithelium: Correlations With Acid and Non Acid Reflux

Study Overview
=================
Brief Summary
-----------------
This study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with GORD symptoms. In addition these patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and oesophageal acid perfusion test. Correlations between the characteristics of the reflux and the biological results will be calculated.

Detailed Description
-----------------
This study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with GORD symptoms. In addition these patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and oesophageal acid perfusion test. Correlations between the characteristics of the reflux and the biological results will be calculated.

Official Title
-----------------
Functional and Molecular Characterisation of Oesophageal Distal Epithelium: Correlations With Acid and Non Acid Reflux

Conditions
-----------------
Gastroesophageal Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Main inclusion criteria : Digestive symptoms suggestive of GORD (heartburn, regurgitation, epigastric pain), or dyspeptic syndrome (nausea, belch, bloating, epigastric discomfort). Need of upper GI endoscopy and pH monitoring. Normal propagation of oesophageal persitaltic waves (manometry < 6 months). Age 18 -70 yrs Signed informed consent Normal coagulation Exclusion Criteria: Barrett's oesophagus Previous oesophageal bleeding Need of NSAID treatment. Previous sus mesocolic surgery Alcool consumption > 40g/d, smoking > 10 cig/j Pregnancy or lack of contraceptive disposal, breast feeding. Allergy to Xylocaïne

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?
-----------------
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
-----------------
GORD - Oesophageal sensitivity- Oesophageal permeability
A Study of the Long-term Safety of ABT-089 for Subjects With Mild-to-moderate Alzheimer's Disease Who Participated in the M06-876 Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with mild-to-moderate Alzheimer's disease.

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: ABT-089


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject was randomized into Study M06-876 and completed the study. The subject must remain on the same dose of AChEI that was used during the M06-876 study. The subject is in general good health, as judged by the investigator Exclusion Criteria: The subject is currently, or plans to participate in another experimental study during the course of this trial. The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ABT-089<br>* 20 mg ABT-089 taken once-daily for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations) |  | Month 1, 2, 4, 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-Cog, CIBIC-plus, MMSE, QoL-AD |  | Month 1, 2, 4, 6 |