linjc16/ctgov huggingface dataset:
Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

Study Overview
=================
Brief Summary
-----------------
This trial was conducted in Asia. The aim of this trial was to investigate the pharmacokinetic properties (the effect of the investigated drug on the body) of NN1250 (insulin degludec) in healthy Chinese subjects.

Official Title
-----------------
A Trial Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: insulin degludec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Chinese subject aged 18-45 years (both inclusive) Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator Body mass index 19.0-24.0 kg/m^2 (both inclusive) Exclusion Criteria: A history of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial product to the subject Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening Not able or willing to refrain from smoking during the inpatient period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDeg<br> | Drug: insulin degludec<br>* For each subject, a single dose of NN1250 will be administered subcutaneously (under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin degludec concentration-time curve |  | From 0 to 120 hours after single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum insulin degludec concentration |  | 0-24 hours (derived on treatment day 1). | 
| Time to maximum observed serum insulin degludec concentration |  | 0-24 hours (derived on treatment day 1). |
Locked-in Syndrome Caused by Pulmonary Arteriovenous Malformation: A Case Report

Study Overview
=================
Brief Summary
-----------------
In this case, we report a case of atresia syndrome (LIS), a serious neurological disease caused by pulmonary arteriovenous fistula (PAVM). We present a previously healthy middle-aged woman who developed atresia syndrome after severe pontine infarction due to basilar artery occlusion due to undiagnosed arteriovenous malformation. This report reviewed the medical history, post-admission examination and related literature, and concluded that PAVM should be considered as the cause of implicit stroke, especially in young patients with right-to-left shunt, and should be actively treated.

Official Title
-----------------
Locked-in Syndrome Caused by Pulmonary Arteriovenous Malformation: A Case Report

Conditions
-----------------
Locked-In Syndrome；Pulmonary Arteriovenous Malformation

Intervention / Treatment
-----------------
* Other: In this study, only cases were collected and reported without any intervention or adverse reactions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A case of Locked-in syndrome due to pulmonary arteriovenous malformation Exclusion Criteria: Patients or family members objected to the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: In this study, only cases were collected and reported without any intervention or adverse reactions|In this study, only cases were collected and reported without any intervention or adverse reactions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locked-in syndrome caused by pulmonary arteriovenous malformation . Check list report | A recommendation is made for the treatment and prognosis of patients with severe atresia caused by arteriovenous fistula. | 1month |
Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

Study Overview
=================
Brief Summary
-----------------
This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.

Detailed Description
-----------------
The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.

Official Title
-----------------
Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis, Arthritis, Avascular Necrosis, Acute Fracture

Intervention / Treatment
-----------------
* Device: Acetabular cup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary hip replacement Sufficient bone stock to support implant Signed Informed Patient Consent form Exclusion Criteria: Prior renal transplant History of active joint sepsis Recent high dose of corticosteroids Primary or secondary carcinoma in the last 5 years Neurological disease Psychosocial disease that would limit rehabilitation Use of structural bone graft Simultaneous participation in another hip study
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Acetabular cup replacement with total hip arthroplasty | Device: Acetabular cup<br>* Acetabular cup replacement<br>* Other names: Pinnacle™ Cup;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score |  | Pre-operative, 6 month and 1, 2, 3, 4, and 5 years. | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |  | Pre-operative, 6 month and 1, 2, 3, 4 and 5 years. | 
| Short Form-36 (SF-36) |  | Pre-operative, 6 month and 1, 2, 3, 4 and 5 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Hip Replacement, post-traumatic arthritis
Sperm Parameters and Sexual Quality of Life

Study Overview
=================
Brief Summary
-----------------
Infertility has important repercussions for couples in their emotional and sexual lives; the same is true of Assisted Procreation, which has an impact on the daily life of couples and a cost to society. Thus, fertility disorders are frequently associated with sexual dysfunction in both women and men (Khademi et al., 2008). In couples with male infertility, men have higher sexual dysfunction scores than couples with infertility without male aetiology (Smith et al., 2009). To study the evolution of the sexual quality of life of infertile men before and after knowing their spermatic parameters

Official Title
-----------------
Sperm Parameters and Sexual Quality of Life

Conditions
-----------------
Men Infertility

Intervention / Treatment
-----------------
* Behavioral: Quality of life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patient presenting infertility status Exclusion Criteria: none

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Quality of life|Assessment of quality of life through measuring scales|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability of quality of life scoring with Male Sexual Health scale |  | 12 months |
Tamoxifen Pharmacogenetics and Clinical Effects

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to try to identify which women who take tamoxifen are likely to suffer from hot flashes or are more likely to have other side effects or benefits from the drug. The researchers will do so by determining whether there are mutations that normally occur in human DNA that might influence the way individuals respond to medications.

Detailed Description
-----------------
The study will test the following hypotheses. There is a relationship between genetically distinct metabolic profiles of tamoxifen and the frequency and severity of hot flashes in women on chronic tamoxifen therapy. Genetically distinct metabolic profiles for tamoxifen effect lipid profile, bone turnover metabolites and bone mineral density, and coagulation factors. Different genetic profiles of estrogen responsive genes influence the pharmacodynamic effects of tamoxifen in cardiovascular system.

Official Title
-----------------
A Pilot Trial Correlating Metabolic Profile of Tamoxifen With Pharmacogenetic Predictors and Clinical Effects

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

Intervention / Treatment
-----------------
* Drug: Tamoxifen (pharmacodynamic analysis)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-years or older Women with a prior breast cancer or who are at a high risk for developing the disease and about to start tamoxifen therapy. Participants must not be treated with concomitant chemotherapy or hormone therapy other than tamoxifen. They must not have ovarian ablation or currently being treated with radiation therapy and/or chronic corticosteroids. The participant must not be taking anti-hot flash therapy (clonidine, bellergal, megestrol acetate). Vitamin E, selective serotonin reuptake inhibitors, or herbal remedies are allowed provided that the participant has been taking the remedy for at least 4 weeks and intends to continue the remedy for at least the first month while on the study, and allows for one-month follow up evaluation (hot flash diaries and blood samples). The participant must not be pregnant or lactating. The participant is able and willing to sign an informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tamoxifen (pharmacodynamic analysis)|Tamoxifen 20mg po daily|

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
-----------------
Breast Cancer, Tamoxifen, Prevention
Healthy Volunteer Study of Sildenafil Effects Upon Vision

Study Overview
=================
Brief Summary
-----------------
Patients sometimes report subjective visual effects when taking sildenafil. Our study set out to measure these in a controlled setting. Subjects were asked to detect patterns presented on a monitor screen.

Official Title
-----------------
A Double-Blind, Randomised, Placebo Controlled Healthy Volunteer Study to Investigate the Nature and Origin of the Disturbance of Vision Induced by Single Oral Doses of Sildenafil

Conditions
-----------------
Blindness

Intervention / Treatment
-----------------
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male - Exclusion Criteria: -

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

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Fontan Imaging Biomarkers (FIB) Study

Study Overview
=================
Brief Summary
-----------------
The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.

Detailed Description
-----------------
This study has the following research questions: What is the reproducibility of ventricular systolic function measurements (including ventricular strain) in Fontan patients using echocardiography (Echo) and cardiac magnetic resonance imaging (CMR)? What is the reproducibility of ventricular diastolic function measurements (including tissue Doppler and strain rate) in Fontan patients using Echo and CMR? Is there a correlation between ventricular function measurements and circulating biomarkers (including galectin-3 levels, NT-proBNP, ST2, and MELD-XI score)?

Official Title
-----------------
Cross-sectional Analysis of Non-invasive Measures of Ventricular Systolic and Diastolic Function and Biomarkers in the Fontan Circulation

Conditions
-----------------
Single-ventricle, Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with Fontan circulation undergoing clinically indicated CMR at Boston Children's Hospital will be considered for the study Exclusion Criteria: Inadequate imaging quality to perform proposed analysis Patients <15 kg will be excluded to simplify compliance with BCH minimal risk research blood draw volume guidelines (minimal risk is defined as < 5% total blood volume)

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- | --- |
| Biomarkers | Correlation of biomarkers and imaging parameters of ventricular mechanics | Through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic function | Reproducibility of parameters of systolic function | Through study completion, an average of 3 years | 
| Systolic function | Reproducibility of parameters of systolic function | Through study completion, an average of 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarkers, Fontan operation, Single ventricle, congenital heart disease
Lung Perfusion With Oxygenated Blood During Aortic Clamping

Study Overview
=================
Brief Summary
-----------------
Pulmonary dysfunction presumably linked to an inflammatory response is frequent after cardiac operations using cardiopulmonary bypass (CPB) and pulmonary hypoperfusion. Aim of the study: To evaluate the protective effect of continuous pulmonary perfusion with oxygenated blood during aortic crossclamping on the inflammatory response.

Official Title
-----------------
Lung Perfusion With Oxygenated Blood During Aortic Clamping

Conditions
-----------------
Postoperative Pulmonary Dysfunction

Intervention / Treatment
-----------------
* Procedure: lung perfusion
* Procedure: no lung perfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 ys Cardiopulmonary bypass procedure FEV1 <80% COPD >II Exclusion Criteria: Emergency cases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Lung perfusion<br> | Procedure: lung perfusion<br>* see literature of proceeding<br>|
| Active Comparator: no lung perfusion<br> | Procedure: no lung perfusion<br>* see literature of proceeding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory marker |  | 5 days |
Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
Can genetic markers be used to predict anti-TNF response? A cohort was established to identify SNPs associated with anti-TNF therapy in patients with inflammatory bowel disease.

Official Title
-----------------
Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice

Conditions
-----------------
Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Biological: infliximab and adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CD or UC, treated with anti-TNF Exclusion Criteria: Missing data

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 |
| --- |
|Biological: infliximab and adalimumab|In this retrospective, observational study, no interventions were undertaken by the researchers.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-step scale | Best response within 22 weeks | 22 weeks |
Quality of Life Impact of Chronic Rhinitis Treatment With Aerin Medical Device

Study Overview
=================
Brief Summary
-----------------
Evaluation of long-term (2-year) quality of life and symptoms after chronic rhinitis treatment with the Aerin InSeca/RhinAer Stylus

Detailed Description
-----------------
This is a prospective, non-randomized, multicenter follow-up study to collect long-term data on a cohort of patients who participated in the Aerin Medical TP668 study, Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis. The study will be conducted in a maximum of 5 centers that participated and enrolled patients in the TP668 study.

Official Title
-----------------
A Prospective, Multi-center, Non-Randomized Study to Evaluate the Quality of Life Impact and Symptoms After Treatment Using Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis

Conditions
-----------------
Chronic Rhinitis

Intervention / Treatment
-----------------
* Device: Radiofrequency Stylus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received treatment for chronic rhinitis in Aerin Study TP668 Exclusion Criteria: Unwilling to participate in this long-term study

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 99 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 |
| --- | --- |
| Long-Term Study Subjects<br>All subjects who were treated with the Aerin Medical InSeca/RhinAer Stylus in the 50-subject TP668 interventional study, who consent to continue to provide quality of life data. | Device: Radiofrequency Stylus<br>* Low power radiofrequency energy delivered to the posterior nasal nerve area<br>* Other names: RhinAer Stylus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline rTNSS | Mean change in reflective Total Nasal Symptom Score (rTNSS) from baseline. The TNSS is an instrument used to collect patient self-rated severity of rhinorrhea, nasal congestion, nasal itching and sneezing. In this study, a reflective score will be collected, in which the subject will be asked to evaluate symptom severity over the preceding 12 hours. Symptom severity is rated on a 4-point scale of 0 (absent symptoms), 1 (mild symptoms), 2 (moderate symptoms, or 3 (severe symptoms), with the total score therefore ranging from 0 to 12. A negative change reported for the change from baseline indicates an improved outcome. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic rhinitis, Posterior nasal nerve, Quality of life
Effects of Heat and Moisture Exchanger in Combination With Air Forced Warming Blankets or Warming Intravenous Solutions on Intraoperative Hypothermia Prevention in Obese and Non Obese Patients During Intravenous Anesthesia

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to evaluate if the combination of heat and moisture exchanger with air forced warming blankets or warming intravenous fluids prevents intraoperative hypothermia in obese and non obese women under target controlled infusion-total intravenous anaesthesia (TCI-TIVA) during lower abdominal surgery.

Conditions
-----------------
Hypothermia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women 18-65 years old gynecologic obesity Exclusion Criteria: fever endocrine disease hypertension vasoactive drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non obese/ Warming blankets<br> | |
| Non obese/ Warming intravenous fluids<br> | |
| Obese/ Warming intravenous fluids<br> | |
| Obese/ Warming blankets<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
-----------------
Hypothermia, Obesity, Heat and moisture exchanger, Warming blanket, Warming fluids, Gynecological surgery, Intravenous anesthesia, Obese patients, Non obese patients