linjc16/ctgov huggingface dataset:
Lifetime Incidence and Socio-economic Implications of Mental Illness

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to estimate the lifetime incidence of any mental disorder in a nationwide population-based register linkage study for the Danish population and to estimate the influence on socio-economic functioning.

Detailed Description
-----------------
The purpose of the present study is to estimate the lifetime incidence of any mental disorder in a nationwide population-based register linkage study for the Danish population in total and according to gender and to estimate the influence on socio-economic functioning. The investigaters hypothesised that the lifetime incidence of any mental disorder is substantially higher than hitherto believed.

Official Title
-----------------
Lifetime Incidence and Socio-economic Implications of Mental Illness - a Nationwide Population-based Cohort Study

Conditions
-----------------
Mental Illness

Intervention / Treatment
-----------------
* Other: Not relevant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study was based on a randomly selected 1,500,000 sample of all persons who were registered in Statistics Denmark on the 1st of January 1995. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 110 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with mental illness according to Danish health registers | Other: Not relevant<br>* This is a non-intervention cohort study<br>|
| Control individuals from the general population<br>Control individuals from the general population matched according to the data of diagnosis/ psychotropic medication, year of birth, sex and calendar year. | Other: Not relevant<br>* This is a non-intervention cohort study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any psychiatric disorder or any psychotropic medication according to data in Danish nationwide registers | Cumulative incidens of any psychiatric disorder or psychotropic medication for any mental illness except sleep disorders, dementia and nicotine dependence in total and according to sex | January 1, 1995 to December 31, 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of any psychiatric disorder according to data in Danish nationwide registers | Cumulative incidence of a diagnosis of any psychiatric disorder in total and according to sex | January 1, 1995 to December 31, 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mental Illness
A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
This an initial proof of concept, phase to study to assess the safety and efficacy of tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease

Official Title
-----------------
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults Diagnosed With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: tofimilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate-severe COPD (GOLD 2003 definition) Smoking history of at least 10 pack-years Exclusion Criteria: Any significant co-morbid disease, particularly cardiovascular Use of any maintenance therapy except short acting bronchodilators

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in FEV1 compared to placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo |  |  |
Objective Systolic Function Recuperation Assessed by Echocardiography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate left ventricular systolic ejection fraction and anterior or apical akinesis 1 month and 3 months after a myocardial infarction treated with primary PCI to determine whether improvement at 1 month differs from improvement at 3 months.

Official Title
-----------------
Objective Systolic Function Recuperation Assessed by Echocardiography

Conditions
-----------------
Myocardial Infarction, Left Ventricular Systolic Dysfunction, Anterior Akinesis, Apical Akinesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years old ST elevation myocardial infarction treated with primary PCI Anterior or apical akinesis and left ventricular ejection fraction ≤ 45% on early echocardiography (48hours - 7 days post myocardial infarction) Initial ECG showing at least 1 mm ST elevation in 2 leads corresponding to the same vascular territory Exclusion Criteria: Known left ventricular systolic dysfunction before myocardial infarction Left bundle branch block Vital prognosis less than 6 months Cardiogenic shock Rescue PCI Sub-optimal echocardiographic imaging (contrast use is allowed) Significant valvular heart disease (moderate or severe) Surgical revascularization Pregnancy or breastfeeding Incapacity to provide informed consent

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 |
| --- | --- |
| Echocardiography 1 month<br>Patients will all have an echocardiography 1 month post myocardial infarction and 3 months post myocardial infarction | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction recuperation 1 month post myocardial infarction | Left ventricular ejection fraction recuperation 1 month post myocardial infarction as compared with the left ejection fraction 3 months post myocardial infarction | 1 month post myocardial infarction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior and apical akinesis recuperation 1 month post myocardial infarction | Anterior and apical akinesis recuperation 1 month post myocardial infarction as compared with 3 months post myocardial infarction | 1 month post myocardial infarction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
echocardiography, ST elevation myocardial infarction, Heart failure, Coronary artery disease, Cardiovascular diseases
Intervention for Pre-Frailty and Frailty in Thoracic Surgery Patients

Study Overview
=================
Brief Summary
-----------------
Frailty has been associated with poor acute and long-term outcomes after major surgery. We recently determined that nearly 70% of patients undergoing major thoracic surgery are pre-frail or frail. We are interested in assessing whether a strength training intervention for frail or pre-frail patients has an impact on surgical decision making and on surgical outcomes.

Official Title
-----------------
Intervention for Pre-Frailty and Frailty in Thoracic Surgery Patients

Conditions
-----------------
Frailty

Intervention / Treatment
-----------------
* Other: Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Age ≥60 years, • Qualified to consent for participation in a research study, •Thoracic disease that may require major surgery (major anatomic lung resection, esophagectomy, repair of giant paraesophageal hernia, chest wall resection, extended pleurectomy/decortication, thymectomy or major surgery for other mediastinal process),• No obvious contraindications to surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would prevent surgery), • Ability to participate in physical therapy and an independent exercise program for frailty mitigation, •No need for induction chemotherapy or radiation therapy, • Recent evaluation including computed tomography of the chest or chest/abdomen. Exclusion Criteria:• Age <60 years, •Unable to provide informed consent, • No indication for major thoracic surgery, •Obvious contraindication to major thoracic surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would preclude surgery),• Inability to participate in physical therapy and/or an independent home exercise for frailty mitigation, •Need for induction chemotherapy or radiation therapy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Therapy<br>Patients will be receiving 6 weeks of an exercise program. | Other: Physical Therapy<br>* 6 weeks of an exercise program.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the degree of frailty after strength training |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in surgeon risk assessment after strength training |  | 18 months |
Cavity Evaluation Before Intracytoplasmic Sperm Injection

Study Overview
=================
Brief Summary
-----------------
Uterine cavity evaluation is an integral part of assessment Of women for ICSI

Detailed Description
-----------------
Transvaginal us is the main role in this aspect

Official Title
-----------------
Cavity Evaluation Before Intracytoplasmic Sperm Injection in Women With Infertility

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with infertility more than one year Exclusion Criteria: 2omen with medical disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal uterine cavity<br> | Diagnostic Test: ultrasound<br>* Transvaginal us to assess the cavity<br>|
| abnormal uterine cavity<br> | Diagnostic Test: ultrasound<br>* Transvaginal us to assess the cavity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women who will has positive pregnancy test | The women who will got pregnant | within a year |
Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in patients with locally advanced HNSCC. The hypothesis is that the response would be increased with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.

Detailed Description
-----------------
Induction chemotherapy followed by radiotherapy is the standard treatment for patients with unresectable HNSCC. However, the role of induction chemotherapy remains uncertain for resectable disease. Therefore, we plan to perform a phase II study to evaluate it, focusing on radiographic and pathologic response after induction chemotherapy. Moreover, a new EGFR monoclonal antibody (nimotuzumab) is incorporated with PF regimen. The hypothesis is the addition of nimotuzumab would improve the response without remarkably increase the toxicity.

Official Title
-----------------
Phase II Study of Nimotuzumab Plus PF as Induction Chemotherapy in Patients With Locally Advanced HNSCC

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

Intervention / Treatment
-----------------
* Drug: nimotuzumab
* Drug: PF regimen (cisplatin and 5-FU)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range 18-70 years old ECOG performance status 0-1 Histologically confirmed and potentially resectable locally advanced (T2-4, N0-3, M0) HNSCC Adequate organ function Exclusion Criteria: History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Pregnant or lactating women Serious uncontrolled diseases and intercurrent infection Previous serious cardiac disease

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nimotuzumab<br>nimotuzumab plus PF regimen | Drug: nimotuzumab<br>* nimotuzumab 400 mg d1<br>* Other names: h-R3;Drug: PF regimen (cisplatin and 5-FU)<br>* cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5<br>* Other names: PF;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathologic complete response |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HNSCC, induction chemotherapy, nimotuzumab
Newborns From Patients Treated With ART (Assisted Reproductive Technology)

Study Overview
=================
Brief Summary
-----------------
The Prospective Cohort Study for Newborns from patients treated with ART was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.

Detailed Description
-----------------
Since the last twenty years, thousands of babies were born from infertile couples treated in our center. However, the short, and especially the long term prognosis of these children were barely known. Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. In addition, information of each newborn from our center has also been kept in CCRM/EMRCD. The current project plans to recruit these newborn babies in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for Newborns from patients treated with ART prognosis.

Official Title
-----------------
Prospective Cohort Study for Newborns From Patients Treated With ART in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)

Conditions
-----------------
Health Related

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All newborns from patients treated with ART in our center. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 40 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 |
| --- | --- | --- |
| Birth weight | Weight of newborns recorded in Kilogram | At delivery | 
| Number of newborns with Congenital malformations | Any newborns with Congenital malformations will be recorded | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height development of newborns | Record the height changes (in centimeters) | at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years |
A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. This study will also evaluate the safety and tolerability of CP-690,550.

Official Title
-----------------
A Phase 1, Non-Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function

Conditions
-----------------
Hepatic Insufficiency

Intervention / Treatment
-----------------
* Drug: CP-690,550
* Drug: CP-690,550
* Drug: CP-690,550


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers who have normal liver function, and subjects who have either mild or moderate liver impairment. Exclusion Criteria: Subjects with severe liver impairment Subjects who have weakened immune systems

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal hepatic function<br> | Drug: CP-690,550<br>* Single 10 mg dose of CP-690,550<br>|
| Experimental: Mild hepatic impairment<br> | Drug: CP-690,550<br>* Single 10 mg dose of CP-690,550<br>|
| Experimental: Moderate hepatic impairment<br> | Drug: CP-690,550<br>* Single 10 mg dose of CP-690,550<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function |  | 10-14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatic impairment
Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the effect of the formation of social networks using smartphones can help increase physical activity and reduce stress in survivors after breast cancer treatment surgery.

Official Title
-----------------
Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology

Conditions
-----------------
Breast Cancer, Mobile Community

Intervention / Treatment
-----------------
* Device: Mobile community
* Other: No Mobile community


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage 0-III breast cancer ECOG Performance Status 0 Patient who underwent surgery for breast cancer Patients with their own smartphones and who can use smartphone apps Exclusion Criteria: Breast cancer recurrence or metastasis Severe medical illness need to Adjubant Chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile community group<br>join the mobile community via the smartphone application | Device: Mobile community<br>* Install an application (app) on subjects' smartphone. Subject's will join the mobile community using the application through which they can check their own and other members daily steps and communicate with each other.<br>|
| Active Comparator: No community group<br> | Other: No Mobile community<br>* No Mobile community<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of moderate to severe distress at 6 months | Using distress thermometer collected by smartphone application based questionnaire | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total weekly steps at 6 months | the total number of weekly steps collected by smartphone application | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer survivors, mobile community, distress