linjc16/ctgov huggingface dataset:
Study on the Efficacy Mechanism of Natural Psychotherapy for Neurosis

Study Overview
=================
Brief Summary
-----------------
We explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder

Official Title
-----------------
Research on the Efficacy Mechanism of Natural Psychotherapy for Neurosis

Conditions
-----------------
Obsessive-Compulsive Disorder

Intervention / Treatment
-----------------
* Behavioral: Natural Psychotherapy
* Behavioral: Mental Health Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of obsessive-compulsive disorder or compulsive behavior Duration of symptoms for not less than 12 months Age 15-50 years old. You can participate in the whole experiment and offline assessment in Beijing Exclusion Criteria: Documented disease of physical diseases including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure, epilepsy, history of brain trauma Subjects who suffered from alcohol or illegal drug abuse/dependence

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Natural Psychotherapy<br>Intervention using natural psychotherapy for OCD patients for two to three hours once a week for eight weeks | Behavioral: Natural Psychotherapy<br>* Natural psychotherapy is based on Morita therapy and is a psychotherapy that fully reflects the characteristics of Chinese culture, taking into account the Chinese cultural background and actual clinical characteristics.<br>|
| Placebo Comparator: Mental Health Education<br>Mental health education was given to another group of OCD patients for two hours once a week for eight weeks | Behavioral: Mental Health Education<br>* Mental Health Education Seminar<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptoms | Obsessive-compulsive symptoms were assessed according to the Obsessive-Compulsive Scale | 12 weeks | 
| Cognitive function | Cognitive function as assessed by RBANS | 12 weeks | 
| Prospective memory | Whether the patient's prospective memory is effectively improved using EEG and NMR | 12 weeks | 
| Mood and behavior | Mood changes judged using gait and face recognition | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obsessive-compulsive disorder, natural psychotherapy
Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture.

Official Title
-----------------
Prospective, Multicentric, Observational Cohort Study for the Evaluation of Implant Survival in Patients With a Metal-on-Metal Pinnacle(R) Ultamet(TM) Device in Conventional Total Hip Joint Replacement.

Conditions
-----------------
Arthropathy of Hip

Intervention / Treatment
-----------------
* Device: Total Hip arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients susceptible to receive a PINNACLE® ULTAMET™ implant as per routine practice Exclusion Criteria: Patient refusal to participate to the data collection Pregnant woman Patients age is less than 18 years old The planned intervention is a revision of a previous intervention on the studied hip joint Previous metal implant, except for pure titanium or titanium alloys Exposure to cobalt and chromium that could influence serum metal ions levels Planned bilateral intervention Patient residing outside France Patient not implanted with a Pinnacle(R) ULTAMET(TM)

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 |
| --- | --- |
| Hip arthroplasty<br>Patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease or true femoral cervical fracture. | Device: Total Hip arthroplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival Rate | Implant Survival Rate as the duration of PINNACLE® ULTAMET™ implantation for the follow-up duration, free of revision surgery, whatever the cause. | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | Measure of hip function using the Harris Hip Score | pre-operative, 1, 2, 3, 5 years |
Bariatric Surgery and Pharmacokinetics of Lisdexamphetamine

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on lisdexamphetamine are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics Lisdexamphetamine: BAR-MEDS Lisdexamphetamine

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Lisdexamfetamine Dimesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lisdexamfetamine Dimesylate|Patients are tested for their normal prescription lisdexamphetamine medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lisdexamphetamine concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Lisdexamfetamine Dimesylate
Letrozole as a Treatment of Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
Some cases of endometrial cancer are dependent on estrogen for their growth. Letrozole blocks estrogen production in the body. The purpose of this study is to determine if the investigators can predict which patients might benefit from Letrozole treatment by studying the many different forms of the estrogen receptor molecule that exist within the cancer tissues. To participate in this study, the patients must be 40 years of age or older and have biopsy-proven endometrial carcinoma, either well differentiated or moderately differentiated forms. Also, to be eligible to participate in this study, the patients need to be healthy enough to have a hysterectomy. If the patients are less than age 60, they will need a blood test (FSH) to confirm that they have gone into menopause.

Official Title
-----------------
Predicting Aromatase Inhibitor Responsiveness in Endometrial Carcinoma

Conditions
-----------------
Endometrial Carcinoma

Intervention / Treatment
-----------------
* Drug: Letrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FIGO grade 1 or 2 endometrioid adenocarcinoma of the endometrium Post menopausal status must be demonstrated Signed informed consent Exclusion Criteria: FIGO grade 3 endometrioid adenocarcinoma or non-endometrioid cancers of the endometrium Younger than 40 or postmenopausal status not established Pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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: Letrozole<br>letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy. | Drug: Letrozole<br>* 2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks<br>* Other names: CAS number 112809-51-5;|
| No Intervention: control<br>no treatemtn prior to hysterectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer | Changes in %Ki67 staining cells by immunoperoxidase of paraffin embedded, formalin fixed tissue | At time of consent and after hysterectomy (generally about 3 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial Cancer, Endometrial Carcinoma, Aromatase Inhibitor, Letrozole, Femara
T-Cell Vaccination in Multiple Sclerosis (MS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of T-cell vaccination in MS patients.

Detailed Description
-----------------
Immunization of MS patients with irradiated autologous encephalitogenic myelin peptides (EMP) specific T-cell lines or clones. Clinical immunologic and neuroradiologic evaluation.

Official Title
-----------------
The Effect of T-Cell Vaccination in Multiple Sclerosis - Phase I/II Safety and Efficacy Trial

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Biological: T-Cell Vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Definite MS (post criteria) Relapsing remitting or primary progressive clinical course. At least one relapse in the last two years. Disease duration > 1 year Expanded Disability Status Scale (EDSS) between 0-6 Brain magnetic resonance imaging (MRI) compatible with MS Not involved in any other clinical trials No other systemic disease Exclusion Criteria: Does not comply with the above

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: T-Cell Vaccination|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety assessment of T-cell vaccination in nonresponding MS patients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T cell
Pre-operative Evaluation of Kidney & Pancreas Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Examine the clinical utility of the dobutamine stress contrast echoes and angiograms obtained routinely in the evaluation of patients prior to kidney or pancreas transplantation.

Detailed Description
-----------------
Although there is an increasing quantity of data demonstrating the value of stress echo in risk stratifying patients for cardiac risk prior to major non-cardiac surgery, the current clinical practice utilized for assessing patients being evaluated for kidney or pancreas transplantation is both a stress echocardiogram and a coronary angiogram. This gap in opinion appears to be a concern on the part of both nephrologists, endocrinologists, and surgeons that the stress echocardiogram may miss significant angiographic disease that could result in major post-operative complications in this high-risk subgroup of patients (unstable angina, non-fatal infarction, or death).

Official Title
-----------------
The Analysis of Data Collected During Angiography and Dobutamine Stress Contrast Echocardiograms in the Pre-Evaluation of Kidney and Pancreas Transplant Patients

Conditions
-----------------
Kidney Transplantation, Pancreas Transplantation

Intervention / Treatment
-----------------
* Procedure: Dobutamine Stress Echocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are being evaluated for a kidney and or pancreas transplant and scheduled for a dobutamine stress echocardiogram and a coronary angiogram will be eligible to participate Exclusion Criteria: Patients with unstable angina at the time of their evaluation, or who have a severe underlying cardiomyopathy or valve disease will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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: Arm 1<br>stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition | Procedure: Dobutamine Stress Echocardiogram<br>* stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition<br>* Other names: Optison;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provide a higher sensitivity required to adequately assess risks in the pancreas/ kidney transplant evaluation |  | I year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eliminate the need for costly and invasive additional procedures |  | 1 year |
Are Comorbidities Related to Frequent Severe Exacerbations of AECOPD

Study Overview
=================
Brief Summary
-----------------
INTRODUCTION: Relationship between comorbidities and COPD is two-sided. While the number of comorbidities increasing, the frequency of acute exacerbations of COPD (AECOPD) is increasing, too. Comorbidity indexes can be used for recognition of comorbidities while managing COPD patients. In the present study, it is aimed to compare comorbidity indexes such as Charlson Comorbidity Index, COMCOLD and COTE in the matter of exacerbation frequency. METHOD: Subjects hospitalized for AECOPD, admitted to the study. Exacerbation severity, frequency, further exacerbations for a 1-year period in the follow-up period and CCI, COMCOLD and COTE scores were recorded. High and low comorbidity groups were compared for AECOPD frequency, severity, and further exacerbations.

Official Title
-----------------
Are Comorbidities Related to Frequent Severe Exacerbations of AECOPD

Conditions
-----------------
Chronic Obstructive Lung Disease, Acute Exacerbation of COPD, Comorbidities and Coexisting Conditions

Intervention / Treatment
-----------------
* Other: Frequency of AECOPD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients Admitted to the ward for AECOPD Exclusion Criteria: Not giving informed consent Unable to perform PFT Lost to follow-up

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High comorbidity group<br>CCI equal or higher than 2 COTE equal or higher than 4 COMCOLD equal or higher than 4 | Other: Frequency of AECOPD<br>* No intervention has been applied. 92 COPD patients divided into 2 groups according to their comorbidity level. Than these groups were compared for their AECOPD frequency<br>|
| Low comorbidity group<br>CCI lower than 2 COTE lower than 4 COMCOLD lower than 4 | Other: Frequency of AECOPD<br>* No intervention has been applied. 92 COPD patients divided into 2 groups according to their comorbidity level. Than these groups were compared for their AECOPD frequency<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of AECOPD | Frequency of AECOPD in the last one year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Having at least one severe AECOPD | having at least one severe AECOPD in the last year | 1 year | 
| Frequency of AECOPD for the next one year | the number of AECOPD for 1 year period from the preceding admission, regardless of severity | 1 year |
Study of Oral Papillomavirus In Teens and Twenties

Study Overview
=================
Brief Summary
-----------------
Recently human papillomavirus (HPV) has been recognized to cause some oropharyngeal (tonsil) cancer. But very little is known about oral HPV infection and risk factors. This study will evaluate how common oral HPV infection is, what sexual behaviors are associated with risk for infection, and how long infections tend to last.

Detailed Description
-----------------
18-25 year old individuals are being recruited from STD clinics in Baltimore County and followed every three months for this study.

Official Title
-----------------
Short-term Natural History of Oral HPV Infection Among Young Adults

Conditions
-----------------
STD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 -26 years Exclusion Criteria: Never received HPV vaccine (Gardasil or Cervarix)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 26 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral HPV infection | Oral rinse samples collected prospectively for 24 months | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV, oral cancer, young adults
The Pediatric Spine Foundation

Study Overview
=================
Brief Summary
-----------------
The Pediatric Spine Foundation is a registry designed to assist spine surgeons to efficiently identify and track patients with chest wall and spinal disorders.

Detailed Description
-----------------
The Pediatric Spine Foundation is a registry designed to assist spine surgeons to efficiently identify and track patients with chest wall and spinal disorders. The registry allows spine surgeons to participate in retrospective and prospective studies for specific spinal disorders.

Official Title
-----------------
The Pediatric Spine Foundation

Conditions
-----------------
Chest Wall and Spinal Disorders

Intervention / Treatment
-----------------
* Other: Standard of Care - Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients 17 and under that are being treated at Children's Hospital Colorado Orthopaedic department for a chest wall deformity, spine deformity and/or spinal disorder. However, patients must be/have been 11 or under at their initial treatment/evaluation at Children's Hospital Colorado to be included in this study. Exclusion Criteria: Enrollment in another spine registry

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- |
| All patients 17 years or younger<br>Standard of Care - Registry. Must have been 11 yrs or under at initial treatment/evaluation. | Other: Standard of Care - Registry<br>* Standard of Care - Registry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and radiographic measures for children with chest wall deformity, spine deformity and/or spinal disorder. | The registry records data from clinical and surgical visits - evaluation date, demographics, cobb angle, kyphosis, ambulatory status, ECG and ECHO measurements, lab results (HbG, Serum CO2, Albumin, Prealbumin), X-rays, pulmonary function test and O2 saturation, primary diagnosis, comorbidities, prior and current treatment, surgical info (days in ICU, blood loss, type of procedure, position of device, fusion details), and complication details. An Early Onset Scoliosis 24-Item Questionnaire is also administered each visit. Questions pertain to general health, pain/discomfort, pulmonary function, transfer, physical function, daily living, energy level, emotion, parental impact, financial impact, and satisfaction. For each category there are 1-3 questions where parents can circle one of the five answer choices that vary in severity grade. The primary outcome would be to complete numerous small retrospective cohort studies using the data collected prospectively from the registry. | Approximately 10 years, recording each clinical and/or surgical visit the patient encounters at Children's Hospital Colorado. |