linjc16/ctgov huggingface dataset:
Chronic Pain and Opioid Dependence Assessment and Treatment

Study Overview
=================
Brief Summary
-----------------
This study involves the development of an integrated psychotherapy that addresses both chronic pain and opioid dependence(POD).

Detailed Description
-----------------
To conduct a pre-pilot study with 20 POD patients to a) evaluate the acceptability and potential efficacy of specific sessions (i.e., reduced illicit opioid use as assessed by urine toxicology and self-report findings, and decreased pain as evidenced by attenuated pain intensity and pain interference on self-report measures from baseline throughout treatment) for inclusion in integrated Cognitive Behavioral Therapy (CBT) for POD and the sequence of sessions, b) assess patients' satisfaction with integrated CBT as evidenced by qualitative feedback from individual exit interviews, and c) develop and modify initial therapist training and process rating measures. Products will include a) a manual for integrated CBT for POD to be used in opioid treatment programs and primary care settings with POD patients, b) therapist training materials, and c) process rating instruments.

Official Title
-----------------
Chronic Pain and Opioid Dependence Assessment and Treatment

Conditions
-----------------
Chronic Pain, Opioid Dependency

Intervention / Treatment
-----------------
* Behavioral: Integrated Cognitive Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years of age currently in Methadone Maintenance Treatment (MMT) at the APT Foundation in New Haven, CT opioid dependence experience moderate to severe chronic pain Exclusion Criteria: current suicide or homicide risk are unable to complete the informed consent or surveys because of psychiatric impairment have cognitive impairment are unable to read or understand English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Other: 1<br>Integrated Cognitive Behavioral Therapy for pain reduction and opioid dependence. | Behavioral: Integrated Cognitive Behavioral Therapy<br>* CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced illicit opioid use and pain |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic pain, opioid dependence, Cognitive Behavioral Therapy (CBT)
Clinical Research of 18F-Alfatide Ⅱ PET/CT in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
18F-Alfatide Ⅱ PET/CT in breast cancer patients

Detailed Description
-----------------
The investigators aim to assess the clinical application of 18F-Alfatide Ⅱ PET/CT in the diagnosis and treatment response monitoring of breast cancer.

Official Title
-----------------
18F-Alfatide Ⅱ PET/CT in the Diagnosis and Treatment Response Evaluation of Breast Cancer Patients

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

Intervention / Treatment
-----------------
* Drug: 18F-Alfatide Ⅱ PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients have been suspected or diagnosed with breast cancer and they have not received any treatment; It must fulfill the ethical requirements and subjects have signed an informed consent. Exclusion Criteria: Pregnancy or nursing mothers; Those patients accompanied by other serious diseases such as cardiac functional insufficiency, hepatic and renal function insufficiency.

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: breast cancer<br>Perform 18F-Alfatide Ⅱ PET/CT in breast cancer patients | Drug: 18F-Alfatide Ⅱ PET/CT<br>* Inject 18F-Alfatide Ⅱ by vein and then perform PET/CT scan after 60 min<br>* Other names: 18F-AlF-NOTA-E[PEG4-c(RGDfk)]2;|
| Active Comparator: benign breast lesions<br>Perform 18F-Alfatide Ⅱ PET/CT in patients with benign breast lesions | Drug: 18F-Alfatide Ⅱ PET/CT<br>* Inject 18F-Alfatide Ⅱ by vein and then perform PET/CT scan after 60 min<br>* Other names: 18F-AlF-NOTA-E[PEG4-c(RGDfk)]2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum standardized uptake value (SUVmax) | the uptake intensity of lesions | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET/CT, Alfatide Ⅱ, breast cancer
The BEAR Therapeutic Program for Women

Study Overview
=================
Brief Summary
-----------------
The current study aims to test a novel therapeutic intervention for women who have a history of interpersonal trauma. The Building Empowerment and Resilience (BEAR) Therapeutic group incorporates psychological skills, psychoeducation, and physical empowerment training, all within a therapeutic process. It will be implemented at several different sites, with women who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect). We aim to understand how this program effects one's self-efficacy and whether the program can reduce rates mental health problems (such as depression and anxiety) and reduce the rates of revictimization.

Official Title
-----------------
The Building Empowerment and Resilience Therapeutic Program for Women With a History of Trauma

Conditions
-----------------
Trauma, Psychological, Depression, Anxiety, PTSD

Intervention / Treatment
-----------------
* Behavioral: BEAR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ages 18-70 History of physical, sexual, and/or emotional abuse/neglect/violence, with subsequent interpersonal or psychological distress (e.g., depression or anxiety) related to this history. Exclusion Criteria: Active, significant substance abuse Significant medical conditions that would preclude safe participation in the study High levels of depression with significant suicide risk Psychiatric instability History of assaultive behavior or is judged to be at potential risk to assault others.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BEAR intervention group<br>BEAR Therapeutic group for women who have experienced interpersonal trauma | Behavioral: BEAR<br>* Building Empowerment and Resilience Therapy group<br>|
| Control Condition<br>Treatment as usual group, women participating in individual or group therapy but not taking the BEAR group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Coping Self-Efficacy Scale (CSES) | The CSES is designed to measure an individual's perception of her competence to carry out coping strategies effectively when faced with a challenge or threat. | baseline to post-group (3 months) | 
| Trauma Symptom Inventory-II (TSI-2). | The TSI-2 is a self-report measure of trauma-related symptoms and behaviors. | baseline to post-group (3 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
therapeutic intervention, empowerment
Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.

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

Intervention / Treatment
-----------------
* Dietary Supplement: New thickened formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants : Aged ≤ 5 months old fully formula fed with at least 5 episodes of regurgitation per day Exclusion Criteria: Breast fed infants Infants presenting symptoms of a complicated gastroesophageal reflux Infants presenting intestinal disorders

Ages Eligible for Study
-----------------
Maximum Age: 5 Months

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: New thickened infant formula<br> | Dietary Supplement: New thickened formula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of regurgitation per day |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regurgitation score |  | 14 days | 
| Regurgitation score |  | 3 months | 
| Digestive tolerance (stools' number and consistency) | Digestive tolerance of the formula assessed through stools' number and consistency | 14 days | 
| Digestive tolerance (stools' number and consistency) | Digestive tolerance of the formula assessed through stools' number and consistency | 3 months | 
| Growth parameters (Weight, height and head circumference) | Weight, height and head circumference | 3 months |
Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective observational study is to evaluate the performance of Amigo RCS in ablation procedures for most common arrhythmias as compared to a conventional manual approach.

Official Title
-----------------
Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation

Conditions
-----------------
Arrhythmias

Intervention / Treatment
-----------------
* Device: Amigo
* Device: Manual ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to our electrophysiology laboratory to treat any type of arrhythmia with catheter ablation Exclusion Criteria: NA
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: Amigo<br>Ablation completed with Amigo | Device: Amigo<br> <br> |
| Active Comparator: Manual<br>Ablation completed with manual catheter | Device: Manual ablation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablation Success | Global efficacy: Recurrence rate Re-do procedures Proportion of patients under anti arrhythmic treatment | 1 year | 
| Safety Endpoint | Any complications that could be attributed to the procedure during follow-up. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Ablation Success | Accessory pathway: Anterograde and retrograde conduction block through the accessory Pathway Atrial fibrillation: % patients with all PV disconnected circumferential ablation with electrical disconnection of all pulmonary veins Common-type atrial flutter: Bidirectional cavotricuspid isthmus block AVNRT/Ventricular tachycardia/other atrial arrhythmias: Arrhythmia termination / absence o induction | During Procedure | 
| Acute Safety Endpoint | Procedure complications: Any complication during the electrophysiological procedure and 1 week post ablation that could be attributed to the procedure: Vascular complication, pericardial effusion/cardiac tamponade, heart failure, others. The number of adverse events will be collected. | During Procedure |
Creatinine Height Index in Elderly

Study Overview
=================
Brief Summary
-----------------
evaluation of the efficacy of two different age adjusted calculations of CHI compared to other nutritional indicators in the elderly medical patients upon hospital admission.

Detailed Description
-----------------
Cross sectional study involving one hundred hospitalized elderly (>60 years), Anthropometric measurements, Mini- nutritional assessment, Hand Grip strength, CBC, total protein, albumin, total cholesterol, triglyceride, and 24 hour urinary creatinine excretion were measured within 24 hours of hospital admission calculation of CHI using 2 age adjusted modification was done accuracy of each measurement in detecting malnutrition was evaluated

Official Title
-----------------
Age- Adjusted Measurements of Creatinine Height Index for Diagnosing Malnutrition in Elderly Medical Patients at Hospital Admission

Conditions
-----------------
Malnutrition in Elderly

Intervention / Treatment
-----------------
* Diagnostic Test: 24 hour urine creatinine excretion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical elderly patients (>60 years) within 24 hours of hospital admission Exclusion Criteria: sepsis fever malignancy liver cirrhosis renal impairment critically ill patients those with any hemodynamic instability were excluded from the study patients receiving diuretics patients can't stand to obtain their weight and height those can't collect 24 hour urine the patients refused to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Elderly Medical Patients at hospital admission<br> | Diagnostic Test: 24 hour urine creatinine excretion<br>* two age corrected calculations of creatinine height index were obtained<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of creatinine height index in Elderly | evaluate the test performance of the two age adjusted calculations of creatinine height index for detecting malnutrition in elderly patients at hospital admission | within 24 hours of hospital admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anthropometric measurements,, creatinine height index, lean body mass, Mini- nutritional assessment, Hand Grip strength
Assessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease

Study Overview
=================
Brief Summary
-----------------
Subjects undergo history, examination, lung function assessment after informed consent has been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is normal they will undergo a second and final scan four weeks later. If abnormal they will undergo two further scans with either nebulized bronchodilator or nebulized saline prior to their second and third scans. Each time they will have repeat lung function tests prior to scanning. We will examine the regional changes in ventilation and perfusion and there relationship to lung function.

Detailed Description
-----------------
As in Brief description

Official Title
-----------------
Assessment of Ventilation-perfusion Abnormalities in Patients With Smoking-related Airways Disease in Stable Condition and the Effect of Bronchodilator Therapy

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

Intervention / Treatment
-----------------
* Drug: salbutamol + ipratropium bromide nebules
* Drug: nebulized saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FEV1 < 70% predicted at baseline on spirometry significant smoking history or alpha 1 antitrypsin deficiency no evidence of current infection or restrictive lung disease Exclusion Criteria: history of other significant respiratory disease significant respiratory infection within 6 weeks history of significant physical or mental illness rendering them unfit for the study in the opinion of the investigator taken part in any other research within the past 12 months, or received exposure to ionizing radiation

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline control<br>nebulized saline | Drug: nebulized saline<br> <br> |
| Active Comparator: salbutamol and ipratropium bromide nebules<br>salbutamol 2.5 mg and ipratropium bromide 0.5 mg | Drug: salbutamol + ipratropium bromide nebules<br> <br> * Other names: Atrovent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scan grade | previously validated grading score | post scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung function |  | pre scan |
Fish and Marine Fatty Acids, Genetic Signatures of Diet Adaptation, and Long-term Weight Changes

Study Overview
=================
Brief Summary
-----------------
the investigators tested whether genetic variants near FADS cluster, which were recently identified to be signatures of adaptation to fish- and n-3 PUFAs-rich diet, interacted with these dietary factors on long-term change of body mass index (BMI).

Official Title
-----------------
Fish and Marine Fatty Acids, Genetic Signatures of Diet Adaptation, and Long-term Weight Change

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: fish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 11,323 women of European ancestry. Informed consent was obtained from all participants. The DNA extraction methods, quality control measures, SNPs genotyping and imputation data are available . Both cases and controls with genotyping data are available based on GWASs Exclusion Criteria: participants without genetic data
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: fish|fish intkae|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight changes | long term weight changes: this study measured body weight at baseline (1990) and follow up body weight in 2000. The long term body weight was defined as changes from baseline to follow up endpoint | 6-10 years |
An Observational Study of the Use and Safety of Raptiva During Pregnancy (FOLLOW)

Study Overview
=================
Brief Summary
-----------------
The Raptiva Pregnancy Registry was a prospective observational study established to obtain data on pregnancy outcomes of women who were exposed to Raptiva.

Official Title
-----------------
The Raptiva Pregnancy Registry: An Observational Study of the Use and Safety of Raptiva (Efalizumab) During Pregnancy

Conditions
-----------------
Psoriasis, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Any patient who has used Raptiva within 6 weeks prior to conception or during her pregnancy may be included in the Registry. Enrollment is based on Raptiva exposure, whether inadvertent or deliberate, in relation to pregnancy. Enrollment should occur as early as possible during the pregnancy and must occur prior to knowledge of pregnancy outcome.
Sexes Eligible for Study
-----------------
Female

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
-----------------
FOLLOW, Psoriasis, Pregnancy