linjc16/ctgov huggingface dataset:
Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Trial compares two preoperative stage II and III rectal cancer treatment strategies: short term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.

Official Title
-----------------
Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer

Conditions
-----------------
Primary Rectal Cancer

Intervention / Treatment
-----------------
* Radiation: radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed stage II and III rectal cancer less than 15 cm from anal verge less than 80 years old no other cancer during 5 years period compensate cardiovascular, pulmonary, hepatic and renal functions. Exclusion Criteria: stage I or IV rectal cancer other cancer in 5 years period radiotherapy or chemotherapy in anamnesis not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc. pregnancy or baby feeding

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: 1<br>preoperative short term radiation group 5x5 Gy and surgery after 6 weeks | Radiation: radiotherapy<br>* Short term radiotherapy 5x5 Gy during 5 days Chemoradiotherapy 50 Gy + 5Fu/Lv<br>|
| Experimental: 2<br>preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks. | Radiation: radiotherapy<br>* Short term radiotherapy 5x5 Gy during 5 days Chemoradiotherapy 50 Gy + 5Fu/Lv<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 years overall and disease free survival |  | 5 years | 
| recurrence rate |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete response and downstaging rates |  | 5 years | 
| Impact on sphincter sparing operation rates |  | 5 years | 
| morbidity and mortality rates |  | 5 years | 
| Impact on quality of surgical resection |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer, radiotherapy, radiochemotherapy
A Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Subjects With Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
A Multi-Center, Open-Label, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects with Plaque Psoriasis

Official Title
-----------------
A Multi-Center, Open-Label, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects With Plaque Psoriasis

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: ADX-629


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a male or non-pregnant female 18 years of age or older. Subject has provided written informed consent. Females must be post-menopausal, surgically sterile, or use a highly effective method of birth control during the trial and for 30 days after the last administration of test article. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline. Male subjects who are not surgically sterile (e.g., vasectomy performed at least 6 months prior to trial entry) and are sexually active with a female partner who is of childbearing potential must agree to use an effective form of birth control for the duration of the trial and for 90 days after completion of treatment. Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of plaque psoriasis or exposes the subject to an unacceptable risk by trial participation. Exclusion Criteria: Subject is pregnant, lactating, or is planning to become pregnant during the trial. Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis or which exposes the subject to an unacceptable risk by trial participation. Subject is currently enrolled in an investigational drug, biologic, or device trial. Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 2/Baseline.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: ADX-629 250 mg administered orally twice daily (BID) for approximately 12 weeks.<br> | Drug: ADX-629<br>* ADX-629 administered orally twice daily (BID) for approximately 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Assessment | Adverse Event Collection | Safety Assessment Period (Day 1 - 85) |
Vaccination With Peptides From Anti-apoptotic Proteins in Relapsed Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
Anti-apoptotic proteins from the Bcl-2 family are known to play a key role in oncogenesis and are overexpressed in myeloma cells. Studies have shown that dendritic cells exposed to proteasome inhibition present exogene antigens better than unexposed dendritic cells. Patients with relapse of multiple myeloma will be offered vaccination with peptides derived from antiapoptotic proteins from the Bcl-2 family in combination with an immunostimulatory adjuvant. The vaccination will be given in relation to treatment with the proteasome inhibitor bortezomib.

Official Title
-----------------
Vaccination With Peptides Derived From Anti-apoptotic Proteins From the Bcl-2 Family, Administered in Combination With Montanide ISA-51 in Relation to Treatment With Proteasome Inhibitors in Patients With Relapsed Multiple Myeloma

Conditions
-----------------
Relapsed Multiple Myeloma

Intervention / Treatment
-----------------
* Biological: peptides derived from antiapoptotic proteins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of multiple myeloma tissue type of HLA-A1, HLA-A2 or HLA-A3 Performance status < 2 Adequate bone marrow - renal and liver function written informed concent Exclusion Criteria: candidate for bone marrow transplantation other malignancies than multiple myeloma other significant medical disease (heart-, lung or liver disease or diabetes) allergy active autoimmune disease treatment with immunosuppressive drugs treatment with other experimental drugs uncontrolled hypercalcemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: peptides from antiapoptotic proteins<br> | Biological: peptides derived from antiapoptotic proteins<br>* 8 Vaccinations on day 2 and 9 in every bortezomib treatment series<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple myeloma, vaccination, antiapoptotic proteins, proteasome inhibition
Worksite Issues in Organizational Health Promotion (Take Heart)

Study Overview
=================
Brief Summary
-----------------
To evaluate the impact of organizational-level health promotion activities and worksite characteristics on employee dietary and smoking behaviors.

Detailed Description
-----------------
DESIGN NARRATIVE: Based upon the organizational literature on adoption and institutionalization of innovative practices, a disseminable intervention protocol and materials (e.g., a guidebook for worksite health promotion steering committees) was developed. This intervention was evaluated in a randomized control trial comparing 13 treatment worksites to 13 delayed-treatment worksites on organizational health promotion practices (policies/environmental control, incentive programs, skills training activities, maintenance activities); employee smoking cessation and saturated fat consumption; and employee cholesterol levels. Following a two-year assessment, worksites in the delayed-treatment condition received a version of the intervention requiring less interventionist time. The effects of this streamlined intervention in these worksites were evaluated relative relative to a third group of 13 quasi-experimental comparison worksites that entered the study at that time. The study also evaluated the impact of organization characteristics and health promotion activities on employees at various stages of health related behavior change (awareness, intention to change, behavior change attempt, maintenance of behavior change). Process measures assessing program implementation and cost-effectiveness data were collected. Finally, the long-term intervention effects (3-4 years following initial intervention) on organizational health promotion practices, employee dietary and smoking behaviors, and cholesterol levels were assessed. In summary, this five year project provided both a) knowledge about how to implement worksite health promotion interventions to promote employee ownership and maintenance, and b) disseminable intervention products (e.g., protocols and employee steering committee guidebooks).

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Preconditioning Volatile Anesthesia in Liver Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery.

Detailed Description
-----------------
Comparing the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery.

Official Title
-----------------
Preconditioning is Indeed Protective

Conditions
-----------------
Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years benign and malign disease any type of liver surgery inflow occlusion during the liver surgery Exclusion Criteria: < 18 years participation on other interventional and treatment randomized controlled trials, trauma of the liver liver cirrhosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| group1<br>continuous volatile anesthesia (sevoflurane) during the liver resection | |
| group2<br>continuous intravenous anesthesia (propofol) during the liver resection | |
| group3<br>preconditioning volatile anesthesia (sevoflurane) 30 minutes before ischemia (inflow occlusion) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak ALT and AST levels representing the ischemia-reperfusion injury |  | post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay, length of ICU stay, blood loss and morbidity (post-operative complications) |  | post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver resection, Continuous volatile anesthesia, Continuous intravenous anesthesia, Preconditioning volatile anesthesia, Comparing three groups of anesthesia during the liver surgery according to their benefit on liver and outcome.
Neural and Antidepressant Effects of Propofol (Phase 2)

Study Overview
=================
Brief Summary
-----------------
Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.

Official Title
-----------------
Neural and Antidepressant Effects of Propofol (Phase 2)

Conditions
-----------------
Treatment Resistant Depression

Intervention / Treatment
-----------------
* Drug: Diprivan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-55 Diagnosis of major depressive disorder or bipolar disorder Current moderate-to-severe depressive episode Episode duration more than 2 months and less than 5 years Failure of at least 2 adequate antidepressant medication trials within the past 2 years Body mass index < 40 16-item Quick Inventory of Depressive Symptomatology, self-rated > 10 Exclusion Criteria: Contraindication to propofol or midazolam Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication Symptomatic coronary artery disease or heart failure Poorly controlled hypertension or diabetes Abnormal kidney or liver function Pregnant or breast feeding Traumatic brain injury or significant neurologic signs (past year) Substance use disorder (past year) Obsessive compulsive disorder (current) Post-traumatic stress disorder (current) Schizophrenia-spectrum disorder (lifetime) Neurocognitive disorder (current) Personality disorder as a current focus of treatment ECT within the past 3 months Inappropriate for ECT, or poor response to ECT within the past 5 years Incompetent to provide consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Propofol<br> | Drug: Diprivan<br>* Similar to the high-intensity propofol treatments in Phase 1, the anesthesiologist will administer an induction dose of propofol followed by a continuous infusion, insert an airway, and begin mechanical ventilation. Propofol dosing will be adjusted with the goal of achieving a burst-suppression state with a SR of 40-60 for 12-15 minutes.<br>* Other names: Propofol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression | 24-item Hamilton Depression Rating Scale, total score Higher values represent more severe depressive symptoms Maximum score, 76; minimum score, 0 Remission defined as total score < 10 Response defined as decrease of total score from baseline > 50% | 3 weeks after baseline |
The Effects of Peer-led Walking Intervention With mHealth Technology

Study Overview
=================
Brief Summary
-----------------
This study will apply the peer-led walking intervention with mHealth technology to maintain physical activity and promote prenatal health. Moreover, the participants of the trained peer mentors support women walking with mHealth technology, which has pregnant women using the APP to set goals, self-monitor, and self-manage, and it will continue to promote physical activity for overweight and obese pregnant women

Detailed Description
-----------------
This study was to investigate the effectiveness of peer-led walking intervention with mHealth technology on physical activity, self-efficacy, weekly steps, exercise involvement and depression status. Participants of the trained peer mentors encourage women walking with mHealth technology, which has pregnant women using the APP to set goals, self-record, and self-monitor, and it will continue to promote physical activity for overweight and obese pregnant women.This study's results will be useful to healthcare providers who need to promote physical exercise and an active lifestyle for overweight and obese pregnant women.

Official Title
-----------------
The Effects of Peer-led Walking Intervention With mHealth Technology for Physical Activity and Prenatal Health Outcomes

Conditions
-----------------
mHealth Intervention

Intervention / Treatment
-----------------
* Behavioral: mhealth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women who had a pre-pregnancy body mass index of more than 25 kg/m2 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomize control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants were used app to record their diet and steps every day<br>Experimental group was the mHealth with peer led to improved their physical activity during pregnancy. Participants received app to record and monitor their physical activity every days and using it until childbirth. | Behavioral: mhealth<br>* the peer-led intervention with mHealth technology (an application (APP) and Sports bracelet)<br>|
| No Intervention: non-mhealth<br>control group was the traditional prenatal care during pregnancy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity | physical activity (pregnancy physical activity questionnaire) | throughout childbirth, average of 20-30 weeks |
Study Comparing Liquid and Tablet Buprenorphine Formulations - 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare liquid and tablet buprenorphine formulations.

Detailed Description
-----------------
Participants were inducted on either liquid or tablet buprenorphine, in a double-blind, double-dummy manner. They each reached a steady state by the second week, and were scheduled to have blood draws in weeks 3, 4, 7, 8, 11, 12, 15, and 16.

Official Title
-----------------
Expanded Steady-State Pharmacokinetic Study, Comparing Liquid and Tablet Buprenorphine Formulations

Conditions
-----------------
Heroin Dependence

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Currently enrolled in the outpatient protocol comparing liquid and tablet formulations of Buprenorphine. Agreeable to conditions of study and signed informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 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
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Retention |  |  | 
| Drug craving |  |  |
Cardiac Amyloid Biorepository

Study Overview
=================
Brief Summary
-----------------
Use samples procured from patients to improve understanding of molecular, cellular, and tissue-level processes produced by cardiac amyloidosis and therapeutic interventions.

Detailed Description
-----------------
This is a prospective study enrolling patients referred for or undergoing cardiac amyloidosis or cardiovascular treatment at the University of Kentucky. The study aims to facilitate the discovery of novel diagnostic biomarkers and therapeutic targets and improve the pathophysiological understanding of cardiac amyloidosis.

Official Title
-----------------
Cardiac Amyloidosis Research Program

Conditions
-----------------
Cardiac Amyloidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing treatment for cardiac amyloidosis or receiving a right heart catheterization who are at least 18 years of age. Exclusion Criteria: Patients without a cardiovascular or amyloidosis diagnosis, under 18 years of age.

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 |
| --- | --- |
| Biological specimens<br>Biological specimens taken from cardiovascular procedures | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discover and quantify the concentration of novel diagnostic and prognostic biomarkers | Use biospecimens procured from patients with cardiac amyloidosis to identify diagnostic surrogate biomarkers using discovery proteomics. The serum levels will be compared between confirmed ATTR and non-ATTR heart failure patients and a diagnostic threshold will be established. | 12/21/2021-12/31/2027 |