TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double Blind, Placebo-Controlled Trial of Memantine for AIDS Dementia Complex (ADC) as Concurrent Treatment With Antiretroviral Therapy
Brief Summary: The purpose of this study is to determine the safety and effectiveness of memantine, an experimental drug, in improving AIDS dementia complex (ADC).

The symptoms of ADC can be improved with zidovudine (ZDV). However, ZDV therapy has been associated with significant toxicities, and the effectiveness of ZDV seems to decrease during the second and third years of therapy. The effectiveness of other antiretroviral drugs as treatment for ADC is not known, so it is important to explore alternative therapies.


Options:
A: Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. (6 months)
B: N/A
C: Change in the Paced Auditory Serial Addition Test and the California Verbal Learning Test II (multivariate end-point) after 15 weeks of treatment.
D: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment Rollover for Subjects Formerly on ACTG 328 With Subcutaneous Interleukin-2 (IL-2) in Combination With Highly Active Antiretroviral Therapy (HAART)
Brief Summary: This study examines the long-term effects of interleukin-2 (IL-2) in combination with anti-HIV drugs, or highly active antiretroviral therapy (HAART). The purpose of this study is to see if IL-2 can increase the number of CD4 cells (cells of the immune system which fight infection) in HIV-infected patients who have completed ACTG 328.

HAART is often successful in decreasing viral load (level of HIV in the blood), but these drugs have not been able to restore the immune systems of HIV-infected patients. IL-2 is a substance naturally produced by the body's immune cells. In ACTG 328, IL-2 is tested to see if it can increase the number of CD4 cells and "boost" a patient's immune system. This study is a follow-up to ACTG 328 so that patients who are benefiting from IL-2 can continue to take it and patients in the control group who do not receive IL-2 can start taking it.


Options:
A: New or Recurrent Disease Progression Events, as Defined, or Death. (From randomization to date last known to be alive or November 15, 2008, whichever is earlier)
B: Mean Change in CD4+ T Lymphocyte Count (Week 32)
C: New or Recurrent HIV Disease Progression Event Including Death (from randomization through study end - median of 7.6 years follow-up)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Bipolar Genetics: A Collaborative Study
Brief Summary: This study looks to identify genes that may affect a person's chances of developing bipolar disorder (BP) and related conditions....


Options:
A: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
B: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))
C: Continuous Abstinence From Smoking at Ten Weeks Post-quit (May 2009)
D: Diagnosis of bipolar disorder or related mental illness by direct interview (Diagnosis is established primarily at the initial study visit. Participants who consent to recontact are re-evaluated when they or family informants report events that could lead to a revised diagnosis.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Endocrine Studies of Healthy Children
Brief Summary: Researchers would like to determine normal ranges for hormone levels and to learn more about the genetics involved in hormone production and action. Researchers will take samples of blood, urine, saliva, and stool from healthy children ages 5-17 in order to study different aspects of hormones.

Establishing a range of normal hormone levels in children will make diagnosing illnesses with abnormal levels of hormones much easier. Hormone levels in the body can change throughout the day. By collecting samples at different times researchers hope to learn more about the normal daytime and nighttime patterns of hormone secretion. Because some hormone levels change with body size, researchers will also take measurements of patient's body composition.

This study will involve children and observe them as inpatients or as outpatients. \<TAB\>


Options:
A: Body weight (24 weeks)
B: Change in Body Mass Index (BMI) (3-month)
C: N/A
D: Change in BMI Standard Deviation Score (baseline to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo-Controlled Trial of the Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome
Brief Summary: Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Girls with Turner syndrome are very short as children and as adults. Although their growth hormone secretion is almost always normal, giving injections of growth hormone to Turner syndrome girls may increase their rate of growth. In addition, most girls with Turner syndrome do not have normal ovaries.

In normal girls the ovaries begin producing small amounts of the female sex hormone, estrogen at about 11 - 12 years of age. As girls grow older the level of estrogen increases. Estrogen is responsible for the changes in girls known as feminization. During feminization the hips grow wider, the breasts develop, there is an increase in the rate of growth, and eventually girls experience their first menstrual period.

This study was designed to evaluate the effect of low dose estrogen, growth hormone, and the combination of low dose estrogen and growth hormone on adult height in girls with Turner syndrome. Patients will be entered into the study from ages 5 to 12 and will be randomly placed into one of four groups.

1. Group one will receive low dose estrogen
2. Group two will receive growth hormone
3. Group three will receive both low dose estrogen and growth hormone
4. Group four will receive a placebo "sugar pill"

Once started, the treatment will continue until the patients approach their adult height, and growth slows to less than 1/2 inch over the preceding year. This usually occurs by the age of 15 or 16.

Patients will be seen at the outpatient clinic every 6 months during the study and will receive a routine check-up with blood and urine tests, and hand/wrist X-rays to determine bone age. On patient's yearly visits they will have the density of bone measured in their spine and forearm.


Options:
A: The size of the uterus evaluated by magnetic resonance (MR)-scan (5 years); Bones evaluated by dual-energy X-ray absorptiometry (DEXA)-scan (5 years)
B: N/A
C: Change in 24 hour ambulatory blood pressure (Before each washout period, then at 0, 3, 6 and 12 months of each treatment); Bone mineral density measurements (DEXA) (Baseline, 14 and 24 months); Uterine ultrasound scan to assess uterine volume, endometrial thickness, and uterine artery blood flow (Before each washout period, then at 0, 3, 6 and 12 months of each treatment)
D: Change in Weight From Baseline at 12 Months (12 months); Change in Body Mass Index From Baseline at 12 Months (12 months); Change in Percent Fat Mass From Baseline in 12 Months (12 months); Change in Fat Free Mass From Baseline at 12 Months (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Population Differences in the Insulin Sensitivity, Resting Energy Expenditure, and Body Composition of Overweight Children and Children of Overweight Parents
Brief Summary: This study focuses on the way weight is gained. Individuals who gain weight primarily in their midsection (visceral weight) are at an increased risk for developing diabetes and high blood pressure.

Research has shown that African Americans suffer more often from high blood pressure, diabetes (non-insulin dependent), and heart disease than Caucasian Americans. These conditions lead to significant numbers of deaths and diseases associated with and made worse by obesity.

African American women in particular suffer from obesity and the associated conditions of obesity more than any other race or gender. However, it is unknown if the conditions seen in African American women are a result of the obesity or differences in their insulin sensitivity, glucose disposal, or fat metabolism.

This study will compare body composition, total and resting energy expenditure, and glucose disposal of obese African American and Caucasian children and of non-obese children of obese African American and Caucasian parents, to characterize the timing and nature of factors that may contribute to the prevalence of obesity and its complications.

Patients participating in this study will be followed for 15 years and be evaluated every 5 years during the study.\<TAB\>


Options:
A: Change in Body Mass Index (BMI) (3-month)
B: Girls with LOC eating will be randomly assigned to IPT-WG or HE to examine their expected BMI change based upon CDC BMI growth chart data versus their actual in BMI over the course of two years. (1 year)
C: Adiposity (Yearly for 15 years)
D: Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) (From randomization up to 6 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Orlistat (Xenical, Hoffmann LaRoche) in African American and Caucasian Children and Adolescents With Obesity-Related Comorbid Conditions
Brief Summary: Obesity is a condition affecting one-third off the U.S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and other disorders of the heart and lungs. Individuals with the onset of obesity during childhood or adolescence are at an increased risk of obesity-related, diseases, both during adolescence and later in adult life.

African American girls and women are at an increased risk for obesity, and have substantial rates of obesity-related diseases and causes of death. Further, many African American adult women fail to respond to many of the therapeutic approaches used to treat obesity. At present there are no medical therapies proven effective for the correction of severe obesity in children or adolescents.

One medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten in the diet. Xenical appears to be effective for reducing weight and obesity-associated diseases in obese adults.

Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17 year old severely obese African American and Caucasian children and adolescents who have one or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).


Options:
A: Treatment Failure (Loss of Glycemic Control) (Study duration - 2 years to 6.5 years of follow up from randomization)
B: Insulin Resistance at 12 months in CB depression prevention versus HE control group.
C: N/A
D: Change in BMI Standard Deviation Score (baseline to 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Study of Radiotherapy Alone vs With Concurrent Chemotherapy With MTX or VBMF (VCR/BLEO/MTX/5-FU) vs Subsequent Chemotherapy vs Concurrent and Subsequent Chemotherapy in Patients With Advanced Head and Neck Cancer
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with advanced head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients with advanced head and neck cancer.


Options:
A: Overall Survival (3-years)
B: N/A
C: N/A
D: Overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5-FU) or the control treatment (PF: Cisplatin plus 5-FU) followed by chemoradiotherapy.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: FOUR ARMS PHASE III CLINICAL TRIAL FOR T3-T4 RESECTABLE RECTAL CANCER COMPARING PRE-OPERATIVE PELVIC IRRADIATION TO PRE-OPERATIVE IRRADIATION COMBINED WITH FLUOROURACIL AND LEUCOVORIN WITH OR WITHOUT POST-OPERATIVE ADJUVANT CHEMOTHERAPY
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery, with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed.


Options:
A: N/A
B: Overall Survival: Time From Randomization to Death From Any Cause (within 6.5 years)
C: To compare the combination of S-1 and oxaliplatin to the combination of capecitabine and oxaliplatin in terms of progression free survival in patients previously untreated by systemic therapy for advanced or metastatic colorectal carcinoma. (9 months)
D: Overall Survival (OS) (From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: FOUR ARMS PHASE III CLINICAL TRIAL FOR T3-T4 RESECTABLE RECTAL CANCER COMPARING PRE-OPERATIVE PELVIC IRRADIATION TO PRE-OPERATIVE IRRADIATION COMBINED WITH FLUOROURACIL AND LEUCOVORIN WITH OR WITHOUT POST-OPERATIVE ADJUVANT CHEMOTHERAPY
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery, with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed.


Options:
A: 3-Year Disease-free Survival (Up to 3 years)
B: Phase II (Feasibility study) Primary Outcome: Recruitment Rate (24 Months); Phase III Primary Outcome: Organ Preservation (30 Months from start day of (chemo)radiotherapy treatment.)
C: Local recurrence (2 years)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
Brief Summary: This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for prostate cancer.


Options:
A: N/A
B: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)
C: Prostate Cancer Deaths (Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.); Prostate Cancer Death Rates (Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.)
D: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage IIA Hodgkin's disease.


Options:
A: Failure-free Survival at 5 Years (Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5)
B: Progression free survival (PFS) (5 years)
C: Survival (12 years)
D: Overall survival; Reduction of late treatment-related toxicity; Maintenance of failure-free survival rate

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage IIA Hodgkin's disease.


Options:
A: Progression-free survival
B: Event-free Survival (5 years)
C: Survival (12 years)
D: Progression-free survival (up to 5 years after randomisation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Intergroup Randomized Comparison of Radiation Alone vs. Pre-Radiation Chemotherapy for Pure and Mixed Anaplastic Oligodendrogliomas
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients who have anaplastic oligodendroglioma.


Options:
A: Overall Survival (From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years or 80 deaths have been reported.)
B: Incidence of neuropsychological and neuroendocrine function in the two arms
C: Overall Survival (From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.)
D: Progression-free survival (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Intergroup Randomized Comparison of Radiation Alone vs. Pre-Radiation Chemotherapy for Pure and Mixed Anaplastic Oligodendrogliomas
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients who have anaplastic oligodendroglioma.


Options:
A: Overall Survival (From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.)
B: Overall Survival (2.5 years)
C: N/A
D: Survival

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: RANDOMISED TRIAL OF ADJUVANT CHEMOTHERAPY WITH HIGH-DOSE DOXORUBICIN, IFOSFAMIDE AND LENOGRASTIM IN HIGH GRADE SOFT TISSUE SARCOMA
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma.


Options:
A: Event-free survival; Overall survival
B: Event-free survival (Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, whichever comes first, assessed up to 5 years)
C: Overall Survival (OS) (approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS
Brief Summary: RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive.


Options:
A: Morbidity - Number of Participants With Residual Shoulder Abduction Deficit (Before and after surgery (within 30 days of randomization)); Morbidity - Number of Participants With Residual Arm Volume Difference (before and after surgery (within 30 days of randomization)); Morbidity - Number of Participants With Residual Arm Numbness (before and after surgery (within 30 days of randomization)); Morbidity - Number of Participants With Residual Arm Tingling (before and after surgery (within 30 days of randomization)); Overall Survival (8 years); Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event. (8 years)
B: N/A
C: Axillary recurrence rate (from randomization)
D: 5-year Disease-Free Survival (5-year estimate reported after a median follow-up of 60 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: COOPERATIVE MULTICENTER TRIAL FOR THE TREATMENT OF INFANTS WITH NEUROBLASTOMA
Brief Summary: RATIONALE: Sometimes neuroblastoma will regress without treatment, but sometimes additional treatment may be necessary. Giving more than one chemotherapy drug after surgery to remove the tumor may kill more tumor cells.

PURPOSE: Phase II trial to study combination chemotherapy or observation following surgery in treating infants with neuroblastoma.


Options:
A: Event Free Survival (R1: MAT therapy) (Up to three years); Event Free Survival (immunotherapy) (Up to three years); Complete metastatic response (R3: Induction therapy) (Up to 95 days); Event free survival (R3: Induction therapy) (Up to three years)
B: N/A
C: N/A
D: N/A

Answer: D