TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Telephone-Based Genetic Counseling; An Equivalence Trial
Brief Summary: RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.

PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.


Options:
A: Inclusion Criteria:

Patients:

* Black
* Male
* Attending FQHC for routine primary care appointment

Providers:

* Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
* Caring for patients that fit inclusion criteria

Exclusion Criteria:

* Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
* Caring for patients that fit inclusion criteria
B: DISEASE CHARACTERISTICS:

* Must have at least 10% chance of carrying the BRCA1/BRCA2 gene, as defined by ≥ 1 of the following:

  * First-degree relative of affected family member with a 50% chance of inheriting a BRCA1/BRCA2 mutation
  * Second-degree relative with BRCA1/BRCA2 mutation with 25% risk of inheritance (parent deceased)
  * Obligate gene carrier or affected woman
* Must live within 100 miles of the Lombardi Comprehensive Cancer Center
* No more than 4 weeks since breast or ovarian cancer diagnosis
* No metastatic or inflammatory breast cancer or ovarian cancer
* No stage III breast or ovarian cancer while undergoing concurrent chemotherapy

PATIENT CHARACTERISTICS:

* No psychiatric illness or cognitive disorder that would preclude informed consent

PRIOR CONCURRENT THERAPY:

* No prior genetic counseling or testing for BRCA1 and/or BRCA2
C: Inclusion Criteria:

* Ages 40-80 years
* Their physician agreed to participate in the study
* Seen in practice for at least one year

Exclusion Criteria:

* Prior history of prostate cancer
* Presenting for acute medical visit
* Non-skin cancer
* Lung disease requiring oxygen
* Renal failure requiring dialysis
* Intensive care visit in last 6 months
* Need assistance with activities of daily living
D: Inclusion Criteria:

* Male or Female
* Self-identifies as being Hispanic or Latino
* 50 to 75 years of age

Exclusion Criteria:

* Previous diagnosis of CRC
* Up to date with CRC screening guidelines.
* Personal history of inflammatory bowel disease
* Personal history of polyps
* Family history of CRC diagnosed before the age of 60 years

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Mechanical Bowel Preparation for Elective Colorectal Surgery. A Multicenter Randomized Study
Brief Summary: Mechanical bowel preparation (MBP) is common practice in elective colorectal surgery. In recent literature the value of MBP is subject of discussion. We conducted a multicenter, randomized study with the goal of comparing outcome of elective colorectal resections and primary anastomoses with and without mechanical bowel preparation in terms of anastomotic leakage and other septic complications.

Within the setting of a multicenter randomized trial,1433 patients were randomized before elective colorectal surgery to receive either MBP or to have no MBP but a normal meal on the day before operation. The primary endpoint was anastomotic leakage. Secondary endpoints were septic complications (wound infection, urinary infection, pneumonia, pelvic abscesses), fascia dehiscence and death.

The incidence of anastomotic leakage was similar in both groups: 5.1% in patients without MBP versus 4.9% in patients with MBP (p=0.93; 95% confidence interval for the difference (no MBP minus MBP) ranges from -2.3% tot +2.7%). There were no significant differences in other septic complications, fascia dehiscence, or mortality. Fecal contamination, number of days until resumption of a normal diet, and duration of hospital stay were similar in both groups.

This study shows that elective colorectal surgery can be safely done without MBP. Therefore, MBP should be abandoned in elective colorectal surgery.


Options:
A: Inclusion Criteria:

* Patients scheduled for anterior rectal resection with primary anastomosis

Exclusion Criteria:

* Emergency operation
* Bowel obstruction
* Existing stoma
* Other reason preventing mechanical bowel preparation
* Allergy to neomycin or metronidazole
* Age \< 18 years
* Lack of co-operation

Exclusion criteria after randomization:

* Patient did not undergo surgery
* Anterior resection was not performed
* Colonic anastomosis was not performed
B: Inclusion Criteria:

The main inclusion criterion was elective colorectal surgery with primary anastomosis

Exclusion Criteria:

Exclusion criteria were an acute laparotomy, laparoscopic colorectal surgery, contraindications for the use of mechanical bowel preparation, an a priori deviating (ileo) stoma, and age less than 18 years old.
C: Inclusion Criteria:

* all colorectal resections

Exclusion Criteria:

* allergy
D: Inclusion Criteria:

* Have a planned of resection of rectum
* Have signed approved informed consent form for the study.

Exclusion Criteria:

* Significant simultaneous surgical procedure (e.g., liver resection of metastasis)
* Bacterial infection at the time of surgery or antimicrobial therapy up to 4 weeks before surgery
* Preoperative severe impairment in renal function (creatinine clearance (MDRD) \< 30 ml/min)
* Allergy on the study drugs .

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Prospective, Multicenter, Open-label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Cervical Dystonia
Brief Summary: The aim of this study is to assess longer term safety and effectiveness of Dysport®.


Options:
A: Inclusion Criteria:

* Cochrane review users
* Authors of systematic reviews
* Health professionals
* Guideline developers
* Researchers

Exclusion Criteria:

-
B: Inclusion Criteria:

* Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
* TWSTRS total score≥ 20; TWSTRS-severity subscale score\> 10;

Exclusion Criteria:

* In apparent remission from Cervical Dystonia
* Diagnosis of pure retrocollis or pure anterocollis
* For non-naïve subjects, previous poor response to either of the last two Botox treatments
* Known requirement of \<100U or \>200U of Botox injected into the neck muscles
C: Inclusion Criteria:

* Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
* TWSTRS severity, disability and total scores meeting the defined criteria at baseline

Exclusion Criteria:

* Pure anterocollis or pure retrocollis
* In apparent remission from cervical dystonia
* Previous poor response to the last two botulinum toxin type A or type B treatments
* Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin
D: Inclusion Criteria:

* Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal
* Returned to pre-treatment status as judged by the Investigator

Exclusion Criteria:

* Pure anterocollis or pure retrocollis
* Known antibodies to botulinum toxin type A
* Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study
* Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: LEVP2005-1/Part A: A Double-blind, Placebo-Controlled, Clinical Study to Investigate the Efficacy and Safety of Purified C1 Esterase Inhibitor (Human) for the Treatment of HAE in Acute Attacks
Brief Summary: The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.


Options:
A: Inclusion Criteria:

* Documented HAE
* Normal C1q level

Exclusion Criteria:

* Low C1q level
* B-cell malignancy
* Presence of anti-C1INH autoantibody
* History of allergic reaction to C1INH or other blood products
* Narcotic addiction
* Current participation in any other investigational drug study or within the past 30 days
* Participation in a C1 esterase inhibitor trial, or received blood or a blood product in the past 90 days
* Pregnancy or lactation
* Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study
B: Inclusion Criteria:

* Documented HAE
* Normal C1q level
* Relatively frequent angioedema attacks (at least 2 per month on average)

Exclusion Criteria:

* Low C1q level
* B-cell malignancy
* Presence of anti-C1INH autoantibody
* History of allergic reaction to C1INH or other blood products
* Narcotic addiction
* Current participation in any other investigational drug study or within the past 30 days
* Participation in a C1 esterase inhibitor trial, or received blood or a blood product in the past 90 days
* Pregnancy or lactation
* Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study
C: Key Inclusion Criteria:

* Written informed consent
* Clinical and laboratory diagnosis of Hereditary Angioedema Type I or II
* An average angioedema attack frequency of 1/week
* Acceptable birth control measures

Key Exclusion Criteria:

* Concurrent use of defined treatments for prophylaxis
* Pregnancy or breast-feeding
* Clinically significant medical condition, laboratory abnormality or medical history
D: Inclusion Criteria:

* Male or female
* Aged ≥ 18 to ≤ 65 years
* A diagnosis of C1-INH HAE or FXII/PLG HAE;
* For subjects with C1-INH HAE: ≥ 4 HAE attacks over a consecutive 2-month period during the 3 months before Screening, as documented in the subject's medical record.

Exclusion Criteria:

* History of clinically significant arterial or venous thrombosis, or current clinically significant prothrombotic risk
* History of an uncontrolled, abnormal bleeding event due to a coagulopathy, or a current clinically significant coagulopathy or clinically significant risks for bleeding events
* Known incurable malignancies

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India
Brief Summary: The primary purpose of this study is to estimate the efficacy of a two-dose regimen of the oral killed bivalent cholera vaccine when administered to individual residing in a cholera-endemic area in India.


Options:
A: Inclusion Criteria:

* Healthy residents of selected vaccination sites
* Aged 2 years and older
* non-pregnant

Exclusion Criteria:

* Age less than 2 years
* Pregnant
B: Inclusion Criteria:

* All healthy, consenting, non-pregnant (as ascertained by history) residents at least 1 year of age of the study area

Exclusion Criteria:

* individuals who are too weak to get out of bed to receive the vaccine;
* pregnant women (identified through verbal screening); and
* those less than 1 year of age
C: Inclusion Criteria:

Healthy subjects \> 1 year of age and above Living in high risk area for cholera Provision of Informed consent for participating in the study by participant /parent or guardian as well as verbal assent for children 11-17 years.

Exclusion Criteria:

Pregnant women Aged less than 1 year History of taking cholera vaccine
D: Inclusion Criteria:

1. Age ≥1 year, stratified into different age groups
2. Living in the Waya Clinic Catchment Area
3. Good health condition, without clinically significant medical history (by participant or guardian, in case of minor)
4. Not pregnant for female subjects.
5. Available to participate for the study duration, including all planned follow-up visits for up to 9 months from screening.
6. Signed informed consent

Exclusion Criteria:

1. Presence of a significant medical or psychiatric condition (Examples include: Diagnosis and treatment of tuberculosis (TB) or HIV; renal insufficiency; hepatic disease; oral or parenteral medication known to affect the immune function, such as corticosteroids, other immunosuppressant drugs; or behavioural or memory issues)
2. Ever having received oral cholera vaccine.
3. Receipt of an investigational product (within 30 days before vaccination).
4. History of diarrhoea in 7 days prior to first dose of vaccine (defined as ≥3 unformed loose stools in 24 hours).
5. History of chronic diarrhea (lasting for more than 2 weeks in the past 6 months)
6. Current use of laxatives, antacids, or other agents to lower stomach acidity?
7. Planning to become pregnant in the next 2 years.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Non-pharmacological Intervention Study for Prevention of Ischaemic Heart Disease Inter99
Brief Summary: In spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated through high blood pressure, high cholesterol and fatness) and smoking. So far intervention studies on lifestyle factors have shown disappointing results, most probably due to insufficient interventions and methodology.

Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons representing a well-defined population. About 13,000 are invited for a health examination and assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three waves over a five year period. A priori the group is divided into a high intensive and low intensive intervention group. The remaining 48.285 individuals serve as control.

After five years all individuals who attended the base-line examination are re-invited to assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk of CHD and biological risk factors. The total cohort (61.301) is followed through central registers to evaluate the effect of the intervention on use of the health care system and the long term effect on incidence of CHD.

The status for the project is that the four waves of intervention have been performed, the last follow-up was in March 2006.

Data collection finalized with 10 years follow-up via Central National Registries and a questionnaire. No further follow-up is scheduled for the main purposes of the study.

Analyses as regard the primary effect (on incidence of cardiovascular diseases) and secondary effect (on incidence of type 2 diabetes) are on-going. Analyses for a large number of spin off project are on-going.

More than 25 Ph.d. studies and more than 200 peer-review publication have so far been produced.

Summary of results, links to articles and theses at: www.Inter99.dk


Options:
A: Inclusion Criteria:

* Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 140-199 mg/dL)
* BMI \>= 24 kg/m2

Exclusion Criteria:

* Underlying disease likely to limit life span and/or increase risk of interventions
* Conditions or behaviors likely to effect conduct of the DPP
* Diabetes or disordered glucose metabolism
* Suboptimally treated Thyroid disease
* Fasting triglyceride level \< 600 mg/dl
* Exclusions related to medications
B: Inclusion Criteria:

* All citizens in a predefined area

Exclusion Criteria:

* Drug abuse
* Language problem
C: Participation as a volunteer in the Diabetes Prevention Program (DPP).
D: Inclusion Criteria:

* BMI\> 97. percentile for age and gender

Exclusion Criteria:

* Psychiatric disorders
* Endocrine disorders

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: LA Health: A Prospective Study of Primary and Secondary Obesity Prevention in Children and Adolescents
Brief Summary: There is a worldwide pandemic of obesity with far-reaching consequences for the health of our nation. Obesity is the second leading cause of preventable death in the United States. Prevention of obesity, especially in children, has been deemed by public health policy makers to be one of the most important objectives for our country.


Options:
A: Inclusion Criteria:

* 1st Grade primary school children on public schools

Exclusion Criteria:

* Physical disabilities
* No written informed consent from parents
B: Inclusion Criteria:

grade of 1 to 5 in primary schools and grade of 6 to 8 and 10 to 11 in secondary schools.

Exclusion Criteria:

Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.
C: Inclusion Criteria:

* Being one of the LA GEAR UP middle schools or a feeder elementary school
* Having an enrollment of at least 100 students per school
* All students in grades 4-6 of participating schools

Exclusion Criteria:

-
D: Inclusion Criteria:

* schools had at least 50% of enrolled children qualifying for free + reduced price meals (FRPM)
* schools did not already have a school garden

Exclusion Criteria:

-

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: LA Health: A Prospective Study of Primary and Secondary Obesity Prevention in Children and Adolescents
Brief Summary: There is a worldwide pandemic of obesity with far-reaching consequences for the health of our nation. Obesity is the second leading cause of preventable death in the United States. Prevention of obesity, especially in children, has been deemed by public health policy makers to be one of the most important objectives for our country.


Options:
A: Inclusion Criteria:

* Healthy kindergarten children

Exclusion Criteria:

* Children with severe chronic disease (restricting physical activity)
B: Inclusion Criteria:

* FCCH must have at least 2 children between the ages of 1.5 and 4 years currently enrolled. \* At least 2 children/families must agree to take part for the FCCH to remain eligible. (Note: Children ages 0-17 months may take part in height and weight measurements only)
* FCCH must have been in business for at least 2 years.
* FCCH must have a working telephone number.
* Provider must be able to read and speak English.

Exclusion Criteria:

* FCCHs cannot serve exclusively special needs children.
* FCCHs cannot close down during the summer months.
C: Inclusion Criteria:

* Being one of the LA GEAR UP middle schools or a feeder elementary school
* Having an enrollment of at least 100 students per school
* All students in grades 4-6 of participating schools

Exclusion Criteria:

-
D: Inclusion Criteria:

* full-term infant(\> 37 0/7 weeks gestational age)discharged from hospital without significant morbidity
* singleton infant
* nursery/NICU/maternity stay of 7 days or less
* primiparous mother
* English speaking mother

Exclusion Criteria:

* presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease
* any major maternal morbidities and/or pre-existing condition that would affect postpartum care such as cancer, multiple sclerosis, lupus, etc.
* maternal age \<=20 years
* prenatal ultrasound presence of intrauterine growth retardation (IUGR)
* infant birth weight \<2500 grams plan for newborn to be adopted
* plan to move from Central Pennsylvania within 3 years
* inability to complete contact form with name, address, phone numbers, etc.
* Practicing pediatrician or pediatric resident

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: LA Health: A Prospective Study of Primary and Secondary Obesity Prevention in Children and Adolescents
Brief Summary: There is a worldwide pandemic of obesity with far-reaching consequences for the health of our nation. Obesity is the second leading cause of preventable death in the United States. Prevention of obesity, especially in children, has been deemed by public health policy makers to be one of the most important objectives for our country.


Options:
A: Inclusion Criteria:

* Being one of the LA GEAR UP middle schools or a feeder elementary school
* Having an enrollment of at least 100 students per school
* All students in grades 4-6 of participating schools

Exclusion Criteria:

-
B: Inclusion Criteria:

* Infants 6 months of age
C: Inclusion Criteria:

* A child and his or her parent(s) will be eligible for the study if:

  * the two to four year old child is scheduled to receive or eligible for (based on an upcoming birthday) a recommended well child visit conducted by a pediatric or family practice care provider;
  * the child has no medical problems that would preclude study participation as determined by the physician conducting the well child visit (e.g. serious disease that would make following guidelines for parent encouragement of healthy diet and physical activity infeasible);
  * the child's BMI is greater than or equal to the 50th percentile according to CDC age and sex reference standards http://www.cdc.gov/nchs/data/nhanes/growthcharts/bmiage.txt;
  * the child's parent/guardian agrees to participation in the study and is not planning to move out of the state in the next three years
  * the primary caregiver is willing and able to complete the evaluation measures and participate in intervention activities if assigned to the active intervention group.
  * the parent speaks either English or Spanish.

Exclusion Criteria:

* A child will be excluded if she or he does not meet the above eligibility criteria
D: Inclusion Criteria:

* One parent (or guardian)-child dyad per family
* The parent or guardian member of the dyad is the person primarily responsible for packing the child's lunch and is able to read English language materials written at the 6th grade level
* The child member of the dyad is age 3 to 5 and participates in daily care during a full day that includes the hours when children eat their lunch

Exclusion Criteria:

* None

Answer: A