TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
Brief Summary: The purpose of this study is to determine whether a structured stress relief management program can prevent the progression of late diabetic complications in patients with type 2 diabetes.


Options:
A: Inclusion Criteria:

* Diabetes Type 2
* Albuminuria
* Age 30-70

Exclusion Criteria:

* Diabetes duration \< 3 years
* Preexisting non-diabetic kidney
* Psychiatric disorders
* Alcohol or drug abuse
* Malignant tumors or hematologic disorders
* Heart failure NYHA III-IV
* Acute coronary syndrome
B: Inclusion Criteria:

* Patients diagnosed with atrial fibrillation.
* Relative to patient with atrial fibrillation.
* To be over 18 years old .

Exclusion Criteria:

* Unwillingness to participate in the study.
* Other complicating illness'.
* Language difficulties that prevent answering surveys.
* Participation in another study.
* Accommodation outside the hospital's catchment area.
C: Inclusion Criteria:

1. Male or female
2. Age: No limitations
3. CHD documented by medical history of at least one of the following: a.acute myocardial infarction (MI) within the preceding 12 months b.coronary artery bypass surgery (CABG) c. percutaneous coronary intervention (PCI, PTCA)d. chronic stable angina
4. Written informed consent

Exclusion Criteria:

1. noncardiac life threatening illness
2. Severe cognitive impairment or physical disability
3. History of major psychiatric disorder, i.e. psychosis, dementia, or substance abuse disorder within the past year.
4. Left ventricular ejection fraction less than 40%
5. Conditions that may be a contraindications to PET perfusion imaging with adenosine stress testing, including unstable angina or myocardial infarction in the past week, aortic stenosis, uncontrolled hypertension, uncontrolled atrial or ventricular arrhythmias, second-degree or higher atrio-ventricular block in the absence of a functioning pacemaker, baseline hypotension (systolic blood pressure \< 90 mm Hg), severe obstructive lung disease or decompensated heart failure.
D: Inclusion Criteria:

* Women with overweight or obesity (BMI above 25);
* Enrolled in nutritional treatment for weight loss in primary care units and Hospitals from Coimbra

Exclusion Criteria:

* Binge Eating Disorder assessed through Eating Disorders Examination Interview;
* Severe psychiatric problems (severe depressive episode, substance abuse, Bipolar disorder and Borderline Personality Disorder) assessed through Structured Clinical Interview for DSM Disorders (SCDI-I and SCID-II);
* medical conditions that affect weight;
* medication that can cause significant weight or appetite changes.

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
Brief Summary: The purpose of this study is to determine whether a structured stress relief management program can prevent the progression of late diabetic complications in patients with type 2 diabetes.


Options:
A: Inclusion Criteria:

* receipt of primary care at a VISN 10 Northeast Ohio CBOC
* GFR (calculated according to the 4 variable Modification of Diet in Renal Disease study equation) less than 45 mL/min per 1.73m2 with a second GFR less than 60 at least 90 to 730 days prior to the index GFR (26); and
* at least one primary care visit in the year prior to study initiation.

Exclusion Criteria:

* ESRD as defined by chronic renal replacement therapy,
* receipt of a renal transplant,
* hospice care, and
* age greater than 85 years or less than 18 years at the time of study initiation.
B: Inclusion Criteria:

* Diabetes Type 2
* Albuminuria
* Age 30-70

Exclusion Criteria:

* Diabetes duration \< 3 years
* Preexisting non-diabetic kidney
* Psychiatric disorders
* Alcohol or drug abuse
* Malignant tumors or hematologic disorders
* Heart failure NYHA III-IV
* Acute coronary syndrome
C: Inclusion Criteria:

* Patients with CKD (defined as estimated Glomerular Filtration Rate \< 60ml/min/1.73m2 or proteinuria consistently over 3 months) who speak English, Spanish or Cantonese and have a primary care provider

Exclusion Criteria:

* Kidney transplant recipients; pregnant women; individuals with an eGFR \<15 ml/min/1.73 m2; prevalent dementia; impaired cognition or severe mental illness; expected life expectancy \<6 months; no phone access; self-reported hearing impairment; severe visual impairment preventing use of a touch-tone telephone keypad; and non-study language
D: Inclusion Criteria:

* English-speaking
* 21 years or older
* Kidney Transplant candidates eligible: 1) completed the first phase of transplant evaluation education, and 2) wait-listed patients expected to receive a transplant within the next 6 months, returning for re-evaluation.

Exclusion Criteria:

* No special classes of study participants, including fetuses, neonates, prisoners, institutionalized individuals, or other vulnerable populations will be included in the proposed study. Although pregnant women will be eligible for participation in the study, they are unlikely to be selected for kidney transplantation.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia
Brief Summary: 7-methylxanthine has been shown to increase the concentration and thickness of collagen fibrils in rabbit sclera. Deficient collagen in the sclera may be the cause of progression of childhood myopia. The study hypothesis is that treatment with 7-methylxanthine will stabilize the sclera and prevent further progression of myopia.


Options:
A: Inclusion Criteria:

Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year.

-

Exclusion Criteria:

Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma)

-
B: Boys must have been between 6 and 12 years of age; girls between 6 and 11 years of age. All children must have had at least 0.5 diopters of myopia in both eyes, near-point esophoria, at least 20/25 acuity in each eye, and 40 seconds of stereopsis and must have been free of ocular disease or systemic disease that may have altered refraction. All subjects were willing to wear bifocal spectacle lenses for 30 months.
C: Inclusion Criteria:

1. The subject must be enrolled in the parent protocol for at least one year.
2. The subject's parent or legal guardian must read and sign the STATEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form.
3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies that may interfere with contact lens wear.
2. Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with contact lens wear.
3. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
8. Diabetes
9. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study.
10. Strabismus.
11. Pupil or lid abnormality or infection in either eye
12. Central corneal scar in either eye
13. Aphakia in either eye
14. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
15. History of participation in prior clinical trials aimed to control myopia progression, except for the parent trial
16. Surgically altered eyes, ocular infection of any type, ocular inflammation.
17. Anterior chamber angle grade 2 or narrower by Van Herrick method.
D: Children with myopia who are able to adapt to rigid contact lens wear

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: D-dimer Test to Establish Duration of Anticoagulation After a First Idiopathic Episode of Venous Thromboembolism; the Prospective Randomized "Prolong" Study
Brief Summary: The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain. The present study addresses the possible role of the D-dimer test in assessing the need for continuation of anticoagulation.The study aims at assessing whether D-dimer assay may have a role in guiding the duration of anticoagulation in these patients


Options:
A: Inclusion Criteria:

* Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate.

Exclusion Criteria:

* DVT/PE severe enough to require thrombolysis or pulmonary embolectomy.
* DVT/PE in the preceding 3 years.
* Neoplasia diagnosed/treated within previous 3 years.
* Pregnancy.
* Known major thrombophilias.
* Prolonged or continuous immobility or confinement to bed.
* Previous allergy to heparin or warfarin.
* Requirement for long-term anticoagulation.
* Inability to give informed consent.
B: Inclusion Criteria:

* acute proximal DVT associated or not with clinically symptomatic pulmonary embolism

Exclusion Criteria:

* history of previous VTE
* active cancer
* indications for permanent anticoagulation
* contraindications to anticoagulation
* pregnancy
* geographical inaccessibility for long-term follow-up
* life expectancy shorter than 1 year
* refusal of informed consensus
C: Inclusion Criteria:

* Age \> 18 years
* After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
* After at least 3 months of oral anticoagulation
* After written informed consent

Exclusion Criteria:

* If the Venous thromboembolism occurred:
* during pregnancy or puerperium
* after recent (i.e. within three months) fracture or plaster casting of a leg,
* after immobilization with confinement to bed for three consecutive days
* after surgery with general anesthesia lasting longer than 30 minutes
* Patients with:
* active cancer
* antiphospholipid antibody syndrome
* antithrombin deficiency
* serious liver disease or renal insufficiency (creatininemia \> 2 mg/dL),
* other indications for anticoagulation or contraindications for this treatment
* limited life expectation
* Patients who live too far from the clinical center
D: Inclusion Criteria:

* First episode of unprovoked and provoked proximal DVT of the lower limbs and treated for 3 month with oral anticoagulants

Exclusion Criteria:

* Active cancer,
* Limited life expectancy,
* Antiphospholipid antibody syndrome, or an other known thrombophilic status (such as antithrombin deficiency),
* Serious liver disease,
* Renal insufficiency (serum creatinine \> 2 mg/dL).

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial
Brief Summary: Hypothesis: Early use of oral metoclopramide can hasten and improve the establishment of lactogenesis II in mothers after preterm and term deliveries.

The study hopes to show that metoclopramide can be effective to establish and sustain Lactogenesis II for both preterm and term infants.


Options:
A: Inclusion Criteria:

* singleton, term delivery
* \>2.5 kg newborn weight
* lactation-deficiency

Exclusion Criteria:

* Neonatal Intensive Care Unit admission
* use of galactagogue drugs
* allergy
B: Inclusion Criteria:

All pregnant women who intend to breastfeed, from 28 weeks to term, who have not met the exclusion criteria

Exclusion Criteria:

1. Patients who have epilepsy or on anti-seizure medications,
2. Patients who have a history of significant depression or are on antidepressant drugs
3. Patients who have pheochromocytoma or uncontrolled hypertension
4. Patients who have intestinal bleeding or obstruction
5. Patients who have a known allergy or prior reaction to metoclopramide, or any other contraindications to the use of metoclopramide
6. Patients who have diabetes and hyperprolactinaemia
7. Patients with HIV infection
8. Current pregnancy complicated by fetal congenital anomalies and multiple fetuses
C: Inclusion Criteria:

* First-time expectant mother, speaks English, receiving OB care at designated practice group

Exclusion Criteria:

* 1) Under 18 years old; 2)no access to local telephone 3) multiple gestation 4) history of major breast surgery
D: Inclusion Criteria:

Women

* healthy women
* inadequate milk supply
* read/speak English

Infants

* healthy term infants (≥ 38 weeks gestational age)
* age ≥ 2wks and ≤3mths
* surpassed birth weight

Exclusion Criteria:

Mother

* cardiac anomalies
* breast or endocrine abnormalities (i.e. breast CA, pituitary adenomas)
* medications contraindicated with domperidone use
* drug or alcohol use
* use of hormonal contraception

Infant

* physical anomalies making breastfeeding difficult (i.e. cleft palate)
* cardiac anomalies

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Risk-stratified Therapy for Primary and Secondary AML and MDS. A Randomized Study by AMLCG in Relation to Cytogenetically Defined Prognostic Factors (1) on the Role of High-dose AraC as Part of Double Induction, (2) on G-CSF Priming, and (3) on High-dose Chemotherapy With Stem Cell Transplantation
Brief Summary: The study in patients with primary and secondary AML and high-risk MDS uses a risk-stratified, randomized design to evaluate the role of high-dose araC in induction, of G-CSF priming, and of autologous stem cell transplantation.


Options:
A: Inclusion Criteria:

* Acute myeloid leukemia (de-novo AML, secondary AML, high-risk MDS)
* Age 16 - no upper age limit
* Written informed consent

Exclusion Criteria:

* Severe comorbidity
* Presence of other malignancy
* Prior anti-leukemic treatment
* Pregnancy
* Severe psychiatric disorder or other circumstances which may compromise cooperation of the patients
B: Inclusion Criteria:

* de novo or secondary acute myeloid leukemia FAB-subtypes M0-M2 and M4-M7
* de novo or secondary myelodysplastic syndrome WHO-type RAEB-2
* age 16 to 60 years
* written informed consent

Exclusion Criteria:

* severe comorbidities
* severe, uncontrolled complications of the leukemia
* prior therapy for AML/MDS
* other simultaneous hematological malignancies
* HIV-Infection
* known allergies against study medication
* pregnancy
* missing written informed consent
C: Inclusion Criteria:

* Age from \>0 to \</=18 years
* De novo AML, including children with Down syndrome, primary myelosarcomas or acute mixed lineage leukemia/biphenotypic leukemia (predominantly myeloid)
* Admission to one of the member hospitals in Germany participating in the study AML-BFM 2004

Exclusion Criteria:

* Children with pre-existing syndromes (except Down syndrome)
* AML as secondary malignancy
* Accompanying diseases which do not allow therapy according to the protocol
* Pre-treatment for more than 14 days with another intensive induction therapy
D: Inclusion Criteria:

* Patients with AML, de Novo or secondary after Myelodysplasy, or with therapy-induced AML after healed primary malignom; or refractory anemia with excess of blasts in transformation (RAEB-t); the diagnosis must be confirmed morphological, cytochemical and with immunological phenotyping
* Cytogenetical tests must be performed for each patient
* Age: 16 - 60 years
* All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.

Exclusion Criteria:

* Organic insufficiency: Insufficiency of the kidneys (Crea \> 1.5 x upper normal serum level), or insufficiency of the liver (bilirubin, SGOT or AP \> 2 x upper normal serum level) uncaused by the AML; severe obstruction or restrictive ventilation disorder, heart failure with a ejection fraction \< 0.5
* Secondary malignom
* Other severe diseases
* Pregnancy
* Participation in an concurrent clinical study

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT)
Brief Summary: The purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with B vitamins can prevent cardiovascular disease


Options:
A: Women, aged 40 and over, at high risk, with a history of cardiovascular disease or three or more coronary heart disease risk factors.
B: Inclusion Criteria:

Patients will be screened by their plasma homocysteine concentration. They must have a level of at least 15 mM/L to be enrolled in the study.

Patients will be excluded by any of the following criteria: age less than 21 years, expected life span less than 6 months, pregnancy, metastatic cancer, end-stage liver disease, treatment with methotrexate, other anti-folate medication or anticonvulsants, unreliable or likely noncompliant, participation in another long-term trial, or unwilling or unable to give informed consent.

Exclusion Criteria:
C: Inclusion Criteria:

* 35 - 75 years old
* Had kidney transplant at least 6 months
* Calculated Creatinine Clearance must be 25 mL/min or greater
* Must be willing to stop supplements (B6, B12, folic acid) for 4-6 weeks prior to visit

Exclusion Criteria:

* If pregnant or lactating
* If of child bearing potential and not on birth control
* If any of the following will limit life expectancy to less than 2 yrs:

  * Cancer
  * Congestive heart failure (CHF) (end stage)
  * Liver disease (end stage)
  * Severe pulmonary disease
  * Progressive HIV
  * Any other chronic wasting illness
* If patient had myocardial infarction (MI), stroke, lower extremity amputation above ankle or percutaneous revascularization procedure (coronary, cerebrovascular, lower extremity) in past 2months
* If patient had coronary artery bypass graft (CABG) or abdominal aortic aneurysm (AAA) in past 5 months
* If patient has conditions that prevent reliable study participation e.g., depression, alcohol or drug abuse, other cardiovascular disease (CVD) studies
* If patient has had multi-organ transplant, except kidney/pancreas
D: Inclusion Criteria:

* Acute myocardial infarction within 7 days prior to randomization
* Men and women aged 30-85 years
* Written informed consent

Exclusion Criteria:

* Coexisting disease that shortens expected survival to less than 4 years
* Ongoing treatment with B vitamins
* Expected poor compliance

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Kansas University DHA Outcome Study (KUDOS)
Brief Summary: The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.


Options:
A: Inclusion Criteria:

* weight at birth equal or above 2500 g;
* gestational age between 37 and 42 completed weeks;
* single birth;
* absence of neonatal or birth abnormalities;
* Apgar score greater than or equal to 7 at 5 m;
* white parents.

Exclusion Criteria:

* presence of neonatal diseases requiring hospitalisation for longer than 7 days;
* unknown father;
* parents unable to understand the protocol requirements and to fill out the infants diary;
* infant already enrolled or selected for another clinical study.
B: Inclusion Criteria:

* Gestational age \<= 15th week of gestation
* Age: 18-43 years
* Written informed consent
* Body mass index (BMI) before pregnancy between 18 and 30 km/m2

Exclusion Criteria:

* High risk pregnancy
* Hypertonus
* Chronic diseases (i.e. diabetes mellitus)
* Psychiatric diseases
* Former supplementation with LC-PUFA
C: Inclusion Criteria:

* Pregnant 8-20 wks at enrollment
* single fetus
* BMI \<40

Exclusion Criteria:

* diabetes (Type I, ii, GDM)
* hypertension (primary, PIH, preeclampsia/eclampsia)
D: Inclusion Criteria:

* infants (age range: newborn to 2-month-old) who are admitted to BCH NICU with a jejunostomy or ileostomy (from surgical intervention for NEC, bowel perforation, midgut volvulus (twisted bowel), atresia or other gastrointestinal surgery);
* who are expected to need full or partial PN for at least 21days from the day of enterostomy placement; and
* have received enteral feedings ≤ 4 days since enterostomy placement

Exclusion Criteria:

* infant with colostomy;
* infants with enterostomy but

  * unable to obtain written informed consent from parent;
  * presence of congenital liver or renal, or metabolic diseases; and
  * ostomy caused by gastroschisis, omphalocele, imperforate anus, and perinatal asphyxia
  * unable to initiate enteral feeds after 28 days of ostomy placement.

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Kansas University DHA Outcome Study (KUDOS)
Brief Summary: The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.


Options:
A: Inclusion Criteria:

* Pregnant 8-20 wks at enrollment
* single fetus
* BMI \<40

Exclusion Criteria:

* diabetes (Type I, ii, GDM)
* hypertension (primary, PIH, preeclampsia/eclampsia)
B: Inclusion Criteria:

* weight at birth equal or above 2500 g;
* gestational age between 37 and 42 completed weeks;
* single birth;
* absence of neonatal or birth abnormalities;
* Apgar score greater than or equal to 7 at 5 m;
* white parents.

Exclusion Criteria:

* presence of neonatal diseases requiring hospitalisation for longer than 7 days;
* unknown father;
* parents unable to understand the protocol requirements and to fill out the infants diary;
* infant already enrolled or selected for another clinical study.
C: Inclusion Criteria:

* healthy term newborn
* gestational age between 37 and 41 weeks
* birth weight between the 3th and 97th weight-for-age percentile according to the EURO-Growth charts
* fully bottle-fed (at the latest with 28 days of age) or fully breast fed
* written parental informed consent
* Serbian nationality

Exclusion Criteria:

* malformations, congenital heart defect, congenital vascular disease, severe diseases of gastrointestinal tract, kidney, liver, central nervous system and/or metabolic disease
* intensive care during first 14 days of life
* participation in any other clinical study intervention
* twins, multiple birth
* neonatal infection
* medication and parenteral nutrition
* metabolic disorders
* birth-related complications
* severe disturbances of neonatal adaption
D: Inclusion Criteria:

* healthy, term, formula fed infants from 1-5 days of age

Exclusion Criteria:

* history of disease that effects normal growth and development
* breast fed, or formula intolerance

Answer: A