TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Single Dose, Randomized, Double-blind Crossover Comparison of Combivent CFC MDI and Albuterol HFA MDI in Patients With Moderate to Severe Persistent Asthma and Persistent Symptoms Despite Treatment With Inhaled Corticosteroids
Brief Summary: The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.


Options:
A: Inclusion Criteria:

* Patient is a user of Inhaled Corticosteroid (ICS) or ICS/Long-Acting Beta 2-Agonist (ICS/LABA) at any dosage
* Peak expiratory flow is \> or = 80% of predicted value on the day of visit 1
* Uncontrolled as per Canadian asthma consensus guidelines

Exclusion Criteria:

* Unwilling to stop regular use of histamine H1 antagonists for allergic rhinitis symptoms
* Unwilling to stop use of antihistamine eye drops or cromoglycate eye drops or ophthalmic corticosteroid
B: Inclusion Criteria:

* Patient greater than or equal to 18 years of age,
* non-smokers,
* diagnosed with asthma, with an FEV1 less than or equal to 70 percent of predicted normal,
* stable use of Beta agonist
* daily use of inhaled steroids for one year

Exclusion Criteria:

* Patients with other significant diseases other than asthma, requiring oxygen,
* intubated within 5 years,
* asthma exacerbation within 6 weeks of trial,
* use of unstable doses (greater than 10 mg/day of prednisone or equivalent) of steroids,
* participating in another interventional trial
C: Inclusion Criteria:

* age 15 or older
* physician diagnosed asthma
* regular use of prescribed asthma medication over preceding year
* post-bronchodilator FEV1 of at least 75% of predicted
* inadequate asthma control over preceding two months

Exclusion Criteria:

* current or past smoking (greater than 10 pack-years)
* serious asthma exacerbation within previous three months
* regular use of oral corticosteroids
* history of respiratory failure due to asthma
* current use of montelukast or history of adverse reaction to montelukast
* concomitant interfering medical condition
* participation in another clinical trial
* inability or unwillingness to perform study procedures
* pregnancy, lack of effective contraception (when appropriate), lactation
D: Inclusion Criteria:

* Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks

Exclusion Criteria:

* Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil
Brief Summary: The perinatal morbidity and mortality rates for Brazil are five to ten-fold higher than those reported for upper income countries. This study tests the likelihood that the joint administration of antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the incidence of preeclampsia among chronically hypertensive pregnant patients and patients with a past history of preeclampsia/eclampsia.


Options:
A: Inclusion Criteria:

* Married women of reproductive age identified as a new pregnancy using a urine test

Exclusion Criteria:

* Menopausal or sterilized woman or currently already pregnant or breastfeeding an infant \<9 months of age
B: Inclusion Criteria:

* Women with cleft lip with/out palate (CLP), 16 to 45 years of age registered at the study clinics in Brazil or Women (16 to 45 years of age) with at least one natural child of any age with CLP registered at the study clinics.
* Women must reside in the catchment area of the study, which includes the states where the study clinics are located and surrounding states.

Exclusion Criteria:

* Consanguineous couples (up to third degree, i.e. first cousins or closer).
* Pregnany at the time of recruitment. Women will be recontacted later at an appropriate time for participation in the study.
* Couples either one of which have been sterilized.
* Taking any form of seizure medication.
* Planning to move outside of the study catchment area within the next year.
* B12 deficiency (\<174 pg/mL or 129.15 pmol/L).
* Being allergic to folic acid.
C: Inclusion Criteria:

All the women of child-bearing age (15-44 years) living in the study area (4 100) will be visited monthly to assess early pregnancy and will be invited to participate in the trial.

Exclusion Criteria:

Will be excluded from the study women :

* planning to move outside the district within the 2 years following the start of the trial.
* regularly using a contraceptive method.
* already pregnant at the start of the trial.
D: Inclusion Criteria:

* Gestational age between 12 weeks and 19 weeks, 6 days, inclusive
* Chronic hypertension
* History of preeclampsia/eclampsia
* Attendance at a participating hospital (Recife, Botucatu, Campinas and Porto Alegre, Brazil)

Exclusion Criteria:

* Planned delivery elsewhere.
* Multifetal gestation.
* Allergy to vitamin C or vitamin E.
* Requirement for aspirin or anticoagulant medication.
* Proteinuria ≥ 2+ on dipstick urine test; or proteinuria = 1+ on dipstick and ≥ 300 mg/24 hours.
* Pre-pregnancy diabetes mellitus.
* Known fetal anomaly incompatible with life.
* Prior participation in the study.
* Unwillingness to take the study medication.

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: RCT of Misoprostol for Postpartum Hemorrhage in India
Brief Summary: Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.


Options:
A: Inclusion Criteria:

* Vaginal delivery
* Postpartum hemorrhage due to suspected uterine atony
* Depending on study group: administration of prophylactic uterotonics in third stage of labor

Exclusion Criteria:

* Known allergy to misoprostol or other prostaglandin
* C-section for current delivery
B: Inclusion Criteria:

* Gestational age equal to or greater than 28 weeks pregnant
* Planning to deliver at home or at a sub-center in the Belgaum District, Karnataka India
* Anticipating a spontaneous vaginal delivery
* Ability and willingness to provide informed consent

Exclusion Criteria:

* Previous caesarian section
* Scheduled for caesarian section
* Hemoglobin level less than 8 Gms%
* Episodes of antepartum bleeding during the current pregnancy
* Blood pressure more than 140 mm of Hg systolic and 90 mm of Hg diastolic
* In active labor and not previously screened, recruited, and consented
* Absence of fetal heart sounds
* Multiple pregnancy
* Known history of bronchial asthma
* Prior enrollment in this study during a previous pregnancy
* History of complications (ante/postpartum hemorrhage/retained placenta/ acute inversion of uterus) during a previous pregnancy
* High risk conditions including: diabetes, cardiac ailments, seizures, placenta previa or anticipated breech delivery.
* Receiving injectable medicine at time of delivery
C: Inclusion Criteria:

* Women who have given birth to 1 or more live-born infants (para 1 or more)
* Vaginal delivery

Exclusion Criteria:

* Refusal or inability to give informed consent
* Delivery regarded as abortion according to local gestational age limits
* Inability to take misoprostol sublingually
* Cesarean section
* Assisted vaginal delivery
D: Inclusion Criteria:

* All women delivering vaginally with clinically diagnosed PPH requiring uterotonics

Exclusion Criteria:

* Refusal to give consent for participation or if the woman is too distressed to give consent
* Woman is not entitled to give informed consent (e.g. minors without a guardian)
* Woman who had a caesarean section
* Delivery is regarded as abortion (gestational age \< 28 weeks)

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder
Brief Summary: The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.


Options:
A: Inclusion Criteria:

* Clinical diagnosis of bipolar I disorder, manic or mixed episode

Exclusion Criteria:

* First manic or mixed episode
* Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
* Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole
B: Inclusion Criteria:

* Age: 8-17
* BD type I or II comorbid with ADHD
* Baseline score in the YMRS \> or = 20

Exclusion Criteria:

* IQ \< 70
* Pharmacologic treatment in the last month
* Pregnancy or absence of a contraceptive method in fertile girls
* Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency
* Risk of suicide or homicide
* Clinical condition that might interfere in the study
* Known sensibility to aripiprazole
C: Inclusion Criteria:

* Age: 8 -17
* BD type I or II comorbid with ADHD
* Reduction of maniac symptoms (30% reduction in the YMRS scores and/or CGI scores ≤ 2)while using aripiprazole during a previous study (NCT00116259)without improvement of ADHD symptoms (reduction in ADHD symptoms \< 30% in the SNAP-IV). Those receiving placebo in the previous protocol will receive a 6- week open label treatment with aripiprazole. The same threshold for reducing maniac symptoms and absence of response in ADHD symptoms will be used.

Exclusion Criteria:

* IQ \< 70
* Pregnancy or absence of a contraceptive method in fertile girls
* Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency
* Risk of suicide or homicide
* Clinical condition that might interfere in the study
* Known sensibility to aripiprazole
D: Inclusion Criteria:

* Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Cognitive Impairment in the ICU: Evaluation and Outcomes
Brief Summary: The purpose of this study is to determine the impact of a new RN/RRT (Registered Nurse/Registered Respiratory Therapist) directed 2-step protocol to wean patients off of a ventilator. This protocol involves daily attempts to halt sedation (spontaneous awakening trials) combined with daily assessments of patients while they are breathing on their own (spontaneous breathing trials).


Options:
A: Inclusion Criteria:

* mechanically ventilated

Exclusion Criteria:

* cardiac surgery patients
* those patients readmitted to the ICU who had been on the study during a previous admission were excluded for any subsequent admissions.
B: Inclusion Criteria:

1. age\>18 years
2. Mechanically ventilated, with anticipated need for MV ≥ 48 hours
3. ICU team has decided to initiate continuous sedative/analgesic infusion(s)
4. informed consent.

Exclusion Criteria:

1. Admission after resuscitation from cardiac arrest
2. Traumatic brain injury
3. Currently receiving neuromuscular blocking agents
4. Allergy to any of the study medications
5. History of alcohol, sedative or analgesic abuse
6. History of psychiatric illness
7. Acute or chronic neurologic dysfunction
8. Administration of sedatives for \>24 hr,
9. Lack of commitment to aggressive treatment
10. Current enrollment in a related trial
11. Previous enrollment in this trial.
C: Inclusion Criteria:

* 18 years of age or over
* Mechanically ventilated, with anticipated need for MV ≥48 hrs
* ICU team has decided to initiate continuous sedative/analgesic infusion(s)
* informed consent from patient and/or SDM

Exclusion Criteria

* Admission after resuscitation from cardiac arrest
* Traumatic brain injury
* Currently receiving neuromuscular blocking agents
* Allergy to midazolam and lorazepam
* Lack of commitment to aggressive treatment
* Previous enrolment in SLEAP, or current enrolment in related trial
D: Inclusion Criteria:

* Recently on mechanical ventilation (less than 2 weeks prior to enrollment)
* Require mechanical ventilation for more than 12 hours
* Over 18 years old
* Under the services of medicine, cardiology, and neurology

Exclusion Criteria:

* Admission after cardiopulmonary arrest
* Inability to obtain informed consent
* Existence of an extubation order at the time of the evaluation
* Dependence upon mechanical ventilation for 2 weeks prior to enrollment

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk
Brief Summary: The purpose of this study is to determine whether maternal periodontal therapy (tooth cleaning) decreases the rate of preterm deliveries at \<37 weeks gestation and to determine the effects of maternal periodontal therapy on the birth weight of infants born less than 37 weeks gestation.


Options:
A: Inclusion Criteria:

* Willing to be randomized and complete treatment protocols and provide informed consent
* Planning on prenatal care and delivery at the enrollment center
* Pregnant and able to complete periodontal treatment prior to 236 weeks gestation
* At least 16 years old at enrollment
* Minimum of 20 teeth present
* Three (3) or more periodontal sites with \> 3mm clinical attachment loss

Exclusion Criteria:

* Multiple gestation
* Positive history of HIV infection, AIDS, autoimmune disease, or diabetes (gestational diabetes is acceptable)
* Any medical contraindication to periodontal probing or periodontal treatment that would require antibiotic prophylaxis, (e.g., congenital heart disease, use of Phen- fen for weight loss without a clear
B: Inclusion Criteria:

* Gestational age between 6 and 20 completed weeks

Exclusion Criteria:

* Periodontal treatment during the pregnancy
* Antibiotic use within 2 weeks of enrollment
* Use of antimicrobial mouthwash within 2 weeks
* Multiple gestation
* Known mitral valve prolapse
C: Inclusion

* Be pregnant in the first 13-16 weeks of gestation as determined by menstrual history and obstetrical ultrasound
* Be at least 16 years of age
* Have at least 20 natural teeth,
* Have bleeding on probing (BOP) on at least 35% of all tooth sites
* Have 4 or more teeth with pockets greater than or equal to 4 mm and attachment loss greater than or equal to 2 mm

Exclusion

* Are unable to provide informed consent or are unable to cooperate with the study protocol.
* May be placed at medical risk as a result of participation (i.e. subjects with hematologic disease or other disorders tha preclude routine non-surgical periodontal therapy).
* Have multiple fetuses as diagnosed by ultrasound.
* Require antibiotic prophylaxis for periodontal procedures
* Require greater than 3 essential dental care visits because of extensive decay and/or broken teeth and are likely to have less than 20 natural teeth following essential dental care
D: Inclusion Criteria:

* Pregnant women, with single pregnancies, between 12 and 20 weeks gestation
* Periodontal disease defined as periodontal pocketing at a threshold of 4mm or more at 10% or more of sites
* Agree to receive periodontal treatment

Exclusion Criteria:

* Unable to attend for treatment
* Less than 16 years of age
* Have a fetus with an abnormality that predisposes the pregnancy to pre-term birth
* Multiple pregnancy
* Cardiac disease that would require antibiotic therapy
* Have fewer than 20 teeth
* Present for antenatal care after 20 weeks gestation
* Unable to understand the implications of participation in the trial
* Currently receiving periodontal treatment

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia
Brief Summary: Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.


Options:
A: Inclusion Criteria:

* patient who completed the 3-month F02207 GE 302 study
* patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study

Exclusion Criteria:

* known hypersensitivity to milnacipran
* major depressive episode
* significant risk of suicide
* generalised anxiety disorder
* substance abuse
* clinically significant cardiac disease
* pulmonary dysfunction
* active liver disease
* renal impairment
* autoimmune disease
* current systemic infection
* epileptic
* active cancer
* severe sleep apnoea
* active peptic ulcer
* inflammatory bowel disease
* unstable endocrine disease
* (for men) prostatic enlargement or other genito-urinary disorders
* (for women) pregnancy or breastfeeding
B: Inclusion Criteria:

* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
* Patients must have a score of \>40 mm on the Visual Analog Scale

Exclusion Criteria:

* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.
C: Inclusion Criteria:

* ACR criteria for fibromyalgia
* A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries

Exclusion Criteria:

* Patients with other severe pain conditions
* Patients with severe depression
* Patients taking excluded medications
D: Inclusion Criteria:

* Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

* Psychiatric illness
* Depression
* Suicidal risk
* Substance abuse
* Pulmonary dysfunction
* Renal impairment
* Active cardiac disease
* Liver disease
* Autoimmune disease
* Cancer
* Sleep apnea
* Inflammatory bowel disease

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse: The Extended Colpopexy and Urinary Reduction Efforts (E-CARE) Study
Brief Summary: The Colpopexy and Urinary Reduction Effort (CARE) trial is a research study designed to evaluate whether the addition of a second surgical procedure in addition to a procedure for female pelvic organ prolapse (POP) affects the rates of urinary incontinence. This study will follow women in the CARE study for 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in CARE. Recruitment into CARE is closed.


Options:
A: Inclusion Criteria:

* Greater than 18 years of age

Exclusion Criteria:

* Prior sacral colpopexy or rectopexy

Contraindication to surgery based on co-existent medical condition

Desire for expectant management or pessary use

Pregnancy or the desire for pregnancy within 24 months of the sacral colpopexy procedure
B: Inclusion Criteria:

* Women enrolled in CARE

Exclusion Criteria:

* Inability to provide informed consent.
* Subjects who, at the time of enrollment into E-CARE, are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation).
C: Inclusion Criteria:

* Women who are 21 years of age or greater
* Status post hysterectomy with apical vaginal prolapse POPQ stages II-IV (prolapse from 1cm proximal to the hymen to all points distal) that desire laparoscopic surgical management.

Exclusion Criteria:

* Patients that are not candidates for general anesthesia
* Inability to consent
* History of prior sacralcolpopexy
* Suspicious adnexal masses or other factors that may indicate pelvic malignancy
* History of pelvic inflammatory disease
* Morbid obesity (body mass index greater than or equal to 40)
* History of prior or need for concomitant rectopexy with sigmoid resection.
D: Inclusion Criteria:

1. Stage II to IV pelvic organ prolapse
2. Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal
3. Vaginal bulge symptoms
4. Minimally invasive surgery is planned
5. Available for 12 months of follow-up
6. Able to complete study assessments
7. Able and willing to provide written informed consent

Exclusion Criteria:

1. Contraindication to laparoscopic or robotically assisted laparoscopic abdominal sacrocolpopexy
2. Subject wishes to retain her uterus (i.e., surgical assignment may involve removal of uterus, if not previously removed)

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Dose Response to Cranberry of Women With Recurrent UTIs
Brief Summary: The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).


Options:
A: Inclusion Criteria:

* At least two UTIs in the year prior to study entry
* Willing to use acceptable methods of contraception
* Willing to refrain from consuming other forms of cranberry supplementation

Exclusion Criteria:

* Current UTI
* Allergy to cranberry-containing products
* Active urinary stone disease
* Insulin-dependent diabetes
* Immunosuppressive disease
* Current corticosteroid use
* Intermittent or indwelling catheterization
* Pregnancy
B: Inclusion Criteria:

* Proven premature rupture of membranes
* less than 35 weeks of gestation with good obstetrical dating
* no suspicion of amnionitis
* signed informed consent

Exclusion Criteria:

* Known sensitivity / allergy to cranberries
* Women treated with warfarin
* Drug intolerance
C: Inclusion Criteria:

* Adults aged 18 to 70, with multiple sclerosis, neurologically stable for at least 3 months
* With an EDSS score ≥ 3
* Symptomatic bladder dysfunction: frequency, urgency, dysuria, incontinence (at least one of these symptoms), needing intermittent catheterization or not
* Ambulatory at inclusion
* Able to undergo evaluation
* Informed written consent

Non-inclusion Criteria:

* Regular consumption of cranberry within 3 months before inclusion
* Symptomatic urinary tract infection at inclusion
* Chronic renal failure (creatinin clearance \< 10ml/min)
* Patients with urinary permanent catheterization
* Patients with hyperuricemia and risk of uric acid lithiasis
* Patients with oral anticoagulant treatment (antivitamins K)
* Peptic ulcer
* Intolerance to cranberry and/or excipients
* Urinary tract infections antibioprophylaxis
D: Inclusion Criteria:

1. Previously essentially healthy
2. Newly acquired spinal cord injury, T12 level or higher
3. Receiving in-patient care on the rehabilitation ward.
4. Expected admission duration \>= 4 weeks
5. 16 years old or older

Exclusion Criteria:

1. Current or previous disorder that increases the risk of urinary tract infection including diabetes, urological disorder, previous operation on urinary tracts or kidneys, immune dysfunction
2. Severe head injury with impairment of cognitive function
3. Allergy to cranberry
4. Renal failure
5. Warfarin (Coumarin) treatment with unstable INR
6. Current symptomatic urinary tract infection

Answer: A