TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.


Options:
A: Inclusion Criteria:

* Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
* Post-salbutamol (FEV1) \< 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%.
* Current or ex-smokers of ≥10 pack-years.

Exclusion Criteria:

* Patients with no history or current diagnosis of asthma.
* No evidence of an exacerbation within 6 weeks prior to the screening visit.
* No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
B: Inclusion Criteria (selected):

* \> 40 years of age
* History of COPD
* Forced expiratory volume in 1 second (FEV1) \</= 70% of predicted and FEV1/Forced vital capacity (FVC) \</= 0.7 value at screening
* Have at least two acute exacerbation episodes in the proceeding year
* Clinically stable with no changes in health status within the last 30 days
* Lifetime smoking history of at least 10 pack-years
* Willing and able to use a daily electronic diary

Exclusion Criteria (selected):

* Use of any systemic or inhaled antibiotics within 30 days prior to baseline
* History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
* Creatinine clearance \< 40 mg/ml/min, AST, ALT \>/= 5 x upper limit of normal (ULN) or total bilirubin \>/= 3 x ULN at Screening
C: Inclusion Criteria:

* Diagnosis of COPD with symptoms over 1 year
* FEV1/FVC \< 70% and FEV1 \>= 30 and \< 80 % of predicted post-bronchodilator
* Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation
* At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit

Exclusion Criteria:

* Past history or current evidence of clinically significant heart disease
* Current diagnosis of asthma
* Patients who require long term oxygen therapy
* Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
D: Inclusion Criteria:

* Diagnosis of COPD with symptoms over 1 year
* Smokers or ex-smokers
* Males or post-menopausal females between 40 and 80 years old
* Able to use electronic devices

Exclusion Criteria:

* Past history or current evidence of clinically significant heart disease
* Current diagnosis of asthma
* Patients who require long term oxygen therapy
* Treatment with antibiotics within 4 weeks of study visit 1b

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Fit For Delivery: A Study of the Effect of Exercise Intervention and Nutritional Counselling on Pregnancy Outcome.
Brief Summary: "Fit for Delivery" is a randomized, controlled study to examine the effects of an intervention during pregnancy which consists of exercise groups and nutritional counselling. The investigators will assess the outcomes of gestational weight gain, postpartum weight retention, large newborns, glucose regulation, and the incidence of complications of pregnancy and delivery such as gestational diabetes and Cesarean section.


Options:
A: Inclusion Criteria:

* Pregnant, African American, Socioeconomically disadvantaged
* Established prenatal care at our clinic before 15-6/7 weeks gestation
* Singleton viable pregnancy
* Gestational age 9 to 15 weeks
* Body Mass Index (BMI) of 25-45 kg/m²

Exclusion Criteria:

* Diagnosis of diabetes prior to pregnancy, or test results suggestive of pre-pregnancy diabetes
* Current use of certain medications
* Contraindications to aerobic exercise in pregnancy
* History of contraindicated medical conditions
B: Inclusion Criteria:

* Pregnancy \< 20 weeks.
* Expressed interest in study and willingness to consent to participate in the study.

Exclusion Criteria:

* Obstetric or medical contraindications for exercise according to 2002 SOCG guideline (ruptured membranes, preterm labor, incompetent cervix, hypertensive disorders of pregnancy, growth restricted fetus, placenta previa, persistent bleeding in 2nd or 3rd trimester, significant metabolic, cardiovascular, respiratory or systemic disorder) (5, 6).
* Pre-existing diabetes (except a history of GDM, but not in current pregnancy).
* Multiple gestations.
C: Inclusion Criteria:

* BMI 30 or more
* Less than 20 weeks gestation
* member of Kaiser Permanente Northwest (NW)
* receive pre-natal care at Kaiser Permanente NW
* speaks English

Exclusion Criteria:

* no current treatment for cancer
* no bariatric surgery
* no current renal disease
* no multiple birth anticipated
* no hyperemesis requiring hospitalization
* no diabetes (type 1 or 2)
D: Inclusion Criteria:

* Expecting first child
* Gestational weeks 12-20
* Residence in one of the following towns: Kristiansand, Søgne, Sogndalen, Vennesla, Lillesand, Mandal

Exclusion Criteria:

* Twin or other multiple pregnancy
* Preexisting diabetes
* Physical handicap which precludes participation in exercise groups
* Ongoing drug addiction
* Serious mental disorder
* BMI at or below 19 before pregnancy
* Inability to read/write Norwegian or English

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome
Brief Summary: The aim of the investigators study was to evaluate the effectiveness of a home programme (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated with CPAP and to analyze the cost of this approach.


Options:
A: Inclusion Criteria:

* self-reported race/ethnic minority
* ages ≥18 years
* accessible by telephone
* consent to participate, which includes permission to release medical record information
* A positive screening for OSA is necessary to be enrolled in the intervention protocol.

Exclusion Criteria:

* are involved in another sleep study.
* are unable to understand and sign this informed consent form.
* know someone who is participating in this study.
* had a heart attack or stroke within the past 12 weeks.
* do not identify yourself as a racial/ethnic minority.
* are pregnant.
* Refuse to use the ARESTM home sleep test device.
* Refuse to use the WatchPATTM home sleep test device.
* are not at risk for sleep apnea.
B: Inclusion Criteria:

* Patients aged \> 18 years of age who are referred to the University of Chicago sleep laboratory for split-night polysomnography by a non-sleep physician and who have a consultation appointment with a sleep physician following the appointment
* Have not had prior contact with a sleep physician or prior exposure to CPAP therapy.

Exclusion Criteria: Subjects will be excluded for any of the following characteristics: -Non-English speaking

* Illiterate
* Sleep study is negative for sleep apnea (apnea-hypopnea index \< 5 events/hr)
* Subject does not undergo CPAP titration during the in-laboratory polysomnogram
* Subject does not have a working telephone number
* Poor eyesight or hearing
* Dementia
C: Inclusion Criteria:

1. Snoring or apneas objectively observed during sleep by a partner;
2. Symptoms that are potentially secondary to apneas/hypopneas with an intermediate-high probability of being treated with CPAP. In operative terms, Epworth scale ≥12 or previous cardiovascular disease;
3. Age between 18 and 70 years;
4. Absence of any clinical suspicion of any other sleep pathology susceptible to coinciding with daytime sleepiness.

Exclusion Criteria:

1. Psycho-physical incapacity to complete questionnaires;
2. Documented structural or coronary heart disease uncontrolled by any medical treatment;
3. Cheyne-Stokes syndrome;
4. Patients subjected to uvulopalatopharyngoplasty;
5. Significant nasal obstruction impeding the use of CPAP;
6. Pregnancy;
7. Lack of informed consent.
D: Inclusion criteria:

Patients with high probability of OSA, defined by two or more of :

* daytime sleepiness
* snoring
* recognized apnoeic episodes
* associating obesity and / or hypertension

Exclusion Criteria:

* Patients with impaired lung function ( overlap syndrome, obesity-hypoventilation syndrome, restrictive disorders), associated pathology (psychiatric disorder, periodic limb movements, dyssomnias or other parasomnias)
* Patients treated with CPAP

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children
Brief Summary: Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas.

The primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area.

The value of performing this research in Ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.


Options:
A: Inclusion Criteria:

* Age 6-24 months
* Ingesting weaning food in addition to breastmilk
* Free from malaria or other major illnesses
* Afebrile
* Living in Brong Ahafo Region of Ghana for duration of intervention and follow-up

Exclusion Criteria:

* Severe anemia (hemoglobin \<70g/L)
* Weight-for-height \<-3 z-score(severe wasting)
* Kwashiorkor (defined as evidence of edema)
* Congenital abnormality
* Treatment with iron supplements within the past 6 months
* Presence of any chronic illness
B: Inclusion Criteria:

* Mothers of 6 to 23 months old children
* Reside in the study area
* Accept to use MNP

Exclusion Criteria:

* Mothers of children aged less than 6 months or more than 23 months.
* Refusal
C: Inclusion Criteria:

* Age of 6-14 months at baseline
* Assessment of good health as assessed by professional staff at Msambweni District Hospital
* Willingness of their caregiver to provide informed consent

Exclusion Criteria:

* Hemoglobin \<70 g/L ; these infants will be referred for treatment according to local standard of care.
* Severe underweight (Z-score weight-for-age \<-3) and /or severe wasting (Z-score weight-for-height\<-3)
* Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
* Participants taking part in other studies requiring the drawing of blood
* Participants who are taking iron-containing food supplements or tablets/drops
* Participants who are taking antibiotics
D: Inclusion Criteria:

* Guatemala: pregnant mothers and subsequently their born children up to the age of 24 months;
* Burundi: cross-sectional study: children 0 to 42 of age.

Exclusion Criteria:

* none

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children
Brief Summary: Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas.

The primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area.

The value of performing this research in Ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.


Options:
A: Inclusion Criteria:

* Mother at least ≥15 years of age, infants 5.5- 6.5 months
* Willingness to provide informed consent
* Apparent good health
* Long-term residence in study site and anticipating residing in the area for at least 3 years
* Speak a Mjikenda language or Kiswahili in the home
* Willingness to provide blood samples during clinic visits

Exclusion Criteria:

* Hemoglobin \<70 g/L for infants; these infants will be referred for treatment at the local health clinic/hospital.
* Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition or any other finding that in the opinion of the PI or co-researchers that would increase risk of participating in the study.
* Other conditions that in the opinion of the PI or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
B: Inclusion Criteria:

* Age 6-36 months at the time of enrollment
* Live within the study area for the duration of the intervention and follow-up period

Exclusion Criteria:

* Unavailable for enrollment on 3 separate household visits
* Parental refusal to give informed consent
C: Inclusion Criteria:

* Age 6-24 months
* Ingesting weaning food in addition to breastmilk
* Free from malaria or other major illnesses
* Afebrile
* Living in Brong Ahafo Region of Ghana for duration of intervention and follow-up

Exclusion Criteria:

* Severe anemia (hemoglobin \<70g/L)
* Weight-for-height \<-3 z-score(severe wasting)
* Kwashiorkor (defined as evidence of edema)
* Congenital abnormality
* Treatment with iron supplements within the past 6 months
* Presence of any chronic illness
D: Inclusion Criteria:

* All pregnant women
* All lactating mothers (upto 6 months)
* All children 6-23 months of age
* All children 24-59 months of age

Exclusion Criteria:

* Refuse to participate in the study
* Having severe chronic disease

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children
Brief Summary: Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas.

The primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area.

The value of performing this research in Ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.


Options:
A: Inclusion Criteria:all schoolchildren, in grade 2 and 3, at four selected schools -

Exclusion Criteria:

-
B: Inclusion Criteria:

* All children 1-35 months of age living in 30 Village Development Committees of Sarlahi District in southern Nepal.

Exclusion Criteria:

* Parent refusal
C: Inclusion Criteria:

* Age 6-24 months
* Ingesting weaning food in addition to breastmilk
* Free from malaria or other major illnesses
* Afebrile
* Living in Brong Ahafo Region of Ghana for duration of intervention and follow-up

Exclusion Criteria:

* Severe anemia (hemoglobin \<70g/L)
* Weight-for-height \<-3 z-score(severe wasting)
* Kwashiorkor (defined as evidence of edema)
* Congenital abnormality
* Treatment with iron supplements within the past 6 months
* Presence of any chronic illness
D: Inclusion Criteria:

* Children aged 12 to 16 years
* Body weight \> 30 kg
* no chronic medical illnesses
* no intake of vitamin/mineral supplements 2 weeks before the study and until the last blood drawing
* For each of the 4 arms the respective disease needs to be present (symptomatic malaria, asymptomatic malaria, hookworm infection, S. haematobium infection) without any other concurrent infection

Exclusion Criteria:

-

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women
Brief Summary: The purpose of this study is to evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before.


Options:
A: Inclusion Criteria:

- nulliparous women with no previous history of IUD use

Exclusion Criteria:

* malformation of uterus
* myomas
* acute gynecological infection
* malignant uterine or cervical tumor

In addition if requesting a Cu-IUD

* heavy menstruations
* iron deficiency
* bleeding disorder
* copper allergy or Wilson's disease
B: Inclusion Criteria:

* Nulliparous, no prior pregnancy beyond 14 week
* Over 18 years of age
* Negative pregnancy test

Exclusion Criteria:

* current pregnancy or pregnancy within 6 weeks
* current cervicitis or PID (active or within 3 months)
* undiagnosed abnormal uterine bleeding
* allergy to copper/ Wilson's disease (for Paragard)
* cervical or uterine cancer
* uterine anomaly altering uterine cavity
C: Inclusion Criteria:

* 18 years
* negative pregnancy test
* no prior pregnancy beyond 19 6/7 weeks
* no pelvic inflammatory disease in last 3 months
* no current cervicitis
* willing to follow up in 1-2 months

Exclusion Criteria:

* active cervical infection
* current pregnancy
* prior pregnancy beyond 19 6/7 weeks
* uterine anomaly
* fibroid uterus distorting uterine cavity
* copper allergy or wilson's disease for ParaGard
* undiagnosed abnormal uterine bleeding
* cervical or uterine cancer
* sepsis associated with the most recent pregnancy
* current breast cancer for levonogestrel IUD
* inflammatory bowel disease
* allergy to misoprostol
D: Inclusion Criteria:

* age 18-45,
* Generally Healthy.
* requesting LNG-IUS for contraception as the primary indication

Exclusion Criteria:

* previous pregnancy beyond 20 weeks,
* previous IUD placement or attempted placement,
* allergy to nitroprusside,
* history of migraines,
* history of heart disease.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized prospective study.


Options:
A: Inclusion Criteria:

* Consent was given
* 15 years old or older
* Underwent acute appendicitis

Exclusion Criteria:

* Lack of follow up
* Younger than 15 years
* Not eligible according to physician decision
B: Inclusion Criteria:

* Adults ≥ 18 years of age.
* Chest pain for \< 12 hours
* ST-elevation Myocardial Infarction including either: 1) Persistent ST-segment elevation of ≥1mm in two contiguous limb leads; 2) ST-segment elevation of ≥ 2mm in two contiguous chest leads, or; 3) New left bundle branch block (LBBB) pattern.
* Able to be transported to a participating hospital

Exclusion Criteria:

* Hypoxia with oxygen saturation measured on pulse oximeter \< 94% with the patient breathing air
* Bronchospasm requiring nebulised salbutamol therapy using oxygen
* Altered conscious state
C: Inclusion Criteria:

* Witnessed out-of-hospital cardiac arrest with ventricular fibrillation (VF) or ventricular tachycardia (VT) as the initial rhythm
* Delay of return of spontaneous circulation (ROSC) 10-45 min from the start of the arrest
* Confirmed or suspected cardiac origin
* Mechanical ventilation
* Markedly impaired level of consciousness (no response to verbal commands and Glasgow coma scale \[GCS\] motor score \< 5)
* Deferred consent possible or likely
* Active intensive care initiated, including targeted temperature management (33-36 C)

Exclusion Criteria:

* Probable withdrawal of active ICU care due to terminal illness or poor prognosis because of severely reduced functional status before cardiac arrest
* Confirmed or suspected intracranial pathology and/or suspicion of raised intracranial pressure
* Pregnancy
* Severe oxygenation problem (PaO2 / FiO2 \< 100 mmHg)
* Severe COPD
D: Inclusion Criteria:

* patients with less than 6 hours septic shock according criteria of Bone
* minimal dose of catecholamines at least 0.1 µg/Kg/min
* patient with mechanical ventilation
* written informed consent

Exclusion Criteria:

* age \< 18 years
* pregnancy
* participation in other trial with the same endpoint
* moribund
* absence of registration in french health care system
* patient protected by law
* hypernatremia \< 130 mmol/l ou \> 145 mmol/l
* patient with P/F \< 100 mm Hg with PEEP \> 5 cms of water
* intracranial hypertension
* patient admitted for cardiac arrest
* overt cardiac failure

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized prospective study.


Options:
A: Inclusion Criteria:

* Consent was given
* 15 years old or older
* Underwent acute appendicitis

Exclusion Criteria:

* Lack of follow up
* Younger than 15 years
* Not eligible according to physician decision
B: Inclusion Criteria:

* mentally competent patients undergoing cesarean section under spinal or epidural anesthesia

Exclusion Criteria:

* fever/chorioamnionitis; GBS positive on antibiotics; immunocompromised / HIV patients; on antibiotics for any reason; general anesthesia; age less than 18 years custody patients stat cesarean section
C: Inclusion Criteria:

* Colon resection expected to last \>2 and \<6 hours

Exclusion Criteria:

* Bowel obstruction
* Fever
D: Inclusion Criteria:

* Age 18 years or older.
* Laparotomy, acute or elective. In case of gynaecological surgery only if malignancy is suspected (defined as risk of ovarian malignancy index \>200 or a specimen with atypical or neoplastic cells).

Exclusion Criteria:

* Other surgery within 30 days (except surgery in local anaesthesia).
* Chemotherapy within 3 months.
* Inability to give informed consent.
* Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry).

Answer: A