TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria: a Randomized Clinical Trial
Brief Summary: Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral malaria. However its administration is often not feasible due to lack of simple equipment or trained staff. When referral is not possible, a viable alternative is needed. The intrarectal route is of interest in children since it is painless and simple. Studies of the efficacy of intrarectal quinine in the treatment of cerebral malaria are limited. The study aims to establish the efficacy of intrarectal quinine in the treatment of childhood cerebral malaria.


Options:
A: Inclusion Criteria:

1. Age between 3 months and 5 years at enrolment.
2. Informed consent obtained from parents or legal guardians.
3. No current participation in another malaria intervention trial.

Exclusion Criteria:

1. Previous adverse reaction to treatment with SP or amodiaquine. If this is unknown, then a history of allergic reaction to any drug.
B: Inclusion Criteria:

1. Age between 3 months and 59 months at enrolment.
2. Informed consent obtained from parents or legal guardians.
3. No current participation in another malaria intervention trial
4. Permanent residence in the study area with no intention of leaving during the surveillance period.

Exclusion Criteria:

1. Previous adverse reaction to treatment with SP, amodiaquine or Coartem. If this is unknown, then a history of allergic reaction to any drug.
2. Temporary residence in the study area
3. Lack of informed consent
4. Presence of a severe, chronic illness such as severe malnutrition or AIDS, likely to interfere with evaluation of the trial results.
C: Inclusion Criteria:

* Children aged 6 months to 5 years admitted to Mulago hospital during the study period who satisfy the World Health Organization (WHO) case definition of cerebral malaria (Unarousable coma lasting more than 30 minutes after a seizure, with peripheral asexual P.falciparum parasitaemia and absence of other causes of coma) and whose caretakers give informed consent.

Exclusion Criteria:

* Patients with diarrhea (more than 4 motions/24 hours)
* Any recent anal pathology (such as rectal bleeding, rectal prolapse)
* Documented quinine treatment in previous 48 hours.
D: Inclusion Criteria:

* permanent resident of the research area
* age \>1 years

Exclusion Criteria:

* severe anemia
* pregnancy

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria: a Randomized Clinical Trial
Brief Summary: Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral malaria. However its administration is often not feasible due to lack of simple equipment or trained staff. When referral is not possible, a viable alternative is needed. The intrarectal route is of interest in children since it is painless and simple. Studies of the efficacy of intrarectal quinine in the treatment of cerebral malaria are limited. The study aims to establish the efficacy of intrarectal quinine in the treatment of childhood cerebral malaria.


Options:
A: Inclusion Criteria:

1. Age: 3 months to 9 years.
2. Haemoglobin concentration 7g/dl on admission to hospital.
3. Residence within 30 km of the study centre and availability for the duration of the study period.
4. Informed consent to participate in the study given by the parent or guardian.

Exclusion Criteria:

1. Simultaneous participation in any other trial.
2. Allergy to sulpha drugs.
3. Residence \> 30 km from the recruitment site.
4. Lack of consent.
B: Inclusion Criteria:

* Children aged 6 months to 5 years admitted to Mulago hospital during the study period who satisfy the World Health Organization (WHO) case definition of cerebral malaria (Unarousable coma lasting more than 30 minutes after a seizure, with peripheral asexual P.falciparum parasitaemia and absence of other causes of coma) and whose caretakers give informed consent.

Exclusion Criteria:

* Patients with diarrhea (more than 4 motions/24 hours)
* Any recent anal pathology (such as rectal bleeding, rectal prolapse)
* Documented quinine treatment in previous 48 hours.
C: Inclusion Criteria:

* Enrolled in primary school, and attending regularly
* Enrolled in nursery or classes 1-7
* Informed consent from parent or guardian

Exclusion Criteria:

* Enrolled in primary class 8
* Haemoglobin level below 70g/L at baseline
* History of reaction to sulfa drugs (e.g. fansidar, septrin)
* History of severe skin reaction to any drug

Withdrawal criteria:

* Withdrawal of parental consent
* Haemoglobin level falling below 70g/L
* Severe adverse reaction to treatment
D: Inclusion Criteria:

* Age 6 months to 10 years
* Agree to seek initial medical care for all medical illness in the study clinic during the study period
* Written informed consent by a parent or legal garden,
* No plan to travel for a long time during the study period.

Exclusion Criteria:

* History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine
* Chronic illness or symptomatic malaria at the time of enrollment

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Misoprostol for Preventing Postpartum Hemorrhage
Brief Summary: This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =\>500 mls within one hour after enrollment.


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:

* 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
C: 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
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: Evaluation of the Efficacy of the Opioid Antagonist Naltrexone on the Incidence and Intensity of Flashbacks and Dissociative States in Patients With Borderline Personality Disorder
Brief Summary: The purpose of this study is to investigate whether naltrexone reduces the intensity and duration of flashbacks and dissociative states in patients with borderline personality disorder.


Options:
A: Inclusion Criteria:

* In- and Outpatients:Borderline personality disorder according to the Diagnostic and Statistical Manual for Mental Disorders, 4.Edition (DSM IV)
* DES-(Dissociative Experience Scale)-score: \> or equal 18 according to amendment4 (former value according to amendment 2 was \> or equal 25).
* Urinary test of opiates negative
* No psychopharmacological treatment for two weeks prior to study (fluoxetine four weeks)
* No Lithium for two months

Exclusion Criteria:

* Lifetime diagnosis of psychotic disorder
* Current major depressive disorder (MDD)
* Lifetime diagnosis opioid dependence or current opioid abuse (10 to 7 days prior to study)
* Comedication with opioid analgetics
* Known naltrexone intolerance
* Liver disease
* Pregnancy and lactation period
* Other severe medical or neurological diseases
* Simultaneous participation in another study
B: Inclusion Criteria:

* Diagnosis of AD
* Diagnosis of BPD

Exclusion Criteria:

* Serious or unstable medical condition
* Opiate dependence
* Major Axis I disorder (bipolar disorder, schizophrenia)
* Taking mood stabilizers and antipsychotic medications
* LFT abnormalities that do not exceed 3 times normal values
C: Inclusion Criteria:

* Meeting the diagnostic criteria for BPD according to DSM-IV criteria
* Meeting the diagnostic criteria for BPD based on the Diagnostic Interview for Borderline - Revised
* Currently receiving psychotherapy.
* English language proficiency to understand written and oral communication

Exclusion Criteria:

* Active suicidality or suicidal intent as identified on the Columbia Suicide Severity Rating Scale
* Suicide attempt within the past month
D: Inclusion Criteria:

* DSM-IV Borderline Personality Disorder;
* between 18 and 65 yrs of age

Exclusion Criteria:

* DSM-IV psychotic disorders,
* mental retardation,
* substance abuse in the forefront

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Tolerability of Fluvastatin in Adults With Dislipidemia With History of Muscle Problems Due to Other Previous Statin Intake
Brief Summary: The purpose of the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.


Options:
A: Inclusion Criteria:

* Dyslipidemia
* History of Myalgia

Exclusion Criteria:

* Previous treatment with fluvastatin
* Age \< 18 years

Other protocol-defined inclusion and exclusion criteria may apply.
B: Inclusion criteria:

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).

Exclusion criteria:

* Age \< 18 or legal age of adulthood, whichever was greater
* Participants without established CHD or CHD risk equivalents
* LDL-C \<70 mg/dL (\<1.81 mmol/L) and participants with a history of documented cardiovascular disease
* LDL-C \<100 mg/dL (\<2.59 mmol/L) and participants without a history of documented CV disease
* Fasting serum triglycerides \>400 mg/dL (\>4.52 mmol/L)

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
C: Inclusion Criteria:

* Signed written informed consent,
* 30 to 85 years old,
* Plan to undergo PCI and LDL-C \>= 100 mg/dL

Exclusion Criteria:

* Familial hypercholesterolemia
* Being treated with Zetia (Ezetimibe)
* Being treated with Fibrates
* Renal insufficiency (serum creatinine \>= 2.0 mg/dl)
* Altered hepatic function (serum aspartate aminotransferase or alanine aminotransferase \>= 3-folds of standard value in each institute)
* Undergoing hemodialysis or peritoneal dialysis
* Allergic to Lipitor and/or Zetia
* Severe underlying disease
* Lack of decision-making capacity
* Recognized as inadequate by attending doctor
D: Inclusion Criteria:

* Must be treated with atorvastatin 40 mg/day for at least 30 days prior to screening
* Have an LDL-C \>70 mg/deciliter(dL) or non-HDL-C \>100 mg/dL
* Have screening triglycerides ≤400 mg/dL (≤4.5 millimoles/Liter)
* Individuals with ASCVD and/or individuals with type 1 or type 2 diabetes

Exclusion Criteria:

* Have a hemoglobin A1c (HbA1c) \>9.5%
* New York Heart Association (NYHA) class III or IV congestive heart failure
* History of either a transient ischemic stroke or ischemic stroke \<30 days
* History of acute coronary syndrome (ACS) \<30 days

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Tolerability of Fluvastatin in Adults With Dislipidemia With History of Muscle Problems Due to Other Previous Statin Intake
Brief Summary: The purpose of the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.


Options:
A: Inclusion Criteria:

* Acute coronary syndrome
* Adults, 18 years and older

Exclusion Criteria:

* History of lipid lowering therapy less than 30 days before index event
* Pregnancy and nursing
* Subject younger than 18 years

Other inclusion and exclusion criteria may apply.
B: Inclusion Criteria:

* Patients with CHD or CHD equivalent with LDL 100-160 mg/dl
* Male or female sex
* Normal values of CK, AST and ALT
* Normal kidney function

Exclusion Criteria:

* CHD Stage III-IV
* St. p. myocardial infarction or coronary artery bypass grafting
* Pregnancy or breastfeeding
* Premenopausal women without certain contraception
* Known hypersensitivity to HMG-CoA reductase inhibitors or ezetimib
C: Inclusion Criteria:

* Dyslipidemia
* History of Myalgia

Exclusion Criteria:

* Previous treatment with fluvastatin
* Age \< 18 years

Other protocol-defined inclusion and exclusion criteria may apply.
D: Inclusion Criteria:

* Renal transplant recipients with stable renal function (plasma creatinine \< 200 µmol/L)
* Renal transplant recipients on an everolimus and fluvastatin based therapy for minimum 3 months prior to inclusion
* \> 18 years of age
* Male patient or female patient without childbearing potential (surgically sterilized or postmenopausal) or if female of childbearing potential; is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 days following discontinuation of the study drugs
* Signed informed consent

Exclusion Criteria:

* Patients experiencing an acute rejection episode within 2 weeks before or after inclusion, whether proven by biopsy or not
* Patients with a known hypersensitivity to rosuvastatin
* Change in enzyme inducing or inhibiting drugs within the last 2 weeks prior to and throughout the study \[e.g. barbiturates, rifampicin, ketoconazole, erythromycin, cimetidine and similar drugs\]
* Pregnant or nursing mothers

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers
Brief Summary: The purpose of this study is to determine whether chest physiotherapy with forced expiratory technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24 months of age.


Options:
A: Inclusion Criteria:

* Child aged 15 days to 24 months
* First acute bronchiolitis
* Indication of hospitalisation
* One or more of these criteria : toxic aspect; apnea or cyanosis; respiratory rate \> 60/min; pulse oxymetry \< 95%; alimentary intake \< 2/3 of the needs.

Exclusion Criteria:

* Prematurity (gestational age \< 32 weeks)
* Brondysplasia
* Chronic lung disease or congenital heart disease
* Respiratory distress necessitating admission in the Pediatric Intensive Care Unit (PICU)
* 3 or more chest physiotherapy procedures since hospitalisation
* Parental refusal
* Any chest physiotherapy contra-indication
B: Inclusion Criteria:

* Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis

Exclusion Criteria:

* presence of comorbidities, such as cystic fibrosis, neuromuscular, congenital heart disease, prematurity or respiratory distress and all the cases that were admitted into the hospital
C: Inclusion Criteria:

* acute viral bronchiolitis diagnosis
* indication for hospital admission

Exclusion Criteria:

* history of lung disease related to prematurity (bronchopulmonary dysplasia)
* heart diseases
* chronic lung diseases (cystic fibrosis)
* pneumonia
* unstable hemodynamic process (ARDS or sepsis)
* subcutaneous edema
* admission to the intensive care unit
* need for mechanical ventilation or tracheostomy
* neurological diseases
D: Inclusion Criteria:

* Clinical diagnosis of acute viral bronchiolitis
* RSV positive

Exclusion Criteria:

* Heart diseases
* Chronic lung disease
* Neurological diseases
* Parental refusal
* Previous wheezing episode
* ventilatory support

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this trial is to determine whether a conservative or a liberal blood transfusion strategy is better for patients with a heart attack and a low blood count.


Options:
A: Inclusion Criteria:

* Patients 65 years and older.
* Osteoporotic hip fracture which require surgical intervention
* Haemoglobin levels between 90-120 g/L
* Signed informed consent form

Exclusion Criteria:

* Bone marrow diseases which could interfere in the erythropoietic process (acute or chronic myelodysplastic syndromes or myeloproliferative diseases, and/or infiltration of the bone marrow due to solid or lymphatic neoplasms)
* Blood coagulation diseases or currently treated with oral anticoagulants and/or heparin at therapeutic doses.
* Documented allergy and/or previous intolerance and/or contraindication of erythropoietin use and/or intravenous iron.
* Patients with rheumatoid arthritis and/or another demonstrated origin of inflammatory anemia and/or not controlled arterial hypertension.
B: Inclusion Criteria:

* Documented cancer
* Planned treatment with chemotherapy
* Age older than 18 years
* Informed consent

Exclusion Criteria:

* Heart failure (NYHA 3 and 4)
* Prior serious complications to blood transfusion
* Medical conditions that require special considerations for blood transfusion
* Treatment with erythropoiesis-stimulating agents
C: Inclusion Criteria:

All of the following must be present:

* Acute myocardial infarction with presentation within 72 hours of randomization (acute myocardial infarction is defined as ischemic-type chest discomfort lasting at least 30 minutes associated with creatinine kinase MB (CKMB) or troponin \>upper limit of normal \[ULN\])
* Admission to CCU
* Hematocrit .30 or less
* Written, informed consent

Exclusion Criteria:

* Inability or unwillingness to receive red cell transfusions
* Active bleeding (overt blood loss accompanied by a decrease in hematocrit of at least 5% in the preceding 12 hours)
* Receipt of red cell transfusion within 7 days of randomization
* Prior severe transfusion reaction
* Pregnancy
* Imminent death
* Decision to provide limited care
* Age \<21
* Participation in another clinical trial in which blood transfusion is a requirement or a component of a primary or secondary endpoint
* Previous participation in the CRIT Pilot
D: Inclusion Criteria:

* Patient in the ICU AND
* Fulfil the criteria for septic shock AND
* Have haemoglobin of 9.0 g/dl (5.6 mM) or less AND
* Consent obtainable from patient or proxy or national law allows delayed consent

Exclusion Criteria:

* Documented wish against transfusion OR
* Previous serious adverse reaction with blood product OR
* Acute coronary syndrome OR
* Life-threatening bleeding OR
* RBC transfusion during current ICU admission OR
* Withdrawal from active therapy or brain death OR
* Lack of informed consent (depending on national law) OR
* Acute burn injury regardless of degree and burn surface area

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: VISN 23 Lung Disease Self Management/Case Management Program
Brief Summary: The purpose of this study is to determine if a program of self management and case management reduces hospitalizations and urgent care visits for patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Inclusion Criteria:

* People diagnosed with COPD or diabetes type 2 who are predominantly treated in primary care and who benefit from more physical activity, will be included. -This means patients who do not comply with the Dutch Norm for Healthy Exercise (30 minutes activity per day of a moderate intensity during five days a week)
* Their age should be between 40-70 years to ensure homogeneity in the groups
* Additional inclusion criteria for the diabetes group are a recent (no longer than a year ago) HbA1c concentration of more than 7% / more than 53 mmol/mol and a body mass index of more than 25kg/m2

For the COPD group the following additional inclusion criteria apply:

-A clinical diagnosis of COPD according to the GOLD-criteria stage 1, 2 and 3 (post bronchodilator FEV1/IVC \<= 70% and FEV1 between 30 and 80% of the predicted value); at least six weeks respiratory stable and on a stable drug regimen

Exclusion Criteria:

-Patients older than 70 years are not included because of a bigger risk for co-morbidity and a higher chance of mobility problems (balance)
B: Inclusion Criteria:

* Male or female participants aged ≥40 years
* Full-time resident in the area (living in area \> 6 months)
* Able to perform adequate quality spirometry
* Capable of providing informed consent

Exclusion Criteria:

* Pregnancy (self-reported)
* Currently has active pulmonary TB or is taking medications for pulmonary TB
C: Inclusion Criteria:

One or more of the following:

* Hospital admission for COPD within the prior year
* Unscheduled visit for COPD within the prior year
* Home oxygen use for COPD
* Systemic steroid use for COPD within the prior year
* Post bronchodilator FEV1 \< 70% predicted
* Post bronchodilator FEV1/FVC \< 70% predicted

Exclusion Criteria:

* Any unstable medical condition that would preclude effective participation in the study, or which would be expected to reduce life expectancy to \< 1 year
* Inability to contact patient by telephone
D: Inclusion Criteria:

* diagnosis of COPD with the presence of an AECOPD
* Age \> 40
* Current or ex-smoker with history of at least 20 pack-years

Exclusion Criteria:

* Past history of asthma, interstitial lung disease, bronchiectasis, presence of airway hardware (e.g. tracheal stents or tracheotomy), lung cancer, any other cancer with a life expectancy of less than 1 year
* Presence of a language barrier
* Residence in a nursing home
* Intensive care unit stay during the current admission
* Delirium or dementia.

Answer: C