TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization
Brief Summary: In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.


Options:
A: Inclusion Criteria:

* Pregnant women with atopic disease, which was determined with atopic history, elevated total IgE \> 100 kU/l and positive specific IgE

Exclusion Criteria:

* Multiple pregnancy
B: Inclusion Criteria:

* Aged 6-10
* Attends Lake Primary School (Mwanza, Tanzania)

Exclusion Criteria:

* Allergic to milk/ milk products
* Lactose intolerant
C: Inclusion Criteria:

* Normal pregnancy
* Healthy women
* Lactational mastitis in, at least, a previous lactation period
* No symptomatic vaginal infections

Exclusion Criteria:

* Any kind of health problems related to pregnancy
* Symptomatic vaginal infections
* Allergy to cow's milk protein
* Intolerance to lactose
* Antibiotic treatment
D: Inclusion Criteria:

* Pregnant women from families with at least one family member having an allergic disease

Exclusion Criteria:

* Women presenting severe immunological or other chronic diseases (rheumatoid arthritis, diabetes, inflammatory bowel disease, thyroid diseases, malignancies etc.)
* Women who cannot be expected to comply with treatment
* Women currently participating or having participated in other clinical trial during the last 2 months prior to the beginning of the intervention.

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea: Double Blinded, Randomized, Placebo Drug Controlled, Parallel Designed, Multi-centered, Phase 2 Study
Brief Summary: The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.


Options:
A: Inclusion criteria:

* IBS subject meeting the Rome III criteria , with a discomfort or pain present more than 1 day per week in whom organic causes of their symptoms have been excluded
* IBS-C with less than 3 complete spontaneous bowel movements/week
* IBS-D with at least 2 or more days/week one stool which has consistency of type 6 or 7 Bristol stool score
* Subject able of and willing to comply with the protocol and to give their written informed consents

Exclusion criteria:

* History of chronic gastrointestinal disorders
* History of lactose intolerance
* History of gluten intolerance
* Treatment able to influence IBS, modifying intestinal sensitivity and motility (antidepressants,opioid, narcotic analgesics)
* Eating disorders
* Pregnancy in progress
B: Inclusion Criteria:

* Aged 18-75 years who satisfied RomeIII criteria for the diagnosis of IBS
* Signed informed consent

Exclusion Criteria:

* IBS-D
* evidence of cathartic colon or history laxative abuse
C: Inclusion Criteria:

* Healthy children

Exclusion Criteria:

* Any chronic or organic illness
D: Inclusion Criteria:

* Age 4-18years;
* Diagnosis of FD and IBS pain according to the Rome III criteria
* All parents or legal tutors must sign an informed consent document indicating their awareness of the investigational nature of this study.

Exclusion Criteria:

* Taking any other type of probiotic in the 2 months prior to enrollment
* Presence of intestinal motility disorders
* Presence of any other significant medical condition
* Presence of previous abdominal surgery
* Inability or unwillingness to give informed consent

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve
Brief Summary: To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.


Options:
A: Inclusion criteria:

1. Patients aged 18-75
2. Patients who have received a bileaflet mechanical heart valve

Exclusion criteria:

1. Prior valve surgery
2. Uncontrolled hypertension
3. severe renal impairment
4. active liver disease
5. increased risk of bleeding
B: Inclusion criteria:

1. Completed study 1160.113 per protocol
2. Continuing need for anticoagulation

Exclusion criteria:

1. uncontrolled hypertension
2. severe renal impairment
3. active liver disease
4. increased risk of bleeding
C: Inclusion Criteria:

* Patient aged 18 years and over followed at the Montreal Heart Institute's Anticoagulation clinic
* Warfarin treatment planned for at least 4 months after inclusion in the study
* Warfarin treatment initiated for at least 6 months
* Last 2 INRs between 1.5 and 4 if target INR is between 2 and 3
* Last 2 INRS between 2 and 4 if target INR is between 2.5 and 3.5
* Provide a signed informed consent

Exclusion Criteria:

* Patient unable to understand (spoken and written) French or English
* Patient refuses or is unable to attend the required training sessions
* Targeted INR other than 2 to 3 or 2.5 to 3.5
* Handicap or physical limitation compromising the patient's ability to initiate self-monitoring in the absence of a proxy helper
* Moderate to severe cognitive impairment or important comprehension problems
* Active neoplasm
* Concurrent chemotherapy
* Hypercoagulable conditions
* Life expectancy of less than 1 year documented in the medical chart
* Inclusion (at time of inclusion or 30 days prior to inclusion) in another research project involving a drug
* Patient anticoagulated with nicoumalone
* Pregnancy or breastfeeding
* Active bleeding (except for menses)
* Recent major bleeding (less than 3 months before inclusion)
* Stroke, acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft, cardiac valve replacement, deep veinous thrombosis or pulmonary embolism in the 3 months prior to inclusion
* Any other condition that, in the opinion of the investigators, of the treating physician or of the healthcare professionals working at the anticoagulation clinic could make self-management by the patient impossible
D: Inclusion Criteria:

* Over 18 years of age
* Anticoagulation to a target of 2.0-3.0
* Warfarin treatment for \> 3 months
* previous medication treatment adherence
* competence judged by demonstrable ability to utilize drug adjustment nomograms
* understand the basic theory of anticoagulation therapy

Exclusion Criteria:

* Coagulopathic disease
* significant psychiatric illness
* significant language barrier
* poor visual acuity

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).
Brief Summary: The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.


Options:
A: Inclusion Criteria:

* Women between 22-36 weeks of pregnancy who are diagnosed with GDM
* A diagnosis of GDM during the current pregnancy by two or more 100g Oral Glucose Tolerance Test (OGTT) values exceeding established thresholds (fasting 95, 1h 180, 2h 155, 3h 140 mg/dL)
* Age 18-45 years old
* A pre-pregnancy body mass index \> 25kg/m2

  * Ability to read and write in English
  * Willingness to consent for themselves and their infant

Exclusion Criteria:

* They have a A1c ≥ 6.5 mg/dL (Type 2 diabetes)
B: Inclusion Criteria:

* Gestational age between 24 and 26 weeks
* Diagnosis of GDM at the 75g oral glucose tolerance test (OGTT)
* Singleton pregnancy

Exclusion Criteria:

* Body mass index \> 40 or \< 12kg/m2
* Any known diseases (pre-existing diabetes mellitus, cardiovascular diseases, liver/kidney diseases, cancers, arterial hypertension)
* Patients on any drugs
C: Inclusion Criteria:

* history of gestational diabetes or overweight (\>25 kg/m2) with family history of type 2 diabetes
* sedentary

Exclusion Criteria:

* history of diagnosis of diabetes, hypertension, heart disease or chronic renal disease
* current medications which adversely influence glucose tolerance
* not planning to continue the pregnancy to term
* \>16 weeks gestation
* contraindications to participating in moderate physical activity
* inability to read English at a 6th grade level
* self-reported participation in \>30 min of moderate or vigorous-intensity exercise on \>3 days/wk
* prior participation in the study
* non-singleton pregnancy
D: Inclusion Criteria:

* GDM diagnosis will be based on International Association of the Diabetes in Pregnancy Study Group (IADPSG), Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study (2 h 75 g oral glucose tolerance test (OGTT): a fasting glucose ≥ 92 mg/dl or a one hour result of ≥ 80 mg/dl, or a two hour result of ≥ 153 mg/dl;
* Aging 18 to 35 years;
* Physically inactive (\< 150' per week based on International Physical Activity Questionnaire.

Exclusion Criteria:

* Kidney disease or collagenosis;
* Previous history of gestational diabetes;
* Diabetes type 1 or type 2;
* Hypertensive disorders related to pregnancy;
* Hemodynamic instability;
* Obstetric labor;
* Vaginal bleeding;
* Cognitive disorder, auditory, visual or motor severely limiting, attested by a medical specialist;
* Skin disorders who have a contraindication to the use of a swimming pool;
* Urinary tract infection;
* Be inserted in the program of regular exercise;

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Vitamin D Supplementation During Lactation on Vitamin D Status, Bone Mineralisation and Body Composition of Mother and Their Exclusively Breastfed Infants.
Brief Summary: The investigators would like to test the hypothesis that maternal vitamin D supplementation during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is more effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate maternal vitamin D status and could be beneficial for maternal and infants bone mineralization and body composition (proper proportion of muscle and fat tissues in body weight) and is safe for both.

The investigators also want to confirm that vitamin D supplementation of exclusively breastfed infants in dose 400IU/d is adequate to build appropriate vitamin D status independently of mother's vitamin D supplementation up to 1200 ID/d.

Additionally the investigators hypothesize that because of changes in lifestyle there will be no substantial seasonal differences in vitamin D status of pregnant women at the delivery and their newborn infants.


Options:
A: Inclusion Criteria:

* Preterm Infants (28-37 wk gestational age)
* Late-onset sepsis defined as clinical signs suggestive of infection after 72 h of birth. Clinical sepsis will be defined as the presence of three or more of the following categories of clinical signs:

  1. Temperature instability (hypothermia, hyperthermia);
  2. Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis);
  3. Neurologic (hypotonia, lethargy, seizures);
  4. Gastrointestinal (feeding intolerance, abdominal distension).

Exclusion Criteria:

* Major congenital anomalies.
* Chromosomal anomalies.
* Known inborn error(s) of metabolism
B: Inclusion Criteria (mother):

* Pregnant women
* Living in Sealand, Denmark
* Fluent in Danish Language
* Willing to let the newborn child participate in the study

Exclusion Criteria (mother):

* Participating in other clinical trial
C: Inclusion Criteria:

* Healthy women without major medical problem delivered at term and planning breastfeeding for next six months delivering term, single, infants with birth weight appropriate for gestational age without major health problem

Exclusion Criteria:

* Maternal endocrine disorders, disturbed calcium- phosphorus homeostasis, anticonvulsant treatment.
* Infants renal, hepatic insufficiency, endocrine disorders, congenital malformations, anticonvulsant treatment.
D: Inclusion Criteria:

Mother:

* Pregnant in week 22-26 of gestation
* Participating in the ABC-cohort
* Living in Sealand, Denmark
* Fluent in Danish
* Willing to let the child participate in the study

Exclusion Criteria:

Mother:

* Intake of more than 400 IU of vitamin D during the last 6 months
* Endocrinological disease such as calcium metabolic disorder, parathyroid disorder, thyroid disorder or Diabetes type 1
* Tuberculosis
* Sarcoidosis
* In need of diuretics or heart medication including calcium channel blockers

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries.
Brief Summary: Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use.

A double-blinded individual randomized controlled study of misoprostol versus placebo in home deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit pregnant women who are likely to deliver at home. All women enrolled in the study will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of their baby (ies) and before delivery of the placenta.

Women who experience a PPH will be randomized to receive either: a) standard of care + 800 mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets resembling misoprostol. In this setting, standard of care is referral.


Options:
A: Inclusion Criteria:

* Women who deliver at home with a study TBA present.
* Women must be willing and able to provide informed consent
* Women must agree to participate in a follow up interview
* Women must agree to have pre and post-partum haemoglobin taken

Exclusion Criteria:

* If the woman does not meet any of the above outlined inclusion criteria
B: Inclusion Criteria:

* Women must be pregnant
* Must be able to provide informed consent
* Must agree to have a community health worker present at the time of delivery
* Must agree to participate in a follow up interview by the study midwife
* Must agree to have pre and postpartum haemoglobin taken

Exclusion Criteria:

* Women who do not meet the inclusion criteria
C: Inclusion Criteria:

* Women with atonic PPH.

Exclusion Criteria:

* Gestational age \<37 weeks.
* Hypertension.
* Preeclampsia.
* Cardiac, renal or liver diseases
* Epilepsy.
* Known hypersensitivity to Carbetocin
D: Inclusion Criteria:

* Older than 18 yrs old
* Giving birth after 32 Weeks of amenorrhea
* Post-partum haemorrhage due to atony
* Inefficiency off the first line treatment
* Written signed consent form

Exclusion Criteria:

* known allergy to prostaglandin
* haemostasis anomalies before labour
* anticoagulant treatment
* fetal death
* accreta or percreta placenta
* under 18 years
* delivery before 32 weeks of amenorrhea
* post-partum bleeding not suspected to be due to atonic uterus

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
Brief Summary: In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.


Options:
A: Inclusion Criteria:

* Cystic fibrosis diagnosis confirmed by 2 positive sudoriparous diagnostic tests
* Age : 7 to 17 years
* Capacity to expectorate
* Clinically stable
* Ability to pedal on a bike and to respect orders for physical session

Exclusion Criteria:

* Haemoptysis \> 50ml
* Permanent non-invasive ventilation
* Respiration or digestive evolutive clinical abnormality
* Exacerbation
B: Inclusion Criteria:

* Diagnosis of cystic fibrosis
* Hospitalised patients admitted with a pulmonary infection
* Forced expiratory volume in one second (FEV1)of 15% predicted or over
* 16 years of age or over

Exclusion Criteria:

* Current severe haemoptysis
* Rib fractures or history of spontaneous rib fractures
* pregnancy
* Lung abscess
* End stage disease
* Requiring more than two assisted treatment sessions per day
* Requiring treatment with positive pressure
* Inability to give consent
C: Inclusion Criteria:

* Patients with a clinical diagnosis of cystic fibrosis
* Patients in steady state

Exclusion Criteria:

* Patients during exacerbation
* Patients treated by oral corticotherapy (\>0.5 mg/kg/j during \>7 days) during the past 2 months
* Pregnant patients
D: Inclusion Criteria:

* Cystic fibrosis diagnosis
* Stable clinical condition (no exacerbation in last 4 weeks)

Exclusion Criteria:

* Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
* Subjects previously involved in exercise training or physiotherapy programs

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
Brief Summary: In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.


Options:
A: Inclusion Criteria:

* Cystic fibrosis diagnosis confirmed by 2 positive sudoriparous diagnostic tests
* Age : 7 to 17 years
* Capacity to expectorate
* Clinically stable
* Ability to pedal on a bike and to respect orders for physical session

Exclusion Criteria:

* Haemoptysis \> 50ml
* Permanent non-invasive ventilation
* Respiration or digestive evolutive clinical abnormality
* Exacerbation
B: Inclusion Criteria:

* Clinical diagnosis of cystic fibrosis
* Able to engage in intense physical activities

Exclusion Criteria:

* FEV1 \<35%predicted
* Esophageal varicosis
* Pulmonary bullae
* Drop in arterial oxygen saturation with exercise \<80%
* Non-CF related chronic diseases
* Signs of pulmonary hypertension (ECG and echocardiogram)
C: Inclusion Criteria:

* Age \>= 18 years
* Patient suffering from cystic fibrosis
* Patient has at least three measures of maximum expiratory volume per second \<= 45% of the theory among the 6 last measures performed
* Affiliation to French social security
* Capacity to consent

Exclusion Criteria:

* Pregnant women
* Contraindication to application of magnetic field
* Pacemaker
* History of neurosurgical intervention
* Presence of metallic particles near the stimulation site.
D: Inclusion Criteria :

* Men or women 18 years and older.
* Diagnosis of CF documented.
* Obstructive ventilatory deficit light to moderate , as defined in the guidelines of the ATS / ERS , an FEV / FVC ratio \> 70% and ≥ 40% FEV .
* Stable health status, no episode of superinfection in the past 6 weeks.
* Impaired glucose tolerance , glucose \> 11.1 mmol / L at the 1st hour of the OGTT or unmedicated CFRD.
* Patients who wants to participate in an exercise program for 12 weeks.
* Sedentary (less than 105 min / week of physical activity ) .

Exclusion Criteria :

* Exacerbation of respiratory symptoms with or without hospitalization , or use of oral antibiotics in the last 6 weeks.
* Exacerbation with intravenous antibiotics .
* Severe obstructive deficit as defined by FEV \<40% , with an FEV / FVC ratio \<70 %.
* Any other disease or condition that may limit exercise performance .
* Without treatment with oral hypoglycemia , insulin, oral anti -inflammatory and other treatments that may influence glucose metabolism (patient under cortef accepted) .
* Hemoptysis ( \> 50-60 cc) in the last 6 weeks.
* Desaturation during exercise.

Answer: A