TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.
Brief Summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Options:
A: Inclusion Criteria:

* Osteoarthritis of the knee

Exclusion Criteria:

* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs
* Other protocol defined inclusion/exclusion criteria may apply.
B: Key Inclusion criteria

• Osteoarthritis of the knee

Key Exclusion criteria

* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs
C: Key Inclusion criteria

* OA of the knee Key Exclusion criteria
* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs
D: Key Inclusion criteria:

• Osteoarthritis of the hand

Key Exclusion Criteria:

* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Resistance Training on Cognitive Performance, Cortical Plasticity, and Fall Risk in Women Aged 65-75 Years Old: A 12-Month RCT
Brief Summary: Primary Objectives:

1. To ascertain whether a 12-month, twice-weekly or once-weekly resistance training (RT) program will significantly improve executive function in community-dwelling women aged 65 to 75 years old compared with a 12-month, twice-weekly stretch and relax (S \& R) program (shame exercise). We will assess executive function by standard neuropsychological tests.

Secondary Objectives:

1. To describe the neural mechanisms that underpin the observed changes in executive function associated with a 12-month, twice-weekly or once-weekly RT training (by using functional magnetic resonance imaging (fMRI)).
2. To investigate whether RT-induced changes in executive function are independently associated with changes in physiological fall risk profile.
3. To investigate the dose response of RT (resistance training) on bone health as measured by dual energy x-ray and peripheral quantitative computed tomography.
4. To conduct a one-year follow-up after the formal cessation of the resistance training programs to determine the persisting effect of resistance training on cognitive performance, cortical plasticity, physiological falls risk, and bone health.


Options:
A: Inclusion Criteria:

* Sedentary (less than twice weekly exercising) women aged 65-75 years old without conditions restricting them from exercising.
B: Inclusion Criteria:

* Community living Caucasian woman ≥ 65 years; live expectation \> 2 years

Exclusion Criteria:

* secondary osteoporosis
* CVD-events including stroke
* Participation in other studies
* Medication with impact on bone during the last 2 years:

  * bisphosphonates
  * parathormone
  * strontium
  * HRT, anabolic steroids
  * calcitonin
  * natriumflourides
  * active Vit-D-metabolites
  * cortisone \> 5 mg/d
* medication with impact on falls
* low physical performance (\<50 Watt during ergometry)
* excessive alcohol-intake
C: Inclusion Criteria:

* Age 65 and over
* Referred to physical therapy for balance training

Exclusion Criteria:

* Age \< 65
* Unable to use treadmill
* Severe vertigo
* Not a candidate for gait/balance PT
* Not competent to consent to research
D: Inclusion Criteria:

* 2 or more falls within 6 months prior to the beginning of the study
* Aged 60-85 years
* Able to walk for 5 minutes unassisted
* Adequate hearing and vision capabilities.
* Stable medication for the past 1 month and anticipated over a period of 6 months

Exclusion Criteria:

* Psychiatric co-morbidity
* Clinical diagnosis of dementia or other severe cognitive impairment (MMSE\<24)
* History of stroke, traumatic brain injury or other neurological disorders (other than PD and MCI, for those groups)
* Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and orthopaedic diseases
* Unstable medical condition in the past 6 months
* Unable to comply with the training
* Interfering therapy

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Esomeprazole Once Daily for the Treatment of Gastroesophageal Reflux Disease (GERD) in Neonatal Patients, Including Premature and up to 1 Month Corrected Age
Brief Summary: The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.


Options:
A: Inclusion Criteria:

* patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations)
* patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams

Exclusion Criteria:

* patients who have used a PPI (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (Day 0)
* patients with a history of acute life-threatening event
B: Inclusion Criteria:

* Greater than 44 weeks beyond neonatal period but less than 12 months
* Presumptive diagnosis of GERD
* Weight greater than 2.5 kg but less than 15 kg

Exclusion Criteria:

* History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
* Clinically significant medical or surgical abnormalities
C: Inclusion Criteria:

* Full-term or gestational age \>/= 28 to 44 weeks
* In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent
* Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization

Exclusion Criteria:

* Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract
* Patients with any condition that may require surgery during the course of the study
* Patients with acute respiratory distress within 72 hours prior to enrollment
D: Inclusion Criteria:

* History of at least 1 Gastroesophageal Reflux Disease (GERD) symptom within 3 months of screening
* Positive esophagogastroduodenoscopy
* Signed informed consent
* Female patients (if menstruating) must be practicing birth control

Exclusion Criteria:

* Patients with history of esophagitis
* Patients who have milk protein allergy
* Patients who have taken Proton Pump Inhibitors or H2-blockers within 3 days
* Patients who have taken sucralate or any medication that affects gastrointestinal motility
* Patients with H. pylori
* Patients with lab values outside the normal age appropriate range
* Patients who have participated in another trial within 30 days before screening
* Patients with allergies to Proton Pump Inhibitors

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives
Brief Summary: Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders.

The present clinical trial intends to compare the effects of oral contraceptives and metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers and indexes of cardiovascular performance, in order to whether or not, as suspected by previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter actually ameliorates such a risk.


Options:
A: Inclusion Criteria:

* Spontaneous intermenstrual periods of greater than or equal to 45 days or a total of 8 or less periods per year
* Elevated testosterone levels
* General good health
* Off of current medications which may confound response to study medications

Exclusion Criteria:

* Pregnancy
* Lactose Intolerance
* Medical Contraindications
* Elevated Prolactin, 17hydroxyprogesterone, or Follicle stimulating hormone blood tests
* Diabetes, liver, heart, kidney or uncorrected thyroid disease
B: Inclusion Criteria:

* Women of fertile age presenting with PCOS
* Non-hyperandrogenic women of fertile age (these women will not receive the interventions and will serve only to obtain normative data for some variables)

Exclusion Criteria:

* Severe disease not related to the condition under study
* Pregnancy
* Medical or surgical treatment of PCOS during the previous 3 months
* Contraindication for the use of oral contraceptives or metformin
* Inability to understand the proposal of the study precluding effective informed consent
* Minors who are not accompanied by their legal representative
C: Inclusion Criteria:

* PCOS

Exclusion Criteria:

* diabetes
* pregnancy
* contraindications to oral contraceptives
D: Inclusion Criteria:

* Ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia

Exclusion Criteria:

* Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep Vein Thrombosis, pregnancy and lactation.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
Brief Summary: To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.


Options:
A: Inclusion Criteria:

* Subjects with PAH (i.e. IPAH or secondary to connective tissue disease or with surgical repair of ASD, VSD, PDA, aorto-pulmonary window) whose baseline six minute walk test distance is \>/= 100 m and \</= 450 m.
* Subjects with a mean pulmonary artery pressure of \>/= 25 mmHg and a pulmonary artery wedge pressure of \</= 15 mmHg at rest via right heart catheterization performed within 12 weeks prior to randomization.

Exclusion Criteria:

* Subjects whose 6 Minute Walk Distance may be limited by conditions other than PAH related dyspnoea or fatigue, e.g. claudication from vascular insufficiency or significant arthritis.
* Subjects who are currently receiving any forms of chronic treatment for PAH such as prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers. Subjects previously receiving any of these drugs must have stopped use for a period of at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3 months).
B: Inclusion Criteria:

* Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1

Exclusion Criteria:

* Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial
C: Inclusion Criteria:

* COPD
* Forced expiratory volume in 1 second (FEV1) \<80% (FEV1/FVC \<0.70)
* Right ventricular systolic pressure (RVSP) \> 30 mmHg or Pulmonary Acceleration time \<120 ms

Exclusion Criteria:

* Pulmonary stenosis or echo left ventricular outflow tract obstruction
* Left ventricular ejection fraction \< 45%
* Patients taking nitrates, nicorandil or doxazosin.
* Drug contraindications:

  * Systolic Blood Pressure \<90 mmHg
  * recent stroke
  * unstable angina
  * past history of non arteritic anterior ischaemic optic neuropathy
D: Inclusion Criteria:

* Patients with PAH who had completed the 12 week pivotal study

Exclusion Criteria:

* Any other patients with PAH that had not been included into the pivotal study

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Antipsychotic Medication Extended Dosing Study
Brief Summary: In patients stabilized on their antipsychotic and demonstrating evidence of good clinical response, there will not be a significant change in symptoms if their medication is decreased to every 2 days rather than daily. This decrease in antipsychotic exposure will lead to a reduction in side effects, as well as improved subjective response to treatment.


Options:
A: Inclusion Criteria:

* After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent

Exclusion Criteria:

* Residence outside of the catchment area
* Legal reasons
* Insufficient knowledge of the German language
* Substance abuse or addiction
* Pregnancy
* Serious physical illness
* Organic brain disease
* Contraindication to neuroleptic treatment
B: Inclusion Criteria:

* first-episode schizophrenia

Exclusion Criteria:

* acute psychosis
C: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizo-affective disorder
* Capacity to provide written, informed consent
* Stabilized\* on a single oral antipsychotic for at least three months (excluding CLOZAPINE or QUETIAPINE)
* Evidence of compliance with previous antipsychotic treatment, i.e. greater than 90% \* defined as 2 consecutively identical CGI evaluations (screening and baseline, at least one week apart)

Exclusion Criteria:

* exposure to depot antipsychotic during 12 months prior to enrollment
* substance-related disorders according to DSM-IV
D: Inclusion Criteria:

* Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent
* One year neuroleptic maintenance treatment
* Reaching stable course

Exclusion Criteria:

* Residence outside of the catchment area
* Legal reasons
* Insufficient knowledge of the german language
* Substance abuse or addiction
* Pregnancy
* Serious physical illness
* Organic brain disease
* Contraindication to neuroleptic treatment

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Falls Prevention for People With Increased Risk of Fractures as a Result of Osteoporosis: a Randomized Controlled Study on the Effects of a Modified Program
Brief Summary: The purpose of this study is to determine wether a falls prevention program can reduce fall incidence in people with osteoporosis.


Options:
A: Inclusion Criteria:

* osteoporosis (DXA T-score \< -2.5 in hip and/or vertebrae)
* able to walk at least 15 minutes without an helping device
* 65 years or older
* community dwelling
* at least one fall in the prior year

Exclusion Criteria:

* severe cardiac, pulmonary or musculoskeletal disorders
* pathologies associated with increased fall risks (i.e. stroke or Parkinson's disease)
* use of psychotropic drugs
B: Inclusion Criteria:

* Sedentary (less than twice weekly exercising) women aged 65-75 years old without conditions restricting them from exercising.
C: Inclusion Criteria:

* aged 70 years or older living independently in the community
* at least one fall in the preceding 12 months and a referral from a healthcare provider indicating the participant is at risk of falls due to gait/balance impairment or medication use or impaired mobility as evidenced by Timed Up and Go result of \>13.5 seconds
* no participation in daily and/or structured vigorous physical activity or walking for exercise that lasted 15 minutes or longer at a time or muscle-strengthening activities on 2 or more days a week in the previous 3 months
* walking independently, with or without the use of an assistive device,
* no severe cognitive impairment (Mini-Mental State Examination score ≥20)
* able to exercise safely as determined by their healthcare provider,
* a willingness to be randomly assigned to an intervention condition and complete the 6-month intervention and 6 month follow-up.

Exclusion Criteria:

* any medical or physical conditions deemed unacceptable by their physician or healthcare provider,
* planned to leave the study area within the next 12 months.
D: Inclusion Criteria:

* Community living Caucasian woman ≥ 65 years; live expectation \> 2 years

Exclusion Criteria:

* secondary osteoporosis
* CVD-events including stroke
* Participation in other studies
* Medication with impact on bone during the last 2 years:

  * bisphosphonates
  * parathormone
  * strontium
  * HRT, anabolic steroids
  * calcitonin
  * natriumflourides
  * active Vit-D-metabolites
  * cortisone \> 5 mg/d
* medication with impact on falls
* low physical performance (\<50 Watt during ergometry)
* excessive alcohol-intake

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Epilepsy Phase III Trial
Brief Summary: The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures.


Options:
A: Inclusion Criteria:

1. Age 18-70 years old,
2. Diagnosis of epilepsy for at least 1 year,
3. Presenting, on average, at least 3 partial onset seizures per month,
4. Currently treated with a stable dose (i.e., for at least 4 weeks) of no more than 3 anti-epileptic drugs (AEDs),

Exclusion Criteria:

1. Have experienced status epilepticus in the past 3 months,
2. Have any serious diseases,
3. History of major psychiatric disorders within the past 2 years.
4. Have received an experimental drug/device within the past 30 days
5. Are pregnant or breastfeeding.
B: Inclusion Criteria:

* Male or Female, 16 year or older
* Clinical diagnosis of focal epilepsy for at least 1 year
* History of poor response to at least 1 anti-epileptic drug in the past
* Current treatment with 1 or 2 anti-epileptic drugs
* Should have at least 3 seizures per month

Exclusion Criteria:

* Generalized epilepsy
* Cannot count your seizures
* Unstable medical disease, such as a recent heart attack or uncontrolled diabetes
* Major psychiatric illness
* Recent drug or alcohol abuse
* Unable to swallow pills
C: Inclusion Criteria:

* Male or Female, 16 year or older
* Clinical diagnosis of focal epilepsy for at least 1 year
* History of poor response to at least 1 anti-epileptic drug in the past
* Current treatment with 1 or 2 anti-epileptic drugs
* Should have at least 3 seizures per month

Exclusion Criteria:

* Generalized epilepsy
* Cannot count your seizures
* Unstable medical disease, such as a recent heart attack or uncontrolled diabetes
* Major psychiatric illness
* Recent drug or alcohol abuse
* Unable to swallow pills
D: Inclusion Criteria:

* Patients must complete Visit 8 (Day 112) of the double-blind treatment phase of Study EPY-2003 to be eligible for entry into the open-label treatment phase of Study EPY-2006.

Exclusion Criteria:

* Patients who have seizures that cannot be quantitated accurately
* Patients with a history of nonepileptic seizures, serious systemic disease, progressive neurologic disorder, a major psychiatric disorder, status epilepticus in the past 3 months, vagal nerve stimulation discontinuation within the past 3 months
* Patients with a history of drug or alcohol abuse within the past 2 years
* Patients currently taking felbamate, vigabatrin, or tricyclic antidepressants
* and patients who are pregnant or nursing.

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Managing Weight in Overweight and At-Risk Children
Brief Summary: The prevalence of overweight children has increased significantly over the past 3 decades and 3 out of every 4 overweight children become obese adults. Additionally, overweight children are now at risk for developing type-2 diabetes while still in their youth. To address the issue of childhood weight management, Golan and colleagues provided a model for intervention development that targets parents as an exclusive agent of change when attempting to treat weight issues for children under 12 years of age. The Kaiser Permanente Colorado (KPCO) Weight Management Program (WMP) developed Family Connections, a condensed two-session program, based on the Golan model, for parents of children between the ages of 8-12 with a Body Mass Index (BMI) greater than the 85 percentile for age and gender. There is a need to determine if the content of Golan's model can be translated into a practical intervention to be used in usual pediatric weight management practice. The Family Connections study uses three arms to determine the effectiveness of healthy eating and active living messages.


Options:
A: Inclusion Criteria:

* Infants 6 months of age
B: Inclusion Criteria:

Local authorities:

* Local authorities providing data from at least 4 Children's Centres
* Courses delivered by trained staff who have been certified by HENRY

Children's Centres:

* At least one course to be delivered per Centre per year
* Sites with a history of providing process data for the previous year.

There will be no exclusions based on the demographics of Children's Centres, but location will be monitored to ensure inclusion of those with diverse social and environmental characteristics.

-

Exclusion Criteria:

Local authorities:

* Areas which have plans to decommission the HENRY intervention during the course of the trial; or who are not planning on running HENRY programmes during the trial period.

Children's Centres:

* Centres where ethnography has taken place during Study 2
* Centres who are not planning on running HENRY programmes during the trial period
C: Inclusion Criteria:

* enrolled in daycare centers at Penn State University

Exclusion Criteria:

* food allergies or intolerances
D: Inclusion Criteria:

* All boys and girls within the KPCO HMO system of the greater Denver area who are between the ages of 8 and 12 at the time of the initial assessment with a BMI of 85% or above.

Exclusion Criteria:

* Parents for whom English is not their language of communication
* Families who intend to move within the first three months of intervention
* Families who do not have access to a telephone
* Did not agree to be randomized.

Answer: D