cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine

This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of the pneumococcal conjugate vaccine, co-admin with a 1st dose or a 2nd dose of MMRV vaccine at 12-14 or respectively 14-16 months of age in children primed with the pneumococcal conjugate vaccine in study 105553. Antibody persistence will be evaluated at 8-10 months after completion of the 3-dose immunization course in study 105553. The immunogenicity, safety and reactogenicity of the 1st and 2nd dose of MMRV vaccine will also be evaluated when co-admin with the pneumococcal conjugate vaccine between 12-16 months of age.

The study has 3 groups.

* The 1st group will receive the booster dose of pneumococcal conjugate vaccine + 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of Infanrix hexa™+ 2nd dose of MMRV vaccine at 14-16 mo of age.
* The 2nd group will receive the booster dose of Infanrix hexa™ + 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of pneumococcal conjugate vaccine + 2nd dose of MMRV vaccine at 14-16 mo of age.
* The 3rd group will receive the booster dose of pneumococcal conjugate vaccine + the booster dose of Infanrix hexa™ at 12-14 mo. Subjects will be offered one dose of Priorix™ and Varilrix™ at 14-16 mo of age, outside the study.


Eligibility Criteria:
Inclusion Criteria:

* a healthy male or female, 12-14 months of age at the time of first vaccination, who received at least one dose of pneumococcal conjugate vaccine during study 105553 and with written informed consent obtained from the parent/guardian of the subject.

Exclusion Criteria:

* use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the entire study period (active phase and safety follow-up).
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and ending 42-56 days after the last dose of vaccine(s).
* Administration of any additional pneumococcal vaccine since end of study 105553.
* Previous vaccination against measles, mumps, rubella and/or varicella. History of, or intercurrent measles, mumps, rubella and/or varicella/zoster diseases.
* Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to study start.
* Immunosuppressive or immunodeficient condition.
* A history of seizures or neurological disease.
Cariprazine: Comparison of Slow- and Immediate-release Forms

The investigators are doing this study to compare blood levels and side effects of cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate release' capsule. The investigators will also find out if food affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.

Comparison of blood levels and side effects of cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate release' capsule. We'll also find out if food affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian males aged 18-55 years with body mass index (BMI) ≥ 18 kg/m2 and ≤ 30 kg/m2
* Have a semisupine pulse rate ≥ 40 bpm and ≤ 100 bpm during the vital sign assessment at screening and on admission (Day 1)
* Agree to use an effective method of contraception and not have their partners become pregnant throughout the study and for up to 4 months after the administration of the IMP, or have been sterilized for at least 1 year

Exclusion Criteria:

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Inpatient Referral to Comprehensive Weight Management for Patients With Obesity

Hospitalized patients with obesity who are not already in CWM (comprehensive weight management), or not comfort care/hospice will be identified by the hospitalists then the study dietitian will consent for the patient for enrollment (and answer any question regarding diet/lifestyle) in the study. The intervention will be a CWM referral at discharge. The outcome will be what percentage of these patients go to the CWM clinic at 6 months. At 6 months, the investigators will also call each participant to get a qualitative idea of the process of inpatient referral and barriers to the CWM clinic visit. Weight loss, starting on anti-obesity medication, bariatric surgery will be assessed as a secondary outcome.

* The investigators will conduct an uncontrolled, one arm interventional study on Adult (≥ 18 years of age) hospitalized patients who have obesity (BMI ≥ 30 kg/m 2 or BMI ≥ 27 kg/m 2 if Asian/South Asian), and after stabilization of their acute medical conditions. Prior to hospital discharge, patients will receive a referral for an outpatient comprehensive weight management clinic, with a message that will be sent to the CWM clinic scheduler. Then the investigators will follow the patients forward for 6 months from hospital discharge to assess primary and secondary outcomes. Also, the investigators will look at a historical control group of hospitalized patients with obesity (age, comorbidity matched) from 2014-2019 (chosen instead of 2020, to avoid any impact of 2020 COVID 19 pandemic) and compare the primary and secondary outcomes. At six months after discharge, patients will receive a phone call from the investigators to ascertain whether they were able to go to the comprehensive weight management clinic and about their experience.
* Hospitalized patients who have decision-making capacity and whose acute medical condition has been stabilized who meet study criteria will be identified by study physician(s) who will look at his/her personal patient list on a regular basis to identify patients who meet enrollment criteria and will refer the patients to the co-investigator who is not directly involved in the patient's care who will then discuss enrollment with patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years of age) hospitalized patients who have obesity (BMI ≥ 30 kg/m2 or BMI ≥ 25 kg/m2 if Asian/South Asian)
* Who have decision-making capacity
* Whose acute medical condition has been stabilized.

Exclusion Criteria:

* Patients in the ICU or requiring \> 6 LPM of supplemental oxygen
* Patients enrolling in hospice/comfort care
* Patients who are already enrolled in weight management or have undergone previous metabolic / bariatric surgery.
* Non-English speaking patients.
* Pregnant patients
Quality of Life in Patients Who Have Undergone Previous Treatment for Primitive Neuroectodermal Tumors

RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for patients with primitive neuroectodermal tumors.

PURPOSE: This phase III trial is studying quality of life in patients who have undergone previous treatment for primitive neuroectodermal tumors.

OBJECTIVES:

Primary

* Determine the quality of survival of patients in the UK and other European countries enrolled in previous International Society of Pediatric Oncology (SIOP) 2 or 3 phase III trials for treatment of pediatric primitive neuroectodermal tumors (PNET).
* Compare the quality of survival between children allocated to different treatments in these trials.

Secondary

* Determine the framework that will allow similar information to be collected across all participating countries in the PNET 4 trial that opened in autumn 2002.

OUTLINE: This is a cross-sectional, multicenter study.

Pediatric oncologists, teachers, patients ≥ 12 years old, and parents of children age 3-11 years old complete six questionnaires to assess the patients' motor and sensory function, cognition, behavior, emotion, educational provision and achievement, social integration, and the subjective experience of the patients and their families.

PROJECTED ACCRUAL: A total of 229 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Surviving primitive neuroectodermal tumor (PNET) patients previously enrolled in International Pediatric Oncology Society (SIOP) 2 or 3 phase III treatment trials
* Surviving PNET patients eligible for and treated according to PNET 3 protocol but not randomized
* No metastatic disease at time of allocation to treatment
* No current progressive disease

PATIENT CHARACTERISTICS:

* No patient deemed unsuitable for this study by treating clinician

PRIOR CONCURRENT THERAPY:

* Not specified
A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants

This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it) study in healthy participants. The study consists of 5 treatments, and each participant will be randomized to receive 4 of the treatments in separate periods in a specific sequence. Each treatment consists of a single dose of PF-07104091 and the treatments differ by tablet formulation and/or whether the dose is to be given under fasted or fed conditions. Plasma pharmacokinetics of PF-07104091 will be assessed following each dose to determine the effect of tablet formulation and fed condition on the relative bioavailability of PF-07104091.


Eligibility Criteria:
Inclusion Criteria:

* Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12 lead ECGs.
* Body-Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of \>50 kg (110 lb).
* Written evidence of a personally signed and dated informed consent document (ICD) indicating that the participant has been informed of all pertinent aspects of the study.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAB) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
* A positive urine drug test.
* History of sensitivity to heparin or heparin induced thrombocytopenia.
Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy

To investigate the performance and safety of the three 2-piece convex ostomy appliances


Eligibility Criteria:
Inclusion Criteria:

Subjects interested in participating in the clinical investigation must comply with the following criteria:

1. Are at least 18 years of age and have full legal capacity
2. Have had an ileostomy for at least 3 months.
3. Have used a convex ostomy appliance for the last month
4. Have given written informed consent
5. Have an ileostomy with a diameter of 33mm or less
6. Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks

Exclusion Criteria:

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

1. Have a loop ostomy (also called double-barrel or ostomy with two outlets)
2. Are pregnant\* or breastfeeding.
3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).
6. Known hypersensitivity toward any of the test products

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Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone

The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patients with HF and left ventricular systolic dysfunction


Eligibility Criteria:
Inclusion Criteria:

* Female/male, over 18 years with previously verified HF with left ventricular systolic dysfunction.
* New York Heart Association(NYHA) class II-IV,
* NTproBNP males\>800 ng/L, females \>1000 ng/L

Exclusion Criteria:

* Planned CV hospitalisation, stroke or acute myocardial infarction (MI) last 3 months,
* Mitral/aortic stenosis,
* Patients already receiving optimal HF treatment,
* Severe reduction of kidney function
Efficacy of Samsung GEMS-H Device Training in Older Adults

The purpose of this study is to evaluate the feasibility of using Samsung robotic hip assist-based mobility intervention for older adults with frailty.

The specific aims of this project are:

Aim 1 Will investigate the feasibility of the Samsung robotic hip assist-based mobility intervention on gait function, sedentary time, and fall risk.

Hypothesis: A 6-week robotic device-based mobility intervention will improve locomotor gait function, sedentary time, and fall risk.

Twelve individuals above the age of 65 years old were recruited to participate in twelve sessions that occurred 2-3 times per week over a 4-6 week period using the GEMS-H. In addition to selecting individuals over the age of 65, qualifying participants also had to be able to walk with or without an assistive device for greater than ten feet. Medical clearance was obtained from each participant's primary physician prior to training with the device.

Gait training included dynamic over-ground walking (both self-selected and fast-paced), variable conditions of multidirectional walking, and training on ramps, stairs, and obstacle negotiation. All training was done under the supervision of a trained physical therapist. The amount of assistance and resistance torque provided by the hip motors of the GEMS-H was personalized according to each participant's specific abilities and self-reported tolerance/comfort throughout each session. These modifications followed a training progression model of increasing resistance and decreasing assistance over the course of the twelve sessions to maximize the challenge and improve strength and endurance in each participant.

Eligibility Criteria:
Inclusion Criteria:

* They are primarily English speaking
* \> 65 years of age
* Able to walk with or without an assistive device \>10 feet
* Able to obtain medical clearance from the participant's primary physician
* We will not include any special populations in this study

Exclusion Criteria:

* Cannot comprehend or provide inform consent
* Unable to fit the device within the hip frame size of310mm-380mm (approximately 12-15 inches)
* Other weight and length limitations that restrict the proper fit of the device
* Any significant neurological diagnosis impacting safe use of the device
Charge: A Text Messaging-based Weight Loss Intervention

This study evaluates different versions of a text messaging-based app for weight loss. This study will place participants to 1 of 32 experimental conditions that reflect different texting components and levels. Participants will be randomized to a condition. The investigators will recruit 448 adults into a 6-month weight loss program, with an additional follow-up 6-months after the intervention ends.

Standalone text messaging-based weight loss treatments are scalable and can achieve population reach. However, these interventions are also modular; they can be delivered independently to maximize cost-effectiveness or combined with other approaches (e.g. provider counseling) to maximize outcomes. This study is a 12-month experimental trial among 448 adults with obesity. All participants will receive a core 6-month weight loss texting intervention that includes tailored behavior change goals, interactive self-monitoring, automated feedback, and skills training. Participants will be randomly assigned to 1 of 32 different experimental conditions.

Eligibility Criteria:
Inclusion Criteria:

* males and females aged 18-65 years
* participants have English language proficiency
* participants have a BMI between 25-40 kg/m2
* Participants will own a smartphone
* Participants will be willing to receive multiple text messages daily.

Exclusion Criteria:

* prior or planned bariatric surgery
* psychiatric hospitalization in past 12 months
* pregnancy, nursing, or planned pregnancy
* history of a cardiovascular event
* history of an eating disorder
* history of a condition (e.g., end stage renal disease, cancer, schizophrenia) or use of medications (e.g., lithium, steroids, anti-psychotics) that would affect weight measurement, for which weight loss is contraindicated, or might promote weight change
* current participation in a weight loss trial and/or recent weight loss \> 10%
* investigator discretion for safety reasons
Comparing MRI to CT on Pediatric Craniosynostosis.

The purpose of this study is to develop and test the effectiveness and diagnostic quality of Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) in comparison to CT.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients 0-18 of age will be recruited by our surgical colleagues based on the clinical concern for craniosynostosis and possible need for calvarial reconstruction.

Exclusion Criteria:

* Lack of consent
* Contraindication/inability to undergo both examinations within the designated time period and/or undiagnostic image quality.
Aripiprazole in Late Life Bipolar Disorder

The purpose of this research study is to analyze the effectiveness and tolerability of a new medication, aripiprazole (Abilify), in individuals age 50 years and older who have bipolar disorder (manic-depressive illness).

While medications such as valproate (Depakote and others) and lithium are generally considered first-line agents in late life bipolar disorder, side effects are common, and many individuals with bipolar disorder continue to have symptoms in spite of medication treatment. A continuing unmet need is the availability of medications that are generally well- tolerated and effective in later life bipolar disorders.

Antipsychotic medications such as Abilify are known to be effective for related conditions such as schizophrenia and are also used by some physicians in clinical settings in combination with mood stabilizing medications (Lithium, Depakote and others) to treat symptoms of bipolar disorder. Currently Abilify is approved by the FDA to treat schizophrenia and to treat bipolar disorder.

Eligibility Criteria:
Inclusion Criteria:

* Must have Bipolar disorder as confirmed by the Mini Neuropsychiatric Interview (MINI)
* Must be age 50 or older
* Must have sub-optimal response to current psychotropic management including at least one of the following:

  * Behaviors and symptoms of irritability, agitation, mood liability or diminished ability to interact with others in their place of residence
  * Diminished ability to take care of basic personal needs in their place of residence due to symptoms of bipolar disorder
  * Intolerance to current psychotropic medications; and
* Must live in the Northeast Ohio area.

Exclusion Criteria:

* An unstable medical illness, or a medical illness, which in the opinion of the study investigators, is likely to affect the outcome of the study
* DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or
* Receiving carbamazepine.
CONCEPT: Comparison of Oxaliplatin vs Conventional Methods With Calcium/Magnesium in First-Line Metastatic Colorectal Cancer

The primary rationale for this study is to develop an optimized schedule of administration of FOLFOX + bevacizumab that maximizes the efficacy and safety of this regimen when administered to patients with advanced colorectal cancer. The hypothesis is that the use of an intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow these patients to continue on treatment for a longer period of time by reducing the proportion of patients who discontinue therapy early because of treatment-related toxicities and thus increasing the possibility of a longer time to progression.

The primary objective is:

* To test the hypothesis that an intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow patients to remain on therapy for a longer period of time compared to a conventional "treat-to-failure" schedule, by reducing the proportion of patients who discontinue therapy for treatment-related toxicities.

The secondary objectives are:

* To evaluate the impact of calcium/magnesium infusions on the incidence and severity of neurotoxicity in subjects receiving either the IO or conventional FOLFOX/bevacizumab treatment schedules as first-line treatment for metastatic colorectal cancer.
* To evaluate the safety and efficacy of the IO versus the conventional schedule + calcium and magnesium infusions, as part of oxaliplatin-based first-line therapy for metastatic colorectal cancer.


Eligibility Criteria:
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Inclusion Criteria:

* Histologically or cytologically documented metastatic, measurable adenocarcinoma of the colon, rectum, or appendix with no prior therapies for metastatic disease
* ECOG performance status (PS) of 0 or 1
* Adequate hematologic, renal, and hepatic function as defined by required baseline laboratory parameters
* No other serious concomitant disease.

Exclusion Criteria:

* Peripheral neuropathy \> Grade 1 at baseline
* History of significant cerebrovascular, cardiovascular, or peripheral vascular disease
* Uncontrolled hypertension (defined as blood pressure \> 150/100 mmHg)
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess, within 6 months prior to start of study drug
* Minor surgical procedure, fine needle aspiration, or core biopsy within 7 days prior to start of study drug
* Serious, non-healing wound, ulcer, or bone fracture
* Active gastroduodenal ulcer
* Evidence of bleeding diathesis or coagulopathy
* Significant history of bleeding within 6 months prior to registration
* Prior history of hypertensive crisis or hypertensive encephalopathy