cyrilzakka/clinical-trials huggingface dataset:
A Real-World Patient-Reported Outcomes Study in Patients With Long-Term Use of Niraparib

This prospective, non-interventional study is designed to evaluate the quality of life of Chinese ovarian cancer patients with long-term niraparib use in a real-world setting. Participants will complete questionnaires or accept telephone follow-up to provide information about their quality of life.

In this prospective, non-interventional study, patients with platinum-sensitive relapsed ovarian cancer who have received niraparib as maintenance therapy for more than two years will agree to be contacted by questionnaire or telephone three times. The interval will be 4-6 weeks. Information on quality of life will be collected and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Histologically confirmed platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer
* Maintenance treatment with niraparib for ≥2 years and continuing for the next 28 days
* No significant cognitive impairment
* Understand the trial procedure and be able to sign the informed consent form before any study-related procedures

Exclusion Criteria:

* Patients who are not suitable for participation in this study according to the investigator's evaluation
* Patients receiving antineoplastic drugs for other malignancies
* Patients who are unable to comply with the protocol procedures
One Month Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

The purpose of this study is to compare the performance of two commercially marketed contact lenses when worn for up to one month in a daily wear modality.


Eligibility Criteria:
Inclusion Criteria:

* Habitual spherical soft contact lens wearer who wears a contact lens brand with a recommended replacement schedule of 2 weeks or greater.
* Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses.
* Willing and able to wear spherical contact lenses within the available range of powers.
* Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks prior to enrollment.
* Currently enrolled in any clinical trial.
* Any use of medications for which contact lens wear could be contraindicated, as determined by the investigator.
* Astigmatism of 1.00D or more.
* Currently wearing contact lenses in a daily disposable modality.
* Currently wearing AIR OPTIX AQUA or ACUVUE ADVANCE Plus contact lenses.
* Currently sleeping overnight in contact lenses on an occasional or extended wear basis.
* Other protocol-defined exclusion criteria may apply.
To Evaluate the Safety and Effectiveness of Atorvastatin Plus a Cholinesterase Inhibitor in AD Patients.

The purpose of this study is to find out if atovastatin, when taken with a cholinesterase inhibitor, is effective for treating Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic evidence of probable Alzheimer's disease consistent with NINCDS/ADRDA and DSM IV criteria.
* Subject's Mini-Mental Status Examination Score (MMSE) must be in the range of 13 - 25 (inclusive) at Screening.

Exclusion Criteria:

* Subjects with dementia due to causes other than Alzheimer's disease.
* Any condition, which, in the investigator's judgment might increase the risk to the subject or decrease the reliability of the data required to meet the objectives of the study.
Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients

OBJECTIVES: I. Determine whether combined intercostal muscle and diaphragm pacing can maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia who are not candidates for phrenic nerve pacing alone.

II. Evaluate the efficacy of the Medlink device to produce synchronous intercostal and diagram activation in these patients.

PROTOCOL OUTLINE: Patients have a Medlink spinal cord electrode surgically implanted and attached to a radiofrequency receiver implanted subcutaneously over the anterior chest wall.

If substantial inspired volumes can be generated by intercostal pacing, a phrenic nerve cuff electrode and radiofrequency receiver are implanted, and patients undergo combined intercostal muscle and diaphragm pacing.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Ventilator dependent quadriplegics who are not candidates for phrenic nerve pacing alone

Must have bilateral partial or unilateral phrenic nerve function

Must have been on ventilator support for at least 6 months and unweanable

--Patient Characteristics--

Cardiovascular: No active cardiovascular disease

Pulmonary: No active lung disease

Other: No active brain disease Stable condition
Risk Stratification for Patients With Hospital-diagnosed Advanced Lung Cancer

This study explores whether supportive care interventions that might reduce rehospitalization could be implemented and feasible, in subjects within a high-risk group of subjects with newly diagnosed hospitalized advanced lung cancer (ALC).

This study screened 50 subjects from health records and consented to 15 of these screened subjects. These 15 subjects responded to PRO questionnaires.

Subjects will be considered high risk if they have small cell histology, longer than 8 days hospitalization, high comorbidity, emergency department use or hospitalization in the previous 6 months, prescription of a wheelchair on hospital discharge, or Black and/or Hispanic race. Supportive care interventions such as navigation and palliative care will be recommended for this group.

All hospitalized subjects with newly diagnosed ALC will be offered web- or telephone-based patient-reported outcome (PRO) symptom monitoring for 90 days following hospital discharge if they provide consent. Medical record evaluation of consented subjects will provide data for risk assessment and the high-risk group definition. Healthcare utilization including emergency department visits, hospitalizations, outpatient palliative care, and cancer treatment received will be compared.

Eligibility Criteria:
Inclusion Criteria for Patient Participants:

1. Age ≥ 18 years at the time of screening.
2. Hospital-diagnosed Advanced lung cancer with histological confirmation of disease or suspected lung cancer in the opinion of the treating oncologist.

For PROs only

1. Able to complete a web-based or telephonic symptom survey.

Exclusion Criteria for Patient Participants:

1. Enrollment in hospice upon discharge from the index hospitalization For PROs only

1. Inability to read or speak English.
2. Dementia, altered mental status, or any psychiatric condition as determined by the clinical or study team that would prohibit the understanding or rendering of informed consent.
3. Current incarceration.
4. Any condition that would prohibit the patient from completing PROs

Inclusion Criteria for Health Care Provider Participants:

1. Thoracic medical oncology physicians, advance practice providers, and nurse navigators work in the study site and respond to the survey that assesses acceptability.
The Videolaryngoscopy in Small Infants

Complications related to infant (≤ 1 year) airway management are under-appreciated because of few rigorous and targeted studies. Investigators have recently shown that multiple tracheal intubation (TI) attempts are a key risk factor for intubation-related complications in small children. Tracheal Intubation using Video laryngoscopy (VL) has become popular in anesthesiology practice because of several advantages over conventional direct laryngoscopy (DL). Studies show that VL improves the view of the airway compared to DL, requires fewer intubation attempts, but may take more time to intubate the trachea. This study compares first attempt success of VL to DL in infants presenting for elective surgery.

Objectives:

* Primary Objective To compare the tracheal intubation (TI) first attempt success rate using VL vs. DL in children ≤ 12 months old.
* Secondary Objectives To compare the lowest oxygen saturation during tracheal intubation with VL vs. DL.

Study Design:

Prospective, randomized, multi-center parallel group trial

Setting/Participants:

This will be a multi-center study with a minimum of four participating centers. The target population will be children ≤ 12 months age scheduled for elective surgery requiring general anesthesia with endotracheal intubation.

Study Interventions and Measures:

The study intervention will be a 1:1 randomization to perform tracheal intubation with the Storz C-Mac Miller 1 (VL) or the conventional Miller laryngoscope (DL).

Main study outcome measures are as follows:

* The first intubation attempt success rate with each device
* The number of attempts for successful intubation with each device
* Complications associated with intubation

Eligibility Criteria:
Inclusion Criteria

1. Males or females age 0 to \<12 months.
2. Scheduled for non-cardiac surgery or procedure lasting longer than 30 minutes under general anesthesia where oral endotracheal intubation will be performed by an anesthesiology clinician.
3. Subject/Parental/guardian permission (informed consent).

Inclusion for clinician participants:

1) Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident

Exclusion Criteria

1. History of difficult intubation
2. History with abnormal airway
3. Predictive of difficult intubation upon physical examination
4. Parents/guardians who, in the opinion of the investigator, may be unable to understand or give informed consent
Physiological Reaction After Food Intake

The goal of this clinical trial is to clarify the normal response of the body after food intake.

Therefore, participants will wear three wearables for two weeks and document their food intake via an app- and picture-based protocol.

The aim of this study is to investigate physiologically measurable reactions of the body to food intake. We want to find out which of the parameters collected can provide information about food intake and which techniques for data collection are expedient in this context. Ultimately, the aim is to develop a way of determining food intake from physiological data from physiological data without the user indicating this to the device.

The following data is collected continuously over a period of 2 weeks: Electrocardiogram (ECG), pulse rate from photoplethysmogram, body temperature, movement, skin conductance, and a continuous glucose measurement in the interstitium (CGM). The test subjects will also be asked to document each of their meals and snacks via an app using a photo. As an optional additional examination, female study participants will be offered an intravaginal temperature measurement. This independently performed measurement enables the core body temperature to be recorded.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5 - 25 kg/m2

Exclusion Criteria:

* vegan diet
* any kind of special diet, e.g. to lose weight
* use of medication, except for thyroid hormones and contraceptives
Efficacy Study of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy

The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed gastric adenocarcinoma in tissue/cell
* Recurrent or metastatic gastric cancer that has progressed following first- line therapy
* Patients must be ≥18 years of age.
* ECOG performance status ≤ 2
* At least one lesion (measurable or non-measurable but evaluable) according to RECIST criteria
* Normal organ and bone marrow function measured within 2 weeks prior to administration of study treatment as defined below: Haemoglobin ≥ 9.0 g/dL White blood cells (WBC) ≥ 3000/µL Absolute neutrophil count (ANC) ≥ 1500/µL Platelet count ≥ 100 x 103/µL Total bilirubin ≤ 1.5 x upper normal limit (UNL) Creatinine clearance ≥ 60 ml/min or Serum creatinine ≤ 1.5 x UNL AST (SGOT)/ALT (SGPT) ≤ 2.5 x UNL unless liver metastases are present in which case it must be ≤ 5x UNL
* Life expectancy ≥ 12 weeks.
* Written informed consent
* Provision of informed consent for genetic research (In case of optional genetic research)

Exclusion Criteria:

* More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
* Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
* Any previous treatment with a taxane, including paclitaxel and docetaxel or irinotecan, in the metastatic or recurrent setting.
* Patients with second primary cancer, except: adequately treated non- melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years.
* Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used).
* Ongoing toxicities (\>CTCAE grade 2) caused by previous cancer therapy.
* Clinically proven gastric outlet obstruction or CTCAE grade 3 or grade 4 upper GI bleeding
* Medically uncontrolled, clinically significant heart disease or infection
* Patients with symptomatic uncontrolled brain metastases.
* Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
* Women who have pregnancy potential or willing to pregnant. Pregnant and breastfeeding women.
* Others Poor medical risk due to a serious, uncontrolled medical disorder, non- malignant systemic disease or active, uncontrolled infection Any psychiatric disorder that prohibits obtaining informed consent and regular follow-up. Inappropriate patient for subjects of this study on investigator's judgment
Companion: Sensor-based Two-way Communication for Physical Activity in Older Adults

This pilot study is a small sample (N=46) 16-week clinical trial with a follow-up after 24-weeks among sedentary adults \>60 y with a BMI \>25 kg/m2 to tests the impact of a hybrid artificial intelligence behavior change system (Companion) on physical activity. Participants will be randomized to a control and intervention group. All participants will engage in a proven supervised exercise program from week 1 to 16. Only the intervention group will receive Companion from week 1 to 16.

This is a single site randomized clinical trial to test if if Companion improves and sustains free-living physical activity and sedentary behaviors in adults \>60 y and improves health outcomes. Forty-six sedentary adults \>60 y with a BMI \>25 kg/m2 will be randomized to a control and intervention group. Both groups will undergo a 16-week supervised training program involving supervised training sessions 45-60 min, twice a week. The intervention group will additionally receive the two-way communication-based Companion meta intervention. Two-way communication during weeks 1 to 4, will focus on gathering information on the adult's motivations, preferences, habits, contexts, and usual behavior patterns to build typical individual behavior models. The model will be used to develop an adaptive physical active and sedentary behavior intervention prescription. Primary outcomes from Aim 1 and exploratory outcomes from Aim 2 will be measured at baseline and then after 16 and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years and above- This intervention study focusses on this population demographic.
* Participants have a body mass index greater than 25 kg/m2- This threshold for BMI is used to classify an adult as overweight or obese
* No conditions preventing participation in physical activity lasting 10 to 30 min- Such conditions will limit prescription of physical activity/exercise components of the training program and that promoted using Companion.
* Have a smart phone- The absence of a smart phone will limit the ability of remote communication with the study participant using Companion.

Exclusion Criteria:

* Engage in structured physical activity for more than 2 days/week lasting 30 min/session- Physically active participants will not be representative of typical adults \>60 y. Being active prior to study participation may mask the effects of the intervention.
* Regularly use any assistive device for walking- Use of an assistive device would limit the ability to engage in prescribed physical activity. Future work can be tailored for sub-groups in the demographic being studied.
* Likely to alter medications pertaining to cardiovascular or metabolic health- Altering medications during the study will influence change in selected outcome measures.
Advanced Cooking Education Feasibility Study

The aim of this study is to look at outcomes related to diet and nutrition, mindfulness, and cooking skills amongst middle school students who participated in a 12-week 4-H after school program called the Advanced Cooking Education Program.

Participants are all assigned to the Advanced Cooking Education Program. Data collection was done before and after the program. The investigators hypothesize that after the program, adolescents' diet quality, cooking-related skills, stress levels will be improved compared to prior of the program.

Eligibility Criteria:
Inclusion Criteria:

* 7th and 8th grade students attending Title I funded schools in New York City
* Caregivers of 7th and 8th grade students attending Title I funded schools in New York City

Exclusion Criteria:

* Do not speak/understand English
Comparative Effectiveness of Rehabilitation Services for Survivors of Acute Ischemic Stroke

Retrospective analysis of Get With the Guidelines-Stroke data linked with Medicare claims and the AVAIL longitudinal data sets to assess patterns, predictors, and outcomes associated with the use of rehabilitation services following hospitalization for ischemic stroke. Primary completion defined as the end of primary analyses, consistent with the end of the PCORI Cycle I grant period. Study completion defined as acceptance of final research report and lay abstract by PCORI.

The investigators will seek to answer three questions:

1. What are the person- and system-level factors associated with use of rehabilitation services following acute ischemic stroke?
2. Among stroke survivors discharged to short-term inpatient rehabilitation, are high-intensity services performed at an Inpatient Rehabilitation Facility (IRF) more effective than lower intensity services performed at a Skilled Nursing Facility (SNF), at improving patient outcomes at 3 and 12 months?
3. Among stroke survivors discharged home, is early follow-up with a physician more effective than follow-up after 7 days at 3 and 12 months?

Eligibility Criteria:
Inclusion Criteria:

* acute ischemic stroke within the Get With the Guidelines-Stroke data set for 2006-2008, and successfully linked to Medicare claims through 2009

Exclusion Criteria:

* death during index hospitalization
Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer

This is a feasibility study to gain preliminary information regarding whether breast imaging with or without a core needle biopsy after neoadjuvant chemotherapy (NAC) but before surgery can accurately predict complete pathologic response (pCR) in women with triple negative or HER2- positive breast cancer. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven triple negative (TN) (ER-/PR-/HER2-) or HER2 positive (ERany/PRany/HER2+) breast cancer for which neoadjuvant chemotherapy is planned
* A biopsy clip placed at the time of diagnostic biopsy
* 18 years of age or older
* Must be able to read and write in English due to the importance of survey (questionnaire) completion to meet the study's endpoint - this is justified as there is no individual benefit to study participation
* Able to provide written consent prior to any research related activities

Exclusion Criteria:

* Stage IV breast cancer
* T4 breast cancer
* Previous ipsilateral breast cancer
* Any contraindication for undergoing a contrast-enhanced breast MRI and/or the breast biopsy between chemotherapy and surgery
Power Training Combined With Interval Treadmill Training

Ambulatory children with cerebral palsy (CP) experience walking limitations which negatively influence their ability to physically participate in day to day life. The investigators propose that impaired muscle power generation is the key limiting factor affecting walking activity and participation. This proposal represents a combined approach where participants undergo resistance training for muscle power generation in combination with locomotor treadmill training that is based on typical pediatric walking and activity patterns rather than adult protocols, which are endurance or time-based. Therefore, the primary objective of this randomized controlled trial is to determine the effect of lower extremity Power Training combined with interval Treadmill Training (PT³) on functional walking capacity and community-based activity and participation in children with CP. We hypothesize that remediating the most pronounced muscle performance impairment (i.e., muscle power) with power training combined with a task- specific approach to walking that is developmentally appropriate will have a significant effect on walking capacity and performance.

The primary purpose of this randomized controlled trial is to test the effect of Power Training combined with interval Treadmill Training (PT³) on walking capacity and performance in children with CP with walking limitations. To identify key muscular mechanisms associated with improved walking mobility, the effects of PT³ on muscle performance and architecture will be examined. The premise of the PT³ protocol is that a combined impairment and task-specific approach that is developmentally appropriate and targets muscle power deficits specifically, is necessary to drive changes in both clinic and community-based walking activity.

In this randomized multi-site clinical trial, 48 ambulatory participants with CP will receive either PT³ or an equivalent dosage of traditional strength training combined with traditional treadmill training (comparison group) for 24 sessions, 3 times per week for 8 weeks. Outcomes will be collected at baseline and immediately post-treatment. Short and long-term retention effects will be assessed at 2 and 6 months post.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bilateral spastic Cerebral Palsy (CP)
* Age 10 to 17 years inclusive
* GMFCS levels I, II, or III

Exclusion Criteria:

* Orthopedic or neurosurgery less than 12 months prior to enrollment
* Injection therapies (phenol, botulinum toxin) less than 3 months prior to enrollment
* Lacking greater than 25 degrees of knee extension
Mobile Micro-learning on Nurses' Self-confidence, Motivation, and Stress

Before and after effect of using mobile micro-learning on their self-confidence, motivation, and stress toward cardiopulmonary resuscitation.

This study aims to determine the effect of mobile micro-learning on critical care nurses' self-confidence, motivation, and stress after cardiopulmonary resuscitation.

The current study will use three scales. Self-Confidence Scale, Cardiopulmonary Motivation Scale, and Post-Code Stress Scale.

Mobile micro-learning is used easily to access video-based learning tips for effective practice for cardiopulmonary resuscitation.

Eligibility Criteria:
Inclusion Criteria:

* Critical care nurses who have worked in the intensive care unit for more than one year.

Exclusion Criteria:

* Critical care nurses who have less than one year of experience.