cyrilzakka/clinical-trials huggingface dataset:
Offering Support and Electronic Resources for Care Partners of Those With Multiple Sclerosis

This study is an enhancement of the Fatigue Management Programs for People with MS study (NCT03550170). The purpose of this randomized clinical trial is to test the effectiveness of two interventions delivered remotely to support unpaid caregivers (UC) of people with multiple sclerosis (MS). We hypothesize that a high resource intervention will be significantly better than a lower resource intervention in terms of the primary outcome (UC anxiety, depression, and stress) and secondary outcome (COVID specific anxiety).

UCs are often caring for persons with chronic disabling conditions, who are at higher risk for severe COVID-19 illness. This presents incredibly stressful situations for UCs, which can result in depression, anxiety, and worse health outcomes both for them and their care recipients. Until a vaccine becomes available, these demands will force UCs to provide more support, whether in-person or remotely, for persons with MS. The aim of this study is to compare 2 modes of supporting UCs of people with MS. We will compare the effectiveness of a high resource highly tailored intervention that includes tele-coaching intervention (delivered via videoconference or phone) + web site information to a low-resource web-site only intervention. Our primary outcomes are UC anxiety, depression, and stress (DASS-42 scale) and a secondary outcome is COVID specific anxiety (CAS scale). These 2 interventions were selected because they will inform administrators and clinicians on whether a resource-intensive or a low-resource intervention is needed to yield meaningful outcomes. The comparison will also help UC decide how they should spend their limited time. These interventions are relevant to UCs of people with MS because of their need for tailored information provided in flexible ways to promote learning and support.

Eligibility Criteria:
Inclusion Criteria:

1. An adult family member or friend (18 years of age or older) of a person with MS
2. Self-identified as an unpaid caregiver for person with MS
3. Access to internet
4. Capable of providing informed consent in English

Exclusion Criteria:

1. Under age 18
2. Cannot speak English
3. Unable to provide consent
4. No access to the internet
Physical and Mental Assessment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

RATIONALE: Learning about physical ability and mental function over time in older patients with acute myeloid leukemia may help doctors learn about the long-term effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is assessing physical and mental status in older patients with newly diagnosed acute myeloid leukemia.

OBJECTIVES:

Primary

* Test the feasibility of pre-treatment, bedside assessment of functional and cognitive status in older adults with newly diagnosed acute myeloid leukemia (AML).

Secondary

* Obtain preliminary data regarding the predictive value of pre-treatment, bedside assessment of functional and cognitive status on overall survival, length of hospitalization and early death.

OUTLINE: This is a prospective study.

At baseline, patients complete questionnaires including the Vulnerable Elders Survey (functional status), the Mini-Mental Status Exam (cognition), and the Center for Epidemiologic Studies-Depression. Patients also undergo physical function testing via the Short Physical Performance Battery and hand grip strength. Further information parameters are obtained by periodic medical chart reviews.

Patients are followed every 3 months for up to 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologically confirmed newly diagnosed acute myeloid leukemia
* Planned induction chemotherapy
* Inpatient status

PATIENT CHARACTERISTICS:

* No requirement for intensive care unit support

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior therapy for acute myeloid leukemia
Comparison of HFNC and COT to Diaphragm Function of Post-upper Abdominal Surgery Patients

This study aims to compare diaphragm thickness, air lung distribution, and several clinical and laboratory parameters on post abdominal surgery patients with conventional oxygen therapy vs high-flow nasal cannula

"Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were recruited using consecutive sampling method. Subjects underwent upper-abdominal surgery were screened. Eligible and consented subjects were randomized into intervention group (high-flow nasal cannula) and control group (conventional oxygen therapy). Subject and operation characteristics were recorded prior to intervention.

Clinical parameters (vital signs, Borg Score, ICON) were recorded in 10 specific times. diaphragm thickness data using abdominal ultrasonography (USG) and air lung distribution data using Electrical Impedance Tomography were collected in 7 specific times while lactate and blood gas analysis were done 4 times. "

Eligibility Criteria:
Inclusion Criteria:

* patients from 18 - 65 yrs old,
* American Society of Anaesthesia (ASA) status I-III,
* BMI \< 30, patent airway,
* Measurement of Exercise Tolerance before Surgery (METS) Score \> 4,
* P-POSSUM score \<10%,
* agreed to the study

Exclusion Criteria:

* uncooperative subjects,
* DNR (do not resuscitate) patients,
* patients with tracheostomy, pleural effusion, pneumothorax or pulmonary atelectasis
Fluorescence Spectroscopy for Gut Permeability Assessment

This research aims to develop portable devices - known as fluorescence spectrometers - to monitor the leakage of fluorescent dyes out of the gut into the blood stream. These devices will measure the leakiness (permeability) of the gut in a non-invasive manner and will provide an early warning that patients are at risk of infections caused by the unwanted flow of bacteria from the intestine to the rest of the body.

"Leaky gut" - or, increased permeability of the intestine - involves the leakage of certain intestinal constituents (e.g. endotoxins or even bacteria) from the gut into the rest of the body. This condition is associated with many widespread diseases including coeliac disease, inflammatory bowel disease, HIV, liver cirrhosis, sepsis and environmental enteric dysfunction (EED). It has a considerable impact on quality of life and, in extreme cases (e.g. sepsis), it can even lead to death. Furthermore, in the developing world (as part of EED), it severely hampers the mental and physical development of young children. Thus, new devices that can help us to learn more about leaky gut and more accurately monitor its effects are urgently needed.

In this project, patients will drink a small dose of a fluorescent dye. Then, by shining light on the patients' skin and recording the color and brightness of the light (fluorescence) that comes back, it will be possible to measure the amount of dye that has leaked into the blood (indicating the likelihood that bacteria are escaping from the gut and causing infections). We refer to this as a "Spectroscopic gut permeability test." We will also ask patients to take a traditional permeability test (known as a PEG permeability test) so that we can validate our new sensor. Overall, this research will deliver vital information that will improve our understanding of leaky gut and help guide the development of treatments for the many diseases in which it occurs.

Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Aged 18 years or above
* No evidence of prior adverse reactions to fluorescein, ICG, dextran or PEG
* No evidence of prior adverse reactions to iodine (for ICG experiments only)
* For healthy volunteers: healthy with no active GI/liver disease (or other condition in which increased gut permeability is expected, e.g. HIV) and no antibiotics taken within the previous four weeks.
* For cases: exhibiting symptoms of GI, liver or other diseases (e.g. HIV) in which increased intestinal permeability is expected.
* For ophthalmology patients recruited in Stage 1: healthy (i.e. as described above for healthy volunteers) and prescribed to have an ophthalmic angiography with an intravenous injection of either fluorescein or ICG.

Exclusion Criteria:

* Unable to give informed consent
* Aged \<18 years
* Previous adverse reaction to fluorescein, ICG, dextran or PEG
* Known allergy to iodine (for ICG experiments only)
* Pregnancy (in Stage 1 this will be at the discretion of the patient's ophthalmologist)
* Breastfeeding (in Stage 1 this will be at the discretion of the ophthalmologist)
Proteogenomic Signatures Analysis In Ovarian Cancer

Proteogenomic analysis to detect individual platinum-induced modifications on tumor tissue of HGSC according to chemotherapy response score (CRS), using a combined approach of High resolution liquid chromatography mass Spectrometry based platform (HR-LC-MS/MS and advanced immunometric methods on illumine platform); multiple supervised machine learning algorithms will be used to discover proteogenomic signatures and biological processes associated with platinum modification during the neoadjuvant chemotherapy treatment. These results contribute to precision medicine by building an accurate proteogenomic profile of ovarian cancer, in order to better understand the underlying mechanisms of different chemotherapy response among affected patients.


Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed advanced International Federation of Gynecology and Obstetrics (FIGO) stage III A or greater epithelial ovarian cancer addressed to neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS);

Availability of freshly frozen tissue and FFPE tissue from both exploratory laparoscopy (baseline) and IDS;

Age between 18 and 80 years;

Estimated life expectancy of at least 4 weeks;

Signed informed consent

Exclusion Criteria:

Non-serous histology at frozen section;

Patients with a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (\> 10 mg equivalent prednisone/daily) or any other form of immunosuppressive therapy within 7 days prior to the enrollment;

Previous diagnosis of cancer within 5 years.
Remote Support for Cochlear Implant Recipients: Evaluation of the HearCare MED-EL App

This clinical investigation intends to assess safety and performance of the HearCare MED-EL App, a remote care option for recipients of MED-EL cochlear implants

Remote care solutions can provide cochlear implant users a greater convenience, accessibility, and personalized care. These advantages stem from the ability to fine-tune and adjust their devices from the comfort of their own environments, without the need for frequent and time-consuming in-person clinic visits.

Remote care allows clinicians to remotely assess data, provide guidance, and make necessary adjustments, all while minimizing the need for physical presence. This streamlined approach translates to increased capacity for serving a larger number of patients, ultimately leading to improved patient outcomes.

The HearCare MED-EL App is a mobile smartphone application designed for recipients of at least one compatible MED-EL cochlear implant and respective audio processor. The app manages technical checks on compatible cochlear implants and audio processors, creates and utilizes backups of audio processor configurations, and performs updates of audio processor configurations by acting as an executive organ of the MAESTRO System Software. The app reduces face-to-face follow-up appointments of users/caregivers with hearing professionals while maintaining safe and ongoing care for all individuals.

This clinical investigation aims to evaluate the HearCare MED-EL App regarding safety and performance.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Implanted with at least one MED-EL Cochlea Implant (CI) for at least 3 months
* Fitted with at least one audio processor compatible with the HearCare MED-EL App (i.e. SONNET 2, SONNET 2 EAS, RONDO 3 or newer)
* Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure

Exclusion Criteria:

* Lack of compliance with any inclusion criteria
* Implanted with C40X and C40C
* Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array
* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study (e.g. psychological disorders, neurologic or motoric comorbidity that could restrict subjects from using the app)
Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population

At present, chronic kidney disease population are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.

This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1, 2, and 6 in chronic kidney disease population.

Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 70 years at the enrolment
* Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
* Sign informed consent, willing to participate in this study

Exclusion Criteria:

* Being pregnant
* Intolerance or allergy to any component of the vaccine
* Any vaccination during the month preceding enrollment
* Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
* Patients with Hepatitis B virus associated glomerulone nephritis or HBV DNA Positive
Adherence and Outcomes in Functional Constipation With a Constipation Action Plan

We will be assessing for improvement in reported symptoms as well as reported quality of life in pediatric patients with functional constipation using a constipation action plan and an adherence log.

Functional Constipation is one of the most common chief complaints for both the general pediatrician and the pediatric gastroenterologist. Treatment for this disorder is multifactorial, and usually involves different medications combined with behavioral techniques, depending on the severity of the underlying constipation. Studies have shown that medication compliance is one of the strongest predictors of successful treatment, but maintaining good medication adherence at home is uncommon for a variety of reasons. In this study, the investigators are aiming to improve home medication adherence for functional constipation to improve treatment outcomes. The investigators will be administering surveys for all enrolled participants to determine the child's and family's overall quality of life related to functional constipation. For the treatment group, the investigators will be providing tools to help with medication adherence. This will include a daily log to determine symptom severity, along with an "action plan" with instructions for how to adjust medicines, if necessary, depending on symptoms. By empowering families with this knowledge and medication roadmap, the investigators hypothesize that there will be overall symptomatic improvement in functional constipation, along with improved quality of life for both the patient and their family. The investigators will measure adherence (by reviewing symptom log and action plan at 2-month and 4-month follow up appointments.) with the treatment group. The investigators will be measuring overall quality of life and symptom improvement using a validated pediatric constipation quality of life survey (PedsQL GI) with both the treatment group and the control group at follow up appointments.

Eligibility Criteria:
Inclusion Criteria:

* Have been potty-trained for stool at some point
* Chief complaint constipation or encopresis
* Meets Rome IV criteria for functional constipation

Exclusion Criteria:

* Preexisting diagnoses of autism, cerebral palsy, developmental delay, and/or thyroid disease
* Prior gastrointestinal surgery
* Presence of "red flag" symptoms for organic etiology:
* Passage of meconium \>48 hours after birth in a term newborn
* Family history of Hirschsprung's Disease
* "Ribbon" stools
* Blood in stools (in absence of anal fissure)
* Coexisting diagnosis of malnutrition, bilious vomiting, abnormal anal positioning, absent anal reflex, decreased lower extremity strength/tone, sacral dimple, and/or tuft of hair on spine
A Study in Children, Teenagers and Adults With Severe Hemophilia A Who Switched From Other Factor VIII Treatments to Adynovate

The main aims of the study are to assess the safety profile of Adynovate as well as how well people respond to the preventive treatment with Adynovate.

This study is about reviewing and collecting data of the participants before and after the switch to Adynovate that are already available. No new information will be collected during this study. The total time for data collection in the study will be approximately 72 months (36 months before and 36 months after switching to Adynovate). Participants will not receive Adynovate as part of this study.

As participants are not treated in this study, they do not need to visit their doctor in addition to their normal visits.


Eligibility Criteria:
Inclusion Criteria:

* Participants with severe hemophilia A.
* All age groups (less than \[\<\] 12 and greater than \[\>\] 12 years of age).
* Participant with greater than equal to (\>=) 150 documented exposure days (EDs).
* Treated with Adynovate:

  * Having a PK analysis done/data available for post-hoc modeling
  * Having recorded clinical outcomes analysis: for \> 6 months
* Treated with a SHL/EHL-FVIII product for at least six months before switching to Adynovate
* To qualify for the secondary objective participants will need to have a WAPPS study performed on Adynovate and on the SHL/EHL-FVIII they were treated before switching.

Exclusion Criteria:

* Any participant who meets any of the following criteria will not qualify for entry into the study:
* Participants with only on-demand Factor VIII (FVIII) use.
* Current presence of FVIII inhibitory antibodies. (Participants with a history of inhibitors, if any, will be considered for a sensitivity analysis).
* Diagnosis of other inherited or acquired hemostatic defect other than hemophilia A.
Molecular Profiling Protocol (SCRI-CA-001)

This is an open-label, multicenter pilot study in patients with advanced solid tumors.

The primary objective of this study is to compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.

To be eligible, patients must have received at least two lines of prior chemotherapeutic, hormonal or biological regimens for advanced disease, have measurable or evaluable, refractory disease and have clear documentation of the time between treatment start and documented progression on the last treatment prior to study entry. Eligible patients must undergo or have available a tumor biopsy for molecular profiling within 2 months of IHC/FISH and/or DNA microarray analysis.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic cancer which has progressed on 2 prior chemotherapeutic, hormonal or biological regimens for advanced disease.
* Be defined as refractory to the last line of therapy
* Have documentation of the best clinical response to the treatment regimen immediately prior to entering this study

Exclusion Criteria:

* Patients with symptomatic CNS metastasis
* Any previous history of another malignancy within 5 years of study entry
* Uncontrolled intercurrent illness
* Known HIV, HBV, HCV infection
* Pregnant or breast-feeding
Acceptable Pressure Range for Continuous Positive Airway Pressure(CPAP) Treatment

Compliance of continuous positive airway pressure （CPAP） derived from auto-titration is similar to that derived from manual titration, although pressure derived from the former was usually 2-5 cmH2O higher than the latter. Therefore the Investigators hypothesize that accurate titration maybe not necessary for successful treatment of obstructive sleep apnea (OSA) as long as CPAP pressure was not lower than the minimal effective pressure.

Study Design: A randomized, cross-over and double-blind study. Objective: To compare the pressure of 10 cmH2O and minimal effective pressure derived from manual titration on the effect of CPAP treatment in OSA. Methods: Patients with suspected OSA (age, body mass index and symptom) to be referred to a sleep centre were recruited. Patients with OSA confirmed by overnight full polysomnography (PSG) were invited to do standard overnight manual titration under PSG based on the Academy of Sleep Medicine (AASM) manual guidelines. Patients whose manual titration pressure lower than 10cmH2O and willing to participate in the study were invited to repeat two more nights (3th PSG and 4th PSG) under CPAP pressure at both 10cmH2O and the pressure derived from manual titration in random order. The sleep apnea-hypopnea index (AHI), obstructive sleep apnea index (OHI), arousal index (ArI), oxygen desaturation index (ODI), sleep structure, and treatment preference were to be observed.

Eligibility Criteria:
Inclusion Criteria:

1. reported snore, apnea and daytime sleepiness;
2. a diagnosis of obstructive sleep apnea with polysomnography according to ASSM guideline(apnoea-hypopnea-index(AHI)≥5 events/h) and need to be treated with continuous positive airway pressure;
3. willing to participate after informed consent.

Exclusion Criteria:

1. Evidence of severe coronary or cerebral, cardiovascular disease and significant memory, perceptual or behavioural disorder;
2. Severe respiratory disease defined as severe chronic obstructive pulmonary disease(ie. FEV1/FVC\<70% and FEV1\<50%predicted) or resting awake SaO2\<90%
3. Have known contraindications with CPAP, like current pneumothorax and hemoptysis, et al.
4. Central sleep apnea\>10 events/h；
5. Frequent nasal congestion；
6. Optimal treatment CPAP pressure(by manual titration) equal or higher than 10cmH2O.