cyrilzakka/clinical-trials huggingface dataset:
The CARE Program: CAncer REhabilitation Pilot Study for Older Adults

The CARE Program is a randomized trial of a cancer rehabilitation program designed to help older cancer patients who have shown to have a loss of function.

This is a prospective, two-arm, single-center randomized controlled pilot trial of a cancer rehabilitation program for older adults, titled the 'CARE program,' which is designed to maintain and/or improve functional status and quality of life in older adults diagnosed with cancer. Adults aged 65 years and older with cancer will be screened with a Geriatric Assessment (GA) for eligibility. Although breast cancer patients will be eligible, this study will focus primarily on other types of cancers. Adults with at least one functional deficit --defined as impairment in ability to perform activities of daily living or instrumental activities of daily living, cognitive decline or balance -- will be randomized to either the intervention (CARE program) or to the control arm (Supportive care services information only). Both arms will receive a brochure about the supportive care program to provide patients who we've identified as having deficits with information about auxiliary services available and because the intent is to limit the difference between the groups. We hypothesize that patients who participate in the CARE program will maintain or improve functional status and quality of life when compared to supportive care services information only.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Has an outpatient appointment within UNC Chapel Hill Lineberger Comprehensive Cancer Center
* Diagnosis of cancer within last two years.
* Has a life expectancy of 12 months or longer. All cancer types are included.
* English speaking
* Willing to complete the UNC GA
* Has at least one functional deficit as defined by GA screen
* Understands study design, risks, and benefits and have signed informed consent
* Willing to be randomized into either study arm
* Ability to safely participate in outpatient rehabilitation program

Exclusion Criteria:

* Unable to safely participate in outpatient rehabilitation.
* Currently receiving rehabilitation.
* Any participant who has urologic cancer or is enrolled in a competing trial.
Efficacy of Methylene Blue for Malaria Treatment in Adults of Burkina Faso: Proof of Principle Study in Semi-Immune Adults of Burkina Faso in the Frame of the A8 Project of the SFB 544

Design: Single-centre, controlled study in adults with uncomplicated falciparum malaria in the Nouna Health District, north-western Burkina Faso

Phase: Phase II

Objectives: The primary objective of this trial is to study the efficacy of different methylene blue regimens given to adults with uncomplicated falciparum malaria in an African area of high malaria transmission intensity.

Population: Male adults with uncomplicated malaria from Nouna town.

Sample size: N= 60 (n=20 for each group; three different dosing regimens of MB).

Treatment: The participants in the three different MB regimens will receive orally twice daily 390 mg MB (total daily dose 780mg) over 7,5 or 3 days respectively. Treatment with the five (three) day regimen will only start after all patients of the seven (five) days regimen have been followed up until day 3.

Endpoints: The primary endpoint is the adequate clinical and parasitological response (ACPR) rate on day 28. Secondary endpoints are the number of adverse events (AE) after drug intake until day 28, clinical and parasitological failure rates on day 14 and 28, changes in haemoglobin/haematocrit until day 28, and fever and parasite clearance time.


Eligibility Criteria:
Inclusion Criteria:

* Male adults (\>17 years;\<55 years)
* Uncomplicated malaria caused by P. falciparum
* Asexual parasites ≥ 1000/µl and ≤ 200 000/µl
* Axillary temperatures ≥ 37.5°C or history of fever during 48 hours
* Living in nouna Health District
* Informed consent

Exclusion Criteria:

* Complicated or severe malaria
* Any apparent significant disease
* Anaemia (haematocrit \< 21%)
* Antimalarial treatment prior to inclusion (last three days)
* Increased creatinine blood levels
Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars

The aim of this study is to compare the clinical retention rates, marginal adaptation, marginal discoloration and secondary caries formation of two different types of resin-modified glass ionomers (Fuji® II LC; Clinpro™ XT Varnish) and giomer-containing fissure sealant materials (Beautifil Flow) with glass ionomer-containing fissure sealant material (Fuji Triage®) used on newly erupted non-carious first permanent molars as a fissure sealant.

The study included 384 teeth belonging to 182 children, aged between 5 to 9 years old, who have two newly erupted mandibular permanent first molars.

Firstly, patients were randomly allocated to three main groups: Group 1; Fuji II LC/Fuji Triage (Control) (62 patients), Group 2; Clinpro XT Varnish/Fuji Triage (Control) (60 patients), Group 3; Beautifil Flow/Fuji Triage (Control) (60 patients). After clinical applications, all samples were evaluated in terms of retention, marginal adaptation, marginal discoloration and secondary caries formation using modified USPHS criteria in 6th, 12th and 18th months. Also samples were evaluated in terms of remineralization effect using the laser fluorescence method. Evaluations on occlusal and buccal surfaces were performed separately.

Eligibility Criteria:
Inclusion Criteria:

* Children who have two newly erupted non-carious mandibular permanent first molars that fissure sealant is indicated,
* Newly erupted first permanent molars show scores of 0 (Sound tooth surface)-1(First visual change in enamel) according to ICDAS II,
* Newly erupted first permanent molars show scores between 0-13 by using DIAGNOdent device,
* Children who haven't any systemic disease that prevents the application,
* Cooperative children who allowed the clinical applications.

Exclusion Criteria:

* Teeth with proximal and initial caries,
* Teeth with applied fissure sealant,
* Teeth with developmental defects such as hypoplasia and restorations,
* Non-cooperative children who don't allow the clinical applications,
* Children and parents who denied the participation in the follow-up appointments.
Association of HMOs and Allergic Manifestations

Compare the HMO composition in breast milk of infants with allergic manifestation (atopic dermatitis and food allergy) in the first 3 years of life, healthy infants with allergic mother and healthy infants with non-allergic mother.

* Parents of breast-fed infant from general pediatric clinic and allergy clinic of King Chulalongkorn Memorial Hospital were approached for informed about the research and ask to join this project
* After completed informed consent, demographic data was collected and filled in case record form
* Milk of mother in both allergic and control groups were collected 60 ml then transferred to freeze at -80oc to for human milk oligosaccharide analysis

Eligibility Criteria:
Inclusion Criteria:

1. mothers with breast-fed infant with or without allergic manifestation
2. Intend to participate for follow up and sign consent to participate in the study

Exclusion Criteria:

1. Mothers with any medical illness or high risk infant pregnant
2. Infants with disease which affected allergic disease
3. No inform consent
4. Anything in the opinion of the investigator that would prevent children from completing the study
The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU)

The purpose of this study is to determine if taking supplemental DHA improves measures of processing speed and executive function in teen and adult women with PKU.


Eligibility Criteria:
Inclusion Criteria:

* Females
* Phenylketonuria
* Ages 12 years and older
* Able to complete neuropsychological testing

Exclusion Criteria:

* Pregnancy
* Currently taking DHA supplement
Mood Patient Powered Research Network (MoodNetwork)

The MoodNetwork, a patient-powered research network (PPRN), is one of 18 PPRNs participating in Patient-Centered Outcomes Research Institute's (PCORI) PCORnet network. Its objective is to improve the nation's capacity to conduct comparative effectiveness research that reflects questions of greatest importance to patients and other stakeholders. A robust data infrastructure will be built that, in phase one, allows participants to contribute data, including those from participant questionnaires, visualize their own health information in intuitive and helpful ways, and share their aggregated de-identified health information within and outside of the Network.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Valid email address
* Self-identify as having a mood disorder

Exclusion Criteria:

* Under 18 years of age
Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.

During the period 1989-1999, a number of patients underwent an ALIF-procedure. Anterior Lumbar Interbody Fusion procedure (ALIF) is a type of lumbar spinal fusion. The approach of the lumbar region is by incision of the abdominal wall. The intervertebral disc is removed and replaced by a bone graft. These patients form the population of this study. The goal of this study is to evaluate their current medical condition and to determine the clinical outcome.

The clinical result will be stipulated by means of standardized questionnaires (VAS-score, Oswestry low Back Pain Questionnaire and SF-36)


Eligibility Criteria:
Inclusion Criteria:

* An Anterior Lumbar Interbody Fusion procedure between 1999 and 2005

Exclusion Criteria:

* None
mHealth Family Self-Management

This innovative research will address a gap in the literature involving the evaluation of the impact of an individualized family-centered mHealth application to enhance daily post-discharge communication following pediatric transplant. This proposal lays the foundation for future research with myFAMI (self-management intervention) at multiple pediatric transplant centers and builds the science from which to consider post discharge monitoring and decrease cost of care in other pediatric chronic illness populations.


Eligibility Criteria:
Inclusion Criteria:

Pediatric patients:

1. Has undergone a heart, kidney, or liver transplant being discharged home from the hospital
2. Has two eligible family members available to answer questions about the patient

Family members will be eligible for participation upon meeting the following inclusion criteria:

1. is English speaking (to date the instruments being used have been validated for English speaking participants only)
2. is 18 years of age or older
3. has a pediatric family member (\< 18 years old) who has undergone a heart, kidney, or liver transplant being discharged home from the hospital.

Exclusion Criteria for the family members are:

1. presence of significant communication or cognitive impairment that would preclude completion of questionnaires based on self-report; or
2. the pediatric family member has experienced a previous transplant based on self report.

Participants unable to speak and read English will be excluded due to the lack of resources to develop the app and communicate via FaceTime in different languages. We will recruit family members from three types of transplant populations to allow for sufficient sample in a limited time frame for this complex pediatric surgery and high-risk population.

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Limited English Proficiency Virtual Family-Centered Rounds

This study will be a pilot test of using telehealth with an interpreter as an additional option for parents with limited English proficiency to join family-centered rounds in the neonatal intensive care unit.


Eligibility Criteria:
We will enroll family units. Family units consist of the hospitalized infant and their eligible parents/guardians.

Inclusion Criteria - INFANT:

* Infants aged less than 365 days who are admitted to the neonatal intensive care unit
* Have at least one eligible parent or guardian (see below for parent eligibility criteria)

Exclusion Criteria - INFANT:

* Have restrictions placed by child protective services, including visitation restrictions or restricted access to patient information
* Infants with a previous neonatal intensive care unit admission (and enrollment) during the trial period
* Infants already enrolled in a different trial that includes a virtual family-centered rounds intervention

Inclusion Criteria - PARENT:

* Aged 18 years or older
* Preferred language that is other than English
* Have at least one infant enrolled in the trial

Exclusion Criteria - PARENT:

* Under age 18 years
Prognostic Counselling in Palliative Head and Neck Cancer (ProCoPall)

The investigators test the effect of providing individualized prognostic information on life-expectancy to head and neck cancer patients in the palliative phase.

In this prospective sequential cohort study, the investigators aim to include 160 patients with a palliative diagnosis of head and neck squamous cell carcinoma, divided into two cohorts. In cohort 1, patients will receive general prognostic counselling, while in cohort 2, patients will receive individualized prognostic counselling using the recently developed prognostic model 'OncologIQ Palliative'. Cohort 2 will commence after completion of cohort 1. The primary outcome will be decisional conflict and satisfaction with the decision-making process and proactive care planning. Additionally, we will assess whether patients undergo palliative treatment and, if so, the type of treatment received. We will also evaluate overall survival, the incidence of palliative sedation or euthanasia, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received a palliative diagnosis of a squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, supraglottic larynx, glottis larynx and unknown primary.

Exclusion Criteria:

* Illiterate patients
* Insufficient knowledge of Dutch language
* Incompetent (due to i.e. mental state) to consider their own treatment choice
Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions

In this open label, single-sequence study, subjects received one dose of XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation at the start of study on Day 1 and Day 6. Omeprazole 40 mg was administered on Day 2, 3, 4, 5 and 6. The study was conducted in two groups.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-60 years
* Sex: Healthy adult males (sterile or using contraception) and females of non-childbearing potential
* Clinical laboratory values should be within the laboratory's stated normal range. If not within this range, they must be without clinical significance, as determined by the Investigator
* No clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by the Investigator
* Any abnormalities/deviations from the acceptable range of medical history, laboratory values, ECG, and vital signs that might be considered clinically relevant by the study physician or Investigator will be evaluated as individual cases
* Able to comply with study procedures, in the opinion of the Investigator(s)
* Willing to give written consent, pregnancy outcome consent, and adhere to all the requirements of this protocol

Exclusion Criteria:

* Any major illness in the last three months or any significant ongoing chronic medical illness
* Does not agree to consume the provided meals
* Participation in any clinical trial 30 days prior to dosing
* Positive results for drugs of abuse or alcohol breath analysis prior to dosing
* Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen, Hepatitis C Virus, or anti-HBc tests
* Females currently breastfeeding, demonstrating a positive pregnancy screen, or using hormone replacement therapy within three months prior to dosing
Analysis of Oncogenes in Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma in Tumor Tissue Samples

The primary objective of this study is to estimate the frequency of FGFR2 fusions in archived intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma (HCC-CCA) tumor samples

This is a non-interventional, observational study of archived human tissue samples; no surgical procedures will be required and no treatment will be provided as part of this study. Approximately 150 archived tissue samples obtained from patients with iCCA or mixed HCC-CCA will be analyzed for somatic alteration status and will include cholangiocarcinoma-specific FGFR2 fusion isoforms.

Eligibility Criteria:
Inclusion Criteria:

* If required by law or local regulations (i.e., the sample is from an identifiable subject), signed written informed consent should be granted prior to use of the sample in the study
* ≥ 18 years of age
* Histologically or cytologically confirmed iCCA or mixed HCC-CCA, who are/were eligible for systemic therapy (samples collected prior to initiation of the systemic therapy may be submitted for testing)
* Have one or more formalin fixed and paraffin embedded blocks available. If blocks are not evaluable, 7-10 unstained, non-baked slides with 5-micron thick sections with at least 20% tumor tissue should be available. (Potential participants who are scheduled to undergo surgical treatment may agree to provide surplus of tissues not required for diagnosis and have to provide informed consent prior to the surgery.)

Exclusion Criteria:

* Not applicable: Patients must meet all of the inclusion criteria.
Using A Novel Classification System in Intravenous GCs Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial

For patients with active moderate-to-severe thyroid associated ophthalmopathy (TAO), the Intravenous Glucocorticoids (GCs) is the recommended therapy. However, the efficacy of GCs is not satisfied. Investigators established a novel classification of TAO for the first time to assess more precisely for better personal treatment.

TAO is one of most common extra thyroid manifestation of dysfunctional thyroid disease. Since the morbidity of TAO has been increasing rapidly, Investigators' team is intended to verify the feasibility of the new type of classification system established by the related parameters of orbital MRI scan. Based on classification, investigators compare the efficacy of two GCs therapy. According to MRI,investigators measure the optimal T2 signal intensity ratio (SIR) for the treatment of TAO, which may help to find a better treatment time for therapy.

Eligibility Criteria:
Inclusion Criteria:

1. The diagnostic standard of TAO is according to Bartley's criteria.
2. Patients with active moderate-to-severe TAO based on 2016 EUGOGO guidelines.
3. CAS≥3/7.
4. None of the patients received any glucocorticoids therapy or orbital radiotherapy in the previous 3 months.

Exclusion Criteria:

1. NOSPECS is 0 or 1.Only signs,no symptoms.Signs include:reduced blink(Stellwag symptoms),two reduced cohesion(Mobius levy),moving slowly on the eyelids(Von Graefe sign),to the point of view,the forehead wrinkled skin should not(Joffroyv levy).
2. Suffering from other eye diseases or wearing contact lenses.
3. Suffering from other autoimmune diseases.
4. Acute and chronic infectious diseases.
5. Diabetic retinopathy or hypertensive fundus lesions.
6. Patients received orbital decompression or other orbital surgery.
7. Suffering from eye trauma or ocular surface disease.
8. Special occupants, and the working environment has obvious air pollution etc.
HD-tDCS to Modulate Connectivity

The purpose of the proposed study is to broaden our understanding on the neural effects of High Definition Transcranial Direct Current Stimulation (HD-tDCS) so that its clinical effects can be further improved.

Normal healthy individuals will be recruited and undergo a standardized neuropsychological assessment (ANAM, MoCA, BDI-II, ToMS, and MAAS) and magnetic resonance imaging (MRI). During MRI, HD-tDCS will be applied. Four different stimulation targets will be investigated, and subjects will be randomly assigned for each target groups or sham group. After HD-tDCS/MRI session, subjects will be re-assessed with standardized neuropsychological tests.

Eligibility Criteria:
Inclusion Criteria:

- All other than excluded.

Exclusion Criteria:

* History or susceptibility to any neurological or psychiatric diseases, particularly seizures
* abnormal MRI
* metal implants or a cardiac pacemaker
* pregnant or breastfeeding women
Gut Microbiome Studies in Patients with POEMS Syndrome and Other Plasma Cell Disorders

A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders

The characteristics and role of gut microbiome rare plasma cell disorders- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) and amyloid light-chain (AL) amyloidosis, have not been explored; and their pathophysiology is quite elusive. To help understand rare plasma cell disorders and its association with gut microbiome, the investigators will study the stool samples of newly diagnosed POEMS patients and AL amyloidosis and compare it with patients with newly diagnosed monoclonal gammopathy of undetermined significance and multiple myeloma as well as healthy controls. Moreover, gut microbiome in newly diagnosed POEMS patients will be compared to POEMS patients in remission. It is the overall hypothesis that in POEMS patients the gut microbiome signature will differ between active disease (at diagnosis) and inactive disease (in remission), and the gut microbiome in POEMS patients will be different from patients with other plasma cell disorders and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with POEMS syndrome (newly diagnosed or in remission) or with newly diagnosed multiple myeloma (MM), monoclonal gammopathy of undetermined significance (MGUS), amyloid light chain (AL) amyloidosis or healthy controls from their households

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Substance abuse
* Antibiotics use or gastrointestinal endoscopy in the 3 months prior to the study participation
* Chronic gastrointestinal disorder
* Gastrointestinal surgeries in the past 2 years
* Chemotherapy (including anti-plasma cell treatment and steroids) or radiation treatment for cancer within the last 2 years or active cancer (other than plasma cell disorder)