cyrilzakka/clinical-trials huggingface dataset:
A Mobile-health Pilot Experiment Targeting Mothers With Newborns in Rural Areas of San Juan Sacatepequez, Guatemala

The purpose of this study was to determine whether exposure to m-health platforms promoting recommended breastfeeding practices was effective in transmitting the exclusive breastfeeding message to participant mothers, and in improving weight evolution of infants.


Eligibility Criteria:
Inclusion Criteria:

* Can read
* Has a baby of less than 4 months of age OR is in her 8th month of pregnancy

Exclusion Criteria:

* Cannot read
* Does not have a newborn
Vitamin D and Microbiota in Cystic Fibrosis

The objective of this study is to assess the effects of a high-dose vitamin D3 on the composition of gut and lung microbiota in adolescents and adults with cystic fibrosis who are vitamin D deficient.

Monocentric, double-blind, randomized, placebo-controlled, interventional pilot study to investigate the beneficial effects of high dose vitamin D supplementation on gut and lung microbiota in patients with cystic fibrosis who are vitamin D insufficient.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to the Cystic fibrosis clinic for routine follow up of cystic fibrosis
* Serum 25(OH)D concentrations obtained within 2 months of enrollment
* Able to tolerate oral medications

Exclusion Criteria:

* Inability to obtain or declined informed consent from the subject and/or legally authorized representative
* Pregnancy or plans to become pregnant in the next 3 months
* History of disorders associated with hypercalcemia including parathyroid disease
* Current hypercalcemia (albumin-corrected serum calcium \>10.8 mg/dL or ionized calcium \>5.2 mg/dL)
* History of nephrolithiasis with active symptoms within the past two years
* Chronic kidney disease worse than stage III (\<60 ml/min)
* Current significant hepatic dysfunction total bilirubin \> 2.5 mg/dL with direct bilirubin \> 1.0 mg/dL
* Current use of cytotoxic or immunosuppressive drugs
* History of AIDS
* History of illicit drug abuse (defined as history of enrollment into a drug rehabilitation program or hospital visits due to drug use within the past 3 years or any use of the following drugs in the past 6 months (cocaine, opiates, amphetamines, marijuana) or any positive toxicology screen for (cocaine, opiates, amphetamines, marijuana)
* Too ill to participate in study based on investigator's or study team's opinion
* Current enrollment in another intervention trial
* In addition we amended our study with three additional criteria 11) systemic antibiotic use in the last 4 weeks, 12) use of probiotics and, 13) inflammatory bowel disease, four months after the start of the study and after 12 subjects were randomized, as we considered that these factors may also influence our study endpoints. Of the 12 subjects who were randomized, only 4 would have been excluded.
Effect of Chewing Gum on Post-operative Ileus (GUMPI)

The purpose of this study is to determine whether chewing gum post-operatively decreases the time to first flatus or defecation in patients undergoing spine surgery as a indirect indicator of post-operative ileus.

The patients undergoing spine surgery are at risk of developing post-operative ileus, which will lengthen the hospital stay and cause gastrointestinal distress in patients. Post-operative sham feeding in form of chewing a gum seems to increase the functionality of gastro-intestinal tract earlier in patients who have undergone gastro-intestinal and gynecological surgeries.

This study will recruit patients undergoing spine surgery at the investigators medical center and allocate them randomly into two equal groups. Patients in one group will be asked to chew gum after surgery and the other group will not be offered anything on chew on. Both groups will be kept nothing per os (NPO) otherwise till the first bowel movement. The first post-operative flatus and defecation time will be recorded as primary measures and other main outcomes will include first post-operative meal, length of stay and presence of ileus. The descriptive parameters of the two groups will also be recorded as related to relevant medical history, surgery, and post-operative care, to adjust for its effect on outcome measures.

This study will identify any beneficial effect that chewing gum will have on post-operative ileus development and might be helpful in establishing better post-operative care protocols in patients undergoing spine surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient 13 years of age or older
* Patients who will undergo spine decompression, laminectomy (cervical, lumbar and/or thoracic), discectomy, foraminotomy, or corpectomy, with or without arthrodesis, with or without instrumentation.

Exclusion Criteria:

* Less than 13 years of age
* Patients who have undergone with abdominal surgery within the last month
* Patients with inability or problems with chewing and/or dysphagia
* Patients who are expected to be kept intubated after surgery
* Patients who are allergic to any chewing gum component
Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC

This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC
* Absence of EGFR, ALK, and ROS1 gene mutations
* Eastern Cooperative Oncology Group (ECOG) status 0-1
* Signed written informed consent prior to the implementation of any trial-related rocedures
* Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy: Absolute neutrophil count ≥ 1,500 х109/L, Thrombocytes ≥ 100 х 109/L, Hemoglobin ≥ 90 mg/L, Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 40 mL/min, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \&gt; 2.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) \&gt; 5 x ULN, Bilirubin \&gt; 1.5 х ULN

Exclusion Criteria:

* Patients diagnosed with any other malignant tumor
* Have received prior therapy with chemotherapy or immune checkpoint inhibitor
* Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
* Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
* Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
* A history of interstitial lung disease or non-infectious pneumonia
* Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years
* Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
* Patients who have received allogeneic stem cell or solid organ transplantation
* Women during pregnancy or lactation
Prevalence of Pancreatic Anomalies of Patients With a 1st Degree Familial History of Pancreatic Adenocarcinoma

Pancreatic adenocarcinoma is the 4th leading cause of cancer in the USA. Its incidence is increasing both in France and in Europe, whereas all the other cancers are decreasing in Europe. Moreover, its seriousness is still high, with a mortality rate higher than the average incidence. The aim of PAPAFA study is to assess the prevalence of the pancreatic anomalies which can be revealed thanks to imaging, for patients having a 1st degree pancreatic adenocarcinoma familial history. This could allow detection of lesions which are less than 10 mm long, and improve the dark prognostic of this pathology.


Eligibility Criteria:
Inclusion Criteria:

* patients with a 1st degree familial history of pancreas adenocarcinoma
* patients older than 40
* patients whose life expectancy is \> 3 months
* inform and consent form signed
* patient insured under the French social security system

Exclusion Criteria:

* contraindication to the MRI (pace-maker, implanted metallic material, medical history of allergy to the contrast agent, end-stage renal failure, pregnancy, claustrophobia)
* contraindication to anesthesia to do the echo endoscopy
* 1st degree family history of 2 pancreas adenocarinomas
* medical history of allergy to benzylic alcool
* contraindication to dimeglumine gadobenate
* pregnant or breastfeeding woman, according to the questioning
* subjets who don't have the legal capacity to consent
Project Matter: Intervention to Improve HIV Self-care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders

This study will implement a pilot randomized controlled trial (RCT, N=60) to assess the feasibility and acceptability a refined emotion regulation intervention designed to improve engagement in HIV-care among substance using HIV+ MSM sub-optimally engaged in HIV care.

Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). Participants will be randomized to an enhanced treatment as usual (E-TAU) arm or the intervention arm. All participants (in both the E-TAU and intervention groups) will receive a one-session behavioral engagement in care intervention, substance use treatment referral information, and the opportunity to discuss and problem solve barriers to substance use treatment with an interventionist, informed by motivational interviewing principles. After randomization, participants in the intervention group will attend 5 therapy sessions focused on behavioral strategies for improving HIV self-care, meta-cognitive awareness of emotions and thoughts, and cognitive restructuring. All participants will receive texts queries about antiretroviral therapy (ART) adherence and substance use, and participants in the intervention group will also receive text queries about mood. All participants will be compensated for every research visit and completed text message blocks.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* Cisgender male
* Man who has sex with men (MSM)
* Elevated levels of internalized stigma related to HIV, substance use, or homophobia
* Poorly engaged in HIV care
* Able to provide informed consent
* 18 years or older
* English speaking

Exclusion Criteria:

* Women
* Non-cisgender men
* Do not identify as gay, bisexual, or MSM
Antihypertensive and PAP Treatment in Obstructive Sleep Apnea Patients With Hypertension (AHPAP)

The investigators will perform a long term registry based prospective analysis on incidence of major cardiovascular events or death in hypertensive patients with obstructive sleep apnea .

Effects of PAP (positive airway pressure) compliance, antihypertensive medication and blood pressure control will be investigated in the study.

By using swedish personal ID numbers the investigators can combine data from several quality registries in Sweden and will start with patients from a primary care registry (QregPV) that had or received a hypertension diagnosis during the period 2008-2012. The investigators will compare those who got an OSA diagnosis in the SESAR (Swedish sleep apnea registry) stratified by high/low PAP compliance with an intraoral device group, a non treated OSA group as well as a control group without OSA until 2021. Main outcome variables will be major cardiovascular events or death. Outcome data will be collected from the National Patient Registry and Cause of death registry.

Groups will be matched by propensity score for known confounders. Secondary analysis will consider modifying effect of different antihypertensive drugs (the Swedish Prescribed Drug Register, type of therapy; DDD comparison) and the actual degree of hypertension control (blood pressure levels) on CV risk. It is intended to stratify the analysis for BP levels in order to evaluate if lower BP targets further reduce CV risk in hypertensive OSA patients. These analyses will likely be reported in separate publications.

HYPOTHESIS

1. PAP treatment in hypertensive OSA patients reduces the long term risk of major cardiovascular events (MCE) and premature death. The risk reduction is modified by PAP compliance, hypertension control and OSA severity.
2. In hypertensive OSA patients, the investigators previously identified betablockade as a drug class leading to better pressure control (1). The investigators hypothesize that any risk reduction by PAP treated OSA is influenced by the types of antihypertensive drugs used.
3. Lower blood pressure targets (ie better BP control) may reduce the risk of cardiovascular events in PAP treated OSA patients.

Eligibility Criteria:
Inclusion Criteria:

* All hypertensive and obstructive sleep apnea patients present in QregPV and SESAR 2008-2021.

Exclusion Criteria:

* Patients in the hypertensive control group (without OSA) will be excluded if they have OSA diagnosis but are not present in the SESAR registry.
* Subjects with missing data on any of the variables in the fitted model unless the missing data can be accurately imputated.
* Patients with low life expectancy (Age\>75 at study start, malignant disease).
* Patients no longer living in VGR 2021.
Adaptive Radiotherapy and MRIs Based on Patients With Newly Diagnosed High-Grade Glioma

The purpose of this study is to find out if performing additional Magnetic Resonance Image (MRI) scans of the subjects' brain during each week of the radiation treatment of their high-grade glioma will help improve the radiation treatment.

Diffusion weighted imaging (DWI) and Perfusion-weighted imaging (PWI) are validated MRI techniques that aid in diagnosis, prognosis, and assessment of treatment efficacy and, while they are utilized in select clinical settings, they have yet to make their way into routine clinical practice at most centers. DWI is a non-invasive MRI modality that has demonstrated an ability to predict for a response to radiation therapy in the primary treatment of patients with glioblastoma (GBM). PWI is one collection of measures that includes dynamic susceptibility contrast (DSC) enhancement and dynamic contrast-enhanced (DCE) imaging. The latter methods of MRI-adapted radiotherapy allow the opportunity to direct high-dose radiation to areas most likely to harbor resistant tumor while avoiding regions having a low likelihood of future recurrence. Multiple MRI sequences have been developed and validated that may identify high-risk areas in patients with High-grade glioma (HGG) and the ability to acquire multiple sequential time points creates an opportunity for dynamic radiotherapy that has not previously been explored. The current standard of care in radiotherapy does not incorporate any additional neuroimaging data.

This study hypothesizes that pre- and mid-treatment advanced imaging with (DWI) and (PWI) in patients with HGG can be used to generate an adaptive radiotherapy boost volume that correlates with areas of future recurrence and that this volume has a higher spatial correlation relative to the current standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically proven diagnosis of glioblastoma, anaplastic astrocytoma, or anaplastic oligodendroglioma
* History and physical examination within 28 days prior to enrollment
* Karnofsky performance status 70 or greater
* Age 18 years or greater
* Negative pregnancy test for females of childbearing potential before 1st research MRI, performed in accordance to institutional guidelines.
* Plan to receive 59.4-60 Gy in 30-33 fractions of radiotherapy. Glioblastoma patients over 65 year-old can receive hypofractionated radiotherapy including 40 Gy in 15 fractions.

Exclusion Criteria:

* Prior therapy for tumor except for biopsy or resection, including prior radiotherapy to the brain.
* Clinical or radiological evidence of metastatic disease outside the brain
* Prior malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years
Effect of Music Therapy on Families of Burn Patients

The purpose of this study is to investigate the efficacy of music therapy in assisting with the coping and adjustment of children of adults with major burns. The investigators hypothesized that there will be a significant decrease in anxiety levels between those children who participated in music therapy compared to non-participants.

The Sound Of Family Together (S.O.F.T.) Music Program was introduced on a 14-bed burn intensive care unit to provide an avenue for communication between adults with major burns and their children. In adherence with unit policies, children under the age of 16 are only allowed onto the unit under very special circumstances, e.g. patient is under DNR status. This restriction may translate into a prolong absence between the patients and their young children; which may result in emotional and psychological stress factors such as separation anxiety, feelings of abandonment, and rejection of the parent when the patient is being discharged to home. Children who participate in the S.O.F.T. Music Program will record and produce an audio CD for their hospitalized parent/grandparent. The contents of the CD might include original songs, poems, and special messages created by the children. Pre and post tests results will determine the efficacy of the program to decrease anxiety levels in the children.

Eligibility Criteria:
Inclusion Criteria:

* Child's age between 6 - 14 years
* Child or grandchild of patient
* Child with limited visitation
* Adequate hearing, with correction
* Consenting non-hospitalized adult family member (NHAFM) speak/read English
* Child speak/read English
* Major physical or mental illness or disability does not interfere with ability to communicate for both consenting NHAFM and child

Exclusion Criteria:

* Child's age below 6 years and above 14 years
* Not the child or grandchild of patient
* Child with unlimited visitation
* Hearing loss that interferes with ability to communicate
* NHAFM does not speak/read English
* Child does not speak/read English
* Major physical or mental illness or disability interferes with ability to communicate for both consenting NHAFM and child
* Patient on observation status, i.e. only one overnight stay
Safety and Immunogenicity of a New Formulation of a Bivalent Killed, Whole-Cell Oral Cholera Vaccine

The purpose of this study is to evaluate the safety and immunogenicity of a new formulation of a locally-produced bivalent, (O-1 and O-139) killed whole cell oral cholera vaccine among Vietnamese adults.

Cholera remains to be a serious public health problem worldwide. In the mid-1980s following technology transfer from Sweden, Vietnamese scientists developed and produced an oral killed monovalent cholera vaccine for Vietnam's public health programs. A 2-dose regimen of this vaccine has been shown to be safe and efficacious. Subsequently, a bivalent vaccine was developed containing the newly emergent O139 V. cholerae. This vaccine has several advantages over the existing Swedish vaccine. It confers protection against the El Tor biotype in younger children, is considerably less expensive, does not require a buffer during administration and does not require strict cold chain requirements. However, this vaccine is not licensed for use in countries other than Vietnam. In order to make this vaccine available to other countries, the IVI has provided technical assistance to produce this vaccine following the WHO Good Manufacturing Practices standards. A new formulation of the current oral cholera vaccine was produced following these guidelines. Since this vaccine is slightly different from the previous vaccine, a study is necessary to demonstrate safety and immunogenicity for local licensure and larger Phase III studies in other countries.

Eligibility Criteria:
Inclusion Criteria:

* Healthy non-pregnant adults
* Available in the study area for 1 month

Exclusion Criteria:

* Diarrhea for the past week
* Antibiotic use in the past week
* Intake of anti-diarrheal medicines in the past week
* One or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months
* Abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours
* Pregnancy
Comparison of Patient-reported Outcomes for Rimegepant and Triptans in the 2023 US National Health and Wellness Survey

This is a cross-sectional study using the cross-sectional 2023 National Health and Wellness Survey (NHWS) data from the US, with a large and nationally representative population (N=75,007).

All data from the NHWS are reported by respondents, who are recruited through an existing, general-purpose, web-based, consumer panel via opt-in e-mails, co-registration with panel partners, e-newsletter campaigns, banner placements, and affiliate networks. All respondents explicitly agree to be a panel member, register with the panel through a unique e-mail address, and complete an in-depth demographic registration profile.

This analysis will focus on respondents who self-report having migraine diagnosed by a physician. Individuals who use rimegepant for acute treatment of migraine will be compared with those who use triptans for acute treatment of migraine. Outcomes of interest include treatment satisfaction, healthcare resource utilization (HCRU), quality of life (QoL), work productivity loss, and migraine-specific disability outcomes.

Inverse probability of treatment weighting (IPTW) will be used to adjust for differences that may exist between rimegepant and triptan users prior to comparing outcomes.

This is a cross-sectional study using the cross-sectional 2023 National Health and Wellness Survey (NHWS) data from the US, with a large and nationally representative population (N=75,007).

All data from the NHWS are reported by respondents, who are recruited through an existing, general-purpose, web-based, consumer panel via opt-in e-mails, co-registration with panel partners, e-newsletter campaigns, banner placements, and affiliate networks. All respondents explicitly agree to be a panel member, register with the panel through a unique e-mail address, and complete an in-depth demographic registration profile.

This analysis will focus on respondents who self-report having migraine diagnosed by a physician. Individuals who use rimegepant for acute treatment of migraine will be compared with those who use triptans for acute treatment of migraine. Outcomes of interest include treatment satisfaction, healthcare resource utilization (HCRU), quality of life (QoL), work productivity loss, and migraine-specific disability outcomes.

Inverse probability of treatment weighting (IPTW) will be used to adjust for differences that may exist between rimegepant and triptan users prior to comparing outcomes.

Additional information is provided in the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* Participated in 2023 NHWS in the US
* Consented to the anonymous use of their data for research purpose
* Aged 18 or older
* Self-reported a diagnosis of migraine by physician
* Currently on rimegepant or triptan (via oral route) at the time of the survey

Exclusion Criteria:

- Currently on both rimegepant and triptans at the time of the survey