cyrilzakka/clinical-trials huggingface dataset:
BabyQ's: Randomized Controlled Trial of Health Messaging in Pregnancy and Infancy

This randomized controlled intervention evaluates the effect of a mobile health behavioral intervention to test messages to reduce sugar-sweetened beverage intake during pregnancy and infancy.

The study team will perform a prospective, longitudinal, interventional, randomized control trial by recruiting 300 WIC families during the first 1,000 days of life (pregnancy through infant age 2 months) at consecutive Women, Infants, and Children (WIC) visits to test two interventions compared to a control group. The study team will implement a mobile-based messaging intervention allocate participants to one of 3 arms for a 1 month period: 1) negative message frames, 2) positive message frames, and 3) attention control.

Childhood obesity prevalence soared over the past four decades with a 10-fold increase globally from 1975-2015 and Healthy People 2020 has declared obesity a national health priority. Socioeconomic and racial/ethnic disparities in obesity exist and may be widening. These disparities are apparent by age 2 years with recent national data showing that Hispanic children continue to have highest obesity prevalence (15.6%) and on-Hispanic black children have 2-fold higher obesity prevalence (10.4%) compared to non-Hispanic white (5.2%) counterparts. The first 1,000 days describes the period from pregnancy through child age 2 years, and is increasingly recognized as a critical period for development of childhood obesity and its adverse consequences. Several risk factors are consistently associated with later childhood obesity during the first 1,000 days and are more prevalent among low socioeconomic groups and racial/ethnic minorities. These modifiable risk factors mediate the development of racial/ethnic disparities in later childhood obesity.

Sugar-sweetened beverage (SSB) consumption during the first 1,000 days is a risk factor for childhood overweight/obesity, and has been linked to dental caries, lower child cognition, and the adverse child health consequences. Recent evidence shows that maternal SSB consumption during pregnancy and infant SSB consumption in the first year of life are associated with childhood obesity later in life. Thus, interventions to curb SSB consumption and promote healthy beverage intake in urban, low-income Hispanic/Latino families must start early in life, yet few SSB-specific interventions have ventured to do so.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women age 18 years or older or; legal caretakers of infants under 24 months enrolled in WIC
* Can respond to questions in English or Spanish
* Report use of a mobile device using iOS or Android
* Give permission to enroll in messaging system

Exclusion Criteria:

* Pregnant women with chronic medical conditions that may impact their nutrition behaviors
* Families whose eligible child has chronic conditions that interest with growth or feeding
Preventing Recurrent Urinary Tract Infections With α-D-mannose

In this trial, women with history of recurrent urinary tract infections (UTIs) will be followed over the course of 6 months. The women will be randomized either to D- Mannose or Placebo.

The primary objective of this study is to investigate if treatment with D-mannose reduces the risk for a UTI recurrence compared to treatment with Placebo.

H0: Women with history of recurrent UTIs treated with D-Mannose on average have the same number of recurrent UTIs over the course of 6 months compared to women treated with Placebo.

H1: Women with history of recurrent UTIs treated with D-Mannose on average have fewer recurrent UTIs over the course of 6 months compared to women treated with Placebo.


Eligibility Criteria:
Inclusion Criteria:

* Women
* ≥ 3 UTIs within the last 12 months or ≥ 2 UTIs within the last 6 months;
* Laboratory urine culture: \<103 CFUs
* Age \> 18 years

Exclusion Criteria:

* UTIs ≥ 12 within 1 year
* Pregnancy or Lactation
* Immune disease
* Lactose intolerance
* Urinary tract anomaly
* Systemic infection
* Newly started hormone therapy within the last 6 months
* Antibiotic prophylaxis within the last 6 months
* α-D-mannose intake within the last month
* Use of catheters
* Diabetes mellitus
* Participation to other studies
Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

This is a Phase 1b/2 study of AVB-S6-500 designed to evaluate the safety and efficacy of AVB-S6-500 in combination with cabozantinib, AVB-S6-500 in combination with cabozantinib and nivolumab and AVB-S6-500 monotherapy in subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC). The phase 1b portion of the study is open label and patients with advanced ccRCC who had progressed on or after at least one prior line of treatment will receive AVB-S6-500 + cabozantinib. Two dose levels will be evaluated. The Phase 2 portion of the study is open-label 3-part study to evaluate efficacy and tolerability of AVB-S6-500 + cabozantinib, AVB-S6-500 + cabozantinib + nivolumab, and AVB-S6-500 alone.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Histologically confirmed advanced or metastatic clear cell Renal Cell Carcinoma confirmed by imaging. Phase 1b and Phase 2 Part A: has progressed on/after at least one front-line of treatment; Phase 2 Part B: No prior systemic treatment; Phase 2 Part C: not amenable to curative intent therapy.
* Must have radiologic imaging with a computed tomography (CT) scan or magnetic resonance imaging (MRI) within 28 days of enrollment
* Must have at least one measurable lesion according to RECIST 1.1
* ECOG performance status of 0-1
* Adequate bone marrow, liver and kidney function
* Life expectancy of \>12 weeks
* At least 28 days between termination of prior major surgery or anticancer therapy or 14 days from last radiation therapy and administration of AVB-S6-500

Exclusion Criteria:

* Received prior treatment with cabozantinib (Phase1b and Phase 2 Part A)
* Received prior treatment with nivolumab (Phase 2 Part B)
* Concurrent anti-cancer therapy or any other interventional treatment or other interventional research trial
* History of prior malignancy within the past 3 years except adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast
* Symptomatic CNS metastasis or metastases
* Active GI disease that would impact absorption of cabozantinib
* Nephrotic range proteinuria at screening
* Evidence of pleural effusion, ascites etc that requires therapeutic intervention within 28 days prior to AVB-S6-500 administration
* Phase 2 Part A and Part B: Has had a major bleed in the last 3 months, uncontrolled hypertension despite treatment with antihypertensives or is not appropriate for treatment with cabozantinib in the Investigator's opinion
* Serious active infection requiring IV antibiotics and/or hospitalization at study entry
* Phase 2 Part B: Has active, known or suspected autoimmune disease, defined as requiring systemic treatment
* Active COVID-19, HIV, Hepatitis B or Hepatitis C virus.
PROM Collected Via a WebApp Versus a Touch Screen Solution Among Patients With SLE

A randomised, within-participants cross-over design trial including 34 patients with systemic lupus erythematosus. The participants will be randomised to data registration of patient reported outcome measures (PROM) through the DANBIO webapp and thereafter via the outpatient touchscreen or vice versa.

The aim of this trial is to evaluate whether electronic reporting of PROMs through the DANBIO web application (webapp) is comparable to the outpatient touchscreen among patients with SLE.

The trial is a randomised, crossover, agreement study where 34 patients with SLE from the Department of Rheumatology at Aalborg University Hospital will be included and randomised in ratio 1:1 to:

* Group 1: PROMs are reported through the DANBIO webapp; thereafter, the touchscreen.
* Group 2: PROMs are reported through the touchscreen; thereafter, the DANBIO webapp.

There will be a wash-out period of 1-2 day between the two registrations to minimise carryover bias.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed in DANBIO with SLE
* Experience with the PROM questionnaires in DANBIO (≥ 1 previous assessments)

Exclusion Criteria:

* Inability to provide informed consent or to comply with the study protocol
* Diagnosis of SLE of ≥ 12 months
* Does not have access to a device that can run the DANBIO webapp
Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study

This study will pilot and assess feasibility of a prenatal intervention for obese pregnant women based on the Diabetes Prevention Program (DPP). Intervention group participants will meet with a clinic dietitian for 15 minutes at every prenatal appointment to complete a DPP-based curriculum and receive breastfeeding education. Control group participants will receive usual prenatal care. Outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum.

This study will pilot and test feasibility of a prenatal lifestyle intervention designed to limit gestational weight gain and prevent gestational diabetes. The intervention is based on the Diabetes Prevention Program lifestyle intervention, will include prenatal breastfeeding education and online peer group support, and will be integrated into the participants' regular prenatal appointments. Women (n=24) will be enrolled in early pregnancy. After baseline assessments (demographics, maternal diet, physical activity, mental health), women randomized equally to the intervention or usual care conditions. Further data collection will occur at approximately 24 weeks gestation, 36 weeks gestation, and 6 weeks postpartum, and clinical data (weight, pregnancy and obstetric complications) will be abstracted from medical records at the end of the study. Outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum. The investigators hypothesize that the intervention will reduce gestational weight gain, improve maternal dietary intake, increase total energy expenditure, and increase breastfeeding exclusivity in the first 6 weeks postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies of \<12 weeks gestation
* Pre-pregnant body mass index \>=30
* Speak and understand English
* Plan to continue care at the clinic through pregnancy and postpartum

Exclusion Criteria:

* Pre-existing diabetes
* History of serious chronic illnesses
* History of prior gestational diabetes
* Prior delivery at \<37 weeks gestation
* Prior delivery of infant weighing \<2500g
Acute Local Metabolomic Alterations in Blood and Muscle Tissue in Intermittent Claudication

The most common clinical presentation of lower extremity arterial disease is intermittent claudication. Current understanding of the pathophysiology of intermittent claudication, as well as its treatment options are limited. The progression of the disease may lead to lower limb amputation, which is devastating for patients' quality of life and is a huge socio-economic burden to society.

Current study allows to determine the acute local metabolomic alterations in the ischaemic limb of the patient with intermittent claudication, and investigate the associations between the metabolomic alterations and the patient's maximal walking distance. This provides potentially valuable insight into the pathophysiology of this disease, and helps lay the groundwork for identifying potential novel targets for instituting more effective therapies for this high-risk population.


Eligibility Criteria:
Inclusion Criteria:

* LEAD group: Patients with diagnosis of lower extremity arterial disease (Fontaine IIa).
* Control group: Healthy volunteers with no leg symptoms and an ankle-brachial index (ABI) of 1.0-1.4.

Exclusion Criteria:

* Fontaine stages I or IIb-IV
* Exacerbation of limb ischaemia within the preceding 2 weeks;
* strong rest pain of any cause;
* age \<18 or \>80 years;
* fasting \< 6 hours;
* time since last use of tobacco products \< 6 hours;
* body mass index ≥ 35 kg/m2
* poor sonographic visibility of femoral artery;
* angina;
* cardiac arrhythmia at the time of presentation;
* presence of cardiac pacemaker;
* myocardial infarction within the preceding 3 months;
* stroke within the preceding 6 months;
* ongoing anticoagulant therapy;
* ongoing dual antiplatelet therapy;
* any revascularization within the preceding 3 month;
* marked heart failure (NYHA III-IV);
* blood pressure ≥ 180/110 mmHg;
* blood pressure \<100/70 mmHg;
* clinically significant heart valve disease;
* acute infectious disease;
* active malignancy or chemotherapy or disease-free \< 5 years;
* type I diabetes or insulin therapy;
* other clinically significant and untreated endocrine disorders;
* moderate to severe bronchial asthma (GINA 2016);
* severe chronic obstructive pulmonary disease (mMRC grade 3-4);
* acute (KDIGO 2012) or chronic renal disease (eGFR-EPI \<30mL/min/1.73 m2);
* acute or chronic liver disease;
* anemia (\<110 g/L);
* neuroinflammatory or neurodegenerative disease;
* active rheumatism;
* other diseases and factors that markedly hinder the subject's ability to walk during the treadmill exercise.
* For control group exclusively: history of lower extremity arterial disease / ABI \<1.0 or \>1.4.
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy

The TNTRect trial is a prospective observational study that will evaluate the outcome of MR-guided stereotactic body radiotherapy (SBRT) with a simultaneous integrated boost in a hypofractionated treatment of rectum cancer. Patients will be treated in 5 daily fractions of 5 Gy within an overall treatment time (OTT) of 5 days. A simultaneous integrated boost (SIB) till 30Gy will be delivered to the gross tumor volume. Patients will be treated with daily adaptive radiotherapy and online tumor gating on the MRIdian system (ViewRay Inc.). The aim of the study is to improve the complete clinical response rate to offer more patients an organ preserving approach.

The primary endpoint is patient response to the treatment, assessed by endoscopy and MRI, or by medical pathology reports after potential resection was performed. As secondary endpoints local control, disease-free survival, overall survival and the patient's quality of life \& hospital anxiety and depression will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced rectal cancer

Exclusion Criteria:

* Patients with unresectable metastatic disease at diagnosis
* Patients with an ECOG performance status \> 2
* Patients not deemed fit for radiotherapy, chemotherapy or surgery
Disseminating Public Health Evidence to Support Prevention and Control of Diabetes Among Local Health Departments

The purpose of this study is to identify and evaluate dissemination strategies to support the uptake of evidence-based programs and policies (EBPPs) for diabetes prevention and control among local-level public health practitioners. Dissemination strategies such as multi-day in-person training workshops, electronic information exchange modalities, and remote technical assistance are hypothesized to associate with improved access and use of public health evidence and organizational supports for program and policy decision making based on evidence-based public health.

Evidence-based public health approaches to prevent and control diabetes and other chronic diseases have been identified in recent decades, and could have a profound effect on diabetes incidence and quality and length of life of those diagnosed. However, barriers to implement approaches continue because of lack of organizational support, limited resources, competing priorities, and limited skill among the public health workforce. The purpose of this study is to determine effective ways to promote the adoption of evidence based public health practice related to diabetes and chronic disease prevention and control among local health departments (LHDs). This stepped-wedge cluster randomized trial aims to evaluate active dissemination strategies on local-level public health practitioners to increase adoption and use of evidence-based programs and policies for diabetes and chronic disease prevention and control among LHDs in Missouri. Twelve LHDs will be recruited and randomly assigned to one of three groups that cross over from usual practice to receive the intervention (dissemination) strategies at 8-month intervals; the intervention duration for groups ranges from 8 to 24 months. LHD staff and the university-based study team are jointly identifying, refining and selecting dissemination strategies. Intervention strategies may include multi-day in-person training workshops, electronic information exchange modalities, and remote technical assistance. Evaluation methods include surveys at baseline and at each 8-month interval, abstraction of LHD chronic disease prevention program plans and progress reports, and social network analysis.

Eligibility Criteria:
Inclusion Criteria:

* Local Health Departments (LHDs, cluster) in the state of Missouri and corresponding public health workforce (individuals within cluster); screenings.

Exclusion Criteria:

* LHDs that have less than 5 employees working in or supporting diabetes or chronic disease control, which includes program areas of diabetes prevention and management, obesity prevention, physical activity, nutrition, cardiovascular health, and cancer
Effectiveness of Neuromuscular Exercise in Patellofemoral Pain Syndrome

The aim of the study is to investigate the effects of a neuromuscular exercise program on strength, balance, sleep quality and functionality in individuals with Patellofemoral pain syndrome.

The research is planned as a quantitative study. Classical knee exercises will be given to 25 individuals in the control group of the study. An exercise program consisting of Neuromuscular exercises will be applied to 25 individuals in the intervention group. In data collection, strength and balance measurements will be measured face to face by a physiotherapist, and the scales to be made through a survey will be sent to the patients online and they will be asked to fill them out. The scales and forms to be used are as follows: 1.Kujala Patellofemoral Score Scale 2.Lysholm Knee Scoring Scale 3.International Physical Activity Survey 4.Pittsburgh Sleep Quality Index 5.Y Balance Test 6.30 Seconds Sit and Stand Test Applied scales will be done by the physiotherapist. The surveys will be uploaded to the Google Forms database and the participants will be contacted via e-mail or mobile phone applications (such as Whatsapp, Telegram) to participate. They will first be asked to fill out the surveys before starting the exercise program and they will be asked to apply the exercise program. It will be explained as follows. Exercises will be planned 3 times a week and for 12 weeks. Participants will be asked to participate in the survey again after completing the exercise program.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study.
* Not under 30 years of age and not over 60 years of age.
* Having patellofemoral pain syndrome.
* Not having a physical disability.
* Not having undergone any knee-related surgery.
* Having access to a computer/tablet/phone and the internet.

Exclusion Criteria:

* Not accepting the voluntary consent form.
* Being under 30 years of age and over 60 years of age.
* Having undergone any knee-related surgery.
* Having cognitive, mental or psychological problems.
* Having impaired vision or hearing.
* Having a physical condition that causes significant loss of function.
Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section

Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid

Women will be approached priors to discharge from the hospital, if they meet inclusion criteria and consent for the study, they will be randomized to one of two possible analgesic regimens. They will be followed at 1-2 weeks and 4-6 weeks after discharge to assess pain level.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaker women who had a cesarean section

Exclusion Criteria:

* Inability or refusal to provide informed consent.
* Reported current or prior opioid or benzodiazepine use disorder, including urine drug screen positive for a non prescribed opioid or benzodiazepine upon admission or during prenatal care.
* Current treatment with methadone, buprenorphine or buprenorphine plus naloxone.
* Known alcoholism disorder.
* Severe renal or hepatic impairment.
* Known creatinine \> 1.5 at the time of delivery or severe proteinuria leading to diagnosis of renal disease prior to delivery.
* Severe peptic ulcer disease
* Severe asthma (if patient has asthma but has previously tolerated NSAIDS, she will be allowed to participate)
* Known CYP450/CY92D6 mutation conferring opioid ultra-rapid metabolizer status.
* Allergy to any of the study drugs (anaphylaxis).
* Incarcerated or institutionalized patients.
* Inability to follow up as outpatient in our outpatient clinic.
* wound dehiscence or infection diagnosed prior to discharge from the hospital
* wound vac placed prior to discharge from the hospital
Plerixafor/G-CSF as Additional Agents for Conditioning Before HSCT in CGD Patients

Treatment Study to assess of safety and efficiency of conditioning with Plerixafor and G-CSF as additional agents for prevention of graft failure after transplantation in patients with chronic granulomatous disease

Severe primary or secondary graft dysfunction is one of major problem in patients with Chronic granulomatous disease (CGD). In this study the hypothesis is that the use of plerixafor and G-CSF as additional agents in conditioning regimen would offers advantages. The effect is based on mobilizing bone marrow stem cells into the peripheral blood and blocking CXCR4 chemokine receptors to prevent stem cell homing. Thus, some have hypothesized that plerixafor and G-CSF make free stromal space of the bone marrow available for donor stem cell engraftment. Moreover, stem cell release probably leads to liberation of host stem cells from the anti-apoptotic effects of the BM stroma for the more powerful effect of chemotherapy. Thus, the purpose of this study is to evaluate the safety and efficiency of myeloablative conditioning with Plerixafor and G-CSF as additional agents for prevention of graft failure after stem cell transplantation in patients with chronic granulomatous disease.

Eligibility Criteria:
Inclusion Criteria:

Patients aged ≥ 1 months and \< 25 years Patients diagnosed with CGD eligible for an allogeneic transplantation Signed written informed consent

Exclusion Criteria:

Lack of informed consent.