rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients With Metastatic Colorectal Cancer
Status: Not yet recruiting

The goal of this phase III, open-label, non-inferiority randomized controlled clinical trial is compare upfront dose-reduced chemotherapy with the standard dose chemotherapy in older patients ( ≥70 years) with metastasized colorectal cancer, with regard to progression-free survival (PFS). The choice between monotherapy (a fluoropyrimidine) and doublet chemotherapy (a fluoropyrimidine with oxaliplatin) will be made for each individual patient based on expected risk of chemotherapy toxicity (according to the G8 screening). Patients classified as low risk of toxicity will be randomized between doublet chemotherapy in either full-dose, or with an upfront dose-reduction of 25%. Patients classified as high risk will be randomized between monotherapy in either full-dose or upfront dose-reduction.

Primary outcome is PFS. Secondary endpoints include grade ≥3 toxicity, QoL, physical functioning, overall survival, number of treatment cycles, dose reductions, hospital admissions, cumulative received dosage and cost-effectiveness.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged 70 years or older with colorectal cancer and distant metastases without localized treatment options. Patients who are candidates for first-line palliative chemotherapy as judged by their treating oncologist Being able to understand the Dutch language Adequate bone marrow and organ function: Absolute neutrophil count (ANC) > 1.5 x 10^9 mmol/L, Hemoglobin (Hb) > 6.0 mmol/L, Platelets >100 x 109 / L, Serum bilirubin ≤ 2 x upper limit of normal (ULN), serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases.  Exclusion Criteria:  Patients who received prior palliative chemotherapy Patients in whom local treatment of metastases is scheduled (i.e. liver surgery or stereotactic radiotherapy) Candidates for triple chemotherapy Patients who received prior adjuvant chemotherapy in the one year before inclusion in the study (chemotherapy before that time is allowed) Patients with complete or incomplete dihydropyrimidine dehydrogenase (DPD) deficiency Patients with Microsatellite instable (MSI)-high colorectal cancer Patients with HIV or active hepatitis Patients with severe kidney failure (defined as GFR ≤30ml/min) Patients with severe cognitive deficits making informed consent not possible - HealthyVolunteers: No - Gender: All - MinimumAge: 70 Years - StdAgeList: Older Adult
Feasibility Study of A VoRo UrologIc ScaffolD (ARID)
Status: Recruiting

The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.

The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male 45-70 years of age Diagnosed with prostate cancer and scheduled for radical prostatectomy Gleason Grade Group 3 or lower Prostate size less than 80 grams Able and willing to provide written consent to participate in the study Able and willing to comply with study follow-up visits and procedures  Exclusion Criteria:  Malignant tumors outside of the prostate capsule confirmed via baseline assessments (e.g., mpMRI, bone scan) History of urinary incontinence, including stress or urge urinary incontinence On medications to treat overactive bladder (OAB) Post void residual >200 ml or > 25% voiding volume Presence of urethral stricture or bladder neck contracture Current or chronic urinary tract infection Prior urologic outlet surgical or minimally invasive procedure (e.g., TURP, HoLEP, Rezum, etc.). Prior pelvic radiation or anticipated need for radiation after radical prostatectomy Presence of stones in the bladder History of neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function Body mass index >35 Insulin-dependent diabetes mellitus Current uncontrolled diabetes (i.e., hemoglobin A1c ≥7.5%) Intravesical prostatic protrusion (IPP) >5mm History of immunosuppressive conditions (e.g., AIDS, post-transplant) Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study per investigator discretion Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires Subject currently participating in other investigational studies unless approved by the Sponsor in writing - HealthyVolunteers: No - Gender: Male - MinimumAge: 45 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Management of Healthy Newborn's Body Temperature at Birth
Status: Not yet recruiting

At birth, the newborn begins a process of adaptation to extrauterine life. One of the phases of this stabilization process is the maintenance of body temperature; indeed, the newborn passes from a warm environment (mother's womb) of around 37°C to an environment with a temperature lower (delivery room) and, therefore, must implement a series of physiological processes to be able to maintain body temperature constant and within ideal ranges through a balance between production and heat loss.

Hypothermia at birth could cause risks or comorbidities such as an increased risk of infant mortality, hypoglycemia, sepsis, metabolic acidosis, respiratory distress syndrome (RDS) and intraventricular hemorrhage (IVH).

One of the factors that affects heat loss in the delivery room is the relationship between surface area, volume and body mass of the newborn. The decrease in body temperature is directly related to gestational age and weight at birth; indeed, this problem is much more present in premature and/or low weight newborns at birth. Even if a full-term newborn has a more developed thermoregulation center than a preterm newborn, this does not mean that this type of newborns is not at risk heat dispersion.

To date, the strategies that are implemented for the physiological newborn are documented in the literature are, in addition to the heat chain described by the World Health Organization (WHO), the implementation of skin-to-skin contact (skin to skin) mother-newborn.

Some studies demonstrating the beneficial effect of this procedure on maintenance of the newborn's body temperature.

The aim of this study is to evaluate two healthcare interventions to prevent heat loss of healthy newborns at birth.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  For mother  Mothers' age over 18 years and good comprehension of Italian language; Signed informed consent of the mother.  For newborn  Informed consent signed by both parents, or in the case of a single-parent family, by mother Gestational age at birth greater than or equal to 37+0 weeks Newborns from singleton pregnancies; Both male and female newborns; Newborns who will be born from vaginal birth.  Exclusion Criteria:  For mother  Mothers who do not want to carry out skin-to-skin contact; Mothers who do not understand/speak the Italian language; Mothers who need assistance procedures that hinder skin-to-skin contact.  For newborn  Newborns whose parents decline participation in the study; Newborns with major congenital anomalies (heart, brain, metabolic, gastrointestinal); Newborns born via cesarean section; Newborns whose parents are under 18 years old, in the case of a single parent the mother who is under 18 years; Newborns requiring neonatal resuscitation after birth with obstruction of the skin-to-skin contact. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and Inflammation Parameters.
Status: Not yet recruiting

The study in question is an interventional study with nutritional intervention.

The aim of the study is to evaluate whether the adoption of two different models of Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise, in patients with obesity and NAFLD can exercise, after only 3 months, effects on:

specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;
circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;
intestinal barrier;
body composition;
intestinal microbiota;
symptoms of IBS (irritable bowel syndrome) in patients with NAFLD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  BMI ≥ 30 Kg/m2 or an abdominal circumference (waist) > 94 cm in men and > 80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the characteristics that characterize metabolic syndrome Age range between 18 and 60 years, both sexes Diagnosis of hepatic steatosis, formulated on the basis of recognized criteria (fibroscan [CAP (controlled attenuation parameter) > 238 dB/m], FLI).  Exclusion Criteria:  Normal weight and underweight subjects Presence of any pathology that could influence the presence of steatosis apart from the pathologies that represent inclusion criteria Treatment with any device, pharmacological or otherwise, which can influence hepatic metabolism and, therefore, the presence of steatosis Pregnancy or breastfeeding Subjects with osteo-articular pathologies that may prevent regular physical exercise - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Improved Access to Quality Care and Healthcare Use
Status: Recruiting

This study is an individual-level randomised controlled trial which looks at the effect of providing free access to higher quality providers in urban South Africa. The study will recruit about 1,500 individuals with a child aged 5 or under. They will be randomly allocate to a control group (CONTROL) with the default free access to government facilities or one of the two treatment groups where they will have free access to private providers located either relatively close (CONVENIENT) by or relatively far (INCONVENIENT). The primary outcomes be overuse and underuse of healthcare services for children under 5

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  parent has a child aged under 6 years old and over 2 months old  Exclusion Criteria:  is planning to move out of the area in the next 3 months has private medical aid - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 2 Months - MaximumAge: 6 Years - StdAgeList: Child
YASU Research Registry: For Young Adults With Cancer
Status: Not yet recruiting

The goal of this observational research registry is to learn about health, wellbeing, and needs of survivors of young adult cancer (diagnosed between the ages of 18 and 39). The main question[s] it aims to understand are:

What are the levels of depression, anxiety, social support, and financial distress
Determine effectiveness of YASU programming by measuring changes over time

With this registry, the investigators also plan to identify survivors who may be eligible for participation in future research studies pertaining to young adult cancer.

Participants will be asked to complete electronic surveys every 6 to 12 months during participation in the registry.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Cancer diagnosis received between the ages of 18 and 39. Able to speak and read English  Exclusion Criteria:  Inability to provide consent (such as neurological illness or mental incapacity) Has not registered as a member of YASU - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Any young adult diagnosed with cancer between the ages of 18 and 39 willing to register on the YASU website and consents to participation in the research registry. - SamplingMethod: Non-Probability Sample
Promoting Caregiver Implementation of an Effective Early Learning Intervention
Status: Not yet recruiting

The goal of this study is to examine the impact of a caregiver-implemented shared reading program, Sit Together and Read (STAR), on children ages 4 to 5 with developmental language disorder. The main questions it aims to answer are:

how much STAR impacts children's literacy skills in the short-term and long-term--up to two-years after completing STAR.
how do caregiver supports in the form of small monetary rewards or encouraging texts help caregivers to implement STAR at its intended frequency of sessions per week.

Caregiver participants will be assigned to either a control group or one of three STAR groups. Children's skills related to literacy and learning will be assessed before the intervention starts, at the end of the intervention, and every six months post-intervention for two years.

Researchers will determine the short term and long term impacts of STAR compared to the control group. Researchers will compare the three STAR conditions to see if the rewards or encouragement helped parents to follow through with completing more STAR sessions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  receiving or on waitlist for speech services primary complaint of impaired language skills receptive, expressive, or mixed language disorder primarily communicates in English  Exclusion Criteria:  1. No known additional diagnoses causal of developmental language disorder including  autism spectrum disorder hearing loss severe intellectual disability - HealthyVolunteers: No - Gender: All - MinimumAge: 48 Months - MaximumAge: 66 Months - StdAgeList: Child
The Effect of Nutrition Education Interventions for Adolescents
Status: Recruiting

The aim of this study is to determine the effect of nutrition education on nutritional literacy, nutritional status, eating habits and eating behavior in high school students. The research will be conducted in six high schools, three of which are intervention schools and three of which are control schools It is planned that a total of 1000 students will be included in the study from the intervention school and 1000 students from the control school. At the beginning of the study (June 2022), an introductory form (sociodemographic characteristics, body image (Stunkart scale), dietary habits, knowledge about weight status) was applied to all students. Adolescent Nutrition Literacy Scale (ANLS), Instrument of Nutrition Literacy, Mediterranean Diet Quality Index (KID-MED), Eating Attitudes Test 26 (EAT-26), International Physical Activity Questionnaire Short Form (IPAQ) were applied, anthropometric measurements and three-day food consumption records were taken. During the study, nutrition initiatives consisting of 8 modules will be made to the intervention schools. Control schools will not be interfered with during this period.At the end of the study, the procedures applied at the beginning will be repeated.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  studying in the 9th and 10th grades in the selected schools agree to participate in the research  Exclusion Criteria:  Type 1 diabetes Metabolic disorders (Phenylketonuria, Maple Syrup Urine Disease, Galactosaemia ect.) Pediatric Malabsorption (Celiac, cystic fibrosis, congenital sucrase isomaltase deficiency ect.) require a special diet - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MaximumAge: 18 Years - StdAgeList: Child, Adult
Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: a Possible Solution for Alveolar Ridge Preservation?
Status: Recruiting

The purpose of the study is to compare a new grafting material for alveolar ridge preservation to a commonly used and well studied material. Alveolar ridge dimensions as well as histology will be compared.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients in good health Require the extraction of at least one premolar with future implant placement Sufficient keratinized gingiva (equal or more than 2mm prior to extraction), No more than 3mm of buccal bone loss Flapless extraction possible Full mouth plaque index of less than 25% The tooth to be extracted must be bordered by two teeth  Exclusion Criteria:  Nicotine consumption equivalent to or more than 10 cigarettes per day Electronic cigarette usage A history of irradiation of head and neck area Immunodeficiency disease Uncontrolled systemic health problems (hypertension crisis 180/120, hyperthyroidism, diabetes with HbA1c over 7, recent history of stroke, cancer) History of medications that affect bone remodeling process (bisphosphonates, RANK-L inhibitors) Previous adverse reaction to the biomaterials used Pregnancy/lactation, or those who are trying to become pregnant. Active uncontrolled or untreated periodontal disease Periapical lesions greater than 1 cm and soft tissue pathology - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
HIP-STITCH (Wound Recovery After THA)
Status: Not yet recruiting

This prospective randomised trial will investigate the effect of four different suturing techniques (Monocryl, Vicryl Rapide with Indermil skin glue, Dermabond Prineo, and Stryker Zip) on the amount of aberrant wound recovery within 14 days after total hip arthroplasty at the RHOC in Zoetermeer, The Netherlands.

This will be done by assessing photographs of the plaster and photographs of the operation wound with a self-developed classification model. The photographs of the plaster will be taken by the test subject at home at 3 days and 11 days postoperatively.

The photographs of the operation wound will be taken by a member of the research team, and the doctor's assistant, respectively, during a visit to the outpatient clinic at 7 days and 14 days postoperatively.

Hypothesis: Monocryl sutures give the highest amount of aberrant wound recovery within fourteen days after primary THA.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Eighteen years or older. Scheduled to undergo Total Hip Arthroplasty via the anterior approach for any indication at the RHOC. No prior operations to the hip which is to be operated on. A good command of the Dutch language Able to give written informed consent.  Exclusion Criteria:  Usage of cytostatics in the period ranging from fourteen days prior, to ninety days after the operation. Unable to, or difficulty with communicating in the Dutch language (e.g. due to mental disability, inability to understand/speak/write Dutch, et cetera). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Optimal Medical Treatment of Difficult-to-treat Hypertension
Status: Recruiting

The purpose of this study is to evaluate best medical management to achieve the BP goals of ESC/ESH (120-129 / 70-79 mmHg) in HT patients who are <65 years old and ineffectively treated (BP ≥ 130/80 mg) with 3 or more antihypertensive drugs

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  documented history of HT HT treated for at least six months, office BP ≥ 130 and / or ≥80 mm Hg (average seated BP at Visit 1) use of 3 or more antihypertensive drugs, including an ACEi/ARB and a thiazide/thiazide-like diuretic or loop diuretic (single drugs or double SPCs) stable antihypertensive treatment regimen - no changes in antihypertensive treatment strategy at least for 4 weeks able and willing to comply with all study procedures and able to attend one of the study centers  Exclusion Criteria:  inability to give informed consent SBP ≥180 mm Hg and/or DBP ≥110 mm Hg and/or DBP <60 mm Hg BMI ≥40 kg/m2 eGFR of <45 mL/min/1.73 m2 potassium serum concentration > 4.8 mmol/L or < 3.5 mmol/L persistent hyponatremia or history of hyponatremia related to TD/TLD treatment (sodium concentration <135 mmol/L) secondary hypertension (not including sleep apnea) chronic oral glucocorticoid therapy myocardial infarction or cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) in the year prior to study inclusion heart failure requiring treatment with diuretic or aldosterone antagonists cardiomyopathy exluding LVH related to HT severe valvular disease ascending aortic aneurysm ≥5 cm prescribed to any standard antihypertensive of cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. chronic coronary syndromes, arytmia) such that discontinuation might pose serious risk to health primary pulmonary hypertension decompensated hyperthyroidism or hypothyroidism severe liver dysfunction (alanine aminotransferase and/or asparagine aminotransferase activity ≥3 times the upper limit of normal value), documented contraindication or allergy to studied drugs limited life expectancy of < 1 year at the discretion of the Investigator any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements all women of child bearing potential; women of child bearing potential can be included in the study ONLY after providing documentation of effective contraception (intrauterine device); concurrent enrollment in any other investigational drug or device trial anticipated change of medical status during the trial (e.g., surgical intervention requiring >2 weeks convalescence) current therapy for cancer - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
POP-UP: a Single-arm, Two-cohort Study: Trimodal Prehab for Upper GI and Pancreatic Cancer
Status: Not yet recruiting

This is a multicenter, two-cohort, open-label, single-arm feasibility study. The primary objective is to assess the feasibility of the 8-week trimodal prehabilitation program alongside perioperative triplet chemotherapy in eligible patients with localized pancreatic ductal adenocarcinoma (PDAC) or oesogastric cancer (OGC) .

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed and dated patient informed consent form (ICF) and willingness to comply with all study procedures and availability for the study duration, Histologically or cytologically localized PDAC or OGC validated by the multidisciplinary team, Indication to a preoperative treatment withtriplet chemotherapy for ≥ 4 cycles (8 weeks), Note: Patient treated for PDAC, first cycle without oxaliplatin is authorized. Age > 18 years; If aged ≥ 75 years: G8 score must be ≥ 14 and if < 14 validation of oncogeriatric specialist, Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 at inclusion visit (first prehabilitation hospital-day), No prior treatment for PDAC or OGC before screening visit, At least one measurable or evaluable lesion as assessed by Computerized Tomography scan or Magnetic resonance imaging according to RECIST 1.1 and feasibility of repeated radiological assessments on baseline imaging before starting chemotherapy, Adequate hematologic and end-organ function allowing the triple combination chemotherapy protocol, Registration in a national health care system (PUMa - Protection Universelle Maladie included).  Exclusion Criteria:  Evidence of metastatic disease at imaging (validated in multidisciplinary team evaluation), Histology of other than adenocarcinoma, Any medical (including cardiovascular, respiratory, psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice, Patients with medical contraindication to surgery due to general condition or comorbidities Pregnancy or breast-feeding, Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his/her consent, - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult