rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Lymphovenous Anastomosis for Breast Cancer Lymphedema
Status: Recruiting

This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment.

Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires.

Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months.

The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated.

The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >18 Female Unilateral arm lymphedema secondary to breast-cancer treatment Active pitting lymphedema Presence of dermal backflow in indocyanine green lymphography Identifiable lymphatic vessel(s) in the affected arm using an infrared camera and indocyanin green Able to provide informed consent Able to read, understand and complete Danish questionnaires  Exclusion Criteria:  Allergy to iodine Pregnant, breast-feeding, or aiming to conceive withing the next year History of bilateral breast cancer - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Study of Sepiapterin in Participants With Phenylketonuria (PKU)
Status: Not yet recruiting

The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood.

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Women of childbearing potential must have a negative pregnancy test at screening and agree to abstinence or the use of at least one highly effective form of contraception for the duration of the study, and for up to 90 days after the last dose of the study drug. Established diagnosis of PKU with hyperphenylalaninemia (HPA) evidenced by at least 1 blood Phe measurement >600 μmol/L as documented in the medical history. For participants ≥1 month of age, a minimum of 1 documented blood Phe measurement <480 μmol/L within 1 month prior to Screening. For participants ≥1 month of age, 2 screening blood Phe concentration values must be in the range ≥120 to ≤480 μmol/L. Willing to continue prescribed diet during Screening and Part 1. For participants ≥30 months to <12 years of age, baseline FSIQ score ≥80.  Key Exclusion Criteria:  History of allergies or adverse reactions to synthetic tetrahydrobiopterin (BH4) or sepiapterin. Serious neuropsychiatric illness (for example, major depression) not currently under medical control or other concurrent disease or condition that, in the opinion of the investigator or sponsor, would interfere with the participant's ability to participate in the study or increase the risk of participation for that participant. Treatment with BH4 supplementation (sapropterin dihydrochloride, KUVAN) within 3 months prior to Screening. Current participation in another investigational drug study or use of any investigational agent within 30 days prior to Screening. Confirmed diagnosis of a primary BH4 deficiency as evidenced by biallelic pathogenic mutations in 6-pyruvoyltetrahydropterin synthase, recessive Guanosine-5'-triphosphate (GTP) cyclohydrolase I, sepiapterin reductase, quinoid dihydropteridine reductase, or pterin 4-alphacarbinolamine dehydratase genes. Any clinically significant laboratory abnormality as determined by the investigator. Any past medical history of an abnormal physical examination and/or laboratory findings indicative of signs or symptoms of renal disease, including calculated (Bedside Schwartz Equation) glomerular filtration rate (GFR) <60 milliliters (mL)/minute (min)/1.73 square meter (m^2). Major surgery within the prior 90 days of Screening.  Note: Other protocol-defined inclusion and exclusion criteria may apply. - HealthyVolunteers: No - Gender: All - MaximumAge: 12 Years - StdAgeList: Child
Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection
Status: Recruiting

Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients older than 18 years of age diagnosed with benign or malignant colorectal diseases undergoing elective open or video-assisted colectomy or proctectomy (resection) at the Hospital de Clinicas de Porto Alegre - Division of Coloproctology.  Exclusion Criteria:  age under 18; surgery classified as dirty; urgent/emergency surgery; patients undergoing multi-visceral resections (pelvic exenteration or partial resection of any adjacent organ); known allergy to iodine. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Tackling Anxiety-related Freezing of Gait in People With Parkinson's Disease
Status: Not yet recruiting

The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinson's Disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men/women of age > 18 years with idiopathic Parkinson's disease, as diagnosed by the UK Brain Bank Criteria;  Presence of daily FOG (as objectified with the new-freezing of gait questionnaire), that is related to anxiety (positive answer to the question: Does FOG occur -or get worse when you are anxious or stressed?); Using a stable dose of PD medication and stability of DBS settings (if applicable) during the trial. Adjustments of PD medication and DBS settings during the trial are allowed if deemed clinically necessary. Written informed consent.  Exclusion Criteria:  Any comorbidity (i.e. neurological, orthopedic) that significantly impacts gait.  Severe cognitive impairment hampering the ability to comply to the study protocol. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Evaluating the Effect of Injectable Platelet-rich Fibrin on Accelerating Orthodontic Tooth Movement
Status: Recruiting

One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement. The previous studies evaluating platelet-rich fibrin (PRF) and orthodontic tooth movement (OTM) are limited, which makes the results difficult to generalize.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The patient's age (18-26). Severe or very severe irregularity of the upper incisors greater than (7 mm) according to Little's index, so it is recommended to extract the upper first premolar.  Class I or Class II malocclusion, first model according to Angle, with skeletal class I or II and a normal or mild vertical growth pattern. All permanent upper teeth, up to the first molar, are present, with the possibility of attaching brackets to all teeth in a correct position. The patient has good oral health.  Exclusion Criteria:  • The presence of any systemic disease that affects orthodontic dental movement.  Severe malalignment of one of the teeth (palatal quadrant, ectopic canine, ectopic premolar). The patient has undergone previous orthodontic treatment. The patient is subject to any drug treatment that may affect orthodontic dental movement (cortisone, non-steroidal anti-inflammatory drugs). The patient has poor oral health. Commitment to periodic follow-up appointments. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 26 Years - StdAgeList: Adult
CFTR Modulators in Pregnancy and Postpartum
Status: Recruiting

Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman  Exclusion Criteria:  none - HealthyVolunteers: No - Gender: All - MaximumAge: 50 Years - StdAgeList: Child, Adult - StudyPopulation: Woman with cystic fibrosis who is pregnant and treated with Kaftrio and her newborn infant - SamplingMethod: Probability Sample
Effects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and Obesity
Status: Not yet recruiting

Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and improvements in some cardiometabolic risk factors have been reported in studies in animals and humans. However, the impacts of TRE combined with aerobic exercise training in individuals with overweight and obesity have been insufficiently investigated.

Additionally, aerobic training performed in a fasted state appears to promote physiological adaptations that may improve the metabolic health in individuals with overweight and obesity.

The present study investigates the effects of 8 weeks of TRE associated with aerobic training in a fasted state versus a fed state on body composition and cardiometabolic parameters in women with overweight and grade 1 obesity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Female; Body mass index (BMI) between 25 and 34.9 kg/m²; Age between 20 and 40 years; Not engaged in any structured exercise program; Weight stable for ~3 months before the beginning of the study; Able to give written informed consent.  Exclusion Criteria:  Current smoker; Habitual drinkers (>1 serving/day) of alcoholic beverages; Cardiometabolic diseases (dyslipidemia, diabetes, hypertension, etc); Current treatment with medication or supplements which significantly affect the main studied variables; Bariatric surgery; Night-shift workers; Strict vegetarian/vegan; Pregnancy, planned pregnancy (within the study period), lactating; Postmenopausal women; Self-reported menstrual cycle irregularities; Habitual fasting window >16 hours; Concomitant participation in other studies. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 20 Years - MaximumAge: 40 Years - StdAgeList: Adult
ESPB vs iPACK+ACB in Total Knee Arthroplasty
Status: Not yet recruiting

Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for knee arthroplasty under spinal anaesthesia.  Exclusion Criteria:  patients who have a history of bleeding diathesis, take anticoagulant therapy, have a History of chronic pain before surgery, have Multiple trauma, cannot assess their pain (dementia), have been operated on under general anaesthesia, have an infection in the area and do not accept the procedure - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult
A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity
Status: Recruiting

Research demonstrated that surgical patients benefit from physical activity, but there is a gap in knowledge regarding the required intensity. In the PHOENIX-Liver study the researchers aim to investigate the optimal rehabilitation intensity after liver transplantation.

Patients will be randomized in one of the three PHOENIX-Liver training groups which all three rehabilitate at a different intensity (low, moderate, moderate to high). The six months rehabilitation training is conducted from the patient's home but supervised by a PHOENIX-investigator via electronical synchronization of extensive trainingsdata.

At baseline, after three months of training and after six months of training, a test moment takes place at which physical fitness, cardiovascular health, liver function, and body composition will be assessed. In the interim, questionnaires are taken monthly to survey well-being, safety, quality of life, physical activity, and cost-effectiveness.

To gather information on the potential for implementation in a real-world setting, a 15-month-long physical activity phase will start after the intervention phase. This entails a maintenance physical activity program tailored to the patients' preferences. A follow-up at Gasthuisberg is planned at three and at 15 months where the same clinical evaluations will be conducted as during the test moments of the intervention phase.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  de novo adult liver transplant recipients with a transplant vintage of two to three months access to a home freezer (± -18°C)  Exclusion Criteria:  Aberrant CPET (abnormal low cardiorespiratory fitness is not considered an exclusion criteria), unstable angina, life-threatening arrhythmias, uncontrolled hypertension/diabetes, HbA1c ≥ 9%, severe pulmonary disease (FEV1 < 50%), musculoskeletal disorders not allowing physical training on a cycle ergometer, or any other medical reasons by the physician considered to be a contraindication for moderate or high-intensity physical exercise multi-organ transplantation (exception: combined liver-kidney transplant is considered eligible for participation) ongoing treatment for malignancies unable to understand Dutch no access to smartphone and/or computer with internet access does not willing to except the general conditions of Coachbox. Preparticipation medical screening (cardiopulmonary exercise testing with 12-lead ECG + stratification of cardiovascular risk factors) will be performed by a cardiologist (Dr. Kaatje Goetschalckx at UZ Leuven). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study)
Status: Not yet recruiting

This is a multicenter international observational prospective cohort study. The main questions it aims to answer are:

PRIMARY AIM: To describe the capability of IRVF demodulation at diagnosis of ARDS to predict development of AKI within 7 days from the ARDS onset
SECONDARY AIMS: A)Describe the capability of IRVF demodulation or pattern of IRVF (continuous, pulsatility, biphasic, monophasic) to predict development of AKI within 14 days from the ARDS onset. B) To describe the RD parameters and VexUS in the AKI and no AKI patients over time. C) Describe the impact of invasive mechanical ventilation (IMV) on the intrarenal venous congestion and VexUS., D) Evaluation of effect of CRRT on IRVF pattern, VexUS and parameters. E) Describe the feasibility of renal doppler to assess IRVF in critically ill respiratory patients. F) Evaluate the incidence of AKD and CKD Participants will Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age > 18 years Critically ill patients admitted to intensive care unit with a diagnosis of ARDS according to Berlino criteria Beginning of IMV less than 48 hours or Clinical decision to begin IMV. Life expectancy > 24 hours Informed consent signed  Exclusion Criteria:  No patient will be excluded from the study because of gender, race, ethnicity, or sexual preference.  AKI prior to the onset of ARDS Chronic respiratory failure due to chronic respiratory diseases Chronic renal disease (CKD stage ≥ 2) and any ureteral obstruction. Definition of CKD patient is according to the latest guideline KDIGO Chronic Heart Failure Chronic liver disease Major trauma in the past 3 months Major surgery in the past 3 months Smoking and Alcohol drinking BMI ≥ 35 Patients needing of VV-ECMO and VA-ECMO Beginning of positive pressure ventilation more than 48 hours (invasive or no invasive) Life expectancy <24 hours Cardio Circulatory Arrest Neoplasm in chemotherapy/radiotherapy Do Not Resuscitate or Comfort Measures Pregnancy at ICU admission Refused Informed Consent by the patient or surrogate decision-maker - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation (IMV). - SamplingMethod: Probability Sample
Effects of HICT and Intermittent Fasting on PCOS
Status: Not yet recruiting

The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.

Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Unmarried females  Diagnosed with PCOS Phenotype A based on Rotterdam Criteria:  PCOM on US Ovulatory dysfunction Clinical Hyperandrogenism (Hirsutism modified Ferriman Gallway score ≥ 8) Not engaged in any regular lifestyle intervention for &lt;3 Months prior to inclusion  Exclusion Criteria:  Use of Estrogen, Progestin or combination. Taking medications or supplements for Insulin resistance &lt; 3 months prior to the inclusion Type I or II DM Hypo/hyperthyroidism BMI ≥27 (Obese according to BMI Asia) - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult
A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers
Status: Not yet recruiting

This study will determine how nanatinostat is absorbed, modified, and removed from the body (Part A), the amount of nanatinostat that becomes available to the body (Part B), and will evaluate the safety and tolerability of nanatinostat (Part C) in patients with advanced cancers.

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Have histologically confirmed advanced stage cancers (excluding gastrointestinal tumors), have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment, and have no available treatment with curative intent. Eastern Cooperative Oncology Group Performance Status of ≤2 at Screening. Body mass index ≥18.5 but ≤30.0 kg/m2 at Screening. Adequate bone marrow, liver, and kidney function.  Key Exclusion Criteria:  Presence of active central nervous system and/or leptomeningeal disease. Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy, or use of other investigational agents within 4 weeks before study entry. Inability to take or tolerate oral medication. Any gastrointestinal, liver, or kidney condition that may affect drug absorption and metabolism. Active infection requiring systemic therapy. Has received radiolabeled material <12 months (excluding that required for imaging) prior to study entry. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial
Status: Not yet recruiting

The goal of this cluster randomized trial is to evaluate the effectiveness of the RISIMA model based on an integrated county healthcare consortium implemented by multi-level family health teams (FHTs)on patients with diabetes and/or hypertension, including CVD risk assessment, treatment, and management.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged between 40 and 70 years old; Patients with hypertension or diabetes; Permanent residents of the county where the research is conducted; Already signed up with the family doctor team in the township where the research is located.  Exclusion Criteria:  Unable to independently carry out the interventions required for the study; Residing far from the village or township health center where the research is located, making it difficult to cooperate with visits; Patients who refuse to participate; Patients with comorbidities such as cancer that may interfere with the study visits or intervention effects; Pregnant or lactating women - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Upper Extremity Asymmetries in Overhead Athletes
Status: Recruiting

Although overhead sports have different characteristics, the movements in the shoulder and upper extremity are similar. These sports may involve a combination of symmetrical, asymmetrical, bilateral and unilateral movements. In sports involving asymmetric movements, biomechanical changes are observed in that area due to the use of the dominant extremity. One of the reliable methods to reveal the stress effects caused by biomechanical stresses is to determine limb asymmetries. Considering the literature, limb asymmetries may be related to injury and performance.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  15 years and older Attending regular sports training and competitions  Exclusion Criteria:  Acute injury during tests - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 15 Years - StdAgeList: Child, Adult, Older Adult
Telerehabilitation Exercise in Older Adults
Status: Recruiting

The aim of this study was to investigate the effectiveness of chair-based exercises and cognitive exercises through synchronous telerehabilitation in older adults.

Older adults will be divided into two groups (intervention group n=16; control group n=16) .

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Getting a score of 6 or above on the Hodkinson Mental Test  Exclusion Criteria:  -Having another chronic disease that can cause pain Having a neurological disease Being blind Having an orthopedic, neurological or mental disability - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult