rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis
Status: Recruiting

The combination of dietary protein ingestion and resistance exercise are essential to increase muscle protein synthesis. The vast majority of studies assessing protein intake following resistance exercise in young adults has been conducted exclusively in men or in studies where both men and women are assessed. The increase in muscle mass is thought to be impacted by sex hormones that fluctuate across different phases of the menstrual cycle. However, the effect of menstrual cycle phase on muscle protein synthesis following exercise is not known.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Female, aged 18-40 years BMI between 18 and 30 kg/m2 Recreationally active Regular menstrual cycle  Exclusion Criteria:  Smoking or use of tobacco containing products Irregular menstrual cycle Currently on any form of hormonal contraception Post-menopausal Pregnant or breastfeeding Diagnosed metabolic/pulmonary/musculoskeletal illness Diagnosed cardiovascular disease or hypertension Use of medications that may impact protein metabolism or are anti-inflammatory Gastrointestinal disorders Allergy to pomegranate or amino acids Injuries that would impact ability to complete study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Evaluation of Bone Density Before and After Placement of Implant Using Osseodensification Technique
Status: Not yet recruiting

The study investigates the impact of osseodensification drills on bone density changes surrounding dental implants. Osseodensification, a novel technique, is hypothesized to enhance primary stability of implants by densifying bone rather than removing it during osteotomy. Participants undergo pre-operative and post-operative DentaScan CT analyses to measure bone density in Hounsfield units at apical, mesial, and distal positions around the implant sites. This intervention-based research aims to quantify the benefits of osseodensification in improving bone quality and implant success. Data from 32 sites, analyzed via the Radiant DICOM software, undergo statistical examination using SPSS to ascertain significant differences in bone density pre- and post-surgery. The outcome could redefine surgical approaches in implantology, emphasizing osseodensification's role in achieving superior bone-implant integration.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with partial or complete edentulous ridge in the maxilla or mandible.  Exclusion Criteria:  Presence of a fractured jaw. General bone or blood disorders that may affect osseointegration - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 50 Years - StdAgeList: Adult
Detection of Endometrial Cancer Through Risk Modelling
Status: Not yet recruiting

The goal of this study is to combine information on risk factors from health questionnaires with minimally invasive biological tests (vaginal DNA and microbiome swabs, pH, hormones) to predict the risk of endometrial cancer (EC), better understand progression of the disease, and identify opportunities for intervention.

This study will recruit patients who are already scheduled to undergo diagnostic evaluation for abnormal uterine bleeding via endometrial biopsy. In Part A, consented participants will be asked to fill out an online risk factor questionnaire. Samples will be collected by the gynecologist at the biopsy appointment. After biopsy results are obtained, all samples from participants diagnosed with EC or precursors, plus a random subset with benign results, will be selected to be sequenced and analyzed.

In Part B, that subset of selected non-malignant participants, based on biopsy, will be invited to take part in lifestyle tracking using a Fitbit, questionnaires, and to provide another round of at-home vaginal samples to identify any persistent genetic mutations or microbiome alterations 6-8 months later.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Study Part A:  40 years and older Experiencing unexplained abnormal uterine bleeding (i.e., not from IUD, etc.) Have an intact uterus Referred for an endometrial biopsy  Study Part B:  Those selected for sequencing (from Part A) and who retained their uterus.  Exclusion Criteria:  Study Part A:  Endometrial sampling, pelvic radiation, or vaginal infection (vaginosis, yeast) in the past 3 months Started hormone therapy (HRT, birth control, IUD) in the past year (with the exception of tamoxifen) Intercourse, vaginal product use, or douching in the past 48 hours  Study Part B:  Same as Study Part A EC or EIN, or anyone who is recommended a hysterectomy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 40 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study investigators will have 10-15 study gynecologists across British Columbia, Canada, who will be recruiting study participants from patients who are referred to them for an endometrial biopsy due to abnormal uterine bleeding. The investigators aim to recruit ~1000 participants in Study Part A in order to achieve their target sample size of n=50 EIN/EC and n=150 EH.  Sequenced participants will be invited to participant in Study Part B and provide additional samples. - SamplingMethod: Non-Probability Sample
A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy
Status: Recruiting

The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is:

• What the body does to the study drug, which is called "pharmacokinetic"

Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected.

Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female aged 18 years or older Diagnosed as NSCLC stage II-IIIA (staging should be confirmed after surgery) Have completely removed all of the cancer from the body surgically Have been received 3 or 4 cycles of platinum-based chemotherapy after surgery  Exclusion Criteria:  Have received anti-cancer therapy before surgery Have or had autoimmune disease in past 5 years - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma
Status: Recruiting

This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The pathological diagnosis was newly diagnosed non-keratinizing squamous cell carcinoma nasopharyngeal carcinoma. The clinical stage is T1-4N0-3M0 (stage I~IVa, UICC/AJCC 8th edition); There is no history of hypothyroidism or hyperthyroidism before treatment; Using intensity-modulated radiotherapy technology, Complete radical dose radiotherapy; KPS≥70 points; Age 18-70 years old; Male or female who is not pregnant or lactating; Hematological examination: white blood cells > 4×109/L, neutrophils > 2×109/L, hemoglobin > 90g/L, platelets > 100×109/L; Liver function: ALT, AST < 1.5×ULN, ALP < 2.5×ULN, bilirubin < ULN. Renal function: creatinine > 60 ml/min; The patient signs the informed consent form;  Exclusion Criteria:  WHO pathological classification is keratinizing squamous cell carcinoma or basaloid carcinoma; palliative treatment; Have a history of other malignant tumors; Pregnant or lactating women (women of childbearing age should consider taking a pregnancy test, and patients are required to use effective contraception during treatment); Have a history of neck surgery; Have a history of hyperthyroidism or hypothyroidism. Previous history of head and neck radiation therapy; - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months
Status: Recruiting

OZURDEX endophthalmitis is a rare and potentially very serious pathology. Different treatments can be carried out early and change the functional prognosis of the patient.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient who had endophtalmitis following an OZURDEX implant injection within 2 months  Exclusion Criteria:  Intra oculaire procedure in the interval between the injection of OZURDEX and endophtalmitis - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis - SamplingMethod: Non-Probability Sample
Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease
Status: Recruiting

This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients with gastroesophageal reflux disease. the age will be ranged from 20 to 50 . body mass index from 20 to 34,9 kg/m2 . low level of physical therapy  Exclusion Criteria:  Pregnancy open wound abdominal or spinal surgery Congenital or acquired disorder - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - GenderBased: Yes - GenderDescription: Both gender patients - MinimumAge: 20 Years - MaximumAge: 50 Years - StdAgeList: Adult
Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study)
Status: Recruiting

This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  age>18yo Chronic Low Back Pain as seen on medical history as well as score of >3 on pain visual analog scale (VAS) at the start of experimental sessions. receiving prescription opioids for three or more months and planning to start tapering their opioids with their provider. willing to be randomized to one of the two behavioral treatment. Patients referred or self-referred to the study from an outside clinic will also be able to participate (we will be in contact with their prescribing provider) able and willing to perform/tolerate pain procedures (e.g., QST) able to communicate fluently in English able to use a smartphone or laptop for the virtual therapy program  Exclusion criteria:  Current illicit substance use (e.g marijuana use will be exempted) at screening or during trial as verified by urine toxicology screen and/or self-report for all participants; Medical condition known to influence QST or participation in the MORE intervention; serious psychiatric condition; regular meditation practice cognitive impairment pregnancy lack of English fluency severe OUD inability to provide informed consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
Status: Recruiting

The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are:

Are comprehensive monitoring and nutritional intervention among pregnant women can improve maternal outcomes (maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and delivery) compared to standard maternal health services?
Are comprehensive monitoring and nutritional intervention among pregnant women can improve neonatal outcomes (neonatal death, low birth weight, intrauterine growth restriction, and neonatal asphyxia) compared to standard maternal health services?

Participants in the intervention group will receive:

Fetomaternal ultrasound examination each trimester
Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination
Supplements: multivitamin, minerals, vitamin D, fatty acid
Intervention regarding any abnormal results of nutritional panel
All standard maternal health services according to Indonesian Ministry of Health protocol

Participants in the control group will receive:

- All standard maternal health services according to Indonesian Ministry of Health protocol

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pregnancy in 1st trimester Gestational age less than 10 weeks Living in Jakarta greater area Agree to participate  Exclusion Criteria:  Assisted reproductive technology (IVF) History of polycystic ovary syndrome History of chronic hypertension History of diabetes mellitus History of preeclampsia in the previous pregnancy Had chronic disease: heart disease, autoimmune disease, malignancy, chronic lung disease Planning to have delivery outside Jakarta greater area Poor obstetric history (miscarriage/ abortion more than 3 times) - HealthyVolunteers: No - Gender: Female - StdAgeList: Child, Adult, Older Adult
Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins
Status: Not yet recruiting

The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  all phototypes only one of the following pigmentary conditions on the face: epidermal or mixed, mild to moderate melasma; mild to moderate acne-induced PIHP; solar lentigo female patient of childbearing potential must use one of the reliable methods of contraception and agree not to change it during the study patient agreeing not to be exposed to ultraviolet radiation (UV), natural (sun) or artificial (tanning salon), during the study  Exclusion Criteria:  female patient who gave birth less than 3 months prior to Day 0, who is pregnant, breast-feeding or who plans to become pregnant during the study male patient with beard or facial hair, which would interfere with clinical evaluation or clinical procedure baseline) patient with any inflammatory dermatosis of the face such as seborrheic dermatitis, rosacea etc. severe melasma, dermal melasma patient with facial pigmentary disorders other than those described in inclusion criteria patient who has used topical depigmenting agents such as hydroquinone and derivatives, glycolic acid, kojic acid, retinoids and derivatives, azelaic acid, niacinamide within 1 month prior to Day 0/Baseline visit patient who has used systemic treatments such as tranexamic acid and oral melatonin within 1 month prior to Day 0/Baseline visit; patient who has used drugs inducing pigmentation such as tetracyclines, fluoroquinolones, antiepileptics within 1 month prior to Day 0/Baseline visit - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis: Prospective Observational Study
Status: Not yet recruiting

Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.

The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  FIbromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups) Patients who are not candidates for surgery or cryoablation  Exclusion Criteria:  Patients with life expectancy <3 months or severely impaired status functional status (ASA 4) Patients with fibromatosis not in active phase, documented clinically and by investigations imaging (MRI, CT) Patients with coagulation deficiency or plateletopenic disease Patients with documented active infection - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients affected by desmoid fibromatoses eligible to be treated with chemoembolization with Doxorubicin - SamplingMethod: Non-Probability Sample
Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants
Status: Recruiting

During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child&#39;s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.

In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant&#39;s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Infant less than 6 months of age still on milk diet (total)  Exclusion Criteria:  Infants with neurological or neurobehavioral disorders Families who wish to relocate within 7 days of inclusion Minor parents deprived of their parental rights, not understanding French, in a state of stress, overwhelmed or vulnerable. Non-affiliation to a social security system - HealthyVolunteers: No - Gender: All - MaximumAge: 6 Months - StdAgeList: Child
Oxytocin Rest to Reduce Cesarean Delivery
Status: Recruiting

Prolonged labor is usually managed with continuous oxytocin infusion. "Oxytocin rest" has been proposed as a strategy to resolve protracted labor in patients who have received continuous oxytocin without progress. This strategy involves discontinuing oxytocin then restarting infusion after a period of time, under the theory that washout of the oxytocin receptor will strengthen uterine contractions to improve labor progress. "Oxytocin rest" is performed on labor and delivery units across the United States. Yet, there is no randomized or prospective data to support the practice.

The purpose of this study is to assess whether oxytocin rest of 60 minutes in patients with prolonged labor reduces risk for cesarean delivery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ≥18 years of age Singleton gestation in vertex presentation ≥36 weeks gestation Prolonged latent labor, defined as cervical dilation <6cm after ≥8 hours since rupture of membranes and on continuous oxytocin  Exclusion Criteria:  Not meeting the above criteria Any contraindication to continuous oxytocin at time of randomization Cesarean section anticipated by the clinical team at time of randomization (for any reason excepting labor dystocia) >18 hours between rupture of membranes and randomization Known intraamniotic infection at randomization Fetal demise Any contraindication to vaginal delivery Maternal eclampsia - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Pre-therapeutic 68Ga-PSMA PET AI Based Dose Prediction for 177Lu-PSMA Targeted Radionuclide Therapy
Status: Not yet recruiting

Targeted Radionuclide Therapy (TRT) is a contemporary approach to radiation oncology, aiming to deliver the maximal destructive radiation dose via cancer-targeting radiopharmaceutical. Radioactive ligands for the prostate-specific membrane antigen (PSMA) have emerged for the treatment of metastatic castration-resistant prostate cancer (mCRPC).Normal organ and tumor dose can be assessed by a series of cross-sectional whole-body SPECT scans, however, these require a large amount imaging time and are often not feasible in routine clinical practice.

An alternative is to generate a 3D time integrated activity (TIA) map per patient based on the PBPK and the pre-therapy imaging

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who received at least one dose of 177Lu-PSMA and for whom a 68Ga-PSMA PET/CT was performed as part of IVRT in the "pre-treatment" assessment  Exclusion Criteria:  Patient opposition to the use of their data as part of this research. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who received at least one dose of 177Lu-PSMA and for whom a 68Ga-PSMA PET/CT was performed as part of IVRT in the "pre-treatment" assessment between 1 2022 and 31 January 2024 - SamplingMethod: Non-Probability Sample